(14 days)
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 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 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 (ACM, Cryo1, and cryolCE), which is intended for cryosurgical treatment of cardiac arrhythmias. However, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against specific acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth for an AI-powered device are not applicable or cannot be extracted from this document, as it describes a non-AI medical device and its regulatory submission.
Here's an attempt to answer the questions based only on the provided text, with explicit notes about what information is missing or not relevant for this type of submission:
Acceptance Criteria and Device Performance for AtriCure Cryo Module System
This 510(k) submission focuses on demonstrating substantial equivalence of the AtriCure Cryo Module System to its predicate device (AtriCure Cryo Module System [K111042]). As such, the "acceptance criteria" are primarily related to conforming to product specifications, relevant safety standards, and demonstrating equivalent performance characteristics to the predicate device, rather than specific clinical performance metrics with predefined thresholds typical for novel AI/ML device evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on 510(k) summary interpretation) | Reported Device Performance (based on 510(k) summary) |
|---|---|
| Safety: Conformance to electrical safety standards (e.g., UL 60601-1, EN 60601-1) | Testing completed; indicated conformance to product specifications and international standards. |
| Electromagnetic Compatibility: Conformance to EMC standards (e.g., IEC 60601-1-2, EN 55011) | Testing completed; indicated conformance to product specifications and international standards. |
| Material Biocompatibility: Materials safe and suitable for intended use, biocompatibility of probes (ISO 10993-1) | "All materials used in the manufacture of the AtriCure Crvo Module System are safe and suitable for their intended use... Testing has been previously conducted in accordance with ISO 10993-1 to ensure biocompatibility of all appropriate materials in the AtriCure cryo-ablation probes." |
| Packaging/Transit Safety: Conformance to transit testing standards (e.g., ISTA Procedure 3A) | Testing completed; indicated conformance (transit testing was completed). |
| Cryosurgical Performance: Conformance to cryosurgical instrument standards (e.g., ASTM F882-84) | Testing completed; indicated conformance to product specifications and international standards. |
| Software Validation: Conformance to FDA Guidance for Software in Medical Devices | Software validation completed. |
| Substantial Equivalence: Equivalent intended use, method of operation, construction, and materials to predicate device. | "The AtriCure Cryo Module System is equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are substantially equivalent to existing legally marketed predicate products." |
| General Product Specifications: Conformance to internal design specifications. | "Appropriate product testing was conducted to evaluate conformance to product specification..." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/not provided in the context of this 510(k) submission. The testing described primarily involves bench comparison testing, transit testing, electromagnetic compatibility, design verification, and software validation of a physical electro-mechanical medical device, not a data-driven AI/ML system tested on a clinical "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. Ground truth in the context of clinical data for AI/ML models is not relevant to this submission for a hardware medical device. The "ground truth" for this device would be its ability to perform its intended cryoablation function and meet engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies to establish a consensus ground truth from expert readers for a dataset, which is not described here.
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 information is not applicable/not provided. An MRMC study is designed for evaluating the impact of AI on human reader performance, which is not relevant for this non-AI medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This device is not an algorithm; it is a physical cryosurgical system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not refer to "ground truth" in the manner relevant to AI/ML devices. For this device, the "truth" is established through:
- Conformance to engineering specifications and design validation.
- Compliance with safety and performance standards (e.g., UL, EN, IEC, ASTM).
- Demonstration of biocompatibility (ISO 10993-1).
- Proof of functional performance in bench testing.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As there is no training set, there is no ground truth to establish for one.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.