(87 days)
To measure systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. Limited to patient over 18 years and wrist circumference between 5.3 to 7.7 inches.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Rossmax Automatic Wristwatch Blood Pressure Monitor. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed study information typically requested for AI/ML device performance.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this document. The device in question is a traditional medical device (blood pressure monitor), not an AI/ML powered device, so concepts like "training set," "AI without human-in-the-loop," and "MRMC comparative effectiveness study" are not applicable.
Here's a breakdown of what can be gleaned:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision) for the device. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that the device's performance is deemed acceptable because it meets the same standards as existing devices on the market.
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.
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 a blood pressure monitor, the "ground truth" would typically come from a reference standard (e.g., a mercury sphygmomanometer following specific protocols), not expert consensus in the way it's used for image interpretation.
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
No such study was conducted or mentioned, as this is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as it is a physical blood pressure monitoring device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
While not explicitly stated, for a blood pressure monitor, the ground truth would typically be established using a reference standard measurement device (e.g., a mercury sphygmomanometer) in a controlled clinical setting, adhering to validated measurement protocols.
8. The sample size for the training set
This information is not available in the provided document. This device does not use an AI/ML training set.
9. How the ground truth for the training set was established
This information is not available in the provided document, as it's not an AI/ML device with a training set.
In summary, the provided FDA 510(k) letter confirms that the Rossmax Automatic Wristwatch Blood Pressure Monitor (model Z44) has been found substantially equivalent to a predicate device for measuring systolic and diastolic blood pressure and heart rate on the wrist using the oscillometric method. The device is limited to patients over 18 years old with a wrist circumference between 5.3 to 7.7 inches. However, the document does not contain the detailed study design and performance metrics typically associated with AI/ML device evaluations.
§ 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).