(76 days)
Restorelle Y Contour 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 Contour is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a Y shaped mesh that is designed for the treatment of apical vaginal prolapse.
The provided text is a 510(k) summary for a medical device (Restorelle® Y Contour, a surgical mesh) and does not contain information about acceptance criteria or a study proving device performance using AI or clinical outcomes data. This document is focused on demonstrating substantial equivalence to a predicate device based on material, design, and intended use.
Therefore, many of the requested categories related to AI models and clinical studies cannot be populated from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance in the context of an AI model or clinical trial with specific performance metrics are provided. The document focuses on demonstrating equivalence to a predicate device.
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. No test set for an AI model or clinical study data is reported.
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 ground truth established by experts for a test set is reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is reported.
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. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the context of an AI model or clinical study is reported. The regulatory filing establishes "ground truth" through comparison to an existing predicate device based on its established safety and efficacy.
8. The sample size for the training set
Not applicable. No training set for an AI model is mentioned.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is mentioned.
Summary of available information from the document:
This 510(k) submission for the Restorelle® Y Contour surgical mesh demonstrates substantial equivalence to a predicate device (Restorelle® Y), rather than providing novel performance data from a specific study against acceptance criteria.
The basis for equivalence is primarily due to:
- Identical materials: Non-absorbable, monofilament polypropylene mesh.
- Identical intended use: As a bridging material for sacrocolposuspension/sacrocolpopexy for vaginal vault prolapse.
- Identical technological characteristics except for a minor dimension change (sacral flap reduced from 4 cm to 3 cm).
- Identical pore size and sterilization method.
The manufacturer states: "Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle Y Contour 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 Contour device."
Therefore, the "proof" the device meets implied safety and effectiveness criteria is by demonstrating it is functionally the same as a previously cleared device. No new studies were conducted or reported for this submission to establish new performance metrics.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.