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The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The PliaForm™ Breast Tissue Expander w/ Suture Tabs is designed for breast reconstruction, designed for thinner components and a reduction of reinforcement features and minimized insertion profile. The integrated port design consists of a plastic needle guard and a smaller magnetic element to improve MR compatibility (MR Conditional). The next generation design control technology (DCT) facilitates predictable expansion and is shape-optimized to better match the entire implant portfolio. An improved Bufferzone features a new sheeting-based self-sealing technology that offers protection from inadvertent needle punctures across the entire coverage area, and a more flexible design, which improves the overall device flexibility. An internally fixated injection port reduces device bulkiness. The injection port will incorporate a new plastic needle guard with a silicone backing and smaller magnet with reduced magnetic field strength compared to the Artoura™ breast tissue expander devices. This feature reduction improves device compatibility with MR-CT imaging, and external beam radiation (such as photon beam).

Identification of the injection port site is accomplished by use of the CENTERSCOPE™ 2.0 Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope™ 2.0 device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection port. Injections into the injection port area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs are provided sterile in three styles (Low Height, Medium Height, and Tall Height) and various sizes.

The following accessories are packaged with the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs:

• Centerscope™ 2.0 Magnetic Injection Port Finder
• Winged Infusion Set (21G)

The provided FDA 510(k) clearance letter is for a physical medical device, the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs, and not for an AI/software as a medical device (SaMD).

Therefore, the requested information regarding AI/SaMD specific aspects like:

• A table of acceptance criteria and reported device performance for an AI model
• Sample sizes, data provenance, expert ground truth, adjudication methods for training and test sets of an AI model
• Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance for an AI model
• Type of ground truth and how it was established for training and test sets of an AI model

cannot be extracted from this document.

The document describes acceptance criteria and studies for a physical medical device, focusing on its mechanical properties, biocompatibility, and compatibility with imaging modalities (MR/CT/RT).

Here's the information that can be extracted, tailored to the context of a physical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs

This document describes the premarket notification for a physical medical device, the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs. The acceptance criteria and supporting studies are focused on the device's physical and material performance, safety, and compatibility, rather than the performance of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that all mechanical performance testing results met their pre-determined acceptance criteria. While specific numerical acceptance criteria (e.g., minimum bond strength in Newtons) are not explicitly detailed in the summary, the categories of tests and the conclusion that they were met serve as the reported performance against the criteria.

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

The document does not explicitly state the sample sizes for each mechanical, biocompatibility, or MR/CT/RT test. For a physical device, testing is typically done on a defined number of manufactured units to demonstrate design validation and manufacturing quality. The data provenance is derived from these laboratory tests, not from patient data, and is prospective based on manufacturing and testing protocols. No specific country of origin for test data is mentioned, as is common for laboratory-based performance testing of medical devices.

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

This question is not applicable in the context of this device. "Ground truth" for a physical device is established through engineering specifications, material science principles, and adherence to industry standards (e.g., ASTM F1441-03 for soft-tissue expanders). The "experts" involved would be engineers, material scientists, and quality assurance personnel responsible for designing, manufacturing, and testing the device against these objective criteria.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or AI evaluations to resolve discrepancies in human interpretations or expert annotations. For physical device testing, results are typically quantitative and objectively measured against pre-defined engineering thresholds. Deviations from these thresholds would be considered failures, not subject to subjective adjudication.

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

Not applicable. MRMC studies are used to assess the diagnostic performance of human readers, often comparing performance with and without AI assistance. This document pertains to a physical implantable device, not a diagnostic AI system or an imaging modality.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

Not applicable. This device is not an algorithm or AI system. Its "performance" is inherent to its physical properties and function when implanted.

7. The Type of Ground Truth Used

The "ground truth" for this physical device is defined by:

• Engineering Specifications: Design parameters, material properties, and functional requirements established during product development.
• Industry Standards: Compliance with recognized standards such as ASTM F1441-03 for soft-tissue expanders.
• Biocompatibility Standards: Adherence to ISO 10993 series for medical device biocompatibility.
  All test methods measure against these predefined, objective criteria.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI model requiring a training set. Its design and manufacturing processes are developed through engineering R&D, not machine learning.

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

Not applicable. As this is not an AI model, there is no "ground truth for a training set." The design and manufacturing are based on established engineering principles, material science, and regulatory requirements.

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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™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastection of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer identical to the predicate device (K241918). Again, identical to the predicate device, the subject device contains superior and anterior reinforcement which allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with self-sealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet. This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.

This FDA 510(k) premarket notification is for the Mentor™ CPX™4 PLUS Enhance Breast Tissue Expander, which is a medical device for breast reconstruction. The submission is specifically to expand the lower limit fill volume of the device from 930cc to 850cc, aligning it with a predicate device (K152496).

Based on the provided text, here's a description of the acceptance criteria and the study that demonstrates the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

No new test set was used for this 510(k) submission. The submission relies on the established performance of the predicate device (K241918) and the equivalence of the materials and design. The change is solely to expand the lower limit of the fill volume range.

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

Not applicable, as no new clinical or performance test set was described for this specific submission. The submission leverages the prior clearance of predicate devices, which would have undergone their own testing and validation processes.

4. Adjudication Method for the Test Set:

Not applicable, as no new test set requiring expert adjudication was described for this specific submission.

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

No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not a diagnostic imaging AI algorithm that would typically be evaluated with MRMC studies.

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

Not applicable, as this is a physical medical device (breast tissue expander), not an algorithm or AI software.

7. The Type of Ground Truth Used:

For the original predicate device clearances on which this submission relies, the ground truth for mechanical performance would have been established through objective measurement of physical properties and performance benchmarks (e.g., pressure testing, leak testing) according to ASTM standards. Biocompatibility ground truth would be established through established biological evaluation tests based on ISO 10993.

8. The Sample Size for the Training Set:

Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.

Summary of the Study Proving the Device Meets Acceptance Criteria for this specific 510(k):

The submission for the Mentor™ CPX™4 PLUS Enhance Breast Tissue Expander with fill volumes from 850cc to 1445cc does not describe new studies or new acceptance criteria. Instead, it presents a special 510(k) where the core argument for meeting acceptance criteria is that:

1. Identical Technology and Materials: The proposed device has the same scientific technology, principles of operation, intended use, indications for use, and all patient contact materials as the cleared predicate device (K241918).
2. Worst-Case Mechanical Testing Already Performed: Previous mechanical testing on the predicate device (K241918) was conducted at the maximum labeled fill volume of 1445cc. This volume represents the "worst case" for overexpansion and bladder leak testing, as it results in the most internal pressure.
3. No Impact of Lower Fill Volume: Reducing the lower limit fill volume from 930cc to 850cc does not adversely affect the mechanical performance (overexpansion and bladder leak) already demonstrated at the worst-case 1445cc. Therefore, no new mechanical testing was deemed necessary.
4. Established Biocompatibility: Since all patient contact materials are identical to the predicate device, which has already established biocompatibility, no new biocompatibility testing was required for this submission.

In essence, the "study" proving the device meets acceptance criteria for this particular submission is the analysis of device equivalence and the justification that prior testing on the predicate device at its most challenging parameters (highest fill volume) sufficiently covers the slightly expanded range offered by the subject device (lower fill volume).

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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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The Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with selfsealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet, This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.

Identification of the injection dome site can be accomplished by use of the CENTERSCOPE™ Magnetic Injection Port Locator provided with the Tissue Expander. Instructions for use of the CENTERSCOPE™ Magnetic Injection Port Locator are provided within this document. Injections must be made using sterile, pyrogen-free Sodium Chloride U.S.P. Solution and into the injection dome area. If injections are made on or outside the injection dome, leakage can occur.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander gives surgeons the option to attach the device to surrounding tissue to enhance device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander, Catalogue Number SCPX-15TH-E, provides fill volume options from 930 cc to 1445 cc.

The following accessories are packaged with the CPX™4 PLUS Enhance Breast Tissue Expander:

• Centerscope Magnetic Injection Port Finder .
• Winged Infusion Set .

The provided text describes the 510(k) premarket notification for the MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's clinical performance. As such, information regarding acceptance criteria for AI/algorithm performance, sample sizes for test and training sets, expert qualifications, or multi-reader multi-case studies is not applicable to this document.

The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by biocompatibility and mechanical testing.

Here's a breakdown of the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related)

The document mentions acceptance criteria related to mechanical testing, but the specific numerical criteria are not detailed. It only states that the results met the pre-determined acceptance criteria.

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

Not applicable. This is not a study involving a "test set" of data in the context of an AI/algorithm. The device underwent physical and material testing.

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

Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm.

4. Adjudication Method

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not an AI/algorithm.

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

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

7. The Type of Ground Truth Used

Not applicable.

8. The Sample Size for the Training Set

Not applicable.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the Provided Text):

The device (MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander) demonstrates that it meets acceptance criteria through:

• Biocompatibility Testing: The device utilizes materials identical to a previously cleared predicate device for permanent tissue contact. This indicates that the materials have already met biocompatibility standards and no new testing was required.
• Mechanical Testing: Specific mechanical tests were conducted in accordance with ASTM F1441-03, "Standard Specification for Soft-Tissue Expanders." These tests evaluated parameters such as overexpansion and bladder leak. The document states that all results met pre-determined acceptance criteria, thus demonstrating substantial equivalence to the predicate device. The changes specifically addressed in this testing were the change to a smooth surface and the addition of three suture tabs, which impacted the connection of external components (Base and Injection Dome) to the shell surface.

The "study" described is primarily a series of engineering and materials tests demonstrating that the modified physical device (with a smooth surface and additional suture tabs) maintains the same safety and performance characteristics as its predicate devices, especially regarding its physical integrity and material compatibility.

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The CPX 14 Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The CPX™4 Tissue Expanders with Smooth Surface consist of a silicone elastomer shell, with superior and anterior reinforcement that allows for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The CPX™4 Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The CPX™4 Tissue Expanders with Smooth Surface are provided sterile. The devices are provided in three styles (Low, Medium and Tall) and in various sizes. The following accessories are packaged with the CPX™4 Tissue Expanders with Smooth Surface: Centerscope Magnetic Injection Port Finder, Winged Infusion Set.

This document is a 510(k) Premarket Notification for a medical device (breast tissue expander). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI device meets specific acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment will not be found in this document.

However, I can extract information related to the device's
mechanical testing performance and the acceptance criteria for those tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria values (e.g., specific force in N, volume thresholds) are not provided in this summary, only that they were "pre-determined" and met.

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

• Sample Size: Not explicitly stated. The document mentions "mechanical testing was conducted on the modified device." It does not specify the number of devices or test repetitions.
• Data Provenance: Not applicable in the context of clinical data for AI. This is a report on mechanical bench testing for a physical device.

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

• Not applicable. This relates to mechanical bench testing, not image analysis or clinical diagnosis where expert ground truth would be established. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication Method for the Test Set

• Not applicable. This relates to mechanical bench testing. Adjudication methods are typically used for subjective human assessments, e.g., in clinical trials or image labeling.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. This document is not about an AI device. It's about a physical medical implant (a breast tissue expander).

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

• No. This is not an AI device.

7. The Type of Ground Truth Used

• Engineering/Physical Measurements: The "ground truth" for this device's performance is derived from standardized mechanical testing (specifically, ASTM F1441-03 for soft-tissue expanders) and risk analysis procedures. The results are objective measurements of physical properties (joint strength, overexpansion).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI device, so there is no "training set."

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

• Not applicable. There is no training set as it's not an AI device.

Summary of what the document addresses regarding the device:

The document focuses on demonstrating that the modifications to the CPX™4 Breast Tissue Expander (specifically, a smooth surface instead of textured and increased suture tabs) do not negatively impact its safety and effectiveness compared to the predicate device. This is primarily done through:

• Comparison of Technological Characteristics: Stating that the fundamental technology, principles of operation, intended use, and indications for use remain the same.
• Mechanical Testing: Bench testing was performed to evaluate parameters related to "joint strength and overexpansion" according to ASTM F1441-03. The key finding is that "All mechanical performance testing results met their pre-determined acceptance criteria."
• Biocompatibility Assessment: Confirming that all patient-contact materials are identical to the predicate device, thus new biocompatibility testing was not warranted.

The "acceptance criteria" are implied to be the thresholds or standards outlined in the ASTM F1441-03 standard and Mentor's internal design control procedures for mechanical performance, which the modified device successfully met.

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The Mentor® ArtouralM Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectony, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface consist of a silicone elastomer shell, with interior structural elements to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface are provided sterile in two styles (High and Ultra High) and various sizes. The following accessories are packaged with the MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface: . Centerscope Magnetic Injection Port Finder . Winged Infusion Set

The provided text describes the 510(k) summary for the MENTOR® ARTOURA™ Breast Tissue Expanders with Smooth Surface. It details the device, its intended use, and a comparison to a predicate device, focusing on mechanical testing and biocompatibility.

Here's the information broken down as requested:

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 for the mechanical testing (test set) in terms of number of devices tested. It mentions that testing was conducted on "the modified device."

• Sample Size: Not explicitly stated.
• Data Provenance: Not specified, but generally, such testing would be conducted in-house by the manufacturer (Mentor Worldwide LLC). The document does not indicate country of origin of data or whether it was retrospective or prospective.

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

This information is not applicable as the study described is for a medical device (breast tissue expander) and involves mechanical and biocompatibility testing, not diagnostic performance where expert ground truth would be established.

4. Adjudication Method for the Test Set

This information is not applicable for mechanical and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of results by multiple experts.

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 information is not applicable. The device is a breast tissue expander, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

This information is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

For mechanical testing, the "ground truth" is typically defined by pre-determined acceptance criteria based on established engineering standards (like ASTM F1441-03) and risk analysis. For biocompatibility, the "ground truth" is that the materials are safe for human implantation, established by prior testing and regulatory clearance of the predicate device's materials.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical and biocompatibility testing for a medical device like a breast tissue expander.

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

This information is not applicable for the same reason as point 8.

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The CPX4 (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastection of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The Mentor® CPX™4 Breast Tissue Expander consists of a silicone elastomer shell, with superior and anterior reinforcement to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE@area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE®is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE®Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the CENTERSCOPE® device is placed on top of the skin, the magnetic arm points to the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The Mentor® CPX™4 Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The Mentor® CPX™4 Breast Tissue Expander are provided sterile and deflated. The proposed Mentor® CPX™4 Breast Tissue Expander is provided in Tall Height Style with fill volume range from 850 cc to 1445 cc.

This document is a 510(k) premarket notification for the Mentor® CPX™4 Breast Tissue Expanders. It describes the device, its intended use, and substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the mechanical testing or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "testing was conducted on the modified device," implying internal testing.

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

Not applicable. This is a medical device submission, primarily focused on mechanical and biocompatibility performance, not diagnostic accuracy requiring expert panel review for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The testing described is objective mechanical and material testing, not subjective assessment requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not an AI diagnostic tool.

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

Not applicable, as this is a medical device, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993-1, which are international standards for biological evaluation of medical devices.

For mechanical testing, the ground truth is established by meeting the requirements of ASTM F1441-03, which is a standard specification for soft-tissue expanders. This involves objective measurements of physical properties like resistance to overexpansion and leak integrity.

8. The Sample Size for the Training Set

Not applicable. This document refers to the evaluation of a physical medical device. There is no "training set" in the context of an AI algorithm here.

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

Not applicable. There is no training set for this type of medical device evaluation.

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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 Artoura (TM) Breast Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The Mentor® Artoura™ Breat Tissue Expander consists of a silicone elastomer shell, with interior structural elements to allow for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE®is intended to minimize and/or prevent leakage in the event of an accidental needle puncture.

Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

The Mentor® Artoura™ Breast Tissue Expander incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The Mentor® Artoura™ devices are provided sterile in various styles and sizes.

The following accessories are packaged with the Artoura™ Tissue Expander:
. Centerscope Magnetic Injection Port Finder
. Winged Infusion Set

Here's a breakdown of the acceptance criteria and the study that proves the device (Mentor® Artoura™ Breast Tissue Expander) meets them, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain an independent clinical study to establish detailed efficacy or safety metrics in the same way a PMA (Premarket Approval) application would. Therefore, the "acceptance criteria" here are geared towards demonstrating equivalence and safety, not a detailed performance study with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

• Joint strength
• Leak performance
• Other performance characteristics | "All mechanical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the proposed device is substantially equivalent to the predicate device." (Specific values for joint strength, leak performance, etc., are not provided in this summary but are stated to have passed). |
  | Compliance with Standards | Testing performed in accordance with ASTM F1441-03, Standard Specification for Soft-Tissue Expanders. | Mechanical testing was conducted "in accordance with ASTM F1441-03." |
  | Technological Characteristics | Maintenance of same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device (K142998). | "The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, CPX™ Control Breast Tissue Expander (K142998)." (The only changes relate to size/dimensions and brand name). |
  | Substantial Equivalence | Demonstrate substantial equivalence to the predicate device, Mentor® CPX™ Control Breast Tissue Expander (K142998), despite minor modifications (size/dimensions). | "The Mentor® Artoura™ Breast Tissue Expander is substantially equivalent to the predicate device, Mentor®CPX™ Control Breast Tissue Expander (K142998). The Artoura® Breast Tissue Expander has the same indications for use, operating principle and technological characteristics as the predicate device. Performance evaluations demonstrate that the subject device is substantially equivalent to the predicate device." |

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

The provided document describes non-clinical (bench) testing for mechanical performance and biocompatibility.

• Sample Size for Test Set: Not explicitly stated as a number of devices in batches, but the testing was performed on the "modified device." This would typically involve a statistically appropriate number of devices to demonstrate reliability for batch release or design verification.
• Data Provenance: The data is generated from internal laboratory testing conducted by Mentor Worldwide LLC, as part of their design control procedures and in support of their 510(k) submission. It's essentially prospective internal testing for regulatory submission purposes. No information is provided regarding the country of origin or whether it's retrospective.

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

This type of information is not applicable to this 510(k) submission for a breast tissue expander. The "ground truth" for mechanical testing is established by technical specifications, engineering standards (like ASTM F1441-03), and validated test methods, not by expert human interpretation like in diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, particularly in imaging or diagnostic AI, where ambiguous cases are resolved by multiple human experts. For mechanical and biocompatibility testing of a medical device, the results are typically quantitative measurements or qualitative observations against predefined criteria, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI systems where human readers interpret patient data (e.g., images). The Artoura™ Breast Tissue Expander is a physical implant used for reconstruction, not a diagnostic tool requiring interpretation by multiple readers. The evaluation here is based on physical and material properties.

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

Not applicable. This device is a physical implant, not an algorithm or an AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

For the mechanical and biocompatibility testing, the "ground truth" is established by:

• Engineering Specifications and Design Requirements: The device must perform within predefined limits for parameters like joint strength and leak performance.
• Established Industry Standards: Specifically, ASTM F1441-03 ("Standard Specification for Soft-Tissue Expanders") serves as a benchmark for acceptable performance.
• Material Equivalence: For biocompatibility, the ground truth relies on the previously established biocompatibility of identical materials used in the predicate device.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train machine learning models. This device is not an AI/ML product; it's a physical medical device. Therefore, there is no training set in this context. The "design" and "development" of the device are based on engineering principles and material science, not data training.

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

Not applicable. As there is no training set for this physical device, the concept of establishing ground truth for it does not apply.

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