(13 days)
RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene.
Restorelle™ polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling.
It maintains excellent isotropic properties arising from its knitted construction.
Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body.
The device is supplied sterile.
The Mpathy Medical Devices, Ltd. Restorelle polypropylene mesh is a surgical mesh device. The provided text, a 510(k) summary, does not describe a study involving an algorithm or AI to meet acceptance criteria. Therefore, most of the requested information regarding AI-specific criteria and studies cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and mechanical testing for the physical mesh product itself, not a digital diagnostic or AI device.
Here's a breakdown based on the provided text, highlighting what is (and isn't) present:
| Acceptance Criteria (Not Explicitly Stated for Performance) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Substantially equivalent to predicate Minimesh (K041632 & K053361) |
| Mechanical Testing (Strength, Flexibility, Durability, Surgical Adaptability) | Substantially equivalent to predicate Minimesh (K041632 & K053361) |
| Sterility | Device is supplied sterile. |
| Indication for Use | Same indications as a combination of predicate devices: repair of abdominal wall hernia (including inguinal, femoral, and incisional), uterovaginal prolapse, and other fascial deficiencies requiring support material |
1. A table of acceptance criteria and the reported device performance
(See table above for the general areas of performance comparison). The document states the device has "the necessary strength, flexibility, durability and surgical adaptability" but does not provide specific quantitative metrics or acceptance criteria for these characteristics. The primary performance claim is "substantial equivalence" to predicate devices.
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. This is for a physical medical device (surgical mesh), not a diagnostic algorithm or AI. The testing performed was biocompatibility and mechanical testing of the mesh material itself. The document does not specify sample sizes for these tests, nor the country of origin of testing data.
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, as this is not a diagnostic device or AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic device or AI.
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, a MRMC study was not done. This device is a surgical mesh, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI device. For the physical mesh, the "ground truth" for its properties would be established through standard material and biocompatibility testing per ISO standards or similar, comparing it to the known properties of the predicate devices.
8. The sample size for the training set
Not applicable, as this is not an AI or algorithm.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI or algorithm.
§ 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.