(37 days)
To measure of systolic and diastolic blood pressure and pulse rates of adults using wrist cuff and oscillometric method.
Full Auto Wrist Digital Blood Pressure Monitor, SE-312
Based on the provided text, the document is a 510(k) clearance letter for the "Full Auto Wrist Digital Blood Pressure Monitor, SE-312" (K012054). This type of document from the FDA primarily focuses on establishing "substantial equivalence" to a predicate device, rather than requiring a detailed study demonstrating device performance against specific acceptance criteria for this particular device.
Therefore, most of the requested information regarding acceptance criteria and performance studies is not present in these documents. The 510(k) process typically relies on comparisons to already-cleared devices to demonstrate safety and effectiveness.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics for this specific device. The entire 510(k) process implies acceptance if substantial equivalence to a legally marketed predicate device is demonstrated for the stated indications for use.
- Reported Device Performance: Not explicitly enumerated in a performance table in these documents. The clearance is based on the comparison to a predicate device, assuming similar performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document does not describe a specific test set or clinical study for this device's performance.
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)
- Not applicable. No test set or ground truth establishment process is described for this device in these documents.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is described.
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 device is a blood pressure monitor, not an AI-assisted diagnostic tool. An MRMC study is not relevant here and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical diagnostic monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for this device. The concept of "ground truth" as used for AI/diagnostic algorithms doesn't apply directly to a blood pressure monitor submission in this context. Substantial equivalence relies on comparing the device's design and operating principle to a predicate, and potentially some basic performance data if presented, but not typically a complex ground truth dataset.
8. The sample size for the training set
- Not applicable. This isn't an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This isn't an AI/machine learning device that requires a training set or ground truth for it.
In summary: The provided 510(k) documents grant clearance based on substantial equivalence to a predicate device. They do not contain the details of a de novo clinical study with explicit acceptance criteria and performance data for the "Full Auto Wrist Digital Blood Pressure Monitor, SE-312." Such detailed performance studies are typically found in the 510(k) submission itself (which is not provided) and would compare the device's accuracy against a recognized standard (e.g., AAMI, BHS protocol for blood pressure devices).
§ 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).