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X-RepairSL is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

X-RepairSL is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

X-RepairSL is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

The X-RepairSL is a bioabsorbable, rectangular, single-layered, flexible, woven surgical mesh manufactured from poly-i-lactic acid (PLLA) fiber. It has locked top and bottom edges and welded ends. It is provided sterile, intended for single use, and labeled non-pyrogenic.

This document describes the premarket notification (510(k)) for the X-RepairSL surgical mesh. The purpose is to demonstrate substantial equivalence to a predicate device, the X-Repair (K083307).

1. Table of Acceptance Criteria (Performance Goals) and Reported Device Performance

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

The document states "Bench testing was conducted to evaluate the tensile strength and suture pullout strength of the subject device." However, it does not specify the sample size used for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective); it's implied to be laboratory-based bench testing.

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

This information is not applicable as the summary describes bench testing of a physical device, not an AI/software device that requires expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the summary describes bench testing of a physical device, not an AI/software device that typically involves adjudication of expert interpretations.

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

A MRMC comparative effectiveness study was not conducted as this is a physical device (surgical mesh), not an AI/software device intended for diagnostic assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not conducted as this is a physical device, not an algorithm. The performance described is the intrinsic physical properties of the surgical mesh.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the measured physical properties of the surgical mesh and its packaging, as determined by standardized engineering and material testing methods. This includes:

• Tensile strength measurements
• Suture pullout strength measurements
• Sterile barrier integrity testing
• Mechanical property retention over time (shelf life testing)

8. Sample Size for the Training Set

This information is not applicable as the device is a physical surgical mesh and does not involve an AI algorithm with a training set.

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

This information is not applicable as the device is a physical surgical mesh and does not involve an AI algorithm with a training set.

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X-Repair is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

X-Repair is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

X-Repair is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

The X-Repair is a bioabsorbable, rectangular, double-layered, flexible, woven surgical mesh manufactured from poly-l-lactic acid (PLLA) fiber. It has locked top and bottom edges and welded ends. It is provided sterile, intended for single use, and labeled non-pyrogenic.

The provided text describes a 510(k) summary for the Synthasome X-Repair surgical mesh. However, it does not contain the specific details required to populate a table of acceptance criteria, reported device performance measurements, study design specifics (like sample sizes for test and training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods), or any information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document focuses on:

• Device Description: Bioabsorbable, rectangular, double-layered, flexible, woven surgical mesh from PLLA.
• Intended Use: Reinforcement of soft tissue where weakness exists, specifically for tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps).
• Comparison to Predicate Devices: Similar intended use, but different material (PLLA vs. Artelon™ or Vicryl). The document states these differences "do not raise new types of safety or effectiveness questions."
• Summary of Performance Data (General Statement): "The results of performance testing, including biocompatibility, mechanical, and animal testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use and do support a determination of substantial equivalence."

Therefore, I cannot provide the detailed information requested in your bullet points because it is not present in the provided text. The document only offers a high-level statement about performance testing without specific criteria or results.

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