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The Soprano™ Cryo-Therapy System is intended for use in the surgical ablation of tissue by the application of extreme cold in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, E.N.T., gynecology, oncology, proctology and urology.

The FemRx Soprano Cryo-Therapy System is designed to be a general use cryotherapy system for the destruction or cryoablation of tissue. The system allows the circulation of a cryorefrigerant from the console to the reusable cryoprobe.

This document is a 510(k) summary for the Soprano™ Cryo-Therapy System, indicating that the device has been reviewed and found substantially equivalent to predicate devices. However, the provided text does not contain detailed performance data, acceptance criteria, or a description of a study that proves the device meets specific acceptance criteria in the manner requested by the prompt for AI/ML device evaluations.

It states: "The results from the nonclinical tests indicate the Cryo-Therapy System is equivalent to the predicate devices in terms of safety and effectiveness." This is a general statement and not a detailed account of performance results against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document does not list specific acceptance criteria or quantitative performance metrics.
• Sample sized used for the test set and the data provenance: No information on test set size or data origin is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no expert-derived ground truth or test set is mentioned.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not mention such a study.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
• The type of ground truth used: Not applicable as no specific test data or ground truth establishment is described.
• The sample size for the training set: Not applicable as no training set is mentioned for this type of device.
• How the ground truth for the training set was established: Not applicable.

This 510(k) summary pertains to a physical cryo-therapy system and evaluates its substantial equivalence to predicate devices based on intended use, principle of operation, and control function, rather than the performance metrics typically associated with AI/ML-driven diagnostic devices.

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