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Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle Y Contour Polypropylene Mesh is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It is designed for the treatment of vaginal vault prolapse. The Y shape design allows the two Y-leg segments to be attached to the anterior and posterior vaginal walls. The base of the Y segment is designed to attach to the sacral ligament.

The provided document is a 510(k) summary for the Restorelle Y Contour Polypropylene Mesh. It is a submission for a Special 510(k), which indicates that the device has the same technological characteristics as a previously cleared predicate device (Restorelle Y Contour, K123914), with only minor changes.

Due to the nature of a Special 510(k) for a surgical mesh, the focus of the submission is on demonstrating that the changes made do not affect the safety or effectiveness of the device compared to the predicate. The "performance data" section explicitly states:

"The changes proposed in this Special 510(K) were evaluated through sterilization validation and packaging integrity testing."

This means there was no clinical study comparing the device's performance in patients, nor was there an AI component. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, expert opinions, and comparative effectiveness studies for an AI/device performance assessment is not applicable to this document.

Here's a breakdown based on the information provided and the nature of this 510(k):

1. Table of acceptance criteria and the reported device performance

   • Acceptance Criteria (for a Special 510(k) on this device type): The primary acceptance criteria for this Special 510(k) revolved around demonstrating that the modified device maintained equivalent sterility and packaging integrity to its predicate device. This is typically assessed against established standards for sterilization validation (e.g., ISO 11137 for radiation sterilization, or other relevant standards for the chosen sterilization method) and packaging integrity (e.g., ASTM F88, F1929, F2096).
   • Reported Device Performance: The document states that the changes "were evaluated through sterilization validation and packaging integrity testing." It then concludes that the device "is substantially equivalent to its proposed predicate device." While specific numerical performance values against the acceptance criteria are not provided in this summary, the FDA's clearance (K140116) indicates that these tests met the required acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • N/A. This 510(k) is for a physical surgical mesh and does not involve a "test set" of data in the context of an AI or diagnostic device. The "testing" involved physical validation of manufacturing processes (sterilization and packaging).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • N/A. Ground truth establishment by clinical experts is not applicable to this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • N/A. Not applicable.

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

   • No. This is a physical surgical mesh, not a diagnostic device involving human readers or AI.

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

   • No. Not applicable to this device.

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

   • N/A. Not applicable. The "ground truth" for this submission would be adherence to validated manufacturing and quality control standards (e.g., successful sterilization, intact packaging) to ensure the device performs as intended and is safe for use.

8. The sample size for the training set

   • N/A. Not applicable. This device does not use a training set as it's not an AI or machine learning product.

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

   • N/A. Not applicable.

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