(22 days)
Orthocord #2-0 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 Blue #6 or 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 text describes a 510(k) premarket notification for a medical device, specifically a suture. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a clinical study with detailed metrics.
Therefore, many of the requested categories for "acceptance criteria" and "study proving device meets acceptance criteria" are not applicable in this context. The information provided is primarily related to regulatory classification, device description, and a claim of substantial equivalence.
Here's an analysis based on the provided documents:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to USP monograph for absorbable sutures | Non-clinical laboratory testing demonstrated conformance to the USP monograph for absorbable sutures. |
| Substantial equivalence to predicate devices based on indications for use, technological characteristics. | Shown to be substantially equivalent to predicate devices: Orthocord #2 suture (K040004, K043298), Mini OA+ / Minilok QA+ (K071622), and Fiberwire (K021434). |
| Safety and Performance | Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures. |
2. Sample size used for the test set and the data provenance
- Not Applicable. The submission states that "Non-clinical laboratory testing was performed." It does not specify a "test set" in the context of human data, nor does it provide details on sample sizes or data provenance for any testing beyond stating "non-clinical laboratory testing." This generally refers to in-vitro or bench testing, not human clinical trials.
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)
- Not Applicable. This information is relevant for studies involving expert review of data (e.g., medical images). The document describes non-clinical laboratory testing, not a study requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. This applies to studies where human experts are making judgments that need to be reconciled. This is not described in the document.
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
- No. An MRMC study is not mentioned. This type of study is relevant for evaluating diagnostic or interpretive AI systems, which is not the nature of this medical device (suture).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical product (suture), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For non-clinical lab testing of a suture, the "ground truth" would be established by physical measurements and material science standards (e.g., tensile strength, knot security, degradation rate) as defined by consensus standards like the USP monograph, rather than clinical outcomes or expert consensus on a diagnostic task.
8. The sample size for the training set
- Not Applicable. As this is a physical medical device and not an AI/ML algorithm requiring a training set, this concept does not apply.
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.