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The AMR-ACV clamp is indicated for use as a clamp for partially occluding coronary vessels.

The AMR Atraumax® Coronary Vascular (ACV) low profile clamps and inserts are a line extension to an existing Applied Medical vascular clamp, model G5048. Differences between the ACV clamp and the predicate G5048 clamp include an expansion of the line to 5 models with sizes ranging from 45mm to 100mm and a reduction in the clamp profile. The AMR-ACV clamps are by design substantially equivalent to the G5048 clamp. The AMR-ACV clamp is of a side-bite configuration and consists of a reusable stainless steel clamp body and a set of disposable soft pad inserts. Inserts mount to the clamp via a snap fit.

The provided text, K962668, describes a 510(k) summary for a medical device called the "Applied Medical Atraumax® Coronary Vascular Low Profile Clamps and Inserts." This document is a pre-market notification for a Class II medical device and focuses on establishing substantial equivalence to a predicate device, not on clinical performance studies or establishing specific performance acceptance criteria based on diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, ground truth type, training set details), which are typically found in clinical validation studies for diagnostic or AI-powered devices, are not applicable to this document.

The K962668 document primarily discusses:

• Device Description: A line extension of an existing vascular clamp.
• Intended Use: For partially occluding coronary vessels.
• Design Changes: Expansion to 5 models, sizes 45mm to 100mm, and reduced clamp profile.
• Substantial Equivalence: Claimed due to similarity to the predicate G5048 clamp (K901565).
• Testing: Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety.

No clinical performance metrics, diagnostic accuracy, or AI-related information are present in this 510(k) summary. The "acceptance criteria" referred to in this context would likely be engineering specifications and biocompatibility standards, not clinical performance metrics related to diagnostic accuracy.

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