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The Contour Profile 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 CPX™4 Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

In order to provide these tissue expanders with elasticity and integrity, the shells are made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the devices have integral, silicone elastomer, magnetically detected, injection ports and incorporate a BUFFERZONE® area with self-sealing technology that is attached to the inside of the anterior surface of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The textured shell provides a disruptive surface for collagen interface.

Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. 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.

Suture fixation tabs are incorporated into some models of the MENTOR® CPX™4 Tissue Expanders to give surgeons the option to attach the device to surrounding tissue for enhanced device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

This document is a 510(k) summary for the Mentor CPX™4 Tissue Expander, a physical medical device, not an AI/ML powered software product. Therefore, many of the requested categories in your prompt, which are typically relevant for AI/ML device studies, are not applicable.

Here's an attempt to extract and frame the information based on the provided document, addressing the prompt's specific points where possible, and indicating "N/A" where the information is not relevant or available for a physical device submission:

Acceptance Criteria and Device Performance for Mentor CPX™4 Tissue Expander

This 510(k) summary describes modifications to an existing physical medical device, the Mentor Contour Profile Tissue Expander. The "studies" conducted are non-clinical performance tests to demonstrate substantial equivalence to the predicate device, not clinical trials or AI/ML model performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria:
The document states, "All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device performs as well as or better than the predicate device." The specific numerical or qualitative thresholds for these criteria are not detailed in this 510(k) summary. The overarching acceptance criterion for the submission is demonstrating "substantial equivalence" to the predicate device.

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

• Sample Size: Not explicitly stated as "test set" in the context of an AI/ML model. For non-clinical performance testing of a physical device, this would typically refer to the number of units tested per parameter. This information is not detailed in the 510(k) summary.
• Data Provenance: N/A for AI/ML data provenance. The testing was non-clinical performance testing conducted by the manufacturer, MENTOR Worldwide LLC.

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

N/A. This concept is not applicable to the non-clinical performance testing of a physical product where "ground truth" typically refers to physical measurements and adherence to engineering specifications, rather than expert interpretation of data.

4. Adjudication method for the test set

N/A. Adjudication methods (e.g., 2+1) are common in clinical studies or AI/ML ground truth establishment. For non-clinical performance testing, results are typically determined by adherence to pre-defined specification limits.

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 is a physical medical device, not an AI/ML system, so MRMC studies involving human readers and AI assistance are 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 AI/ML algorithm.

7. The type of ground truth used

For physical device testing, "ground truth" refers to established engineering specifications, performance standards, and the physical properties of the device. The non-clinical testing was based on meeting pre-determined acceptance criteria for parameters like joint strength and leak performance, likely against internal specifications and potentially relevant industry standards.

8. The sample size for the training set

N/A. There is no AI/ML model or "training set" for this physical device.

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

N/A. There is no AI/ML model or "training set" for this physical device. The "ground truth" for physical device manufacturing and testing would be based on validated design specifications and quality control procedures.

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