(80 days)
The Microlife Wrist Watch Blood Pressure Monitor, Model BP3AX1 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 wrist.
The Microlife Wrist Watch Blood Pressure Monitor BP3AX1 is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique with an inflatable cuff wrapped around wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic semiconductor pressure sensor instead of a stethoscope and uses an electronic convention to define the systolic, diastolic and electrical signals, by analyzing those signals. The method for calculating pulse rate is a well known technique in the market and is the so called "oscillometric method".
The provided text describes the Microlife Blood Pressure Monitor Model BP3AX1 and its 510(k) submission. However, it does not contain a detailed table of acceptance criteria, reported device performance metrics, or a comprehensive study report with the specific information requested in your prompt (e.g., sample sizes for test/training sets, ground truth establishment details, MRMC study results, etc.).
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Microlife Wrist Watch Automatic Blood Pressure Monitor, Model BP-3BU1-5, K# 021305) and lists the non-clinical and clinical tests performed at a high level.
Here's what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from standard) | Reported Device Performance (from study) |
|---|---|
| Clinical Performance: Per ANSI/AAMI SP10-1992 "National Standard for Electronic or Automated Sphygmomanometers" | "All relevant sections were met" (for the clinical standard) |
| Non-Clinical Performance: | |
| - General Functions Test: (Met, implies compliance) | |
| - Reliability Test Operation Conditions: (Met, implies compliance) | |
| - Reliability Test Drop Testing: (Met, implies compliance) | |
| - Reliability Test Storage: (Met, implies compliance) | |
| - Reliability Test Vibrating Testing: (Met, implies compliance) | |
| - EMC Test: (Met, implies compliance) | |
| - IEC 60601-1 Safety Test: (Met, implies compliance) |
Missing Information: The document states that the device "met all relevant requirements" of AAMI SP10-1992. However, it does not provide the specific numerical acceptance criteria (e.g., mean difference, standard deviation limits) or the actual measured performance data (e.g., 2.3 mmHg ± 5.6 mmHg) from the clinical study. Similarly, for non-clinical tests, it only states "None of the testing demonstrated any design characteristics that violated the requirements" and "the relevant requirements...were met," without providing specific pass/fail criteria or quantitative results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions that ANSI/AAMI SP10-1992 testing was performed, but does not provide the number of subjects or measurements included in this clinical validation.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a clinical validation study for a blood pressure monitor, it would typically be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not specified. For a blood pressure monitor, "ground truth" during clinical validation is typically established by trained human observers using a mercury sphygmomanometer simultaneously or sequentially with the automated device on the same subject, following a standardized protocol like AAMI SP10. The document does not specify the number or qualifications of these human observers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified. The document does not describe any specific adjudication method for discrepancies during the clinical testing. For AAMI SP10, there are specific requirements for agreement between observers, but the details of implementation are not provided here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve "human readers" or "AI assistance" in the sense of image interpretation or complex clinical decision support. Therefore, an MRMC study and effect size for human readers improving with AI are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, effectively. The "standalone" performance here refers to the device's ability to accurately measure blood pressure on its own. The clinical testing against the ANSI/AAMI SP10-1992 standard is a standalone performance evaluation of the automated device against a reference standard (typically a trained human observer using a mercury sphygmomanometer). The results state that "All relevant sections were met," indicating its standalone performance was deemed acceptable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical study would have been established by trained human observers using a reference standard (e.g., auscultation with a mercury sphygmomanometer), as prescribed by the ANSI/AAMI SP10-1992 standard. This is the accepted method for validating automated blood pressure devices.
8. The sample size for the training set
Not applicable/Not specified. This is an oscillometric blood pressure monitor, not a machine learning or AI-based device that typically requires a distinct "training set" in the context of model development. The algorithm for oscillometric measurement is well-established, and its "training" would be more akin to calibration and design refinement rather than statistical model training. If any internal data was used for initial algorithm development or parameter tuning, it is not disclosed as a "training set" here.
9. How the ground truth for the training set was established
Not applicable/Not specified. As mentioned above, a "training set" in the context of machine learning is not directly applicable here. The fundamental principles of oscillometric measurement are physics-based, and calibration procedures would rely on traceable pressure standards, not "ground truth" derived from clinical data in the same way an AI model's training data would be established.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).