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The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.

The Antegrade Cardioplegia Cannula (N-Type) by MAQUET is used to administer cardioplegia solution into the heart in operative procedures where cardiopulmonary bypass is utilized. The cardioplegia solution causes asystole so that the operative procedure can be performed on a still heart.

The Antegrade Cardioplegia Cannula (N-Type) is inserted into the aortic root through a purse-string suture towards the aortic cross clamp. This method allows the cardioplegia solution to flow into the coronary arteries, which is known as antegrade delivery.

This document is a 510(k) premarket notification for a medical device called the "Antegrade Cardioplegia Cannula (N-Type)". This type of document is used to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device to the predicate rather than presenting a standalone study of the new device's absolute performance against acceptance criteria in a detailed clinical study format that would be typical for a novel device.

Therefore, many of the requested elements about detailed study design (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, specific effect sizes, and detailed training set information) are not typically found in this type of FDA submission (510(k) for substantial equivalence), especially for a device like a cannula that's comparing a design change (DEHP replacement and new configurations) to a predicate. The focus is on non-clinical performance and biocompatibility to show it performs "as expected" and comparably to the predicate.

Here's an attempt to extract and infer the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device "met all of the acceptance criteria" for various non-clinical performance tests. However, the specific quantitative acceptance criteria values are not explicitly stated in this summary. The table below lists the performance parameters evaluated and the reported outcome.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: Not specified. The document mentions "non-clinical performance testing" and "biocompatibility testing" but does not provide details on the number of units tested for each parameter.
• Data Provenance: The testing was conducted by MAQUET Cardiopulmonary AG, a company based in Rastatt, Germany. The data is retrospective in the sense that the tests were completed before the submission, but the specific origins of materials or test environments are not detailed beyond the company's location.

3. Number of Experts and their Qualifications for Ground Truth (Test Set)

• Not Applicable. This document describes non-clinical engineering and biocompatibility testing of a physical medical device. It does not involve human interpretation of data where expert consensus for ground truth would be relevant (e.g., radiology images, pathology slides).

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, this is non-clinical performance testing, not human interpretation requiring adjudication. Decisions are based on objective pass/fail criteria for each test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study is not mentioned. Such studies are typically conducted for diagnostic devices or AI systems where human reader performance is a key metric, and comparing performance with and without AI assistance is relevant. This document pertains to a physical cardioplegia cannula.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This device is a physical medical instrument, not a software algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests consisted of:

• Pre-defined engineering specifications and standards (e.g., for flow rate, pressure resistance, tensile strength, kink resistance, stress cracking, functional operation, corrosion). These are objective, measurable criteria.
• Biocompatibility standards and protocols (e.g., ISO 10993 series) for evaluating cytotoxicity, sensitization, systemic toxicity, hemocompatibility, and genotoxicity. These results are typically determined by laboratory assays with established pass/fail metrics.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device; there are no "training sets" in the context of machine learning or algorithms. The device design and manufacturing processes are developed through traditional engineering methods, not machine learning training.

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

• Not Applicable. See point 8. Engineering design and material selection are based on established medical device development practices, material science, and regulatory standards, not on "ground truth" derived for a training set in the AI sense. The "ground truth" during development would be user needs, design requirements, and performance targets based on clinical understanding and predicate device performance.

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