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AtriCure's cryolCE 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 cryosurgical handpieces, or cryo-ablation probes, utilized in the AtriCure Cryosurgical System are hand held, single use, cryosurgical instruments intended for the cryosurgical treatment of cardiac arrhythmias during cardiac surgery. The cryosurgical handpieces utilize a high-pressure cryogen (nitrous oxide, N2O) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. The cryosurgical handpieces provide probe temperatures below -40°C, the temperature at which intracellular ice formation occurs which is considered lethal to cells. When high pressure nitrous oxide is supplied to the cryoprobes via the AtriCure Cryo Module, rapid cooling is achieved via the Joule-Thompson effect. The end effector, or cryotip, of the probes are malleable to allow access to varying anatomy and anatomical sites.

The cryo-ablation probes are comprised of a cryotip end effector, shaft, handle, thermocouple, inlet tube, and exhaust tube. The cryotip consists of an aluminum boiler or stainless-steel boiler and three internal inlet orifices distributed throughout the cryotip internally to provide uniform cooling. The 4-mm diameter, cryotip is malleable throughout its 10-cm length. A supplied forming tool can be used the cryotip into the desired form. The cryotip is attached to an insulated rigid shaft that allows the surgeon to adjust the length of the exposed cryotip up to 10 cm in therapeutic length. A thermocouple is affixed to the proximal external surface of the shaft to display real time temperatures on the console. The handle is attached to the shaft. Inlet and exhaust tubes and thermocouple wire pass through the handle and connect to the AtriCure Cryo Module (ACM).

The provided text is a 510(k) premarket notification from the FDA, describing a medical device called the AtriCure cryoICE cryo-ablation probe. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove a device meets specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission. This submission is about a modified device and primarily relies on non-clinical bench testing to show that the modifications do not alter the device's performance, safety, or intended use compared to the predicates.

Here's a breakdown of what can be extracted and what information is missing/not applicable based on the provided document:

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

The document does not provide a table with specific quantitative acceptance criteria (e.g., minimum temperature achieved, specific ablation zone size) or their corresponding reported performance values from a clinical study. Instead, it relies on demonstrating equivalence through non-clinical bench testing for specific attributes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in terms of clinical cases or individual patient data. The "test set" here refers to the number of devices or components subjected to non-clinical bench testing. The document states "Non-clinical Bench Testing" was conducted but doesn't specify the sample size for these tests.
• Data Provenance: Not explicitly stated as retrospective/prospective or country of origin for clinical data, because this submission is based on non-clinical bench testing of the device itself, not clinical data from patients.

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)

• Not applicable. This submission does not involve human expert interpretation of clinical data to establish ground truth. The "ground truth" for this device's performance is based on direct physical measurements and engineering specifications verified through bench testing.

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

• Not applicable. This relates to clinical data adjudication by multiple readers, which is not part of this 510(k) submission.

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 medical device (cryo-ablation probe), not an AI-assisted diagnostic tool. Therefore, MRMC studies and human reader improvement with AI assistance are irrelevant to this submission.

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

• Not applicable. This refers to AI algorithm performance. This is a physical medical device.

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

• The "ground truth" for this device's performance is based on engineering specifications, direct physical measurements (e.g., temperature, mechanical integrity), and functional testing to ensure it meets its design requirements and operates comparably to the predicate devices. It relies on the inherent physical properties and verified performance during non-clinical bench testing.

8. The sample size for the training set

• Not applicable. This refers to AI model training data. This is a physical medical device.

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

• Not applicable. This refers to AI model training data. This is a physical medical device.

Summary of the K180137 Submission's Approach:

This 510(k) submission (K180137) is a "Special 510(k)" because it deals with minor modifications to an already cleared device. The core argument for clearance is substantial equivalence to predicate devices. This is established by demonstrating that the modifications (non-patient contacting tube-sets, packaging) do not affect the device's fundamental operating principle, performance specifications, patient-contacting materials, or intended use.

The study that proves the device meets the (implied) acceptance criteria is Non-clinical Bench Testing. The document states that these tests:

• "Demonstrated equivalency in performance" for Mechanical Reliability, Transit, Shelf-life, and Cryogen Performance/Thermal Insulation.
• "Did not raise any new issues of safety."

This type of submission typically avoids extensive new clinical trials if the modifications are minor and substantial equivalence can be demonstrated through rigorous non-clinical testing.

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