(289 days)
The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.
The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.
This document is about the FDA 510(k) clearance for Implantech Associates Inc.'s Customized Contour Implant. It is a premarket notification, and as such, it does not typically contain detailed studies with acceptance criteria in the same way a clinical trial for a new drug or a more complex medical device would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, the information regarding acceptance criteria and studies proving the device meets them, especially in the context of AI/ML performance, human readers, sample sizes for test/training sets, and ground truth establishment, is not applicable to this document.
The document primarily focuses on:
- Device Description: A patient-matched device made of medical-grade silicone elastomer for augmentation, reconstructive, and cosmetic surgery (facial, gluteal, calf, pectoralis implants).
- Predicate Device Identification: Listing several previously cleared Implantech implants (K191130, K052504, K052505, K952708) with similar materials and intended uses.
- Non-Clinical Testing: The only "studies" mentioned are non-clinical tests to demonstrate safety based on industry standards, including:
- Sterilization validation per ISO 17655-1 and ANSI/AAMI/ISO 20857
- Packaging validation per ISO 11607
- Shelf life validation with accelerated and real-time aging studies
- Cytotoxicity testing per ISO 10993-5
- 3D printer validation
- Conclusion: These non-clinical tests indicate that the device does not raise new issues of safety or effectiveness compared to the predicate device and is substantially equivalent.
No information is provided in the document regarding:
- A table of acceptance criteria and reported device performance (in the context of clinical/AI performance): Not applicable for this type of device and submission.
- Sample sizes used for the test set and data provenance: No clinical test set discussed.
- Number of experts used to establish ground truth and their qualifications: Not applicable; no ground truth establishment for AI performance.
- Adjudication method for the test set: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not done; this is not an AI-assisted diagnostic device.
- Standalone (algorithm only) performance: Not applicable; this is a physical implant, not an algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable; there is no training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 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.