(100 days)
Synthes (USA) Titanium Wire is indicated for use in soft tissue approximation and/or ligation, for canthoplasty, canthopexy and/or canthal tendon repair.
The Synthes Titanium Wire is a non-absorbable, monofilament, sterile surgical wire composed of Commercially Pure Titanium wire is available in a length of 500mm with different gauge sizes (26, 28, 30, 32) and is available with or without a permanently attached stainless steel needle.
The provided text describes a 510(k) submission for the Synthes (USA) Titanium Wire, which seeks to establish substantial equivalence to a predicate device, Ethilon™ Nylon Suture. The submission focuses on comparing the new device's characteristics and performance to the predicate and relevant standards.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (USP Standards) | Reported Device Performance (Synthes Titanium Wire) |
|---|---|
| Meet USP standards for length | Met USP standards for length |
| Meet USP standards for tensile strength | Met USP standards for tensile strength |
| Meet USP standards for needle attachment strength | Met USP standards for needle attachment strength |
| Meet USP standards for diameter | Did NOT explicitly meet USP standards for diameter (stated as "not diameter" in the text, implying this was a point of difference or non-conformance compared to the predicate, though overall "technically equivalent") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set of the comparative study. It mentions "tests according to methods presented in United States Pharmacopia (U.S.P.) were conducted for titanium wire with and without needle." The data provenance (country of origin, retrospective/prospective) is also not specified.
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)
This information is not applicable to this submission. The device is a surgical wire, and its performance is evaluated against physical and mechanical standards (USP), not by expert interpretation of images or clinical outcomes that typically require ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The evaluation methods are laboratory-based, objective measurements against USP standards, so no human adjudication process typical of clinical or imaging studies is involved.
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
This information is not applicable. This is a submission for a surgical wire, not an AI-powered diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device (surgical wire), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's technical equivalency was based on United States Pharmacopeia (U.S.P.) standards for materials and mechanical properties of sutures/wires. These are objective, pre-defined standards.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.