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510(k) Data Aggregation
(470 days)
The BP-2BIO Digital Blood Pressure Monitor is a device intended to measure the systolic and diastolic blood pressure 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-2BIO Digital Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a noninvasive technique which an inflatable cuff is wrapped around the upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but uses an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well known technique in the market so called "oscillometric method".
The MicroLife Manual Blood Pressure Monitor, Model BP-2BIO, has shown to meet acceptance criteria through various tests, primarily guided by the ANSI/AAMI SP-10-1992 "National Standard for Electronic or Automated Sphygmomanometers".
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard | Device Performance |
|---|---|---|
| Electrical, Mechanical, and Environmental Performance | Requirements outlined in the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND. | Met all relevant requirements. Specific tests conducted include: |
- General Functions Test
- Reliability Test-Operation Conditions
- Reliability Test-Drop Testing
- Reliability Test-Storage
- Reliability Test-Vibration Testing
- EMC Test Report
- EN1060 Regulations and Test Report
- CE Certification |
| Blood Pressure Monitoring Accuracy | ANSI/AAMI SP-10-1992 "National Standard for Electronic or Automated Sphygmomanometers" | Met all relevant requirements. The device uses an oscillometric method similar to the predicate device (Omron HEM-405C) but with an improved software interface to the sensor. The software utilizes a split slope resolution (0-100mmHg, 100-200mmHg, 200-300mmHg) to reduce nonlinearity error from 1% to 0.33%, enhancing accuracy. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size for the clinical test set used for the ANSI/AAMI SP-10-1992 standard. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their qualifications. The ANSI/AAMI SP-10-1992 standard typically mandates specific protocols for clinical validation, often involving trained human observers using mercury sphygmomanometers as a reference, but these details are not present in this submission.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or reported in this submission. The evaluation focuses on the standalone performance of the device against a standard and its substantial equivalence to a predicate, not on human-AI collaboration.
6. Standalone Performance Study
Yes, a standalone study was performed. The "Discussion of Clinical Tests Performed" section explicitly states: "ANSI/AAMI SP-10-1992 'National Standard for Electronic or Automated Sphygmomanometers' testing was performed. All relevant sections were addressed and testing conducted. The BP-2BIO met all relevant requirements of this standard." This indicates an evaluation of the algorithm's performance in determining blood pressure and pulse rate without human-in-the-loop assistance during the measurement process itself.
7. The Type of Ground Truth Used
Based on the reference to ANSI/AAMI SP-10-1992, the ground truth for blood pressure measurements would typically be established by expert auscultation using a mercury sphygmomanometer, considered the gold standard for non-invasive blood pressure measurement at the time. This standard defines precise protocols for comparing automated device readings against human-observed readings by trained professionals.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This device appears to be a traditional medical device (hardware with embedded software for signal processing) rather than an AI/ML-driven device that requires a separate "training set" in the modern sense. The software's accuracy is improved by a "split slope resolution" that maps to the sensor's output, a calibration approach rather than a machine learning training process.
9. How the Ground Truth for the Training Set was Established
As no "training set" is explicitly mentioned in the context of machine learning, there is no information on how ground truth for such a set would have been established. The device relies on a "well known oscillometric method" and a software interface designed to optimize accuracy against the sensor's output through calibration, rather than learning from a diverse dataset.
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