(52 days)
The Withings Blood Pressure Monitor, Upper Arm Type: HP-800 is noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to be 9'' 7' (22cm42cm) for Upper Arm type.
Withings Blood Pressure Monitor, Upper Arm Type:BP-800 uses the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
The provided document is a 510(k) summary for the Withings Blood Pressure Monitor, Upper Arm Type: BP-800. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study report with specific acceptance criteria and outcome measurements as might be found in a clinical trial publication.
Based on the information provided, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance
The document references "AAMI / ANSI SP10" as the performance standard. While it states "Withings believes this information and referred document to be sufficient...", it does not explicitly list the specific acceptance criteria defined by AAMI/ANSI SP10 or the device's reported performance against those criteria in a table format within this document.
AAMI/ANSI SP10 is a standard for automated sphygmomanometers, and it sets limits for accuracy (e.g., mean difference and standard deviation between the device and a reference method). However, these specific numerical criteria and the device's measured performance are not provided in this 510(k) summary. The summary only states "PERFORMANCE & CLINICAL TEST 3. AAMI / ANSI SP10" implying that the device was tested per this standard, but the results are not detailed.
Key Missing Information: Specific numerical acceptance criteria for blood pressure accuracy (e.g., mean difference and standard deviation as per AAMI/ANSI SP10) and the actual performance results of the BP-800 device against these criteria.
| Acceptance Criteria (AAMI/ANSI SP10 - Not explicitly stated in document) | Reported Device Performance (BP-800 - Not explicitly stated in document) |
|---|---|
| (e.g., Mean difference between device and reference ≤ ±5 mmHg) | (e.g., Mean difference = X mmHg) |
| (e.g., Standard deviation between device and reference ≤ 8 mmHg) | (e.g., Standard deviation = Y mmHg) |
2. Sample Size Used for the Test Set and Data Provenance
The document references "AAMI / ANSI SP10" for performance and clinical tests. This standard typically requires a specific number of subjects for clinical validation. However, the sample size used for the test set is not explicitly stated within this 510(k) summary.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide details on the number of experts used to establish the ground truth for the test set or their qualifications. For an AAMI/ANSI SP10 validation, typically multiple independent observers (often with specific training in auscultatory blood pressure measurement) are used to establish reference measurements.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the test set. In AAMI/ANSI SP10 validation, often a consensus of multiple observers or a specific protocol for resolving discrepancies between observers' measurements is employed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, is not applicable to this device. This is a standalone blood pressure monitor, not an AI-powered diagnostic imaging tool that assists human readers.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was done, implicitly, as the device is an automated blood pressure monitor. The "AAMI / ANSI SP10" standard is specifically for validating the accuracy of such automated devices against Riva-Rocci/Korotkoff auscultation (the traditional "human-in-the-loop" method with a stethoscope). The document states the device "uses the Oscillometric method... and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure." This describes its standalone algorithmic operation. The lack of specific results, however, prevents a quantitative answer here.
7. Type of Ground Truth Used
Based on the reference to "AAMI / ANSI SP10," the standard ground truth for automated blood pressure monitors is typically auscultatory blood pressure measurement performed by trained human observers using a stethoscope and sphygmomanometer, often referred to as the "reference method" or "gold standard" for non-invasive blood pressure.
8. Sample Size for the Training Set
The document describes the device as being "substantially equivalent" to predicate devices and mentions the use of the oscillometric method and microcomputer calculations. It does not mention or provide details about a "training set" in the context of machine learning or AI models. This device is a traditional electronic medical device, not one that relies on a machine learning model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" for a machine learning model, this question is not applicable in the context of this device's description. The device's operation is based on an established oscillometric algorithm rather than a data-trained AI model.
§ 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).