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The Cordis Opta 5™ PTA Balloon Catheter is intended to dilate stenoses in peripheral arteries and is applied to the iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries.

The Cordis Opta 5TM PTA Balloon Catheter is a coaxial design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.
The recommended working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. 3mm through 10mm diameter balloons reach their nominal size between 5 and 6 atm internal pressure. The 12mm diameter balloons reaches its nominal size between 3 and 4 atm internal pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal size pressure range.
The injectate lumen is used to deliver contrast medium by using a 10-cc syringe, hand injection only (150 psi maximum), and to track the catheter over a prepositioned guidewire. The compatible guidewire size, catheter shaft French size and catheter length are printed on the injectate lumen hub.
The inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the balloon lumen hub.

This document describes a medical device, the Cordis Opta 5™ PTA Balloon Catheter, and its intended use, but it does not contain the information requested about acceptance criteria and a study proving those criteria are met.

The document is a "Summary of Safety and Effectiveness" (likely a 510(k) submission) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with specific acceptance criteria that an AI/algorithm would typically undergo.

Therefore, I cannot populate the requested information from the provided text. To answer your questions, I would need a different type of document, such as a clinical study report or a validation report for a medical device that includes detailed performance metrics and acceptance criteria.

Specifically, the document lacks information on:

1. Acceptance criteria and reported device performance: No specific performance metrics like sensitivity, specificity, accuracy, or any thresholds for acceptable performance are mentioned.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance: These are all aspects of a clinical or performance study that are not present in this summary.
3. Type of ground truth, training set sample size, how ground truth for training set was established: These are relevant for AI/algorithm validation, which is not what this document is about.

This document primarily establishes "substantial equivalence" to existing devices based on "basic design, construction, indication for use and performance characteristics," which is a regulatory pathway for certain medical devices but does not provide the detailed performance study data you're looking for.

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