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AOC "M is indicated for as a water-solubic implant material and as a water-soluble space occupying material, as an adjunct during the natural healing process.

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The provided text describes a 510(k) premarket notification for a medical device (AOC™ Soluble Implant Material) and its substantial equivalence to predicate devices. However, it does not contain any information about specific acceptance criteria, device performance metrics, or a study that proves the device meets such criteria.

The document is a regulatory submission for market clearance, focusing on:

• Identification of the device and its manufacturer.
• Classification and product codes.
• Identification of predicate devices.
• Formal FDA notification of clearance.
• Indications for Use statement.

Therefore, I cannot provide the requested table and study details based on the input text. The information required, such as specific performance metrics (sensitivity, specificity, accuracy, etc.), sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone performance, is not present in the provided excerpt.

To reiterate, the input does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance details.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Details about a standalone (algorithm only) performance study.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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