(106 days)
AtriCure Cryo Module Indication for Use Statement: The AtriCure Cryo Module is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation probes.
cryolCE™ Indication for Use Statement: AtriCure's cryoICE™ cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.
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 the AtriCure cryo-ablation probes. The AtriCure's cryo-ablation probe (CRYO2) is a sterile, single use, cryosurgical device to be used in conjunction with the AtriCure Cryo Module or ACC2 Cardiac Cryosurgical System [K811390] to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The cryolCE™ probe can also be used to temporarily ablate peripheral nerves.
The information provided in the document focuses on the substantial equivalence of the AtriCure Cryosurgical System to predicate devices, rather than establishing specific acceptance criteria and detailed study results for a new medical device's performance. The document describes the system and its indications for use, and then lists various non-clinical bench tests that were conducted. However, it does not provide the specific acceptance criteria for these tests, nor does it present detailed performance data that would allow for a direct comparison against such criteria. The "Results" column in the "Non-clinical Bench Testing" table simply states "Passed" for all tests, without quantitative or qualitative metrics.
Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and sample sizes for effectiveness studies (especially related to human-in-the-loop or standalone AI performance) cannot be extracted from the provided text. This document is a 510(k) summary, which typically focuses on demonstrating equivalence to legally marketed devices rather than presenting novel performance studies in the way a PMA application might.
Based on the provided text, here is what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria for the various tests. The 'Performance Data' section only lists the types of tests performed and states "Passed" as the result, without providing specific metrics or targets that define "Passed".
| Acceptance Criteria (Inferred/Not Provided) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | "Passed" for all listed Non-clinical Bench Tests |
| CRYO2 Comparison testing (Bench testing) | Passed |
| CRYO2 Mechanical Reliability (Bench testing) | Passed |
| CRYO2 Performance testing (Bench testing) | Passed |
| CRYO2 Acute Animal Verification Lab (Bench testing) | Passed |
| CRYO2 ASTM Testing (Bench testing) | Passed |
| Evaluation Against Similar Product (Bench testing) | Passed |
| ACM Software Validation (Software testing) | Passed |
| ACM Display Board Verification (Bench testing) | Passed |
| ACM Controller Board Verification (Bench testing) | Passed |
| Handpiece Connector Board Verification (Bench testing) | Passed |
| ACM Power Board Verification (Bench testing) | Passed |
| ACM Reliability Testing (Bench testing) | Passed |
| ACM Simulated Use (Bench testing) | Passed |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size used for any of the non-clinical bench tests or studies. It also does not specify the provenance of any data (e.g., country of origin, retrospective/prospective nature). The "Acute Animal Verification Lab" test implies animal data, but no specifics are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Given that the studies are non-clinical bench tests and a single "Acute Animal Verification Lab" test, it's unlikely that 'experts for ground truth' in the context of clinical interpretation (like radiologists) would be relevant. The "ground truth" for these types of engineering tests would typically be established by established test methodologies and reference standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
No such study is mentioned or implied. The device described, the AtriCure Cryosurgical System, is a cryo-ablation device, not an AI or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of "ground truth" used for any of the tests. For bench testing, the "ground truth" would typically be defined by engineering specifications, physical measurements, and adherence to validated test protocols. For the "Acute Animal Verification Lab," this would involve physiological measurements and potentially histological examination, but no specifics are provided.
8. The sample size for the training set
Not applicable. The device is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).