(15 days)
The Elevate Prolapse Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
The Elevate System is part of the AMS Pelvic Floor Repair System family of devices. It consists of permanently-implanted mesh assemblies and non-implanted surgical instruments that are used as aids to place the mesh assembly in the pelvic floor.
This document is a 510(k) summary for a medical device called the "Elevate Prolapse Repair System with PC Coated IntePro Lite". This is a regulatory submission for a surgical mesh, and as such, it does not describe a study in the way one would for an AI/ML device or diagnostic test.
Instead, the document details a comparison to a predicate device and performance testing to demonstrate substantial equivalence, which is the regulatory pathway for this type of device.
Here's an analysis of the provided text in the context of your request, highlighting where the information is present or not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain existing performance parameters of the predicate device (Elevate Prolapse Repair System with IntePro Lite) post-modification. | "The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised." |
| No new safety or efficacy issues introduced by the addition of the synthetic phosphorylcholine (PC) polymer coating. | "The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised." |
| Functional equivalence to the predicate device in terms of intended use. | The device is "identical to the previous version with the exception of a synthetic phosphorylcholine (PC) polymer coating". Note: The "Supporting Information" section implies a comparison of performance parameters to ensure the modification (PC coating) does not negatively impact existing functions. Specific quantitative performance metrics are not provided in this summary but would have been part of the underlying testing documentation. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this 510(k) summary. The summary refers to "testing" performed but does not quantify the sample sizes for any tests conducted.
- Data Provenance: Not specified. This would typically be internal testing conducted by the manufacturer, American Medical Systems. The nature of the device (surgical mesh) suggests bench testing and potentially in vitro/in vivo animal studies would be used rather than human clinical data in this type of submission for a modification. It is likely prospective testing on material samples or animal models.
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. For a surgical mesh modification, "ground truth" as you'd define it for an AI/ML or diagnostic device (e.g., expert consensus on images) is not relevant. The "ground truth" here is the established safety and performance profile of the predicate device, against which the modified device's performance is compared through engineering and material testing. The experts involved would be engineers, material scientists, and regulatory specialists within the company assessing the test results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for clinical endpoints or image interpretations. For this device, the "adjudication" would involve internal review and approval of the test protocols, results, and conclusions by the manufacturer's R&D, quality, and regulatory departments, followed by FDA's review of the submission.
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 is a physical medical device (surgical mesh), not an AI/ML diagnostic or image analysis tool. Therefore, MRMC studies are not relevant nor performed for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For this type of device, the "ground truth" (or more accurately, the comparator) is the established performance and safety profile of the legally marketed predicate device (Elevate Prolapse Repair System with IntePro Lite). The testing (e.g., mechanical properties, biocompatibility, coating adhesion) aims to demonstrate that the new device meets or exceeds these established parameters and introduces no new risks.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Applicable. This device does not involve a "training set" in the context of AI/ML.
Summary of the Study (as described in the 510(k) summary):
The "study" in this context is a Design Failure Mode Effects and Criticality Analysis (dFMECA) of the modification (adding a PC coating) to the predicate device. This analysis identified potential performance parameters that could be affected by the coating. Subsequently, performance testing was conducted to evaluate these identified parameters. The results of this testing formed the basis for demonstrating that the modified device is substantially equivalent to the predicate. The key finding reported is that: "The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised."
In essence, this is a substantive equivalence demonstration based on engineering and performance testing rather than a clinical efficacy trial or an AI/ML performance study.
§ 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.