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An orthosis worn on the wrist for medical purposes:

• to support and/or immobilize for functional improvement.
• for conservative treatment of symptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist.
• to keep wrist motion to a minimum while worn allowing the body to recover from the damage of repetitive motion or other injuries.
• to provide temporary relief of associated symptoms of some wrist conditions.

Not Found

I am sorry, but the provided text from K031576 does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance for the Spartan Orthopaedic Wrist Brace, Model SCT-1.

This document is an FDA 510(k) clearance letter, which means the device was found substantially equivalent to a predicate device already on the market. This type of clearance typically relies on demonstrating similarity to existing devices rather than extensive new clinical studies with detailed acceptance criteria and performance reports as would be expected for novel or higher-risk devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness study.
6. Information on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document only states the device's indications for use and confirms its substantial equivalence to a legally marketed predicate device. It does not include performance data or studies defining and meeting specific acceptance criteria.

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