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The Remote Access Perfusion (RAP) femoral venous cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to six hours

RAP Femoral venous cannulae are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The device is composed of a cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the femoral vein till the vena cava. The cannula and the obturator are packaged within the same pouch and sold together.

The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" to ½" barbed connector for standard cardiopulmonary bypass tubing.

The RAP femoral arterial cannulae are the modified version of the disposables currently marketed as the RAP Femoral Venous cannula (K052081).

This document, an FDA 510(k) Clearance Letter, is for a medical device (a cannula) and not for a software or AI-based medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and studies that prove a device meets acceptance criteria for an AI/software device.

The questions in your prompt are highly specific to AI/Machine Learning device validation, such as:

1. Acceptance criteria for AI performance: (e.g., sensitivity, specificity, AUC)
2. Sample size, provenance, expert ground truth, adjudication: These are standard for evaluating AI model performance.
3. MRMC study and effect size: How AI assists human readers.
4. Standalone performance: Algorithm without human input.
5. Type of ground truth: Pathology, outcomes, expert consensus.
6. Training set details: Sample size and ground truth establishment.

None of this information is relevant or present in the provided 510(k) clearance letter for the RAP Femoral Arterial Cannulae, which is a physical device subject to mechanical, material, and biocompatibility testing.

The document confirms the device meets acceptance criteria through:

• Non-Clinical Performance Data: Extensive verification and validation testing of the physical device components and function (e.g., visual inspection, connector testing, flow rate, kink test, pull strength, blood trauma characterization, biocompatibility tests).
• No Clinical Performance Data: The submission explicitly states "No clinical testing was conducted in support of the RAP Femoral venous cannulae, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."

Therefore, I cannot extract the information asked in your prompt from this particular document.

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