(62 days)
FORA P11/TD-3019 Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure 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 wrist.
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The provided document is a 510(k) premarket notification letter for a blood pressure monitor, not a study report or clinical trial. Therefore, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.
However, based on the information provided in the letter, I can extract some relevant details and infer others about the device and its regulatory context.
Here's an attempt to answer your questions based on the limited information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state the acceptance criteria for the device's performance (e.g., specific accuracy ranges for blood pressure measurements) or report the device's performance against such criteria. The letter is a communication from the FDA stating that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is expected to be comparable to established standards.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided document. The 510(k) letter is an FDA decision letter, not the submission itself, which would typically contain such details.
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)
This information is not available in the provided document. For blood pressure monitors, the "ground truth" for accuracy studies is typically established by trained clinical observers using auscultation with a sphygmomanometer, often with specific training and certification according to relevant standards (e.g., ISO 81060-2).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
This is not applicable. The device is a "Blood Pressure Monitor," which is a diagnostic tool for measuring blood pressure, not an AI-assisted diagnostic imaging system that would involve "human readers" or MRMC studies in the traditional sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not explicitly stated. For a blood pressure monitor, the "standalone" performance refers to the accuracy of the device itself in measuring blood pressure against a reference method. It's implied that such testing would have been done as part of the substantial equivalence demonstration, likely following a recognized standard like ISO 81060-2.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For medical devices like blood pressure monitors, the "ground truth" for performance evaluation is typically established through direct comparison with a validated reference method, such as auscultation by trained observers using a mercury or an appropriately validated aneroid sphygmomanometer. This would be considered a form of clinical measurement ground truth.
8. The sample size for the training set
This is not applicable/not available. Blood pressure monitors like the FORA P11/TD-3019 typically rely on pneumatic and oscillometric principles, not AI algorithms trained on large datasets in the way that image analysis or predictive models do. While some internal calibration may occur, there isn't a "training set" in the common AI sense.
9. How the ground truth for the training set was established
This is not applicable. As mentioned above, there isn't a "training set" in the AI sense for this type of device. The device's calibration and validation would be against physical standards and clinical measurements.
Summary of what can be gleaned from the document given its nature:
- Device Name: FORA P11/TD-3019 Blood Pressure Monitor
- Intended Use/Indications: To measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual, over age 18, at home by using an inflatable cuff around the wrist.
- Regulatory Status: Class II, 510(k) cleared as "substantially equivalent" to predicate devices.
- Regulatory Number: K091897
- Product Code: DXN (Noninvasive blood pressure measurement system)
- Manufacturer: TaiDoc Technology Corporation
To find the detailed performance criteria and study results, one would typically need to review the original 510(k) submission document (if publicly available) or the associated testing reports, which are not part of this FDA clearance letter. The substantial equivalence determination signifies that the FDA concluded the device meets the safety and effectiveness standards comparable to existing legally marketed devices, implying that it has met relevant performance criteria, even if not explicitly detailed in this short letter.
§ 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).