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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.

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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

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.

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