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510(k) Data Aggregation
(70 days)
X-REPAIR
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.
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(26 days)
X-REPAIRSL
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.
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(137 days)
SYNTHASOME X-REPAIR
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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