(176 days)
The Arthrex FiberTape™ Family suture products, like it's predecessor the FiberWire™ Family, are intended for use in approximation and/or ligation of soft tissue, including use of allograft tissue for orthopedic surgeries.
Arthrex, Inc. FiberTape™ Family consists is a ribbon-like suture consisting of FiberWire components along with several needle types for specific surgical uses. r locatified of long chain polyesters which are braided and sterilized froos taps se. They are available in dyed and non-dyed varieties, with or without needles.
I am sorry, but I cannot provide information on acceptance criteria and study data for the device described in the provided text. The document is a 510(k) summary and related FDA correspondence from 2004 for the Arthrex FiberTape™ Family. This type of document is primarily focused on demonstrating "substantial equivalence" to existing legally marketed devices, rather than presenting detailed performance studies with acceptance criteria in the manner you've outlined for AI/ML devices.
Specifically, the document focuses on:
- Intended Use and Description: Describing what the product is and what it's for.
- Substantial Equivalence: Comparing the new device to existing predicate devices (other sutures) to argue that it is equally safe and effective.
- Regulatory Classification and Limitations: FDA's confirmation of the device's classification and any specific warnings or limitations required for its labeling (e.g., "The safety and effectiveness of this device for use as an artificial ligament or tendon has not been established.").
This document does not contain the kind of detailed performance study data, acceptance criteria, sample sizes for test sets, expert consensus, ground truth establishment, or specific metrics (like sensitivity, specificity, or effect sizes for human reader improvement with AI assistance) that you are requesting. Those types of studies and details are more characteristic of submissions for complex diagnostic devices, particularly those involving AI or algorithms, which require extensive validation of their performance against a defined ground truth.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text, as this information is not present within this 510(k) submission.
§ 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.