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The Implantech Conform™ Combined Submalar® Implant is indicated for implantation to augment or reconstruct the underdeveloped or traumatized malar region of the face. The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.

The soft, flexible Conform Combined Submalar Implant is designed to easily conform to the facial skeleton in the malar area.

This document does not contain information about acceptance criteria or a study proving that a device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a medical device (Implantech Conform™ Binder Submalar® Implant), indicating that the device has been found substantially equivalent to a legally marketed predicate device. This letter allows the device to be marketed, subject to general controls and other regulations.

The letter explicitly 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..." This is a regulatory clearance based on equivalence, not a performance study demonstrating specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. 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.

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