(77 days)
The Suture Lock is intended to be use to secure soft tissue to bone, by securing the placement of sutures used in surgical procedures. The Suture Lock is indicated for use in Bankart and Rotator Cuff Repair procedures.
The Suture Lock is a sterile, single-use device manufactured from polyacetal.
This is a medical device 510(k) summary for a "Suture Retention Device" called Suture-Lock. It is a physical device, and therefore the request for information on "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance metrics is not applicable. The provided document does not contain information about an AI/algorithm-based device or its performance studies.
Therefore, I cannot answer the questions regarding acceptance criteria and performance studies in the requested format. This document describes a traditional medical device and its substantial equivalence to a predicate device based on characteristics like materials, intended use, and indications.
§ 878.4930 Suture retention device.
(a)
Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.