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The Perma Facial Implants are solid silicone implants that are intended for use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections in the face, including areas such as the nose, chin, and cheeks.

The SurgiSil™ Perma Facial Implants are injection-molded (pre-formed) silicone implants with a hardness of 40 on the shore "00" scale. The SurgiSil™ Perma Facial Implants have a cylindrical shape with tapered ends. The implants will be provided in various sizes, with diameters of 2-6 mm and lengths of 50-75 mm. The Perma Facial Implants are individually packaged and sterilized by gamma irradiation and are labeled for single use. The Perma Facial Implants are designed with tapered ends to reduce visibility of the implant ends following implantation. The smooth surface of the implant prevents tissue ingrowth permitting easy removal and/or exchange of the implant. The Perma Facial Implants are ideal for use in soft tissue augmentation anywhere in the face where, in the physician's experience, use of a soft silicone elastomer is appropriate.

Here's an analysis of the provided text regarding the SurgiSil™ Perma Facial Implants, focusing on acceptance criteria and study details.

Based on the provided 510(k) summary, typical "acceptance criteria" and "study" details like those associated with performance testing for AI/software devices are not present. This document is a 510(k) summary for a physical implant, not a software device, and therefore the evaluation process is fundamentally different.

The 510(k) pathway focuses on demonstrating substantial equivalence to a predicate device, primarily through material composition, intended use, and technological characteristics, rather than establishing specific performance metrics for the device itself.

Here's a breakdown of the information that is available and why certain criteria typically asked for AI/software studies are not applicable:

Acceptance Criteria and Reported Device Performance

Study Details (As applicable to this type of device)

Given that this is a 510(k) for a physical implant, many of the requested study details (especially those related to AI/software performance) are not relevant or are not found in this type of submission.

1. Sample size used for the test set and the data provenance:

   • Not explicitly stated in terms of a "test set" for performance. The document mentions "Testing was conducted that confirms that the Perma Facial Implants are biocompatible and safe for the intended use." This likely refers to material testing (e.g., mechanical properties, biocompatibility per ISO standards) rather than a clinical "test set" of patients.
   • Data provenance: Not mentioned. It's likely laboratory testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for this physical implant. Biocompatibility testing is assessed by laboratory analysis against standards, not expert consensus on an output.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No adjudication process is described as there isn't a diagnostic outcome being evaluated.

4. 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:

   • No. This is not an AI-assisted diagnostic device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable in the AI/diagnostic sense. The "truth" for this device relates to material properties meeting specifications and biocompatibility standards.

7. The sample size for the training set:

   • Not applicable. There is no "training set" for a physical implant.

8. How the ground truth for the training set was established:

   • Not applicable. There is no "training set" for a physical implant.

Summary of the Device's "Proof" of Meeting "Acceptance Criteria" (Substantial Equivalence):

The "study" presented in this 510(k) summary is primarily a demonstration of substantial equivalence to legally marketed predicate devices, not a performance study in the way one would analyze an AI or imaging device.

The key arguments for meeting acceptance criteria (which, in this context, are the requirements for 510(k) clearance based on substantial equivalence) are:

• Identical Intended Use: The Perma Facial Implants are intended for use in plastic and reconstructive surgery for cosmetic augmentation and corrections in the face, which is stated to be similar to the predicate devices.
• Similar Material Composition: Both the proposed device and the predicate devices are manufactured from medical grade silicone elastomer.
• Technological Characteristics: While there are design differences (sizes and shapes), the core technology (silicone implant for facial augmentation) is considered similar.
• Biocompatibility Testing: The document states that "Testing was conducted that confirms that the Perma Facial Implants are biocompatible and safe for the intended use." While details aren't provided, this implies that the device passed relevant biocompatibility tests (e.g., ISO 10993 series) typical for implantable materials.
• Sterilization Method: Gamma irradiation, a common and accepted method.

In essence, the "study" that proves the device meets the "acceptance criteria" (of substantial equivalence) is the comparison to established predicate devices combined with implicit or explicitly mentioned (but not detailed) biocompatibility and material testing. The FDA's clearance (K071823) confirms that the agency agreed with this assessment of substantial equivalence.

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