(310 days)
BPM16B automatically measures human's Systolic, Diastolic blood pressure and heart rate by using the oscillometric method during inflation. All values can be read out in one LCD panel. Measurement position is at human being's wrist. The intended use of this over-the-counter device is for adults aged 18 years and older with wrist circumference ranging 125 ~ 210 mm (approx. 4.9 ~ 8.3 inch) and for home use
Blood Pressure Monitor is a device intended for use in automatically measures human's Systolic, Diastolic blood pressure and heart rate.
This document is a 510(k) Premarket Notification for a Wrist Type Blood Pressure Monitor (BPM16B). The core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices.
The information provided does not describe an AI/ML device, nor does it detail a study proving the device meets acceptance criteria related to AI/ML or human augmentation. Instead, it focuses on the performance testing required for a non-invasive blood pressure measurement system.
Therefore, many of the requested criteria regarding AI/ML studies, expert adjudication, MRMC studies, and ground truth establishment for training sets are not applicable to this document. The document primarily focuses on compliance with established medical device standards for blood pressure accuracy and safety.
Here's a breakdown of the relevant information from the document as it pertains to acceptance criteria and performance testing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to compliance with ISO 81060-2 and IEC 80601-2-30 for performance. While it states that the device "meets the performance specifications for its intended use" and "the required limits for mean difference and standard deviation are fulfilled," it does not provide a specific table with numerical acceptance criteria and reported device performance values for blood pressure accuracy.
However, in the comparison table (Table 1 predicate device) in Section 6, "Technological Characteristics and Substantial Equivalence Comparison with Predicate," it lists the following for "Accuracy":
| Acceptance Criteria (from predicate AVITA BPM16 / claimed) | Reported Device Performance (from subject device) |
|---|---|
| Pressure ± 3mmHg | Pressure ± 3mmHg |
| Pulse ± 4% | Pulse ± 4% |
Note: This table only shows that the claimed accuracy of the new device is the same as the predicate and the general industry standard for non-invasive blood pressure monitors. It does not present the specific results from the clinical validation study proving these accuracies beyond stating "the required limits for mean difference and standard deviation are fulfilled."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "clinical investigation" but does not specify the sample size used for the performance testing (test set).
- Data Provenance: Not explicitly stated, but the submission is from Taiwan (Avita Corporation, New Taipei City, Taiwan). The testing would presumably be conducted in Taiwan. The study is a prospective clinical validation study, as it's testing the performance of the device against clinical standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable in the context of expert review for AI/ML ground truth. For a blood pressure monitor, the "ground truth" for blood pressure measurements is established by a reference method, typically auscultation by trained medical professionals, not by expert review of images or data in the way one might establish ground truth for an AI diagnostic algorithm. The ISO 81060-2 standard outlines the methodology for clinical validation, which involves direct comparison to a reference method. The document does not specify the number or qualifications of the individuals performing the reference measurements.
4. Adjudication Method for the Test Set:
- Not Applicable for a blood pressure monitor in the context of expert adjudication. The "adjudication" for a blood pressure monitor pertains to how the reference measurements are taken and compared to the device measurements according to the ISO standard. This does not involve an adjudication panel for discordant readings in the way an AI diagnostic study might.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, this was not done. This type of study is relevant for diagnostic AI tools where human readers interpret medical images or data, and the AI assists or replaces them. This is a blood pressure monitor, not an AI diagnostic algorithm.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, in spirit. The performance testing (compliance to ISO 81060-2) is essentially a standalone performance assessment of the device's accuracy in measuring blood pressure compared to a reference method, without human intervention in the measurement process of the device itself. The device is "automated" and provides readings directly.
7. Type of Ground Truth Used:
- Comparator Measurement / Clinical Reference Standard: The ground truth for blood pressure accuracy is established by a reference method (e.g., auscultation with a sphygmomanometer by trained observers) as defined by the ISO 81060-2 clinical validation standard. It is not expert consensus, pathology, or outcomes data in the traditional sense of an AI/ML study for diagnosis.
8. Sample Size for the Training Set:
- Not Applicable. This is a medical device, not an AI/ML algorithm that requires a "training set." The device's measurement algorithm is based on oscillometric principles and is likely deterministic or uses fixed, non-AI algorithms, not machine learning that would require a distinct training set for model development.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See point 8.
§ 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).