(48 days)
Collagen Tendon Sheet-DDI is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Collagen Tendon Sheet-DDI is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet-DDI is designed to provide a layer between the tendon and the surrounding tissue during healing. When hydrated, Collagen Tendon Sheet-DDI is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet-DDI is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and is packaged preloaded in a cartridge, for use with the Rotation Medical Delivery Instrument, in a dual sterile seal tray-in-tray configuration.
This document describes a 510(k) premarket notification for a medical device called "Collagen Tendon Sheet-DDI." This device is a resorbable type I collagen matrix used for the management and protection of tendon injuries. The key aspect of this submission is that the Collagen Tendon Sheet-DDI is substantially equivalent to a previously cleared predicate device, "Collagen Tendon Sheet-D" (K122048). The only difference between the two is the packaging, which has been modified to facilitate arthroscopic delivery.
Therefore, the "study" proving the device meets acceptance criteria is not a clinical trial in the traditional sense, but rather a series of non-clinical performance tests designed to demonstrate that the change in packaging does not adversely affect the device's safety and effectiveness.
Here's the breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
Since this submission is based on substantial equivalence due to packaging changes, the acceptance criteria are linked to ensuring the new packaging and delivery system maintain the integrity and functionality of the core collagen sheet. The document highlights specific tests performed.
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Packaging Performance | |
| Suture Pull-Out Testing | Evaluated to confirm performance of the device in new packaging. (Passed implicitly, as no issues were reported). |
| Hydrothermal Transition Temperature | Evaluated to confirm performance of the device in new packaging. (Passed implicitly, as no issues were reported). |
| Endotoxin Testing | Evaluated to confirm performance of the device in new packaging. (Passed implicitly, as no issues were reported). |
| Cartridge Assembly Performance | |
| Biocompatibility | Evaluated for the cartridge assembly itself. (Passed implicitly, as no issues were reported). |
| Simulated Use | Evaluated for the cartridge assembly itself. (Passed implicitly, as no issues were reported). |
| Mechanical Integrity | Evaluated for the cartridge assembly itself. (Passed implicitly, as no issues were reported). |
| Regulatory Compliance | |
| FDA Blue Book Memorandum G95-1 | Passed all applicable testing. |
| ISO 10993-1 (Biological Evaluation) | Passed all applicable testing. |
| FDA Guidance for Surgical Mesh | Conducted testing in accordance with this guidance. (Passed implicitly, as no issues were reported). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of collagen sheets tested for suture pull-out). These tests are typically performed in a laboratory setting, and the data provenance would be internal to the manufacturer (Rotation Medical, Inc. in Plymouth, MN, USA), and would be considered prospective in the sense that the tests were carried out specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable for this submission. The "ground truth" for non-clinical performance tests like suture pull-out or biocompatibility is established by adherence to recognized standards (e.g., ISO, ASTM) and established industry protocols, not by expert consensus in a clinical context. The performance is measured against quantifiable physical or chemical properties, or established biological response endpoints.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting subjective outcomes or imaging results where agreement among multiple evaluators is needed to establish a "ground truth." For the non-clinical tests described, the outcomes are objectively measured.
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
This is not applicable. MRMC studies are related to evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiology scans) often in the context of AI assistance. This submission pertains to a surgical mesh and its delivery system, not a diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical performance tests is based on:
- Established engineering principles and material science standards: For tests like suture pull-out strength, hydrothermal transition temperature, and mechanical integrity.
- Recognized biocompatibility standards (e.g., ISO 10993): For evaluating the biological safety of the materials.
- Sterility and endotoxin limits: For ensuring the safety of the product related to manufacturing processes.
8. The sample size for the training set
This is not applicable. The Collagen Tendon Sheet-DDI is a physical medical device. There is no "training set" in the context of machine learning or AI, as the device's function is mechanical and biological, not based on learned patterns from data.
9. How the ground truth for the training set was established
This is not applicable as there is no 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.