(83 days)
SAM Facial Implant materials are indicated for plastic and reconstructive surgery. No new intended uses or new indications will be implemented as a result of this submission's clearance.
The only change that this optional manufacturing modification proposes is the creation of one or more tunnels within the implanted prosthesis. These tunnels provide additional sites for native tissue attachment and also facilitate in the placement of the implantable prosthesis. No new materials or technological characteristics are being introduced, the device's therapeutic effect is not altered and the proposed change to the manufacturing process has no deleterious iffects on the safety or efficacy of the devices when they are used as intended. These devices will still continue to meet all product specifications established for the original devices.
This is a 510(k) premarket notification for a medical device, specifically the SAM® Facial Implant, and not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML device performance (like sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable here.
The submission focuses on a manufacturing modification to an existing device and aims to prove "substantial equivalence" to its predicate devices, rather than establishing numerical performance metrics against specific acceptance criteria in the way an AI/ML device would.
Here's how to address the request based on the provided text for a non-AI/ML device:
Acceptance Criteria and Study for SAM® Facial Implant (Manufacturing Modification)
| Category | Description from Text |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | The acceptance criteria are implicitly tied to proving "substantial equivalence" to the predicate devices. The key criteria for this modification are that the device: - Does not materially affect the devices. - Introduces no new materials or technological characteristics. - Does not alter the device's therapeutic effect. - Has no deleterious effects on safety or efficacy when used as intended. - Continues to meet all product specifications established for the original devices. Reported Performance: The "histological evaluation presented in Attachment 2" (not provided in the input) "reveals that the proposed modification will allow the devices to perform at least as well as the original devices." The submission concludes that the devices with the modification are substantially equivalent. |
| 2. Sample size and data provenance (test set) | Not applicable in the context of an AI/ML test set. The study involves a histological evaluation of the modified device. The specific sample size for this evaluation is not provided in the summary, nor is the data provenance (e.g., in vivo animal study, in vitro testing). |
| 3. Number of experts and qualifications (ground truth) | Not applicable. Ground truth as typically defined for AI/ML does not apply here. The evaluation would likely be performed by histopathologists or similar experts, but their number and specific qualifications are not detailed. |
| 4. Adjudication method (test set) | Not applicable. No adjudication method in the AI/ML diagnostic sense is mentioned. |
| 5. MRMC comparative effectiveness study | Not applicable. This is not an AI/ML device, and no MRMC study is mentioned. |
| 6. Standalone performance | Not applicable. This concept applies to AI algorithms. The device itself is a physical implant. |
| 7. Type of ground truth | For the purpose of substantiating the claim of "performance at least as well as the original devices," the "ground truth" would be derived from histological evaluation (likely examining tissue response, integration, and integrity) and potentially other in-vitro or in-vivo testing to ensure mechanical properties and biocompatibility are maintained based on established product specifications. |
| 8. Sample size for training set | Not applicable. This is not an AI/ML device, so there is no "training set." |
| 9. How ground truth for training set was established | Not applicable. This is not an AI/ML device. |
Summary of the Study:
The study presented to establish substantial equivalence for the modified SAM® Facial Implant is a histological evaluation. The details of this evaluation ("Attachment 2") are not provided in the summary, but it served to demonstrate that the device with the new manufacturing modification (creating intraprosthetic tunnels) performs "at least as well as the original devices." The core argument is based on the fact that no new materials or technological characteristics are introduced, the therapeutic effect is unaltered, and safety/efficacy are maintained. The focus is on demonstrating that the modification does not negatively impact the existing, cleared device.
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PREMARKET NOTIFICATION 510(k) SUMMARY
- Submitter Information: W. L. Gore and Associates, Inc. 1. 3750 West Kiltie Lane Flagstaff, Arizona 86002-0900 Phone: (520) 779-2771 Contact: John W. Nicholson Summary Preparation Date: March 27, 1996
- SAM® Facial Implant 2. Device Trade Name: Device Common Name: Facial Augmentation Implant Material Device Classification Name: Surgical Mesh
| 3. Substantially EquivalentPredicate Devices: | SAM Facial Implant |
|---|---|
| Non-Reinforced SAM Facial Implant | |
| SAM Facial Implant with Introducer |
Because the proposed manufacturing modification does not materially effect the devices, they serve as their own predicates.
4. Device Description:
The only change that this optional manufacturing modification proposes is the creation of one or more tunnels within the implanted prosthesis. These tunnels provide additional sites for native tissue attachment and also facilitate in the placement of the implantable prosthesis.
No new materials or technological characteristics are being introduced, the device's therapeutic effect is not altered and the proposed change to the manufacturing process has no deleterious iffects on the safety or efficacy of the devices when they are used as intended. These devices will still continue to meet all product specifications established for the original devices.
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- Intended Use:
SAM Facial Implant materials are indicated for plastic and reconstructive surgery. No new intended uses or new indications will be implemented as a result of this submission's clearance.
- Intended Use:
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Premarket Notification Summary -page two-
Technological Characteristics: 6.
The manufacturing processes which were cleared in the Non-Reinforced SAM Facial Implant submission are identical to those used to produce these devices. There are no technological characteristic changes related to the implanted device and it achieves its clinical function in the same manner. The intraprosthetic tunnels serve merely to provide additional sites for host tissue attachment and to facilitate in device placement.
7. Conclusion:
The devices produced by this optional manufacturing process have the same indications, the same contraindications and enlist the same technological characteristics to achieve their equivalent clinical functions as implants for plastic and reconstructive surgery. The histological evaluation presented in Attachment 2 reveals that the proposed modification will allow the devices to perform at least as well as the original devices. The descriptive characteristics within this submission are precise enough to ensure that the devices produced by this optional process are substantially equivalent to the original devices.
SAM is registered in the United States Patent & Trademark Office
§ 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.