(167 days)
The TRELLIS Collagen Ribbon is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, peroneal, posterial tibial, and other tendons. The TRELLIS Collagen Ribbon is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair. Sutures used to repair the tear and suture or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
The subject TRELLIS™ Collagen Ribbon is a narrow, ribbon-like collagen matrix which is identical in material and processing to the predicate WMT Collagen Ribbon (rebranded TRELLISTM Collagen Ribbon - K120019) and includes the sizes of the predicate with an additional thickness offering. The ribbon-like dimensions of the subject device allow for the same surgical techniques as the predicate and the subject has the same intended use-reinforcement of soft tissue in orthopedic applications. The subject TRELLIS™ Collagen Ribbon is the identical source material to the predicate and is manufactured and sterilized in the same manner.
The provided text is a 510(k) summary for the TRELLIS™ Collagen Ribbon. It describes acceptance criteria in terms of performance characteristics. However, it does not describe an AI device, and therefore does not have information related to expert ground truth establishment, sample sizes for training/test sets for AI, or MRMC comparative effectiveness studies.
Here's the information extracted and formatted as requested, with "N/A" for sections not applicable to this non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Revascularization | No difference from predicate | No difference from predicate |
| Cellular Infiltration | No difference from predicate | No difference from predicate |
| Rehydration Characteristics | Acceptable | Acceptable |
| Tensile Strength | Substantially equivalent to predicate | Substantially equivalent to predicate |
| Suture Retention | Substantially equivalent to predicate | Substantially equivalent to predicate |
Explanation of Acceptance Criteria: The document directly states that "Histology results indicated no difference in revascularization and cellular infiltration for the subject versus the predicate." and "Rehydration, tensile, and suture retention testing... shows acceptable performance characteristics and substantial equivalence to the predicate." This implies that the acceptance criteria for the new device were primarily non-inferiority or substantial equivalence to the predicate device in these specific performance measures.
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated, as this was an animal study and mechanical testing. The document refers to "an animal study" and "tensile, and suture retention testing" without specifying the number of samples or animals.
- Data Provenance: The animal study suggests prospective data collection in an animal model. The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A (This is not an AI device, so ground truth in the context of expert consensus on data interpretation is not applicable here.)
4. Adjudication Method for the Test Set
- N/A (Not an AI device; not applicable for this type of testing.)
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- N/A (Not an AI device; no human-in-the-loop performance or AI assistance involved.)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A (Not an AI device; no algorithm performance to evaluate.)
7. The Type of Ground Truth Used
- Animal Histology: For cellular infiltration and revascularization.
- Mechanical Testing Results: For rehydration, tensile strength, and suture retention.
8. The Sample Size for the Training Set
- N/A (Not an AI device; no training set in this context.)
9. How the Ground Truth for the Training Set Was Established
- N/A (Not an AI device; no training set in this context.)
§ 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.