(91 days)
DYNACORD™ suture is indicated for orthopedic procedural use in soft-tissue approximation, and/or ligation, including use with allograft tissue.
DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™ Suture has a double sheath and core design, and contains Ultra High Molecular Weight Polyethylene, Polyester and a Silicone/NaCl core.
The provided text describes a 510(k) premarket notification for the DYNACORD™ Suture, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria were met for an AI device.
The document is for a non-AI medical device (surgical suture) and therefore does not discuss AI-specific metrics like sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC comparative effectiveness studies (which are relevant to AI's impact on human readers).
However, I can extract the information that is present regarding the non-clinical testing performed for this suture, which serves as its performance and safety evaluation.
Here's the information I can provide based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (from Non-clinical Testing) |
|---|---|
| USP Diameter | DYNACORD™ is oversized (meets USP requirements except for oversized diameter) |
| USP Knot Tensile Strength | Tested and results contributed to suitability for intended use |
| USP Needle Attachment | Tested and results contributed to suitability for intended use |
| in-vitro approximation force over time | Performance evaluated (specific quantitative results not provided) |
| Biocompatibility | Tested and found suitable |
| Sterility | Tested and found suitable |
| Shelf-life | Tested and found suitable |
| Bacterial Endotoxin | Meets endotoxin limits |
| in-vivo Efficacy Evaluation (GLP) | Found suitable for intended use |
| in-vivo Safety Evaluation (GLP) | Found suitable for intended use |
Study Proving Device Meets Acceptance Criteria:
The document states: "Performance testing included: USP Diameter (DYNACORD™ is oversized), USP Knot Tensile Strength, USP Needle Attachment, in-vitro approximation force over time, GLP in-vivo efficacy evaluation. Safety testing included: biocompatibility, sterility, shelf-life, GLP in-vivo evaluation of DYNACORD™ safety. Bacterial endotoxin testing has been completed and results have demonstrated that the proposed devices meet the endotoxin limits."
The conclusion is: "Results of non-clinical testing have demonstrated that the proposed devices are suitable for their intended use."
Regarding AI-specific questions:
- 2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established for this device.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or reference standards would be established by the standardized methods for each test (e.g., USP monographs for suture properties, recognized biocompatibility standards, sterility testing protocols, in-vivo animal model observations for efficacy and safety).
- 8. The sample size for the training set: Not applicable. This is not an AI device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI device.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.