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Vertessa™ Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Vertessa Lite Y-Mesh is designed to be used in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa Lite Y-Mesh is provided sterile and is comprised of non-absorbable macroporous monofilament polypropylene warp knit blue mesh in a y-shape design.

The provided text is a 510(k) summary for the Vertessa Lite Y-Mesh device, which is a surgical mesh for treating vaginal vault prolapse. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with a detailed performance analysis as might be done for an AI/ML device.

Therefore, many of the requested elements are not applicable or cannot be extracted from this type of document. This document outlines bench and failure mode testing and biocompatibility testing to show substantial equivalence, but it does not describe a study involving human subjects or AI/ML performance.

Here's an attempt to address your points based on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding "device performance" in the way one might expect for a clinical study with a primary endpoint. Instead, it lists various mesh characteristics that were assessed and states that the device "passed all testing requirements" or "demonstrates substantial equivalence."

Study Description: Substantial Equivalence Evaluation

The study described is an evaluation to demonstrate substantial equivalence of the Vertessa Lite Y-Mesh to two predicate devices: Alyte Y-Mesh Graft (K101722) by C.R. Bard, Inc. and Restorelle Y-Mesh (K112322) by Coloplast A/S. This evaluation was based on non-clinical bench testing, simulated use, surgeon feedback, and validation testing, in accordance with FDA guidance documents for surgical mesh.

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

• Sample Size (Test Set): Not specified. The document mentions "non-clinical bench, simulated use, surgeon feedback and validation testing," but does not provide specific sample quantities for these tests (e.g., number of mesh samples tested for tensile strength, number of surgeons providing feedback).
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal to Caldera Medical or conducted by contracted labs validating performance against established standards and predicate devices. The study is non-clinical as it involves laboratory and bench testing, not patient data.

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

• Number of Experts: Not specified. "Surgeon feedback" is mentioned, but the number of surgeons, their qualifications, or how their feedback was used to establish a "ground truth" (as typically understood in AI/ML contexts) for performance metrics is not detailed.
• Qualifications: "Surgeon" is the only qualification mentioned.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML product requiring diagnostic output adjudication. The evaluation involved testing physical and material characteristics against standards and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. This type of study is typically performed for diagnostic devices, especially those incorporating AI, to assess reader performance with and without AI assistance. The Vertessa™ Lite Y-Mesh is a surgical implant, not a diagnostic device.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done? Not applicable in the context of AI/ML algorithms. The device itself is the physical mesh. Its performance (e.g., tensile strength, biocompatibility) is evaluated directly, which could be considered "standalone" in the sense that its inherent properties are tested independent of user interaction during the test, but this is not analogous to an AI algorithm's standalone performance.

7. Type of Ground Truth Used

The "ground truth," in this context, is primarily derived from:

• Established Mechanical and Material Specifications: Performance characteristics (e.g., tensile strength, pore size, stiffness) are compared against known properties of the predicate devices and general standards for surgical mesh.
• Biological Safety Standards: Biocompatibility testing results are compared against established FDA guidance and ISO standards (e.g., ISO-10993).
• Sterilization and Shelf Life Standards: Testing results are compared against FDA guidance and ASTM standards (e.g., ASTM F-1980-07).
• Predicate Device Performance: The "truth" for demonstrating substantial equivalence is the existing, legally marketed predicate devices' performance and characteristics.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable, as there is no training set for this type of medical device.

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