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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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The EasyFlow Aortic Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass for up to 6 hours.

The EasyFlow Duo Cannula with guidewire is intended for use with cardiopulmonary bypass as an arterial return femoral cannula for up to 6 hours.

Easyflow & Easyflow Duo are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The Easyflow & Easyflow Duo are composed of the cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the Artery.

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" barbed connector for standard cardiopulmonary bypass tubing

In the Easyflow Duo models the device has a 0.035" hole punched in the very distal tip of the cannula and the obturator has an approx. 0.035" internal diameter central lumen to accommodate a 0.035" guide wire used to drive the cannula along the vessel till its final placement. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the arterial line.

The Easyflow is packaged as sterile stand-alone device while the Easyflow Duo is packaged into a tray containing also a Guidewire, a Needle and Vascular Dilators in order to have a kit for vascular access packaged together with the cannula.

The Easyflow & Easyflow Duo are the modified version of the disposables currently marketed as the Easyflow cannula (K060101) and the Easyflow Duo cannula (K091542). Both modified and unmodified cannulae models are recommended for use as an arterial return cannula during cardiopulmonary bypass up to six hours

The provided FDA 510(k) Clearance Letter for the Easyflow Cannulae does not contain any information related to a study proving the device meets acceptance criteria for an AI/ML (Artificial Intelligence/Machine Learning) powered medical device.

This document describes a medical device (cannulae for cardiopulmonary bypass) which is a physical, single-use, non-toxic, non-pyrogenic fluid path device. The clearance is based on "substantial equivalence" to predicate devices, meaning it has similar indications for use and technological characteristics, with the primary change being the removal of phthalates (DEHP and DnHP) from the PVC materials.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device, as this information is not present in the provided text.

The information you asked for, such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are all highly specific to the validation of AI/ML algorithms, which are not relevant to the Easyflow Cannulae as described in this FDA clearance.

In summary, based on the provided document, there is no AI/ML component to the Easyflow Cannulae, and thus no such study or acceptance criteria as you've outlined would be applicable or present.

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The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

The SMARxT Tubing and Connectors, subjects of this application are part of the Heart/Lung Perfusion Pack (K881330), a customized system of tubing and other devices built to user specifications designed for use during surgery requiring cardiopulmonary bypass.

This is a 510(k) summary for the SMARxT Tubing and Connectors, a medical device used in cardiopulmonary bypass. The document states that the modified device, which uses a different surface treatment material (Tegomer additive material is changing from Tegomer H-Si6441 P), is substantially equivalent to its predicate device. This determination is based on non-clinical testing.

Here's the detailed breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for each of the in vitro tests. It only states that "in vitro testing was performed."
• Data Provenance: The data provenance is retrospective in the sense that it's a submission for regulatory clearance based on testing already completed. The tests were performed by Livanova USA Inc., presumably in a controlled laboratory environment. The country of origin of the data is not explicitly stated but can be inferred to be from the manufacturer's testing facilities, likely in the US or Europe given Livanova's global presence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications, not human expert interpretation of data.

4. Adjudication Method for the Test Set

This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications. There was no need for human adjudication of test results in the way it might apply to image-based diagnostic AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is hardware (tubing and connectors) and does not involve AI or human readers for its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not conducted. This device is hardware and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its substantial equivalence determination, was established through adherence to recognized medical device standards and rigorous in vitro performance testing. This includes:

• International Standard ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
• FDA Guidance Document: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process of September 4, 2020."
• Internal performance specifications/requirements: The specific acceptance criteria for "Blood pathway integrity and coverage," "Surface Modification Integrity," "Connection testing," "Life to failure testing," and "Spallation" would have been defined by the manufacturer based on the predicate device's performance and clinical requirements for cardiopulmonary bypass tubing.

Essentially, the ground truth is that the device must perform equivalently to its predicate and meet established safety and performance benchmarks for its intended use.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware and does not involve machine learning or an AI algorithm, therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set.

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