(29 days)
The AtriCure cryolCE BOX is a non-sterile, reusable medical device which delivers cryogenic energy, namely nitrous oxide, to AtriCure's cryo-ablation PROBES.
The AtriCure cryolCE BOX (ACM) is an electro-mechanical cryogenic surgical system that delivers a Nitrous Oxide (№0) cryo-genic energy source to a PROBE to create lines of ablation through tissue. The ACM includes single use PROBES (not part of this submission), Component and Accessories. The ACM provides controlled lesion forming temperature that is below -40°C (-40°F).
In addition to the Activation Button on the front panel of the ACM, an accessory Footswitch can also be used to activate and terminate the cryo ablation cycle.
The ACM is designed to operate only with AtriCure's PROBES. Refer to the AtriCure's PROBE Instruction for Use for detailed use and description.
The provided text is a 510(k) summary for the AtriCure cryoICE BOX (ACM) and does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria.
However, based on the limited information available in the "V. Performance Data" section, here's what can be extracted and then what cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a general statement in "V. Performance Data": "The AtriCure cryoICE BOX device met the predetermined acceptance criteria ensuring substantial equivalence to the previously cleared AtriCure Cryo Module."
It does not provide a specific table of acceptance criteria or detailed reported device performance. It only states that the device met the criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "Performance Data" section indicates "bench testing was conducted," but no details on sample size, data provenance, or whether it was retrospective or prospective 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 in the document. The device is a "Cryosurgical Unit And Accessories" and the testing mentioned is "bench testing," which typically does not involve expert-established ground truth in the context of medical image analysis or diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here for this device's performance testing.
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 provided in the document. A MRMC study is relevant for assessing diagnostic performance, especially of AI/CAD systems that assist human readers. This device is a cryosurgical unit, not an AI or diagnostic imaging device, so such a study would not typically be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document. This concept is typically relevant for AI/algorithm performance. The device is hardware (a cryosurgical unit), and its performance would be assessed through functional bench tests, not as an "algorithm only" product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document beyond the general statement that "predetermined acceptance criteria" were met during "bench testing." For a cryosurgical unit, "ground truth" would generally involve objective measurements against engineering specifications (e.g., temperature achieved, power output, flow rates) rather than clinical ground truth like pathology or outcomes data, which are more applicable to diagnostic or therapeutic devices where a direct clinical outcome is being measured against a gold standard.
8. The sample size for the training set
This information is not provided in the document. This is only relevant for machine learning or AI models, which is not applicable to the AtriCure cryoICE BOX as described.
9. How the ground truth for the training set was established
This information is not provided in the document for the same reason as point 8.
§ 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).