(89 days)
ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.
Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed (D&C Violet #2 or D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.
The provided text does not contain a study or detailed performance data that would allow for a complete answer to your request. The document is a 510(k) summary for a medical device (Small Size Orthocord® Suture) seeking substantial equivalence to previously cleared devices.
Instead of a detailed study with acceptance criteria and performance metrics, it states that:
- "The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards."
- "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures, except for oversized diameter."
This indicates that the device's equivalence and safety/performance were established primarily through comparison to existing predicate devices and adherence to general standards, rather than a novel clinical or non-clinical study with specific acceptance criteria and reported device performance as you've requested for AI/software-based devices.
Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text.
However, I can extract the following limited information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Conformance to Standards | Conformed to consensus and voluntary standards. |
| USP Monograph for Absorbable Sutures | Conformed to the USP monograph for absorbable sutures, except for oversized diameter. (The specific parameters within the USP monograph are not detailed, nor is the extent of the oversized diameter mentioned). |
| Material Composition | Comprised of the same materials as the predicate Size 2 Orthocord suture (K040004/K043298). |
| Design Similarity | Similar design to the predicate Size 2 Orthocord suture (K040004/K043298), with differences in size and braid construction. |
2. Sample sized used for the test set and the data provenance: Not applicable. No specific "test set" or data provenance (country of origin, retrospective/prospective) is described for a study in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is not mentioned for this type of submission.
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 device is a surgical suture, not an AI/imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be its physical and mechanical properties conforming to established standards and predicate device performance, not clinical ground truth in the AI sense.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.