(26 days)
AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite: The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.
AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite: The Elevate PC Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.
The AMS Elevate PC Prolapse Repair Systems with IntePro Lite consist of a mesh assembly, non-implantable needle passers, and other surgical aids that are designed to help place the mesh assembly in the pelvic floor. The devices are identical to the predicate device AMS Elevate PC Prolapse Repair System with the following exception of the modification of the Apical Needle Passer Sheath. There are no changes to the mesh design, shape, size, material or Indications for Use.
The provided text describes a 510(k) premarket notification for a medical device, the "AMS Elevate® PC Anterior and Apical Prolapse Repair System with IntePro® Lite" and "AMS Elevate® PC Apical and Posterior Prolapse Repair System with IntePro® Lite". This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for performance.
Therefore, many of the requested details about acceptance criteria, efficacy studies, sample sizes, expert involvement, and ground truth establishment are not applicable or not found in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This submission is for a modification to a previously cleared device. The focus is on demonstrating that the modifications do not negatively impact safety and effectiveness compared to the predicate device, rather than meeting new, specific quantitative performance acceptance criteria.
The submission states:
- "The test results for design verification, biocompatibility, sterilization, and packaging are virtually equivalent to the predicate device." (Section 2)
- "The proposed Elevate PC Anterior and Elevate PC Posterior device performance and fundamental scientific technology remains unchanged." (Section 2)
2. Sample size used for the test set and the data provenance
Not applicable. No specific 'test set' in the context of an efficacy study is described. The document refers to "test results for design verification, biocompatibility, sterilization, and packaging" (Section 2), implying engineering and materials testing, but does not provide details on sample sizes or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set in the context of device performance or efficacy is described.
4. Adjudication method for the test set
Not applicable. No adjudication method is described.
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 device is a surgical mesh system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical mesh system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth, in the context of an efficacy study, is not described as this is a substantial equivalence submission for a surgical device modification.
8. The sample size for the training set
Not applicable. No training set for an algorithm is described.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is described.
Summary of Device and Rationale for Substantial Equivalence (as provided in the document):
The submission details a change to the AMS Elevate PC Anterior and Apical Prolapse Repair System with IntePro Lite and the AMS Elevate PC Apical and Posterior Prolapse Repair System with IntePro Lite.
The modification is solely to the Apical Needle Passer Sheath (a non-implantable surgical aid). There are no changes to the mesh design, shape, size, material, or Indications for Use.
The rationale for substantial equivalence is based on the following points:
- The devices are identical to the predicate device with the single exception of the Apical Needle Passer Sheath modification.
- There are no changes to the existing indications for use.
- The modifications are deemed equivalent, with no changes to the device indications for use/intended use and/or device functional scientific technology.
- The subject devices use the same surgical approach and mesh placement procedures as the predicate devices.
- Components underwent design verification, biocompatibility, sterilization, and packaging tests, with results "virtually equivalent" to the predicate device.
- The proposed devices have identical indications for use/intended use, identical implant materials, identical sterilization methods, and similar delivery tool materials/characteristics as the predicate.
- The proposed device performance and fundamental scientific technology remain unchanged.
- The differences between the proposed device and the predicate device do not have any negative effect on the safety and effectiveness of the device.
Therefore, the submission asserts that the modified devices are substantially equivalent to their predicate devices, implying that their safety and effectiveness are maintained despite the minor modification. No new clinical or performance studies demonstrating effectiveness against specific acceptance criteria are presented because the modification is considered minor and does not alter the fundamental performance or intended use of the device.
§ 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.