(245 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 with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm and has a permanently attached stainless steel needle.
This document, K042606, is a 510(k) summary for a medical device called "Synthes (USA) Titanium Wire." This type of document is typically for regulatory clearance, not for publishing detailed study results to demonstrate device performance against acceptance criteria in the way you've described for AI/ML device studies.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies cannot be extracted from the provided text.
Here's why and what can be inferred:
- Device Type: This is a physical medical device (titanium wire for surgical use), not a software or AI/ML device.
- Regulatory Pathway: A 510(k) submission generally demonstrates substantial equivalence to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria through extensive clinical studies in the same manner as an AI/ML device. For physical devices like this, the "study" often involves bench testing (material properties, tensile strength, fatigue) and biocompatibility, rather than clinical efficacy studies with human readers and ground truth.
- Missing Information: The document focuses on regulatory classification, intended use, and substantial equivalence to a predicate device. It does not contain any sections detailing:
- Acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity).
- Results of a performance study demonstrating these metrics.
- Sample sizes for test sets or training sets in the context of algorithm performance.
- Details about expert readers, ground truth adjudication, or an MRMC study.
Therefore, I cannot populate the table or answer the specific questions about device performance studies as they pertain to AI/ML devices based on this document.
The document states:
- "Comparative information presented supports substantial equivalence." This is the core "proof" in a 510(k) submission, meaning the device is as safe and effective as a legally marketed predicate device.
- The "study" would have involved demonstrating that the Synthes (USA) Titanium Wire (the new device) has equivalent material properties, mechanical performance, and intended use as the Predicate Device: Synthes Titanium Wire.
If this were an AI/ML device submission, the requested information would be crucial. However, for this type of physical device, the "study" is of a different nature and is not detailed in terms of performance metrics like accuracy or sensitivity in this summary.
§ 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.