Search Results

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 non-sterile, reusable device-used with the Crvo1 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 crvolCE) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or frigitronics CCS-200 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

The provided text describes the AtriCure Cryo Module System, a Class II medical device intended for the cryosurgical treatment of cardiac arrhythmias. However, the document focuses heavily on the regulatory approval process (510(k) submission) and substantial equivalence to a predicate device. It does not contain specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy, etc.) for a device that relies on such metrics, nor does it describe a study designed to validate such performance.

Instead, the "Testing" section refers to product testing for conformance to specifications, substantial equivalence, and international standards. This suggests that the device's acceptable performance is defined by its adherence to engineering and safety standards, rather than clinical performance metrics typically associated with AI-driven diagnostic or prognostic devices.

Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary, as it pertains to a physical cryosurgical device rather than an AI/ML-based system.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

• UL 60601-1 (Medical Electrical Equipment Safety)
• EN 60601-1 (Medical Electrical Equipment Safety)
• IEC 60601-1-2 (Electromagnetic Compatibility)
• EN 55011 (Electromagnetic Disturbance Characteristics)
• ISTA Procedure 3A (Packaged Product for Parcel Delivery Shipment)
• ASTM F882-84 (Cryosurgical Medical Instruments Performance and Safety)
• FDA Guidance for Software Contained in Medical Devices (if applicable) |
  | Biocompatibility | "Testing has been previously conducted in accordance with ISO 10993-1 to ensure biocompatibility of all appropriate materials in the AtriCure crvo-ablation probes (Cryo1 and cryolCE)." (Note: ACM is not intended for patient contact). |
  | Software Validation | "Software validation, etc. were completed." |
  | Transit Testing | "Transit testing... were completed." |
  | Design Verification and Validation | "Design verification and validation... were completed." |

Note on Acceptance Criteria: For this type of device (a cryosurgical system), acceptance criteria are primarily related to safety, electrical performance, material compatibility, and manufacturing quality, rather than diagnostic or predictive accuracy metrics. The 510(k) process primarily assesses "substantial equivalence" to a predicate device, meaning it performs similarly and is as safe and effective.

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

Not applicable. The document describes engineering and regulatory testing, not a clinical study involving a "test set" of patient data for performance evaluation in the context of AI/ML.

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

Not applicable. There is no mention of "ground truth" establishment by experts in the context of performance metrics for an AI/ML system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is not an AI/ML system requiring adjudication of results based on a test set.

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. This is a physical surgical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of AI/ML performance. The "ground truth" for this device's approval relates to its adherence to engineering specifications, safety standards, and performance benchmarks established for the predicate device.

8. The sample size for the training set

Not applicable. This device does not use a training set as it is not an AI/ML system.

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

Not applicable. This device does not use a training set or ground truth in the AI/ML context.

Summary regarding AI/ML context: This 510(k) submission describes a traditional Class II medical device (a cryosurgical system) and its regulatory path. It does not involve artificial intelligence or machine learning, and thus the acceptance criteria and study descriptions are focused on engineering, safety, and substantial equivalence rather than performance metrics typically associated with AI/ML systems.

Ask a specific question about this device