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The GYNECARE PROSIMA* Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

The GYNECARE PROSIMA Anterior, Posterior, and Combined Pelvic Floor Repair Systems consist of pre-cut GYNECARE GYNEMESH PS Mesh Implant(s), and instruments to facilitate Mesh Implant placement and postoperative support.

The provided document is a 510(k) premarket notification for the GYNECARE PROSIMA Pelvic Floor Repair Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics for a novel technology like AI/ML.

Therefore, many of the requested categories are not applicable to this kind of regulatory submission. The document explicitly states that the approval is "Based on the similarities to the predicate devices identified in this submission," rather than a study against a pre-defined performance criterion for the new device.

Here's an attempt to address the request based on the provided text, indicating where information is not applicable:

Acceptance Criteria and Study Analysis for GYNECARE PROSIMA Pelvic Floor Repair Systems

This 510(k) submission for the GYNECARE PROSIMA Pelvic Floor Repair Systems establishes substantial equivalence to predicate devices, rather than demonstrating performance against pre-defined acceptance criteria for a novel device through a clinical study. The "performance data" section focuses on material biocompatibility and functional bench/cadaver testing.

1. Table of Acceptance Criteria and Reported Device Performance

• Mesh Implant: Made from GYNECARE GYNEMESH* PS Nonabsorbable PROLENE* Soft Mesh, identical polymers to current Ethicon product.
• Vaginal Support Device-Balloon Assembly: Provides support to vaginal canal to reduce contracture, stenosis, adhesions; balloon inflated with air (like predicate); made of silicon (like predicate); remains in vaginal canal for up to four weeks (predicate up to twelve weeks).
• Intended Use: For tissue reinforcement and stabilization of fascial structures of the pelvic floor, and maintenance of vaginal canal during healing. |

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

This document does not describe a clinical "test set" with human subjects in the context of an AI/ML algorithm evaluation. The testing mentioned is "bench and cadaver testing." No specific sample sizes for these tests are provided, nor is data provenance in terms of country of origin or retrospective/prospective status for clinical data, as it's not a clinical study.

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

Not applicable. There is no mention of "experts" establishing ground truth for a test set in the context of this 510(k) summary. The evaluation focuses on material properties and functional tests, not diagnostics or interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is mentioned as there is no diagnostic test set requiring human consensus for ground truth.

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

Not applicable. This is not a study involving human readers or AI assistance.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

For the biological reactivity, the "ground truth" (or standard of acceptability) was established by ISO Standard 10993-1. For functional performance, the "ground truth" was whether the device "meets or exceeds all functional requirements," which would be defined by internal engineering specifications or industry standards for mechanical performance. No pathology, outcomes data, or expert consensus serving as ground truth for clinical performance is described.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable.

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