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The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.

The MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.

The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implant to be implanted.

The MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer STERILE (Gel Sizer) is designed for temporary intra-operative placement in the surgically prepared breast pocket. The Gel Sizer is used to evaluate the appropriate breast implant size and shape for each patient prior to implantation of a MemoryShape™ (contour shape) breast implant. The Gel Sizer is provided sterile and can be used out of the box for the initial use. The Gel Sizer is then resterilized 9 additional times for a total of 10 uses. The MemoryShape™ sizers are offered in various sizes to match the corresponding MemoryShape™ breast implants. These gel sizers contain raised orientation marks on the anterior and posterior of the device to help the physician with placement.

The MENTOR™ Resterilizable Gel Breast Implant Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ breast implant size and shape for each patient prior to implantation of a breast implant. It is provided non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times.

The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intra operative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast lmplant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.

The provided text is a 510(k) summary for the MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer, MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer, and MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer. The primary change described is a material change for the Dip Coat component from Krayden / Dow DC 92-009 to NuSil MED6-6605.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides two tables outlining acceptance criteria and results for:

• Dip Coat Process PQ Testing (Table 4): This assesses the manufacturing process of applying the new dip coat material.
• Sizers Reprocessing Product Lifetime Testing (Table 5): This evaluates the durability and integrity of the new dip coat material over the expected device lifetime.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not explicitly state a specific numerical sample size for the "Dip Coat Process PQ Testing" or the "Sizers Reprocessing Product Lifetime testing." For the PQ testing, it mentions "each of the lots" and "100% acceptable Dip Coat," suggesting all manufactured units in the tested lots were visually inspected. For the lifetime testing, it refers to "any of the test samples."
• Data Provenance: The studies were conducted by MENTOR™ as part of their performance qualification and product lifetime testing for their manufacturing process in MENTOR™ Texas. This is an internal, prospective study to validate a material change.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This submission concerns mechanical and material performance, not diagnostic accuracy requiring human expert interpretation for ground truth. Therefore, there were no human experts used to establish a ground truth as would be relevant for an AI/CADe device. The ground truth for performance was established by measurable engineering and material integrity criteria.

4. Adjudication Method for the Test Set:

Not applicable, as no human expert interpretation or adjudication was involved for establishing ground truth performance for this type of device and material change. The criteria were objective (e.g., visual inspection for yield, integrity, and absence of leakage/cracking).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. This is not a comparative effectiveness study for human readers with and without AI assistance. The device is a breast implant sizer, and the studies focus on the physical performance and biocompatibility of a material change.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This submission is not for an algorithm or AI device. It is for a physical medical device (breast implant sizer).

7. The Type of Ground Truth Used:

The ground truth used for these performance studies is based on objective engineering and material integrity criteria. This includes:

• Visual inspection for manufacturing yield.
• Visual inspection for dip coat integrity (adherence, absence of cracking, delamination).
• Detection of leakage.
• Biocompatibility test results (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity) against established standards and historical data for similar materials.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set. The studies are physical performance tests of a material.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for a training set.

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The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer is indicated for single use only for temporary insertion intraoperatively to evaluate the shape and size of the MemoryGel™ Enhance Breast Implanted.

The MENTOR™ MemoryGel™ Enhance Single Use Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ Breast Implant size and shape for each patient prior to implantation of a breast implant. It is provided sterile and is for single use only. The Sizer should not be resterilized.

The provided text is a 510(k) summary for the MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer. It outlines the device description, indications for use, comparison to a predicate device, and summaries of non-clinical testing and performance data.

However, the request asks for specific details about the acceptance criteria and the study proving the device meets these criteria, particularly in the context of an AI medical device. The provided FDA document does not pertain to an AI medical device. Instead, it describes a physical medical device (a breast implant sizer). Therefore, many of the requested points, such as AI-specific performance metrics (e.g., effect size of human readers with AI assistance, standalone algorithm performance), and details about training/test sets for an AI model, are not applicable to this document.

The document discusses biocompatibility testing and physical performance data for the sizer device. I will extract the relevant "acceptance criteria" and "device performance" information from the provided text as best as possible, mapping it to the closest available information, while explicitly noting when requested information is not present or not applicable due to the nature of the device described.

Device: MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
Type of Device: Physical Medical Device (not an AI medical device)

Acceptance Criteria and Reported Device Performance

The provided document details non-clinical testing for biological safety (biocompatibility) and physical properties. The acceptance criteria are implicitly that the device "passed" these tests or showed "no significant effects."

Study Details (as applicable to a physical device, not an AI device)

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

   • The document does not explicitly state sample sizes for each specific test. It mentions "test articles" (e.g., "Intact, smooth and Siltex MemoryGel breast implants" for cytotoxicity) which implies physical samples were used.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be laboratory-based performance and biocompatibility testing of manufactured units, rather than human subject data or image data. It refers to established standards (e.g., EN ISO 10993-1, FDA Guidance).
   • Retrospective or Prospective: Not applicable in the context of device design verification; these are laboratory tests.

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

   • Not applicable. This relates to physical and biological testing metrics, not interpretation of clinical data by experts for ground truth establishment. Biocompatibility results are typically determined by laboratory assays and objective measurements against established standards, not expert consensus. The "ground truth" for physical properties would be engineering specifications and measurements.

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

   • Not applicable. This is relevant for image-based or clinical human-in-the-loop studies (e.g., for AI). For physical device testing, results are typically determined by validated testing methods and equipment.

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:

   • Not applicable. This is a physical breast implant sizer, not an AI device. No human-in-the-loop studies involving AI assistance are described.

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

   • Not applicable. This is a physical device, not an algorithm.

6. The type of ground truth used:

   • For Biocompatibility: Laboratory test results, conducted according to ISO 10993 standards and FDA guidance, measuring specific biological responses (e.g., cytotoxicity, sensitization).
   • For Physical Performance: Engineering specifications and objective physical measurements (e.g., strength, elongation, break force, cohesiveness). This leverages testing conducted to qualify the device as an implant, implying adherence to implant design specifications.

7. The sample size for the training set:

   • Not applicable. This refers to a physical device, not an AI model requiring a training set. The "training" for this device is its manufacturing process and design.

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

   • Not applicable. As above, there is no "training set" in the context of an AI model for this physical device. The device's "ground truth" for its design and manufacturing would be established through established engineering principles, material science, and quality control processes. The document states that the testing "leverages the testing conducted to qualify the device as an implant" and confirms it "meets implant design specifications."

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