(70 days)
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.
This submission pertains to the X-Repair surgical mesh (K141394). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device (X-Repair, K083307) rather than establishing novel acceptance criteria for a new type of device or an AI/software. Therefore, many of the typical questions for AI/software-based medical devices regarding acceptance criteria, study design, and ground truth are not directly applicable or explicitly stated in this document.
However, I can extract the relevant performance data and study information that is provided for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this surgical mesh, the "acceptance criteria" are implicitly based on demonstrating equivalence to the predicate device's performance regarding mechanical properties and integrity. The document states that the new device has "similar performance characteristics as the predicate device," which serves as the de facto acceptance criterion.
| Performance Characteristic | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Similar to predicate X-Repair (K083307) | "the subject device has similar performance characteristics as the predicate device" |
| Suture Pullout Strength | Similar to predicate X-Repair (K083307) | "the subject device has similar performance characteristics as the predicate device" |
| Package Integrity | Maintains sterile barrier up to 5 years | "adequate for its intended use" and "maintenance of the sterile barrier" |
| Maintenance of Mechanical Properties | Maintains mechanical properties up to 5 years | "adequate for its intended use" and "maintenance of mechanical properties" |
2. Sample Size Used for the Test Set and Data Provenance
The document only states "Bench testing was conducted" to evaluate tensile strength, suture pullout strength, package integrity, and maintenance of mechanical properties.
- Sample Size: Not specified.
- Data Provenance: Not specified, but generally, bench testing results are generated in a laboratory setting for the specific device being evaluated. It is prospective testing designed to characterize the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable in the context of this device. The "ground truth" for physical characteristics like tensile strength and suture pullout strength is determined by standardized engineering tests, not by expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. Physical performance tests do not typically involve adjudication by experts in the same way clinical or imaging studies do.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a traditional medical device (surgical mesh), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.
6. If a Standalone Performance Study Was Done
Yes, the bench testing described "evaluated the tensile strength and suture pullout strength of the subject device" and its package integrity and mechanical properties over an extended shelf life. This constitutes a standalone performance evaluation of the device itself.
7. The Type of Ground Truth Used
The ground truth for the bench testing was based on:
- Objective measurements of physical properties (tensile strength, suture pullout strength).
- Standardized tests for package integrity and material degradation over time.
The "truth" is derived from direct physical measurement outcomes.
8. The Sample Size for the Training Set
Not applicable. This device is not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an algorithm that requires 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.