(98 days)
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."
| Acceptance Criteria Category | Specific Test/Property | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO Agarose Overlay and ISO Elution) | Device passes cytotoxicity requirements. | Passed |
| Sensitization (Maximization Method) | Device passes sensitization requirements. | Passed | |
| Intracutaneous Reactivity | Device passes intracutaneous reactivity requirements. | Passed | |
| Acute Systemic Toxicity | Device passes acute systemic toxicity requirements. | Passed | |
| Hemocompatibility (Direct Contact and Extraction) | Device passes hemocompatibility requirements. | Passed | |
| Pyrogenicity - Material Mediated | Device is non-pyrogenic. | Non-pyrogenic. | |
| Pyrogenicity - Limulus Amebocyte Lysate (LAL) | Device is non-pyrogenic. | Non-pyrogenic. | |
| Genotoxicity (Bacterial Reverse Mutation Assay) | Negative for genotoxic activity. | Negative for genotoxic activity. | |
| Genotoxicity (Unscheduled DNA Synthesis Assay in Mammalian Cells In Vitro) | Negative for genotoxic activity. | Negative for genotoxic activity. | |
| Genotoxicity (Chromosome Aberrations in Chinese Hamster Ovary (CHO) Cells) | Negative for genotoxic activity. | Negative for genotoxic activity. | |
| Genotoxicity (Micronucleus Cytogenetic Assay in Mice) | Negative for genotoxic activity. | Negative for genotoxic activity. | |
| Implantation | Device is non-irritating. | Non-irritating. | |
| Immunotoxicity | No significant effects on immunological response. | No significant effects of the test articles on the immunological response. | |
| Autoantibody Production | No significant differences for serum IFN-γ levels among treatment groups. | No significant differences were found for the serum IFN-γ levels among the treatment groups of this experiment. | |
| Adjuvancy | Unlikely to cause an adjuvant effect in humans. | Unlikely that silicone gels cause an adjuvant effect in humans. | |
| Reproductive Toxicity/Teratogenicity | Does not cause reproductive or teratogenic effects. | Did not cause reproductive or terotogenic effects. | |
| Chronic Toxicity/Carcinogenicity | Not considered to be carcinogenic. | Not considered to be carcinogenic. | |
| Physical Performance | Shell/Patch Joint Strength | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. |
| Shell Elongation | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. | |
| Shell Tension Set | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. | |
| Shell Break Force | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. | |
| Gel Cohesiveness | Meets defined acceptance criteria. | Passed the acceptance criteria as defined in the protocol. | |
| Microbiological Safety | Bioburden Testing | Verification of device microbiological safety. | Conducted to verify device microbiological safety. (No specific "passed" or "failed" for Bioburden, but implied by overall conclusion that "all physical characteristics passed the acceptance criteria.") |
| Routine LAL Testing | Verification of device microbiological safety. | Conducted to verify device microbiological safety. (No specific "passed" or "failed" for LAL, but implied by overall conclusion that "all physical characteristics passed the acceptance criteria.") |
Study Details (as applicable to a physical device, not an AI device)
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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