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The Pinnacle LITE Pelvic Floor Repair Kit is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior vaginal vault prolapse.

The Uphold LITE Vaginal Support System is indicated for tissue reinforcement in women with pelvic organ prolapse, for the transvaginal repair of anterior and apical vaginal wall prolapse.

The proposed devices were submitted for a leg assembly modification to the previously cleared LITE Pelvic Floor Repair Kits: Pinnacle LITE Posterior and Uphold LITE Vaginal Support System. The modification to the leg assembly removes the mesh tack welds, separator weld and adds a second leader loop to maintain the mesh leg location within the sleeve to facilitate mesh leg placement. There are no changes to the mesh design, shape, size, material or indications for use.

The proposed mesh configurations were designed for performing transvaginal vaginal wall repair to facilitate treatment of anterior apical and posterior prolapse repairs. These devices are sterile, single use devices, consisting of one lightweight synthetic mesh assembly and a needle holder.

The mesh assembly consists of a macroporous polypropylene knitted mesh body with integrated legs that are protected by disposable polymer sleeves. At the distal end of the disposable polymer sleeve is a lead with dart designed for use with the Capio™ Suture Capturing Device. The disposable lead was designed to facilitate the passage of the proposed mesh through bodily tissues for placement.

The provided text describes a 510(k) summary for the Boston Scientific Pinnacle LITE Pelvic Floor Repair Kit, Posterior, and Uphold LITE Vaginal Support System. The submission is for a modification to an already cleared device, specifically a change in the leg assembly.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for each of the performance tests (Leg Assembly Flexibility, Mesh/Leg Tensile, Leader/Dilator/Sleeve Tensile, Sleeve Removal).

The data provenance is bench evaluation (laboratory testing) conducted by Boston Scientific. The text does not mention any human clinical data, retrospective or prospective studies, or country of origin for such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the provided study involves bench testing of device components, not a clinical study requiring expert assessment for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the provided study involves bench testing, not an assessment requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The study described is a bench evaluation of physical device characteristics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as the device is a surgical mesh, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the bench tests would be the pre-defined engineering specifications and performance characteristics of the predicate device. The goal was to prove "equivalence" to the predicate, meaning the modified device performs similarly within acceptable tolerances for these physical and mechanical properties.

8. The Sample Size for the Training Set:

This question is not applicable as the study did not involve machine learning or AI, and therefore no training set.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as above.

Summary of the Study:

The study described is a bench evaluation to demonstrate substantial equivalence of a modified surgical mesh device (Pinnacle LITE Pelvic Floor Repair Kit, Posterior and Uphold LITE Vaginal Support System) to its predicate device. The modification was solely to the "leg assembly" of the device, specifically removing mesh tack welds and a separator weld, and adding a second leader loop to facilitate mesh leg placement. No changes were made to the mesh design, shape, size, material, or indications for use.

The study involved four types of performance testing:

• Leg Assembly Flexibility
• Mesh/Leg Tensile Strength
• Leader/Dilator/Sleeve Tensile Strength
• Sleeve Removal Performance

The results of these tests indicated that the modified device performed equivalently to the predicate device in these aspects. This bench testing was deemed sufficient to support the claim that the modified device is as safe, as effective, and performs as well as the predicate devices, thereby establishing substantial equivalence for 510(k) clearance.

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