Search Results

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

Restorelle L Polypropylene Mesh is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a flat mesh measuring 24cm x 8cm and is designed for the treatment of apical vaginal prolapse.

This 510(k) summary for the Coloplast Restorelle® L surgical mesh does not describe a study that involves analyzing device performance based on acceptance criteria in the manner typically seen for AI/ML or diagnostic devices. Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis based on the information provided, specifically addressing your points where possible:

Analysis of Acceptance Criteria and Device Performance Study for Restorelle® L (K122440)

The provided document describes a 510(k) submission for substantial equivalence of the Restorelle® L surgical mesh. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, and often doesn't involve the same kind of performance study with defined quantifiable acceptance criteria as might be expected for an AI/ML or diagnostic device.

The core argument for equivalence is that the Restorelle® L is identical in materials and design to a predicate device (Restorelle® Y), with the only difference being its size, which falls within the range of existing predicate devices. For this reason, the submission states that "Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle L since the proposed mesh is identical in materials and design as that used in the predicate Restorelle Y device. The results and data from these studies are applicable to the Restorelle L device."

Therefore, many of the typical acceptance criteria and study details you'd expect are not explicitly present for the subject device itself in this document, as its performance is inferred from predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, this submission primarily focuses on comparative characteristics for substantial equivalence, rather than a standalone performance study against specific acceptance criteria for the Restorelle® L itself. The "performance" for Restorelle® L is essentially that it matches the properties of its predicate devices, implying equivalent safety and effectiveness.

The study that "proves" the device meets the acceptance criteria is the substantial equivalence comparison to predicate devices. The primary proof is the identical nature of its materials and manufacturing processes to the Restorelle Y, and its size falling within the acceptable range of established meshes.

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

Not applicable for this type of submission. There is no "test set" in the sense of patient data or clinical imagery evaluated against ground truth. The submission relies on comparative physical and material characteristics and the established safety and performance of predicate devices.

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)

Not applicable. No expert review for ground truth was performed for the Restorelle® L in this context. The "ground truth" for its equivalence is based on engineering and material specifications matching predicate devices.

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

Not applicable. See point 3.

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

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

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

Not applicable. This is a medical device (surgical mesh), not an algorithm.

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

The "ground truth" for this substantial equivalence determination is the physical and material specifications and established safety/efficacy profiles of its predicate devices (Restorelle® Y and Vertessa™ Polypropylene Mesh), as previously cleared by the FDA. Specifically, the material composition, pore size, sterilization method, and indications for use being identical to Restorelle® Y, and the dimensions being within an acceptable range.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. See point 8.

Ask a specific question about this device