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Cryosurgical unit used for ablative type surgical technique on multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.

Cryosurgical instrument used to necrose unwanted tissue in the gynecological and dermatological practice

The CryoPen system provides a safe means of freezing tissue without the use of cryogenic liquids or greenhouse gases. The system consists of multiple pen cores, a Stirling cooler which rejects heat, and a variety of reusable tips for dermatologic and gynecology applications. When used properly, the system will deliver effective temperature for tissue ablation. The model number of this Cryosurgical system is CT-2000.

The Stirling cooler is used to lower the temperature of the CryoPen units to temperatures of -105 degrees Celsius. It operates on a 24 V DC external power supply powered by 115 (or 220) V AC obtained from conventional convenience outlets. The housing of the cooler provides necessary electrical safety features and electromagnetic compatibility. A temperature indicator indicates the readiness of the CryoPen units during cool down,

The provided text appears to be a 510(k) summary for a medical device called the "CryoPen Cryosurgical System." It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies.

The document states: "based on the nonclinical bench testing performed on ballistic gelatin. Data generated from bench testing shows the CryoPen is able to freeze the same volume and mass as the Wallach LL100." This indicates that the equivalence was demonstrated through bench testing, not a clinical study with human patients or expert evaluations.

Therefore, I cannot provide the requested information about acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

Based on the provided text, the most relevant information regarding performance and its comparison to a predicate device is:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document mentions "nonclinical bench testing performed on ballistic gelatin." This indicates that the testing was not performed on human subjects. No specific sample size (e.g., number of tests, volume of gelatin) is provided, nor is the country of origin of the data specified. The data is from retrospective bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" was established through physical measurements of freezing volume and mass in ballistic gelatin during bench testing, not through expert human evaluation.

4. Adjudication method for the test set
Not applicable. There was no expert adjudication process for this bench 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
Not applicable. The CryoPen is a surgical instrument and not an AI device, so MRMC studies involving human readers and 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. The CryoPen is a physical cryosurgical system, not an algorithm. Its performance is inherent to its mechanical and thermal properties.

7. The type of ground truth used
The ground truth used was physical measurements of freezing volume and mass in ballistic gelatin, compared to the performance of the predicate device.

8. The sample size for the training set
Not applicable. Bench testing for substantial equivalence does not typically involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established
Not applicable. There was no training set in the context of this 510(k) submission.

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