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The moorVMS-LDF1 and moorVMSLDF2 laser Doppler perfusion and temperature monitors are intended for simultaneous measurement of tissue temperature and blood flow in the microcirculation. The devices are intended for clinical research use.

moorVMS-LDF1 Laser Doppler perfusion and temperature monitor
moorVMS-LDF2 Laser Doppler perfusion and temperature monitor

The provided text is a 510(k) summary for the moorVMS-LDF1 and moorVMS-LDF2 Laser Doppler perfusion and temperature monitors. It outlines the device, its classification, and the substantial equivalence determination by the FDA. However, it does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical study report.

The document states that the FDA has determined the device is substantially equivalent to a legally marketed predicate device (DRT4 Laser Doppler perfusion and temperature monitor, K011070). This means the FDA believes the new device is as safe and effective as the predicate, but it does not detail specific performance metrics and their validation studies.

Therefore, I cannot provide the requested information in the structured format you asked for.

Here's why each point cannot be addressed with the provided text:

1. Table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory approval based on substantial equivalence, not detailed performance criteria.
2. Sample size used for the test set and the data provenance: No test set information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication method is mentioned.
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 device is a Laser Doppler perfusion and temperature monitor, not an AI-based diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a monitor, not an algorithm, so this is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no specific performance study with ground truth is detailed.
8. The sample size for the training set: Not applicable as this is not an AI-based device that would require a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

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