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The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone.

Soft Tissue Anchoring Washers [washers], [washer, bolt nut]

This document is a 510(k) premarket notification from the FDA for a device called "Soft Tissue Anchoring Washers." It is a regulatory letter determining substantial equivalence to a predicate device.

The provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data of the device. It is a regulatory approval letter, not a device study report. Therefore, I cannot extract the requested information.

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The RBM is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair. The indications for the RBM are for use as a suture retention device to facilitate percuraneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repar), rotator cuff repair, meniscal repair, and gastrostomy.

The RBM is a suture retention device manufactured from polyester suture, poly(L-lactide) bar, stainless steel needle and a plastic handle.

The provided text is a 510(k) summary for the RBM suture retention device. It describes the device, its intended use, and compares it to a predicate device (MR-III). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory submission for substantial equivalence based on technological characteristics and intended use alignment with a predicate device, rather than performance testing against specific acceptance criteria.

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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.

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