(26 days)
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
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Similar to predicate X-Repair (K083307) | "The results showed that the subject device has similar performance characteristics as the predicate device." |
| Suture Pullout Strength | Similar to predicate X-Repair (K083307) | "The results showed that the subject device has similar performance characteristics as the predicate device." |
| Package Integrity | Maintain sterile barrier and mechanical properties up to five years | "The results of performance testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use..." and "...maintenance of mechanical properties up to five years." |
| Functionality | Adequate for intended use | "The results of performance testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use..." |
| Integrity | Adequate for intended use | "The results of performance testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use..." |
| Safety | Adequate for intended use | "The results of performance testing demonstrated that the functionality, integrity, and safety of the X-Repair are adequate for its intended use..." |
| Shelf Life | Established at five (5) years | "...the shelf life has been established at five (5) years." |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.