(102 days)
ORTHOCORD Suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
ORTHOCORD suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Violet #2) absorbable polydioxnone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.
The provided document is a 510(k) summary for the ORTHOCORD Suture and does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance. This type of document is a regulatory submission for medical devices that demonstrates substantial equivalence to a legally marketed predicate device, rather than a detailed report of clinical or performance studies with specific acceptance criteria.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance to USP monograph for absorbable sutures | Device conformed to the USP monograph for absorbable sutures. |
| Substantial equivalence to predicate devices (PDS II suture, FiberWire suture) | Determination of substantial equivalence was based on a detailed device description, and conformance to consensus and voluntary standards. The device was shown to be substantially equivalent to predicate devices. |
Missing Information: Specific quantitative acceptance criteria (e.g., tensile strength thresholds, degradation rates, knot security values) are not provided in this 510(k) summary. The document broadly states "conformance to consensus and voluntary standards" and "USP monograph for absorbable sutures" as the basis for performance.
2. Sample size used for the test set and the data provenance
Missing Information: The document states "Non-clinical laboratory testing was performed" but does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically contained in the full testing report, not the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable: For a suture device, "ground truth" established by experts as in an image-based diagnostics study is not relevant in the same way. Performance is typically assessed through laboratory testing against established physical and mechanical standards.
4. Adjudication method for the test set
Not Applicable: See point 3.
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 a physical medical device (suture), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable: See point 5.
7. The type of ground truth used
For a suture, "ground truth" would be established by:
- Physical and Mechanical Standards: Measurements against the USP monograph for absorbable sutures, and other consensus/voluntary standards (e.g., tensile strength, knot pull strength, degradation profile, biocompatibility, sterility). These standards themselves define what "truth" means for a functional suture.
- Comparison to Predicate Devices: Performance characteristics were compared to already approved predicate devices (PDS II suture and FiberWire suture) to demonstrate substantial equivalence.
8. The sample size for the training set
Not Applicable: As a physical medical device, there is no "training set" in the context of machine learning or AI models. Performance is evaluated through laboratory testing of the manufactured product.
9. How the ground truth for the training set was established
Not Applicable: See point 8.
§ 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.