(30 days)
The LARIAT® RS Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.
The LARIAT® RS Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size "0" polyester suture loop that is pre-loaded on a retractable Delivery Snare on the distal end of the device. The pre-tied suture loop is held onto the Delivery Snare and allows for multiple opening and closings of the suture loop without release. Upon tightening of the suture loop, the suture is released from the Delivery Snare. An accessory lumen within the LARIAT RS device is designed for aspiration. flushing or to accommodate a guide wire of up to 0.035" diameter. The LARIAT RS device offers the additional feature of allowing the user to release the Delivery Snare from the tissue during device removal from the target location following suture deployment. The LARIAT RS device is compatible with access site diameters of 4.3mm and larger. The suture is itself a cleared medical device as a part of K021019.
The provided document is a 510(k) summary for a medical device called the LARIAT® RS Suture Delivery Device. It describes the device, its intended use, and claims substantial equivalence to a predicate device (LARIAT III Suture Delivery Device). However, the document does not contain information about the acceptance criteria or the study that proves the device meets specific acceptance criteria in the context of AI/ML performance.
This document pertains to the regulatory clearance of a physical medical device based on its substantial equivalence to a previously cleared device, not an AI/ML system's performance. The "testing in support of substantial equivalence determination" listed focuses on mechanical and functional aspects of the physical device (e.g., joint strength, actuation, aspiration, suture properties), typical for a traditional medical device submission.
As such, I cannot extract the requested information (acceptance criteria, device performance table, sample sizes for test/training, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types) because the document does not describe a study involving an AI/ML algorithm or its performance characteristics.
The specific questions you've asked are relevant to assessing the performance of AI/ML-driven medical devices, which typically involve metrics like sensitivity, specificity, AUC, and rigorous validation studies comparing an algorithm's output to a 'ground truth' established by human experts or pathology. This document does not describe such a validation 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.