(296 days)
The proposed LITE Pelvic Floor Repair Kits are indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The proposed devices were submitted to introduce lightweight versions of previously cleared pelvic floor repair kits: Pinnacle Anterior/Apical, Pinnacle Posterior, Pinnacle Duet and Uphold Vaginal Support System. The proposed mesh configurations were designed for performing transvaginal vaginal wall repair to facilitate treatment of anterior, apical and posterior prolapse repairs. These devices are sterile, single use devices, consisting of one or two light-weight synthetic mesh assemblies and a needle holder.
The mesh assemblies consist of a macroporous polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with needle designed for use with the Capio The Open Access Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.
The provided text from K103426 describes the LITE Pelvic Floor Repair Kits and their substantial equivalence to predicate devices, rather than a study with acceptance criteria for device performance in detecting or diagnosing conditions, or comparing AI assistance with human performance. The "performance testing" mentioned refers to bench testing of the physical characteristics of the mesh, not clinical performance or diagnostic accuracy.
Therefore, many of the requested fields cannot be populated based on the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document describes several mechanical performance tests and biocompatibility tests. It does not provide specific acceptance criteria or quantitative reported values in the format of a table. It states that "The results of the performance testing demonstrate equivalence of the LITE Pelvic Floor Repair kits to the predicate devices." This implies that the LITE kits met the performance characteristics consistent with the predicate devices but doesn't quantify those.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Mesh thickness consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Pore size consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Density consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Tensile strength consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Stiffness consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Burst strength consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Suture pullout strength consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Mesh flexibility consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Tensile strengths of mesh assembly components consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Force to remove leg assemblies from mesh consistent with predicate devices | Demonstrated equivalence to predicate devices. |
| Biocompatibility: | |
| Cytotoxicity within acceptable limits | Demonstrated equivalence to predicate devices. |
| Sensitization within acceptable limits | Demonstrated equivalence to predicate devices. |
| Irritation within acceptable limits | Demonstrated equivalence to predicate devices. |
| Acute systemic toxicity within acceptable limits | Demonstrated equivalence to predicate devices. |
| Sub acute toxicity within acceptable limits | Demonstrated equivalence to predicate devices. |
| Genotoxicity within acceptable limits | Demonstrated equivalence to predicate devices. |
| Implantation response within acceptable limits | Demonstrated equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes bench testing of materials and device components, not a clinical study on a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was bench testing, not an expert-based evaluation of clinical images or data.
4. Adjudication method for the test set
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 document does not mention any MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe an algorithm or AI.
7. The type of ground truth used
For the mechanical and biocompatibility testing, the "ground truth" was established by standardized test methods and validated measurements for the physical and biological properties of the mesh and its components, with predicate device characteristics serving as the benchmark for equivalence.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a 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.