(91 days)
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
| Acceptance Criteria (Not explicitly stated as such for this device) | Reported Device Performance |
|---|---|
| Biocompatibility: Acceptable for intended use (implied by ISO 10993-1) | "Biological reactivity of the materials has been assessed using methods specified in ISO Standard 10993-1, with results to date demonstrating that the materials are acceptable for the intended use." |
| Functional Performance (Bench & Cadaver): Meets or exceeds all functional requirements | "Results of functional performance testing (bench and cadaver testing) indicate that the proposed device meets or exceeds all functional requirements." |
| Substantial Equivalence: Similar technological characteristics to predicate devices | The document extensively details the similarities: |
- 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.
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.