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The Spectrum Designs Anterior Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.

AI/ML Overview

This submission is a 510(k) premarket notification for a medical device, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device already on the market. It does not contain acceptance criteria or a study proving the device meets those criteria in the way a clinical trial or performance study would for a novel device or software.

Here's a breakdown based on the provided text, and where certain information is likely not applicable (N/A) for a 510(k) for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance	Reported Performance
Substantial Equivalence (Primary Criterion for 510(k))	The device must be demonstrated to be as safe and effective as a legally marketed predicate device, with the same intended use and technological characteristics, or if different, those differences do not raise new questions of safety or effectiveness.	The FDA letter (K980444, K980445, K980446) states: "We have reviewed your Section 510(k) notification... and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..."
Material Composition	Medical grade solid silicone elastomer.	The device is manufactured from medical grade solid silicone elastomer. (Implied: meets standard for medical grade silicone).
Indications for Use Alignment	Intended to augment or reconstruct congenital or traumatic chin deficiencies.	"The Spectrum Designs Anterior Chin Implant is a silicone facial implant, designed to augment or reconstruct congenital or traumatic chin deficiencies." The FDA concurs with this indication.
Non-Sterile Status	Device is provided non-sterile.	"It is provided non-sterile". (Implied: this matches the predicate or is acceptable for this type of device).
Availability in Sizes	Available in multiple sizes.	"available in six sizes". (Implied: this range of sizes is adequate and comparable to predicates).

Note: For a 510(k) for an implant like this, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a predicate device. This often involves comparing technological characteristics, materials, and intended use. There isn't typically a performance study with numerical metrics like sensitivity/specificity as would be seen for a diagnostic AI device.

2. Sample Size Used for the Test Set and Data Provenance

This information is N/A. This document describes a 510(k) submission for a physical medical implant (a chin implant). It does not involve a "test set" in the context of an algorithm or diagnostic device. The evaluation for substantial equivalence would have been based on specifications, biocompatibility data (if new materials), and comparison to existing predicate devices, not algorithm performance on a dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is N/A. See point 2. There is no "test set" or "ground truth" to be established by experts in the context of an algorithm's performance for this type of device submission.

4. Adjudication Method for the Test Set

This information is N/A. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

This information is N/A. This is a physical implant, not an AI or diagnostic device that would involve human readers interpreting cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is N/A. This is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

This information is N/A for an algorithm's "ground truth." For a physical implant, the "truth" is its ability to perform its intended function safely and effectively, which is generally established through material testing, biocompatibility studies (if applicable), mechanical testing, and clinical history of substantially equivalent predicate devices. This document doesn't detail specific "ground truth" methods beyond the general regulatory requirement of substantial equivalence.

8. The Sample Size for the Training Set

This information is N/A. This is not an AI/algorithm-based device, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

This information is N/A. This is not an AI/algorithm-based device, so there is no training set or ground truth establishment for such a set.

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