(71 days)
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.
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 permanentlyimplanted synthetic 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 is identical to the predicate device AMS Elevate Prolapse Repair System with PC Coated IntePro Lite, with the following exceptions: (1) The anterior needle passer has been modified to add a release mechanism on the handle; and (2) as a result of the anterior needle passer modifications, the connection interface for the tissue fixation elements of the anterior center graft that correspond with the anterior needle passer also changed. The geometry of the internal diameter and the base of the tissue fixation elements changed slightly to accommodate the new shape of the anterior needle tip. There are no changes to the mesh design, shape, size, or material.
The document provided describes a Special 510(k) Device Modification for the AMS Elevate® PC Prolapse Repair System with IntePro® Lite, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that modifications do not raise new questions of safety or effectiveness and primarily relies on non-clinical testing to prove equivalence, rather than extensive clinical studies with human participants.
Therefore, many of the requested categories related to clinical study design, human reader performance, and ground truth establishment from patient data are not applicable in this context.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Equivalence to Predicate | Substantial equivalence to predicate device in terms of safety and effectiveness. | The test results conclude the AMS Elevate PC Prolapse Repair Systems with IntePro Lite to be substantially equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite. |
| Design Verification | N/A (General requirement for device safety and functionality) | Performed, and included in the claim of substantial equivalence. |
| Biocompatibility | N/A (General requirement for implanted devices) | Performed, and included in the claim of substantial equivalence. |
| Sterilization | N/A (General requirement for sterile devices) | Performed, and included in the claim of substantial equivalence. |
| Packaging | N/A (General requirement for maintaining device integrity) | Performed, and included in the claim of substantial equivalence. |
| Product Performance | N/A (General requirement for device functionality) | Performed, and American Medical Systems considers the product performance to be significantly equivalent to the predicate device. |
Explanation of the "N/A" for Acceptance Criteria: The document states that the components were "subjected to testing which included design verification, biocompatibility, sterilization, packaging, and product performance requirements." It does not provide specific quantitative acceptance criteria for each of these tests, but rather states that the results conclude substantial equivalence. In a 510(k) submission, the "acceptance criteria" for these non-clinical tests would typically be defined internally by the manufacturer (e.g., specific tensile strength thresholds, cytotoxicity limits) and compared against the predicate's performance or established standards. The summary statement provides the overall conclusion of meeting these criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (design verification, biocompatibility, sterilization, packaging, product performance), not a clinical test set from patients.
- Data Provenance: Not applicable. The data is generated from laboratory and bench testing of the device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth as typically defined in diagnostic AI/clinical studies (e.g., patient outcomes, pathology) is not relevant for this non-clinical submission. The "ground truth" for the non-clinical tests is established by industry standards, engineering specifications, and comparison to the predicate device's known performance.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" of patient data requiring adjudication in this context.
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 medical device modification notification focused on non-clinical equivalence, not an AI-enabled device or a comparative effectiveness study involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is established by engineering specifications, material science standards, and performance characteristics of the predicate device. For instance, biocompatibility would be assessed against ISO standards, and mechanical performance against the predicate's known capabilities.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this traditional medical device submission.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set" for which ground truth would be established.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a summary of non-clinical testing. This testing included:
- Design Verification: To ensure the modified anterior needle passer and connection interface for tissue fixation elements function as intended and meet design specifications.
- Biocompatibility: To demonstrate that the device materials are safe for implantation.
- Sterilization: To validate the sterilization process ensures the device is sterile.
- Packaging: To confirm the packaging protects the device and maintains sterility during shelf life.
- Product Performance Requirements: To show the device performs mechanically and functionally equivalently to the predicate.
The conclusion of these non-clinical tests "substantially equivalent to the predicate device, AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite" serves as the proof that the device meets the acceptance criteria for a 510(k) modification. The key modifications were the addition of a release mechanism to the anterior needle passer handle and slight changes to the geometry of the internal diameter and base of the tissue fixation elements to accommodate the new needle tip shape. The study demonstrated that these changes did not negatively impact the safety or effectiveness, thus proving substantial equivalence to the legally marketed predicate 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.