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Seare Biomedical Chin Implants are utilized to augment or reconstruct the chin or anterior mandibular contour.

Seare Biomedical Chin Implants are crescent shaped concave convex silicone elastomer rubber implants made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. The chin implant is used to augment or reconstruct the chin. It is placed over the anterior aspect of the mandible in the midline and placed under the periosteum. It is inserted via an intra-oral or submental incision according to the surgeon's preference. The Seare Biomedical Chins will be available in many sizes and styles, all of which are very similar differing only by a few millimeters in length and projection. The Seare Biomedical Chin Implants will be provided sterile and nonsterile.

This document describes a 510(k) submission for the Seare Biomedical Chin Implants, which are silicone elastomer implants used for chin augmentation or reconstruction. The submission states that no clinical tests were performed to establish substantial equivalence or device performance.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data from a study are provided.
2. Sample size used for the test set and the data provenance: No test set was used for clinical evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set.
4. Adjudication method: Not applicable as there was no clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, the document explicitly states "Clinical Tests: None". Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not a software algorithm.
7. The type of ground truth used: Not applicable as there was no clinical test.
8. The sample size for the training set: Not applicable as there was no training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

The basis for the 510(k) clearance was substantial equivalence to a predicate device (Allied Biomedical Chin Implants) in material, function, performance, and design, with identical indications for use and similar sizes and options.

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