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Repair of removable partial and full dentures

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The provided text is an FDA 510(k) clearance letter for a dental device called "Acrifix" (K230341). This document does not contain any information about acceptance criteria or a study proving the device meets the acceptance criteria for an AI/ML medical device.

The letter is a standard clearance for a Class II medical device based on substantial equivalence to predicate devices, specifically "Denture Relining, Repairing, Or Rebasing Resin." It discusses regulatory aspects like general controls, registration, labeling, and good manufacturing practices. There is no mention of AI/ML, clinical study results, performance metrics, ground truth, or expert review processes typically associated with the evaluation of AI/ML-driven medical devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number and qualification of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth.
8. Training set sample size.
9. Method for establishing training set ground truth.

This information is simply not present in the provided document, as it pertains to a different type of medical device review.

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