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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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NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.

NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures.

NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants.

NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.

The provided text is an FDA 510(k) clearance letter and summary for a medical device: "NATRELLE INSPIRA® Single Use Sizers." This document does not contain information about an AI/ML-driven device or a study involving human readers or ground truth establishment relevant to AI/ML performance.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Natrelle® Re-Sterilizable Breast Implant Sizers) through non-clinical performance data, primarily mechanical testing and biocompatibility. The device itself is a physical sizer filled with silicone gel, used by surgeons during breast augmentation procedures.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, including:

• Table of acceptance criteria and reported device performance (for AI/ML): Not applicable. The "performance data" mentioned in the document refers to non-clinical tests like mechanical testing and biocompatibility, not AI performance metrics.
• Sample size and data provenance (for AI/ML test set): Not applicable. There is no AI test set.
• Number of experts and qualifications (for AI/ML ground truth): Not applicable. There is no AI ground truth establishment.
• Adjudication method (for AI/ML test set): Not applicable.
• MRMC comparative effectiveness study: Not applicable. This is a physical medical device, not an AI system.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable. The ground truth for this device's testing relates to physical properties and biocompatibility, not diagnostic or clinical accuracy determined by experts or pathology.
• Sample size for training set (for AI/ML): Not applicable. There is no AI training set.
• How ground truth for training set was established (for AI/ML): Not applicable.

The document explicitly states that "Non-clinical performance data including mechanical testing and biocompatibility data were submitted to support clearance... All pre-established acceptance criteria were met." However, these acceptance criteria and the associated study are not related to the performance of an AI/ML device, human reader improvement, or ground truth for diagnostic accuracy, which are the typical focus of the questions posed.

To summarize, the provided text describes a traditional medical device and its clearance process, not an AI/ML device study.

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The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term Sientra OPUS® Breast Implant to be implanted.

The Sientra OPUS® Silicone Gel Breast Implant Sizer is a single-use, sterile, intraoperative device indicated for temporary placement during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size Sientra Breast Implant to be implanted. The Sientra Gel Sizers are designed to complement the portfolio of Sientra OPUS® Silicone Gel Breast Implants ("Breast Implants" or "Implants"), and are therefore available in the same range of styles, dimensions and fill volume as Sientra Implants. The Sientra OPUS® Silicone Gel Breast Implant Sizers are constructed with a smoothsurfaced, silicone elastomer shell and a filler made of clear, high-strength silicone gel. Sientra's Gel Sizers have been demonstrated to be biocompatible. The printing on the exterior of the Gel Sizer shell is clearly marked, "SIZER", "SINGLE USE ONLY", and "DO NOT IMPLANT", to clearly differentiate the Gel Sizers from Sientra's OPUS Breast Implants. Each Sientra Gel Sizer is dry-heat-sterilized, for single patient use only, and is not intended for long-term implantation or re-sterilization.

This document describes the Sientra OPUS® Silicone Gel Breast Implant Sizer, a medical device, and its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each bench test conducted. It generally refers to "performance testing" being conducted. The data provenance is from non-clinical bench testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying the data was generated to meet U.S. regulatory standards. The testing is retrospective in the sense that the device was developed and then tested, but it pertains to the device itself and not to patient data.

3. Number of Experts and Their Qualifications for Ground Truth

This information is not applicable as the evaluation of this device relies on non-clinical bench testing against engineering and material specifications, not on expert interpretation of clinical data. Therefore, there was no ground truth established by medical experts for the test set.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation of this device relies on non-clinical bench testing against predefined acceptance criteria, not on expert consensus or adjudication of clinical cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a physical breast implant sizer, not an AI or imaging-based device that would benefit from such a study. The document explicitly states: "No clinical testing was performed to support this 510(k) submission."

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not applicable / not done as this is a physical medical device (a breast implant sizer), not an algorithm or software. The performance testing was of the physical properties and characteristics of the sizer itself.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on predefined engineering specifications, material properties, and regulatory standards for biocompatibility, sterility, and physical integrity that the device must meet to be considered safe and effective and substantially equivalent to its predicate.

8. Sample Size for the Training Set

This information is not applicable as this device is not an AI/machine learning model that requires a training set. The device is a physical product.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

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Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are temporary intraoperative placement devices used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term breast implant to use.

Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are sizing devices designed for temporary intraoperative placement, to assist in determining the desired breast implant volume and shape for each patient prior to implantation of a Motiva Implant Matrix® silicone breast implant. They are used during breast augmentation or reconstruction procedures.

The Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are constructed with a low diffusion shell featuring a barrier layer between various layers of silicone elastomer to minimize gel diffusion; a patch, and cohesive restricted medical grade silicone gel, which is aimed for intraoperative temporary implantation only. The filling gel is tinted with pigments, in order for the Round Sizers to be clearly differentiated from the long term implantable devices.

The Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® have been designed to match every Motiva Implant Matrix® silicone breast implant reference, and are therefore available in the same range of bases or diameters, projections and volumes as the long term implants.

The provided document is a 510(k) premarket notification for a medical device: "Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the document describes performance testing to establish equivalence, not to meet independent acceptance criteria in the same way a novel device might.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense for a new clinical claim. Instead, it describes non-clinical testing performed to demonstrate that the new device meets established specifications necessary for consistent performance and does not raise new safety or effectiveness concerns compared to the predicate device.

The non-clinical tests conducted are listed as:

• Gel Cohesion and Penetration
• Patch to Shell Joint Testing
• Elongation
• Break Force
• Tension Set
• Tear Force

The reported device performance is summarized as: "The collective results of the non-clinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Intraoperative, Single-Use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® meet the established specifications necessary for consistent performance during its intended use."

The acceptance criteria are implicitly that the device's performance in these tests is comparable to or better than the predicate device and meets established specifications for such devices, ensuring it is "as safe and as effective as the predicate device." However, specific numerical thresholds or comparative data points are not provided in this summary.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for the non-clinical tests. It only states that "All necessary bench testing was conducted." Since the data is from bench testing of the device itself (materials, manufacturing, design), the "data provenance" would be the manufacturing site or testing facility. There is no mention of country of origin of data or whether it was retrospective/prospective in the context of human subjects, as no clinical testing was performed.

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

This question is not applicable. The evaluations were non-clinical bench tests of physical and mechanical properties. There was no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis.

4. Adjudication method for the test set

This question is not applicable. There was no clinical ground truth or human interpretation requiring adjudication.

5. 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

This question is not applicable. The device is a physical intraoperative sizer, not an AI or imaging diagnostic tool. No MRMC study was performed.

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

This question is not applicable. The device is a physical intraoperative sizer, not an algorithm.

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

This question is not applicable in the clinical sense. The "ground truth" for the non-clinical tests would have been industry standards, internal specifications, and performance characteristics of legally marketed predicate devices, against which the new device's material and design properties were compared.

8. The sample size for the training set

This question is not applicable, as no machine learning or AI component is involved, and no clinical training set was used.

9. How the ground truth for the training set was established

This question is not applicable, as no machine learning or AI component is involved, and no clinical training set was used.

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The MENTOR® MemoryShape™ Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ 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 document describes a 510(k) premarket notification for the MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer STERILE. It compares this device to a predicate device (MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer, K131853) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device is substantially equivalent to the predicate device." However, the specific quantitative acceptance criteria for each test are not provided in this document. The document lists the types of tests performed:

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

The document does not explicitly state the sample size used for each non-clinical performance test. It only mentions that "non-clinical performance testing was conducted." The provenance of the data (country of origin, retrospective or prospective) is also not specified.

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

N/A. This is a medical device for surgical sizing, not an AI or diagnostic imaging device that typically requires expert-established ground truth for a test set. The "ground truth" here would be the physical and mechanical properties of the device meeting engineering specifications, verified by laboratory testing.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving expert interpretation, which is not applicable to the non-clinical performance testing described here.

5. 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

N/A. This device is a physical surgical sizer, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is not relevant.

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

N/A. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance testing is based on engineering specifications and established material science properties. The tests (Elongation, Tension Set, Break Force, Patch to Shell Joint Testing, Gel Cohesion, Stability, Sterilization, and Packaging) are designed to confirm that the physical and mechanical characteristics of the device meet predetermined quality and safety standards.

8. The Sample Size for the Training Set

N/A. This is a physical medical device undergoing performance testing, not a machine learning model requiring a "training set."

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

N/A. As mentioned above, a training set is not applicable here.

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The Mentor Resterilizable MemoryShape™ Gel Sizer is indicated for temporary insertion intra-operatively to evaluate the size and shape of the MemoryShape™ breast implant to be implanted.

The Mentor Resterilizable MemoryShape™ Gel Breast Implant Sizer (Gel Sizer) is designed for temporary intraoperative 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 non-sterile to be sterilized prior to initial use and 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.

This document describes the validation of the Mentor MemoryShape™ Resterilizable Gel Sizer, which is a device used to evaluate the appropriate size and shape of breast implants during surgery. The validation process focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data for human or image-based evaluation. The performance data is derived from non-clinical performance testing (physical and material properties). Therefore, the concept of sample size for human users or geographical data provenance is not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for this device's performance is established through physical and material property testing, not expert human evaluation of clinical outcomes or images.

4. Adjudication Method for the Test Set

Not applicable. There is no human-based "test set" or adjudication process described. The performance is determined by meeting pre-determined engineering and material science criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes the testing of a physical medical device (an implant sizer), not a diagnostic or AI-driven system that would involve human readers or comparative effectiveness studies with AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. This document describes the testing of a physical medical device. The concept of an "algorithm only" or a "standalone" performance for human-in-the-loop systems is not relevant.

7. Type of Ground Truth Used

The ground truth used for this study is based on pre-determined engineering and material science specifications and standards. These specifications define the acceptable physical and chemical properties of the device components.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The testing described is for the physical attributes of the product.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, the ground truth establishment for such a set is not relevant. The "ground truth" for the device's performance is founded on established engineering best practices and material science principles.

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The Mentor 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 Resterilizable 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 non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times.

This document describes the validation of the Mentor Resterilizable Gel Breast Implant Sizer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set in the material biocompatibility or physical properties testing. It mentions "materials being used" and "the Sizers."

The data provenance is prospective, as these tests were conducted specifically for the device's clearance. The country of origin is USA, as the manufacturer is Mentor Corporation, located in Santa Barbara, CA and Irving, TX.

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

This information is not provided in the document. The studies described are technical performance tests (biocompatibility, physical integrity, sterilization effectiveness) which typically rely on standardized laboratory testing protocols rather than expert medical interpretation of results for "ground truth."

4. Adjudication Method:

The document does not describe an adjudication method as it's not relevant for the types of technical performance tests conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not performed or described. The device is a physical breast implant sizer, not an AI or imaging diagnostic tool that would typically involve human reader performance comparisons.

6. Standalone Performance:

Standalone performance for the device was performed. The studies focused on the intrinsic properties and performance of the Sizer itself (biocompatibility, physical durability, sterilization effectiveness) without human interaction as part of the primary measurement.

7. Type of Ground Truth Used:

The ground truth used for these studies was based on:

• Standardized laboratory testing protocols and established thresholds: For biocompatibility (ISO 10993), physical properties (design specifications and defined acceptance criteria in a protocol), and sterilization effectiveness (achieving a minimum SAL of 10⁻⁶). This is a form of empirical measurement against defined standards.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device validation. Training sets are typically used for machine learning algorithms. This device is a physical medical device, and its validation relies on engineering and biological safety testing, not AI model training.

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

As there is no training set for a physical device, this question is not applicable.

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The mammary sizer is designed for single use, temporary intraoperative placement in a surgically created pocket. The sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implantation of a mammary prosthesis.

Not Found

This document is a 510(k) clearance letter for a device called "Mammary Sizer." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth details. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the provided text.

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