(125 days)
Nexus™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Nexus Suture is a nonabsorbable, sterile, surgical suture provided in sizes 2-0, 0 and 2. It is composed of either undyed (white) ultra high molecular weight polyethylene (UHMWPE) or white UHMWPE braided with one or two strands of blue polypropylene to add color. The blue colorant is [phthalocyaninato(2-)] copper with a concentration not to exceed 0.5% by weight. It does not have a coating. Nexus Suture will be provided to the user in a variety of cut lengths without needles or on reels that facilitate suture handling.
Nexus Suture meets all USP requirements for non-absorbable surgical suture, except for oversized diameter.
This document is a 510(k) premarket notification for a surgical suture, and as such, it focuses on demonstrating substantial equivalence to predicate devices through performance testing, rather than an "AI device" style acceptance criteria and study. Therefore, some of the requested information (like multi-reader multi-case studies, ground truth for AI models, or human-in-the-loop performance) is not applicable or present in this type of submission.
However, I can extract the information related to the performance testing of the Nexus™ Suture as it relates to demonstrating its safety and effectiveness compared to the predicate devices.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document states that the Nexus™ Suture meets all USP requirements for non-absorbable surgical suture, except for oversized diameter. The specific acceptance criteria themselves (e.g., maximum allowable diameter deviation, minimum tensile strength) are not explicitly stated in this summary but are referenced by adhering to USP standards. The reported device performance is that it met these standards, except as noted.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet biocompatibility standards (e.g., ISO 10993) | Testing performed, results support substantial equivalence. |
| Diameter | Meet USP requirements for surgical suture diameter | Meets USP requirements, except for oversized diameter. |
| Tensile Strength | Meet USP requirements for non-absorbable surgical suture strength | Meets USP requirements, results support substantial equivalence. |
| Material/Composition | As described (UHMWPE, with optional polypropylene/colorant) | As described. |
| Sterility | Sterile | Sterile. |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes for the biocompatibility, diameter, or tensile strength testing.
The data provenance is from benchtop testing performed by the manufacturer, Baylis Medical Company Inc., in Canada (Mississauga, Ontario). The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here. This is not an AI or diagnostic imaging device where "experts" establish ground truth for a test set. The "ground truth" for a surgical suture is its physical and biological performance as measured against established standards (like USP).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication of results. The performance is measured objectively against engineering and biological standards.
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 not an AI device or a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The device's performance is inherently "standalone" in that its physical properties are tested directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is based on established industry and regulatory standards for surgical sutures, specifically the United States Pharmacopeia (USP) requirements for non-absorbable surgical sutures.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for a physical medical device like a surgical suture.
9. How the ground truth for the training set was established
Not applicable.
§ 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.