By berrymed | 29 November 2024 | 0 Comments
Focusing on the Leading Advantages of BERRY's SpO2 Technology
Accuracy of Berry Pulse Oximetry in Individuals with Both Light and Dark Skin Tones
Background
Post-pandemic analysis has revealed that non-invasive blood oxygen measurement methods, such as pulse oximetry, are notably influenced by variations in skin pigmentation. Multiple studies published in Nature have highlighted a significantly higher mortality rate among individuals with darker skin tones compared to those with lighter skin tones. BERRY's pulse oximeter products are currently used by over 10 million individuals globally. In a commitment to ensuring device accuracy across diverse populations, BERRY conducted a comprehensive clinical trial from August 27th to 29th, 2024, at the University of California laboratory. This trial followed the recommendations outlined in the FDA white paper and adhered to Monk's updated skin color classification system, recruiting volunteers across skin tone levels 1 to 10. Skin tones were categorized as light (levels 1-4), brown (levels 5-7), and dark (levels 8-10). The study sample comprised 25% individuals with light skin and 25% with dark skin, including a balanced representation of 14 males and 10 females.
Test Conclusions
The ARMS (Accuracy Root Mean Square) value is a statistical metric used to evaluate the variance between device readings and reference measurements. BERRY’s new clinical trial, conducted in accordance with the FDA's updated guidelines on skin pigmentation, successfully met the required standards. BERRY's SpO2 technology demonstrated industry-leading accuracy within the 70%-100% oxygen saturation range.
Test Subjects
A total of 24 volunteers participated in the study, consisting of 10 women and 14 men.
Inclusion criteria:
Male and female participants who passed a comprehensive medical health screening, including chest X-ray, ECG, routine blood tests, liver and kidney function tests, urinalysis, blood coagulation function tests, and HCG tests for female participants.
Healthy individuals capable of safely undergoing controlled hypoxemia to the levels defined in the desaturation profile.
Subjects with a positive Allen’s Test and classified as ASA Category 1.
Subjects meeting the demographic requirements for the study.
Exclusion criteria:
Smokers or individuals with elevated carboxyhemoglobin (COHb) levels above 3%, as tested by the Hypoxia Laboratory SZU.
Subjects with methemoglobin (MetHb) levels above 2%.
Individuals at medical risk due to the desaturation profile.
Subjects with significant arrhythmias.
Individuals under 18 or over 50 years of age.
Pregnant women.
BERRY's SpO2 technology demonstrates reliable performance even during user movement.
Background
Post-pandemic analysis has revealed that non-invasive blood oxygen measurement methods, such as pulse oximetry, are notably influenced by variations in skin pigmentation. Multiple studies published in Nature have highlighted a significantly higher mortality rate among individuals with darker skin tones compared to those with lighter skin tones. BERRY's pulse oximeter products are currently used by over 10 million individuals globally. In a commitment to ensuring device accuracy across diverse populations, BERRY conducted a comprehensive clinical trial from August 27th to 29th, 2024, at the University of California laboratory. This trial followed the recommendations outlined in the FDA white paper and adhered to Monk's updated skin color classification system, recruiting volunteers across skin tone levels 1 to 10. Skin tones were categorized as light (levels 1-4), brown (levels 5-7), and dark (levels 8-10). The study sample comprised 25% individuals with light skin and 25% with dark skin, including a balanced representation of 14 males and 10 females.
Test Conclusions
The ARMS (Accuracy Root Mean Square) value is a statistical metric used to evaluate the variance between device readings and reference measurements. BERRY’s new clinical trial, conducted in accordance with the FDA's updated guidelines on skin pigmentation, successfully met the required standards. BERRY's SpO2 technology demonstrated industry-leading accuracy within the 70%-100% oxygen saturation range.
Test Subjects
A total of 24 volunteers participated in the study, consisting of 10 women and 14 men.
Inclusion criteria:
Male and female participants who passed a comprehensive medical health screening, including chest X-ray, ECG, routine blood tests, liver and kidney function tests, urinalysis, blood coagulation function tests, and HCG tests for female participants.
Healthy individuals capable of safely undergoing controlled hypoxemia to the levels defined in the desaturation profile.
Subjects with a positive Allen’s Test and classified as ASA Category 1.
Subjects meeting the demographic requirements for the study.
Exclusion criteria:
Smokers or individuals with elevated carboxyhemoglobin (COHb) levels above 3%, as tested by the Hypoxia Laboratory SZU.
Subjects with methemoglobin (MetHb) levels above 2%.
Individuals at medical risk due to the desaturation profile.
Subjects with significant arrhythmias.
Individuals under 18 or over 50 years of age.
Pregnant women.
BERRY's SpO2 technology demonstrates reliable performance even during user movement.
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