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510(k) Data Aggregation
(64 days)
MESO TENDON MATRIX
Meso Tendon Matrix is indicated for use in sports medicine procedures for the reinforcement and repair of soft tissue where weakness exists including but not limited to, rotator cuff, patellar, Achilles, biceps, quadriceps and other tendons. Meso Tendon Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. Meso Tendon Matrix is supplied sterile and for one time use.
Meso Tendon Matrix is a resorbable surgical mesh intended to reinforce soft tissue where weakness exists. The implant is derived from porcine mesothelium tissue. The material is supplied sterile in double-layer packages. The implant is packaged dry and prior to use is hydrated with saline or autologous body fluids such as blood, bone marrow aspirate, or blood concentrates such as platelet rich plasma.
Here's an analysis of the acceptance criteria and supporting studies for the Meso Tendon Matrix device, based on the provided text:
This document is a 510(k) summary for a medical device (Meso Tendon Matrix) seeking substantial equivalence to a predicate device (Medeor Matrix). The acceptance criteria are primarily demonstrated through equivalence to the predicate, rather than meeting specific performance thresholds against a diagnostic "ground truth" as would be the case for a diagnostic AI device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria | Reported Device Performance (Meso Tendon Matrix) | Evidence/Study |
|---|---|---|
| Biocompatibility: Acceptable biological safety profile (evaluated per ISO 10993-1:2009 for cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, hemocompatibility, subacute systemic toxicity, chronic systemic toxicity, viral inactivation, residual chemical assessment). | Acceptable biocompatibility profile. | Biocompatibility testing on finished sterile device in accordance with ISO 10993-1: 2009. Results indicate acceptable biocompatibility. |
| Biomechanical Performance: Equivalent to predicate device (Medeor Matrix) and meets requirements for intended use for tensile strength, burst testing, wet tear testing, and suture retention testing. | Device is equivalent to the predicate device and meets the requirements for its intended use for tensile strength, burst testing, wet tear testing, and suture retention. | Biomechanical bench testing, comparing to predicate. |
| Functionality and Tissue Response (in vivo): Normal tissue healing response and confirmed remodeling capability. | Normal tissue healing response and confirmed remodeling capability. | Animal implant studies. |
| Material Composition: Identical to Kensey Nash ECM Surgical Patch (K094061) and substantially equivalent to Medeor Matrix (K103787). | Porcine tissue, resorbable single layer surgical mesh. | Reported. The document states "Meso Tendon Matrix is identical regarding material composition to Kensey Nash ECM Surgical Patch (K094061), cleared May 10, 2010." and comparison table shows "Porcine tissue" for both proposed and predicate devices. |
| Technological Characteristics: Substantially equivalent to Medeor Matrix (K103787) regarding intended use, principles of operation, and technological characteristics (Origin, Device Characteristics, Biocompatibility, Reusable, Shelf Life, Sterilization Method, Packaging). | All listed characteristics are either identical or substantially equivalent to the predicate. Minor difference in Shelf Life (24 months vs. 36 months for predicate), which is an inherent characteristic and usually not considered a point of failure for substantial equivalence if the shorter shelf life is still clinically acceptable. | Performed performance testing (biocompatibility, biomechanical, in vivo) and comparison to predicate device characteristics as detailed in the table provided in the 510(k) summary. The summary explicitly states: "Performance testing has confirmed that the Meso Tendon Matrix is substantially equivalent to the predicate device Medeor Matrix (K103787) with regard to material, intended use, principles of operation, and technological characteristics, pursuant to section 510(k)." |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: The text does not specify the sample size for each test conducted under ISO 10993-1:2009. These typically involve standardized protocols where sample size is determined by the specific test method (e.g., number of cell cultures, animals per group).
- Biomechanical Testing: Not specified.
- Animal Implant Studies: Not specified.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing and studies conducted by DSM Biomedical or contracted testing facilities. Given the nature of these tests, it's prospective testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of device (surgical mesh) does not involve a "ground truth" established by experts in the sense of a diagnostic interpretation (e.g., radiologists reviewing images). Instead, acceptance criteria are based on objective, standardized scientific and engineering tests (biocompatibility, mechanical properties) and animal model outcomes for tissue response. The "ground truth" is established by the validated methods of these scientific tests themselves and the comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations. The "adjudication" is essentially the comparison of the test results to predefined acceptance criteria or to the predicate device's characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an AI or diagnostic imaging device. An MRMC study is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the device's inherent properties (biocompatibility, mechanical strength, in vivo tissue response) were tested independently without a "human-in-the-loop" component. The device itself is not an algorithm, so this question is interpreted as the device's performance being evaluated in a standalone manner.
7. The Type of Ground Truth Used
The "ground truth" for this medical device's performance is established through:
- Compliance with International Standards: For biocompatibility, adherence to ISO 10993-1:2009.
- Objective Engineering Measurements: For biomechanical properties (tensile strength, burst, tear, suture retention).
- Observed Biological Response: In animal implant studies, observing normal tissue healing and remodeling.
- Comparison to Predicate Device: The primary "ground truth" for regulatory clearance is substantial equivalence to the Medeor Matrix (K103787) across material, intended use, principles of operation, and technological characteristics.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm requiring a training set. The "training" in a broad sense would be the research and development phase where materials were selected and manufacturing processes optimized, but this is not a data-driven "model training" process.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
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