(178 days)
The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
The Pre-Sutured Tendon is for single patient use only.
The Pre-Sutured Tendon is a donated human nonbone tendon pre-sutured with sterile Ultra-high-molecular-weight polyethylene (UHMWPE) nonabsorbable sutures. The tendon is processed via the BioCleanse® Tissue Sterilization Process (The BioCleanse Process). The Pre-Sutured Tendon device is offered as a single strand and as a quadruple (quad) strand.
This is a 510(k) summary for a medical device called the "Pre-Sutured Tendon." It does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device submission.
As such, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document describes a traditional medical device (a pre-sutured tendon for ligament reconstruction) and its regulatory clearance based on substantial equivalence to existing predicate devices, rather than an AI/ML-driven diagnostic or prognostic device requiring specific performance metrics related to diagnostic accuracy or reader studies. The "Performance Data" section briefly mentions bench testing and a human cadaver study to demonstrate feasibility and user needs, but these are not presented in the format of acceptance criteria for an AI/ML device study.
§ 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.