(50 days)
The Arthrex Suture is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft or autograft tissue are used for repair.
The Arthrex Suture is a dyed or non-dyed braided suture construct made of 100% UHMWPE. The Arthrex Suture strands that are dyed black are made of nylon. Suture ends are stiffened with cyanoacrylate. The Arthrex Suture will be supplied in pre-cut lengths with or without various swaged needles. The Arthrex Suture constructs meet USP standards for suture. The Arthrex Suture is available in straight and loop configurations; and sizes #2 to #5 for suture, and 1.5mm to 4mm (width) for tape.
The provided document specifies the acceptance criteria and the study conducted for the Arthrex Suture, a non-absorbable surgical suture. However, many requested details regarding the methodology of the study are not present in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile (pull-out) strength | Meets or exceeds established minimum criteria | "The mechanical testing demonstrates that the proposed device meets or exceeds the established minimum acceptance criteria for tensile (pull-out) strength..." |
| Knot Pull | Meets or exceeds established minimum criteria | "...and knot pull for the desired indications." |
| USP Standards | Meets USP standards for suture | "The Arthrex Suture constructs meet USP standards for suture." and "the UHMWPE suture meets USP." |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the mechanical testing (tensile/pull-out strength and knot pull).
- Data Provenance: Not specified, but generally, such testing is conducted in a laboratory setting by the manufacturer (Arthrex, Inc. in Naples, FL, USA). It is a prospective study on the device itself.
3. Number of Experts and Qualifications for Ground Truth of Test Set
This information is not provided in the document. Mechanical testing of sutures typically relies on standardized test methods and instrumentation rather than expert interpretation of a 'ground truth' in the clinical sense.
4. Adjudication Method for Test Set
Not applicable. Mechanical testing does not involve adjudication as seen in clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for evaluating human reader performance, often with AI assistance, in interpreting clinical data (e.g., images). The Arthrex Suture is a physical medical device, and the evaluation focuses on its mechanical properties.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical suture, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the mechanical testing is based on established minimum acceptance criteria for tensile strength and knot pull, and USP standards for suture. These are objective, quantifiable physical properties.
8. Sample Size for the Training Set
Not applicable. As a physical product being evaluated for mechanical properties, there is no "training set" in the context of an algorithm. The "training" for such a device would be the manufacturing process and material selection.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set as it would be understood for an AI or imaging device. The "ground truth" for the device's design and manufacturing would be the material properties, engineering specifications, and adherence to relevant standards (like USP).
§ 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.