(184 days)
Collagen Repair Patch is intended for the reinforcement of soft tissues which are repaired by sutures or suture anchors, during rotator cuff repair surgery. Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair. Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.
Not Found
The provided text describes a 510(k) premarket notification for the Zimmer® Collagen Repair Patch, a surgical mesh intended for reinforcing soft tissues during rotator cuff repair surgery. However, the document does not contain specific acceptance criteria or detailed study results that would enable the construction of the requested table and the comprehensive answers to the questions about a device performance study.
Here's a breakdown of what can be extracted and what information is missing:
Information Present:
- Device Name: Zimmer® Collagen Repair Patch
- Intended Use: Reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff repair surgery. It's not intended to replace normal body structure or provide full mechanical strength, but to reinforce soft tissue and provide a scaffold for incorporation into the patient's own tissue.
- Predicate Devices: Permacol® Surgical Implant (K021056), Restore® Orthobiologic Soft Tissue Implant (K031969), CuffPatch™ (K042809).
- Performance Data Mentioned: "Biocompatibility and bench studies have been completed and support the safety and effectiveness of Zimmer® Collagen Repair Patch for its intended use." It states that "biocompatibility test results show that the material... are non-toxic and non-sensitizing..." and "Test results demonstrate that the materials chosen and the design utilized... will meet the established specification necessary for consistent performance during its intended use."
Missing Information Crucial for Your Request:
The document does not provide:
- Specific acceptance criteria (numerical or descriptive targets).
- Reported device performance data (e.g., tensile strength, degradation rate, cell infiltration, etc.) quantified with actual values.
- Sample sizes for any tests mentioned (e.g., number of specimens in bench studies, number of animals in biocompatibility).
- Data provenance (country of origin, retrospective/prospective for any study). The studies mentioned are general "biocompatibility and bench studies."
- Number of experts, their qualifications, or adjudication methods. These generally apply to clinical studies involving human interpretation or pathology, which are not detailed here.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies. These are typically for diagnostic devices, not surgical meshes.
- Information about standalone algorithm performance. This is irrelevant as the device is a physical surgical mesh, not a software algorithm.
- Type of ground truth used. Similarly, this is generally for diagnostic or prognostic algorithms.
- Sample size for training sets. Again, irrelevant for a physical medical device.
- How ground truth for training data was established.
Based on the provided text, I cannot complete the requested tables and answers comprehensively. The document focuses on regulatory submission (510(k) summary) rather than detailed study results.
However, I can structure what is available and highlight the gaps:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state acceptance criteria or specific numerical performance data. The "Performance Data" section makes general statements about meeting specifications. Therefore, this table cannot be filled with concrete values.
| Acceptance Criteria (e.g., Tensile Strength > X MPa, Biocompatibility: Non-cytotoxic) | Reported Device Performance (e.g., Tensile Strength = Y MPa, Biocompatibility: Meets ISO 10993) |
|---|---|
| Not specified in the provided text. | Biocompatibility: Non-toxic, non-sensitizing to biological tissues. Materials and design meet established specifications for consistent performance. |
| (Likely would include mechanical properties, degradation rates, cellular response in vivo/vitro) | (Actual quantitative results for the above are not provided.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document mentions "biocompatibility and bench studies" but does not give sample sizes for these tests (e.g., number of samples tested for tensile strength, number of animals for in-vivo biocompatibility).
- Data Provenance: Not specified. The studies mentioned ("biocompatibility and bench studies") are not described with details about their origin (e.g., country) or whether they were internal lab studies, external contract studies, etc. They are inherently prospective lab/bench studies in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. This information is typically relevant for studies involving human interpretation of data (e.g., radiologists reading images for an AI device). For a physical medical device like a surgical mesh, "ground truth" would be established by scientific measurements and histological analyses, not by expert consensus in the same way. The document does not discuss any such expert panel for the given studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not specified. As above, this applies to expert reviews, typically for AI or diagnostic device studies.
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
Not applicable. The Zimmer® Collagen Repair Patch is a physical surgical mesh, not an AI or diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This question pertains to AI algorithms. The device is a physical surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "biocompatibility and bench studies," the "ground truth" would implicitly be based on:
- Standardized test methods: (e.g., ISO standards for cytotoxicity, sensitization, irritation).
- Quantitative measurements: (e.g., tensile strength, elongation, burst strength for bench studies).
- Histological assessment: (for tissue response in vivo in biocompatibility studies, typically interpreted by pathologists or toxicologists).
The document does not detail which specific ground truth metrics were used, only that the material was found to be "non-toxic and non-sensitizing" and met "established specifications."
8. The sample size for the training set
Not applicable. There is no "training set" in the context of developing a physical surgical mesh. This term is relevant for machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
§ 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.