(73 days)
The polyester nonabsorbable surgical sutures USP are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.
Polyester nonabsorbable surgical sutures USP, manufactured by R.K. Medical, L.L.C. are equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck. The polyester nonabsorbable surgical sutures USP manufactured by R.K. Medical and Davis & Geck are braided and coated with silicone. The R.K. Medical polyester suture is dyed green (D&C Green #6). Davis & Geck's Ti-cron* is dyed blue (D&C Blue #6).
Here's an analysis of the provided text regarding acceptance criteria and device performance:
This document describes a 510(k) submission for a medical device, but it fundamentally lacks the detailed information required to answer most of your detailed questions about AI device performance and studies. The device described is a Polyester Nonabsorbable Surgical Suture, which is a physical, non-AI medical device. The document predates the widespread use of AI in medical imaging and diagnostics, and thus, its content is focused on traditional medical device equivalency rather than AI performance.
Therefore, the following answers are based on the limited information provided for a non-AI device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (R.K. Medical Polyester Suture) |
|---|---|
| Suture Diameter | Meets or exceeds USP specifications |
| Suture Length | Meets or exceeds USP specifications |
| Knot Pull Tensile Strength | Meets or exceeds USP specifications |
| Needle Attachment Strength | Meets or exceeds USP specifications |
Additional Note: The document states the R.K. Medical sutures are "equivalent to Ti-cron* polyester nonabsorbable surgical suture USP manufactured by Davis & Geck" in terms of the above parameters.
Regarding the remaining questions on AI device studies:
The provided document does not contain any information about an AI-powered device, image analysis, diagnostic algorithms, or any type of study that would involve:
- AI performance metrics (sensitivity, specificity, AUC)
- Sample sizes for test or training sets for an AI model
- Data provenance for AI input data
- Experts establishing ground truth for AI analysis
- Adjudication methods for AI
- Multi-reader multi-case (MRMC) comparative effectiveness studies with AI assistance
- Standalone (algorithm-only) AI performance studies
- Types of ground truth for AI (pathology, outcomes)
- Training set details for AI algorithms
Therefore, it is impossible to provide answers to questions 2 through 9 based on the given text. This document is for a physical surgical suture, 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.