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The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

The ESTECH Arterial Remote Access Perfusion Cannula is a sterile, disposable, flexible polyurethane tube with three integrated lumens and an inflatable polyurethane balloon at the distal end of the cannula. The outside diameter of the cannula is 21 French. The cannula has a central lumen for delivery of arterial blood through multiple distal outlets at a flow rate up to 5 liters per minute, a small lumen for delivery of cardioplegia or venting at the aortic root, and an additional smaller lumen for control of the distal balloon. The blood outlet ports are multiple elongated openings along the cannula proximal to the occlusion balloon. Radiopaque balloon markers and insertion depth marks aid in positioning the device. The cannulas are provided sterile in individual packages for single use.

The provided S510(k) summary for the ESTECH Arterial Remote Access Perfusion Cannula focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of its performance against explicit acceptance criteria. The document describes various tests performed but does not explicitly state quantitative acceptance criteria or report specific performance values from these tests that can be directly compared in a table.

Therefore, many of the requested sections below cannot be fully answered due to the nature of the provided document, which is a regulatory submission for substantial equivalence based on a predicate device, rather than a standalone performance study with defined criteria.

Here's an analysis of the provided information, addressing what can be inferred and highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the tests performed, nor does it provide specific numerical performance results for the ESTECH Arterial Remote Access Perfusion Cannula that would allow for a direct comparison in a table format.

The document implicitly suggests that the acceptance criterion for most tests was to demonstrate performance comparable or superior to the predicate device or within "ESTECH specifications." However, these specifications are not detailed or quantified.

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

The document does not provide specific sample sizes for the test sets used in any of the described tests (Occlusion Balloon, Hemolysis, Flow, Biocompatibility, Animal Testing, Clinical Investigation).

• Animal Testing: Mentioned as "Animal studies." No number of animals or specifics provided.
• Clinical Investigation: Mentioned as "A Clinical Investigation." No number of participants or specifics provided.

The data provenance is generally implied as laboratory testing conducted by ESTECH. The country of origin for the studies is not specified but the company location is in Danville, CA, USA, and the submission is to the FDA. The studies are prospective in nature, as they were conducted to test the performance of the new device.

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

This information is not provided in the document. The tests described (e.g., balloon inflation, hemolysis, flow) appear to be objective engineering and biological tests that do not typically rely on expert consensus for ground truth but rather on measured physical or chemical properties. For animal and clinical studies, the evaluation would be performed by veterinarians and clinicians, respectively, but their numbers and qualifications are not disclosed.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The tests described are not of a nature that would typically involve an adjudication method like 2+1 or 3+1 (which are common in image interpretation studies).

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

This question is not applicable to the provided document. The ESTECH Arterial Remote Access Perfusion Cannula is a medical device (a cannula), not an AI algorithm or a diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study or the effect of AI assistance on human readers is irrelevant to this submission.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the various tests would be based on:

• Engineering Measurements: For occlusion balloon characteristics and flow testing (e.g., pressure, diameter, volume, burst pressure, flow rate).
• Laboratory Assays: For hemolysis testing (e.g., free hemoglobin levels).
• Standardized Biocompatibility Tests: For biocompatibility (e.g., cytotoxicity, irritation, sensitization).
• Clinical Observations/Outcomes: For animal and clinical testing (e.g., successful cannulation, adequate perfusion, absence of adverse events, physiological parameters).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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