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The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a nonsterile, reusable device-used with the Cryo1 cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.

The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic cryogenic surgical system that delivers a cryogenic energy source, namely Nitrous Oxide, to an AtriCure cryo-ablation probe to create lines of ablation through cardiac tissue for the treatment of cardiac arrhythmias. The AtriCure cryo-ablation probe (Cryo1 or cryolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or AtriCure ACC2 (Frigitronics CCS-200) Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

This looks like a 510(k) summary for a medical device (AtriCure Cryo Module System), not a study demonstrating that a device meets acceptance criteria. A 510(k) submission generally aims to prove "substantial equivalence" to a predicate device, rather than meeting specific performance acceptance criteria through clinical or rigorous standalone studies as you might see for novel devices or AI/ML-based systems.

Here's a breakdown based on the provided text, indicating what information is not present because this is a substantial equivalence submission, not a study demonstrating performance against acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) for a modified cryosurgical system seeking substantial equivalence. The document describes product testing for conformance to product specifications, design verification and validation, software validation, and electrical safety testing. These are engineering and safety tests, not clinical or performance studies with a "test set" in the context of AI/ML or comparative clinical device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth and expert consensus are relevant for studies evaluating device performance against a clinical "truth," often in diagnostic or prognostic AI/ML applications. This document concerns a physical cryosurgical system and its modifications.

4. Adjudication method for the test set

Not applicable. No test set or clinical performance adjudication is mentioned.

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

Not applicable. An MRMC study is relevant for evaluating diagnostic performance, particularly for AI-assisted image interpretation. This device is a cryosurgical system, not a diagnostic AI tool.

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

Not applicable. This is a physical cryosurgical device, not an algorithm. The testing mentioned (design verification, software validation, electrical safety) is for the device's functionality and safety, not for standalone algorithmic performance.

7. The type of ground truth used

Not applicable. No clinical ground truth (e.g., pathology, outcomes data) is mentioned as part of the submission for validating the modified device's performance. The "truth" here relates to compliance with engineering standards and existing predicate device characteristics.

8. The sample size for the training set

Not applicable. Training sets are relevant for AI/ML models. This document describes a physical medical device.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary based on the provided text:

The document describes a 510(k) premarket notification for the AtriCure Cryo Module System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K111042, K112072, and K121507) for the cryosurgical treatment of cardiac arrhythmias.

The "study" described is a series of product tests to evaluate conformance to product specifications and substantial equivalence, including:

• Design verification and validation
• Software validation
• Electrical safety testing

These tests were performed to show that the modified device is substantially equivalent and conforms to international standards and device specifications. The standards referenced include:

• UL 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)

The basis for substantial equivalence relies on similarities to predicate devices in:

• Intended use
• Operating principle
• Fundamental scientific technology
• Cryo-ablation probes used
• Materials used
• Module design
• Electronic solenoid valves

The document does not contain information about clinical trials, performance studies with specific acceptance criteria, or the use of AI/ML algorithms that would necessitate ground truth establishment, expert adjudication, or MRMC studies. The focus is on demonstrating that the modified device maintains the safety and effectiveness characteristics of its predicates through engineering and safety testing.

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