(60 days)
The intended use for the AART Chin Implant is augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.
The intended use for the AART Chin Implant is for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be inserted via intra-oral or submental incision.
The AART Chin Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped convex implants. They are provided in seven styles with dimensions varying in length, width, and height. The AART Chin Implants are intended to be used for augmentation and reconstruction of the chin or anterior mandibular contour. The surface characteristic of the implant is smooth. The AART Chin Implants will be offered sterile and non-sterile.
This is a 510(k) premarket notification for a medical device, the AART Chin Implant. It is not a study proving the device meets specific acceptance criteria in the way a diagnostic AI/ML device would be evaluated. Instead, this document demonstrates substantial equivalence to predicate devices already on the market. Therefore, most of the requested information regarding acceptance criteria, study details, and AI/ML specific evaluations are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or device performance in the way a clinical study would for a diagnostic or AI/ML device. The "acceptance criteria" here implicitly refer to the demonstration of substantial equivalence to existing predicate devices in terms of material, design, function, and performance, which allows the device to be marketed.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (as per document) |
|---|---|
| Material equivalence to predicate devices | Manufactured from medical grade silicone elastomer, same as predicate devices. |
| Design equivalence to predicate devices | Molded into various crescent shaped convex implants; seven styles with varying dimensions, similar to predicate devices. |
| Functional equivalence to predicate devices | Intended for augmentation and reconstruction of the chin or anterior mandibular contour, identical to predicate devices. |
| Performance equivalence to predicate devices | Not explicitly detailed in quantitative terms for performance, but implied through substantial equivalence to predicate devices. |
| Sterilization following established standards | Sterilized by Gamma radiation, cycle validated following ANSI/AAMI/ISO 11137-1994 standard. |
2. Sample sized used for the test set and the data provenance
Not applicable. This is a 510(k) submission based on substantial equivalence to existing devices, not a study involving a test set of data for performance evaluation in the context of AI/ML or diagnostics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a test set is not established in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no ground truth, expert consensus, pathology, or outcomes data used in the typical sense of a performance study for this type of device. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. No training set is involved as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.