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510(k) Data Aggregation
(464 days)
The BP-2BHO Digital Blood Pressure Monitor is a device intended to measure the systolic, diastolic and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
The BP-2BHO Digital Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable curr is wrapper als manufactory of the upper arm. Our technique which an infiatable curr is wrapper als similar to the auscultatory method but uses an electronic capactive sensor rather than stethoscope and mercury manonical. - no onnalyzing those signals to define the cuff pressure to electrical signals, by andryzing the subscripmarket so called "oscillometric method".
The MicroLife Automatic Blood Pressure Monitor, Model BP-2BHO, was evaluated for both non-clinical and clinical performance to demonstrate its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Tests | ||
| General Functions | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| Reliability (Operation Conditions) | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| Reliability (Drop Testing) | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| Reliability (Storage) | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| Reliability (Vibration Testing) | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements |
| EMC | Meets requirements of "Reviewer Guidance for Premarket Notification Submissions", DCRND (Nov 1993) | Met all relevant requirements (EMC Test Report submitted) |
| EN1060 Regulations | Meets EN1060 Regulations | Met all relevant requirements (EN1060 Test Report and CE Certification submitted) |
| Clinical Tests | ||
| Blood Pressure Measurement Accuracy | Meets relevant sections of ANSI/AAMI SP-10-1992 "National Standard for Electronic or Automated Sphygmomanometers" | Met all relevant requirements of the standard |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set or training set.
The data provenance (e.g., country of origin, retrospective/prospective) for the clinical study is not specified in the provided text.
3. Number of Experts and Qualifications for Ground Truth Establishment
The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The clinical testing was performed according to ANSI/AAMI SP-10-1992, which typically involves comparison against reference measurements from trained observers.
4. Adjudication Method
The document does not describe the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study evaluating the improvement of human readers with AI vs. without AI assistance was reported. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done for the device. The clinical testing against ANSI/AAMI SP-10-1992 demonstrates the algorithm-only performance of the MicroLife Automatic Blood Pressure Monitor.
7. Type of Ground Truth Used
For the clinical study, the ground truth was established by comparison to the "National Standard for Electronic or Automated Sphygmomanometers" (ANSI/AAMI SP-10-1992). This standard outlines procedures for accuracy testing, typically involving simultaneous measurements by the device and a trained human observer using a reference method (e.g., auscultation with a mercury sphygmomanometer). Therefore, the ground truth would be best described as expert consensus/reference method (as defined by the standard).
8. Sample Size for the Training Set
The document does not specify the sample size for the training set.
9. How Ground Truth for the Training Set was Established
The document does not provide details on how the ground truth for the training set was established. The device utilizes an "oscillometric method" based on a software algorithm to determine blood pressure. This implies that the algorithm itself might have been developed using various data, but the specifics of that development and ground truth establishment for training are not described in this summary.
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