(49 days)
Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.
Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.
Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.
Each Elevate System consists of a permanently-implanted graft and non-implantable surgical instruments that can be used as aids to transvaginally place the graft assembly in the pelvic floor. The graft assemblies for the Elevate Anterior & Apical Prolapse Repair System and Elevate Apical & Posterior Prolapse Repair System are made from polymeric mesh (IntePro Lite), and in the case of the Elevate Apical & Posterior Prolapse Repair System with InteXen LP, the graft assembly is made from a combination of lyophilized porcine dermis and polymeric mesh (IntePro Lite).
The devices are identical to the predicate devices, AMS Elevate Prolapse Repair Systems, with the exception of the modification to the Apical Needle Passer Sheath. There are no changes to the implant graft design, shape, size, and material. The revisions to the indications for use of the modified devices are to further clarify the intended use of Elevate System as a kit for transvaginal surgical treatment.
The provided document, K121612, is a 510(k) summary for the Elevate® Anterior and Apical Prolapse Repair System, Elevate® Apical and Posterior Prolapse Repair System, and Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP. This document states that the devices are substantially equivalent to their predicate devices and focuses on non-clinical testing for a modified sheath component. It explicitly states that no clinical testing was required. Therefore, a study demonstrating device performance against acceptance criteria in a clinical setting, including details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.
The document primarily addresses the substantial equivalence of the modified devices to their predicates based on manufacturing process and design verification of a component (sheath).
Here's a breakdown of the available information from the document related to testing, recognizing that it does not provide the clinical study details requested:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical study demonstrating device performance against acceptance criteria is described, a direct table cannot be created as requested. The document focuses on performance of a modified sheath through non-clinical testing.
| Acceptance Criteria (for modified sheath) | Reported Device Performance (Non-Clinical) |
|---|---|
| Sheath compression strength | Tested |
| Sheath depth stop strength | Tested |
| Trigger/sheath locking interface push strength | Tested |
| Sheath cutout shear off strength | Tested |
| Trigger/sheath locking interface pull strength | Tested |
| Sheath engagement force into lock | Tested |
| Biocompatibility (cytotoxicity & physiochemical testing) | Tested |
Note: The document only states that these tests were performed and that the modified devices are considered substantially equivalent, implying the tests met their internal acceptance criteria for design verification. No specific numerical results or thresholds are provided in this summary.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of clinical performance. For the non-clinical design verification tests of the sheath, the sample sizes are not specified.
- Data Provenance: Not applicable for a clinical study. For design verification, the data would be laboratory-generated from American Medical Systems, Inc.
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 was established by experts from a clinical study for this 510(k) submission.
4. Adjudication method for the test set
Not applicable. No clinical test set or human 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
No MRMC comparative effectiveness study was done, nor is there any mention of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a surgical mesh kit, not an algorithm or an AI-based system.
7. The type of ground truth used
Not applicable in the context of clinical performance. The "ground truth" for the non-clinical testing was defined by the specifications and parameters of the design verification tests for the components.
8. The sample size for the training set
Not applicable. This document describes a surgical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (and why no clinical study is presented):
The document K121612 outlines that the device (Elevate® Prolapse Repair Systems) underwent a 510(k) submission for a modification to an existing, legally marketed device. The modification was specifically to the "Apical Needle Passer Sheath" component.
The core of the submission relies on demonstrating substantial equivalence to the predicate devices (K082677, K082730, and an unnamed system). The rationale is that:
- There were "no changes to the implant graft design, shape, size, and material."
- There were "no modifications made to the packaging or sterilization."
- There was "no change to the intended use or the implant procedure."
Therefore, the only testing required was non-clinical design verification and biocompatibility testing for the modified sheath. These tests included:
- Sheath compression strength and depth stop strength.
- Trigger/sheath locking interface push strength.
- Sheath cutout shear off strength and trigger/sheath locking interface pull strength.
- Sheath engagement force into lock.
- Cytotoxicity & physiochemical testing for biocompatibility.
The document explicitly states: "no clinical testing was required to support the sheath modification" because "the Elevate Prolapse Repair Systems have equivalent clinical performance to the predicate devices." The acceptance criteria for these non-clinical tests would have been internal design specifications to ensure the modified sheath performed as intended and did not negatively impact the safety or effectiveness of the overall device compared to the predicate. The document concludes that based on these non-clinical tests and the unchanged nature of the implant and procedure, the modified devices are "substantially equivalent to the predicate devices."
§ 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.