(354 days)
Pre-sutured allograft tendons are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.
This device consists of a combination of tendons that have been cleaned and disinfected using a proprietary process. The tendons are pre-sutured and terminally sterilized by low dose electron beam irradiation. The device may include anterior tibialis, posterior tibialis, peroneus longus, semitendinosus and/or gracilis tendons and is pre-sutured with Force Fiber UHWMPE nonabsorbable surgical suture. Through a contractual agreement with Teleflex Medical, AlloSource has the license rights to manufacture pre-sutured tendons using their UHMWPE non-absorbable surgical suture cleared 15-Sept-2009 under pre-market clearance K092533. All products are provided sterile and for single patient use.
The provided text describes a 510(k) premarket notification for a medical device called "ReConnex™ Pre-Sutured Tendon". It details the device's characteristics, intended use, and the justification for its substantial equivalence to a predicate device.
However, the provided document does not contain any information about an AI/ML device, nor does it discuss acceptance criteria and study results in the context of an AI/ML algorithm's performance.
The document primarily focuses on:
- The regulatory classification of the device (Class II, surgical suture).
- The components of the device (pre-sutured allograft tendons).
- Its intended use (ACL/PCL reconstruction).
- Comparison to a predicate device (Arthrex Suture Grafting Kit) and a reference device (Force Fiber UHWMPE Non-absorbable Surgical Suture).
- Biocompatibility requirements (donor eligibility, infectious disease screening).
- Performance testing related to physical properties of the tendon/suture construct (visual characteristics, tensile strength, suture pull-out, knot pull strength).
- A cadaver feasibility study demonstrating biomechanical equivalence to a surgeon-sutured construct and feasibility of implantation.
- Bacterial endotoxin testing.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML device based on the provided text. The prompt's requirements (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, AI assistance effect size, standalone algorithm performance, training set details) are all relevant to the validation of an AI/ML system, which is not what this document is describing.
§ 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.