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510(k) Data Aggregation
(193 days)
The Myo-train V may be used for the following indications:
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- Relaxation of muscle spasm.
- Prevention or retardation of disuse atrophy. 2)
- Increasing local blood circulation. 3)
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- Muscle re-education.
- Maintaining or increasing range of motion. 5)
Not Found
The provided document is a 510(k) clearance letter for a medical device called "Myo-train V". This type of document does not typically contain detailed information about acceptance criteria, specific study designs, or performance metrics for the device.
510(k) clearance signifies that the device is substantially equivalent to a legally marketed predicate device. This process primarily focuses on demonstrating equivalence in terms of intended use, technological characteristics, and safety/effectiveness, rather than independent clinical trial data meeting specific performance acceptance criteria as might be seen for a PMA (Premarket Approval) or a more rigorous clinical study submission.
Therefore,Based on the provided document, I cannot answer the following questions:
- A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available. The 510(k) process typically relies on comparison to a predicate device, not necessarily new MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document states that the FDA "reviewed your Section 510(k) notification of intent to market the device... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies that the device's performance was compared to existing predicate devices, but the specifics of how that equivalence was demonstrated (e.g., specific test data, statistical analyses, or human reader studies) are not disclosed in this letter.
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