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The Wrist Automatic Blood Pressure Monitor LD-737 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Wrist Automatic Blood Pressure Monitor Model: LD-737

The provided text is a 510(k) summary for a Wrist Automatic Blood Pressure Monitor and primarily focuses on regulatory approval. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for any test set.
• Information about multi-reader multi-case studies or standalone algorithm performance.
• Details on the type of ground truth used or how it was established.
• Sample size for a training set.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is expected to be similar to existing approved devices. However, it does not provide the actual performance data or the specific studies conducted to establish this equivalence, beyond simply stating it was reviewed.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document is purely a regulatory approval letter.

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The Wrist Automatic Blood Pressure Monitor LD-733 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Wrist Automatic Blood Pressure Monitor Model: LD-733

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a blood pressure monitor, which primarily confirms that the device is substantially equivalent to legally marketed predicate devices. It does not detail specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/algorithm-based device as requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions about a study design proving the device meets acceptance criteria.

Ask a specific question about this device