(168 days)
The device is noninvasive and provides systolic, diastolic blood pressure and pulse rate measurements by using an cuff which is wrapped around the arm. All values can be read out in one LCD panel. Measurement is for adult only.
AVITA BPM6 series Blood Pressure Meter(or Monitor) is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual).
The provided document is a 510(k) summary for the AVITA BPM6 series Blood Pressure Meter. It lacks detailed information on specific acceptance criteria and a dedicated study report proving those criteria were met, as would be expected for a comprehensive clinical study. However, some pieces of information can be inferred or extracted.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Repeatability (compared to auscultatory method) | "statistically and clinically acceptable" |
| Conformance to EN-1060-1 | Conforms |
| Conformance to EN-1060-3 | Conforms |
| Conformance to ANSI/AAMI SP-10 | Conforms |
| Conformance to IEC 60601-1 | Conforms |
| Conformance to IEC 60601-1-2 | Conforms |
Note: The document only provides a high-level statement about "statistically and clinically acceptable" repeatability without specific numerical thresholds or results. ANSI/AAMI SP-10 defines specific accuracy requirements for automated sphygmomanometers, which would constitute the numerical acceptance criteria for blood pressure accuracy. While the document states conformance, it does not explicitly list the detailed results demonstrating this conformance.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "comparison study with device that use auscultatory method" but does not provide any details regarding the sample size used for this clinical comparison or the provenance (country of origin, retrospective/prospective nature) of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states a comparison study was performed using the "auscultatory method." This method typically involves trained healthcare professionals (e.g., clinicians, nurses) using a stethoscope and sphygmomanometer to measure blood pressure. However, the document does not specify the number or qualifications of these experts who established the ground truth.
4. Adjudication Method for the Test Set
The document does not provide any information about an adjudication method. For a comparison study based on the auscultatory method, the ground truth is often established by a single trained observer. If multiple observers were used, a method like averaging or consensus might be employed, but this is not mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes a "comparison study" with the auscultatory method, which is a method for generating ground truth for device performance, not an MRMC study comparing human readers with and without AI assistance. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The "comparison study with device that use auscultatory method" evaluated the performance of the AVITA BPM6 series Blood Pressure Meter itself (the algorithm/device) against a accepted reference standard (auscultatory method). This constitutes a standalone performance evaluation of the device's accuracy in measuring blood pressure.
7. The Type of Ground Truth Used
The ground truth used was based on the auscultatory method, which is considered a clinical reference standard for blood pressure measurement. This method involves direct observation by a trained human using a stethoscope and sphygmomanometer.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. Given that this is a 510(k) for a blood pressure monitor, the focus is on demonstrating equivalence to an existing device and conformance to standards, rather than the development of a complex machine learning algorithm that would require a distinct training set. The device likely relies on a well-established oscillometric algorithm, not one trained on a large, novel dataset in the context of this submission.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the context of this 510(k) submission, there is no information provided on how ground truth for such a set would have been established. Any underlying algorithm development would have occurred prior to this submission and is not detailed here.
§ 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).