(60 days)
The intended use of the AART Malar Implant is for augmentation or reconstruction of the check areas of the face.
The AART Malar Implants are manufactured from a medical grade silicone elastomer that has been molded into various crescent shaped concave convex implants. They are provided in four styles in pairs of right and left mirror images with dimensions varying in length, width, and height. The AART Malar Implants are intended to be used for augmentation and reconstruction of the cheek areas of the face. The surface characteristic of the implants is smooth, The AART Malar Implants will be offered sterile and non-sterile.
The provided text is a 510(k) summary and FDA clearance letter for the AART Malar Implant. This type of document establishes substantial equivalence to predicate devices, rather than conducting new studies to prove performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not present in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The 510(k) submission focuses on demonstrating substantial equivalence to already marketed devices, not on proving performance against a specific set of new acceptance criteria through a clinical study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present because no new clinical or performance test set data is described. The submission is based on the characteristics of the device itself and its similarity to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present because no new clinical or performance test set data requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present because no new clinical or performance test set data requiring adjudication 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
This information is not present. The device is an implant, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present. The device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present because no new clinical or performance test set data requiring ground truth is described. The "ground truth" for this type of submission would relate to the long-standing safety and effectiveness of the predicate devices.
8. The sample size for the training set
This information is not present because the document does not describe the development or training of any algorithm.
9. How the ground truth for the training set was established
This information is not present because the document does not describe the development or training of any algorithm.
Summary of Device Equivalence (from the document):
The AART Malar Implant is deemed substantially equivalent to the Duralastic Anatomical Malar Implants (Allied Biomedical Corporation) and the Seare Biomedical Malar Implants (Seare Biomedical Corp.). This equivalence is based on:
- Function
- Design
- Performance
- Materials (medical grade silicone elastomer)
- Intended Use (augmentation and reconstruction of the cheek areas of the face)
- Similar shapes and sizes
The sterilization cycle will be determined and validated following ANSI/AAMI/ISO 11137-1994 for radiation sterilization, which is a standard for ensuring sterility, not specific performance criteria for the device's function within the body.
§ 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.