(185 days)
The device is a noninvasive blood pressure measurement system 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 arm. The cuff circumference is limited to be 7"-15".
noninvasive blood pressure measurement system
This is a 510(k) premarket notification for a blood pressure monitor, not a study report for a medical device that uses AI or image analysis. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance in the context of AI or expert evaluation is not present in the provided text.
The document describes the FDA's clearance of the Mytech Happy Life Blood Pressure Monitor (Models HPL-300 and HPL-300A) as substantially equivalent to a legally marketed predicate device. The core of this clearance is based on the device meeting the requirements for a noninvasive blood pressure measurement system as defined in 21 CFR 870.1130.
Here's what can be extracted and inferred, with explanations for what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Regulation) | Reported Device Performance (Inferred from Clearance) |
|---|---|
| Compliance with 21 CFR 870.1130 (Noninvasive Blood Pressure Measurement System) | Device meets regulatory requirements for its classification. |
| Measurement of systolic and diastolic blood pressure, and pulse rate. | Device is intended for this purpose with an arm cuff. |
| Intended for adult individuals over age 18. | Stated indication for use. |
| Cuff circumference 7"-15". | Stated limitation for use. |
| Performance substantially equivalent to a legally marketed predicate device. | Found to be substantially equivalent by FDA. |
| Good manufacturing practices (21 CFR Part 820) | Assumed compliance for market clearance. |
| Labeling requirements (21 CFR Part 801) | Assumed compliance for market clearance. |
| Annual registration and listing (21 CFR Part 807) | Assumed compliance for market clearance. |
Explanation: The document does not provide specific numerical acceptance criteria (e.g., accuracy +/- X mmHg) or a detailed summary of device performance (e.g., mean difference, standard deviation compared to a reference method). These would typically be found in a detailed test report submitted as part of the 510(k) application, but are not included in the FDA's clearance letter itself. The "reported device performance" in this context is the FDA's determination of substantial equivalence based on the provided data in the 510(k) submission.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the provided text.
- Data provenance: Not specified in the provided text. It is common for these devices to undergo clinical validation studies (e.g., according to ISO 81060-2 or similar standards), which would involve prospective data collection from human subjects. However, the document does not detail this.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. This type of information is relevant for devices involving subjective interpretation, such as image analysis. For a blood pressure monitor, ground truth is typically established by using a highly accurate reference method (e.g., invasive arterial blood pressure measurement or auscultation by trained observers using a mercury sphygmomanometer) performed by trained technicians or medical professionals, not necessarily "experts" in the context of interpretation. The document does not detail the specific methodology for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used when there's subjective interpretation by multiple readers (e.g., radiologists) and a disagreement resolution process is needed. For a blood pressure monitor, the measurements are objective, and while there might be multiple measurements or different observers for the reference method, "adjudication" in this sense is not typically used.
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
- No. This is not relevant for a blood pressure monitor. MRMC studies are specific to diagnostic devices where human readers interpret medical images or data, and AI assistance might augment their performance. This device is a standalone measurement system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, effectively. A blood pressure monitor operates as a standalone device. While a human initiates the measurement and reads the display, the core function (blood pressure measurement) is performed algorithmically by the device itself without human interpretation influencing the measurement outcome. The performance assessment would focus on the accuracy of the device's measurements against a reference.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Most likely a reference blood pressure measurement method. For blood pressure monitors, the ground truth is typically established using a highly accurate, often invasive or a validated auscultatory method (e.g., mercury sphygmomanometer with trained observers), against which the device's readings are compared. The document does not specify which method was used.
8. The sample size for the training set
- Not applicable / Not specified. The provided document does not mention a training set, as modern AI/machine learning models are not typically involved in the fundamental operation of this type of traditional blood pressure monitor. If the device uses adaptive algorithms, those might be "trained" or calibrated, but the document does not provide details.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As there's no mention of a traditional "training set" in the context of AI/ML, this information is not available.
In summary, the provided FDA clearance letter focuses on regulatory compliance and substantial equivalence for a non-AI medical device. It does not contain the detailed study design, performance results, or expert evaluation specifics that would be present in a study report for an AI-powered diagnostic device.
§ 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).