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The Myoscience Cryo---Touch IV is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo--- Touch IV is not indicated for treatment of central nervous system tissue.

Device Description

The Myoscience Cryo-Touch IV is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N-O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or Latent Heat of Vaporization. The Cryo-Touch IV may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired. The device is comprised of four main components: A reusable Handpiece, A Charging Dock, A single-patient use Smart Tip, and A Cartridge (Nitrous Oxide).

AI/ML Overview

The Myoscience Cryo-Touch IV is a cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through the application of extreme cold. The provided document describes nonclinical testing performed to demonstrate that the product met design requirements for system performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Temperature reproducibility	Substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Mechanical Integrity for System	Substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Nitrous Exposure	Substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Cryozone Size	Substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Needle Integrity	Substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Device Durability	Substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Sterilization and Shelf Life Testing	In compliance with pertinent standards (ISO 11137-1) and substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Electrical Safety Testing	In compliance with pertinent standards (IEC 60601-1, IEC 60601-1-2) and substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Software Testing	Substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Safety Testing	Substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate
Biocompatibility Testing	In compliance with pertinent standards (ISO 10993-1) and substantially equivalent to predicate devices	PASS, Substantially equivalent to predicate

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Verification testing was performed on the Cryo-Touch IV device," but does not specify the sample size used for the test set. The data provenance is not explicitly stated. These were nonclinical tests, likely performed in
a laboratory setting, rather than on human subjects or clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. Given that these are nonclinical device performance tests, the "ground truth" would likely be established by engineering specifications, validated measurement techniques, and comparison to predicate device performance, not clinical expert consensus.

4. Adjudication Method for the Test Set:

This information is not provided in the document. As these are nonclinical tests, an adjudication method in the human-in-the-loop sense is not applicable. The assessment would be based on meeting predefined engineering and performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. The tests described are nonclinical performance validations of the device itself, not studies comparing human reader performance with and without AI assistance. The Cryo-Touch IV is a physical surgical device, not an AI or imaging diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The concept of a "standalone" algorithm performance is not applicable to the Cryo-Touch IV. It is a physical medical device. The "standalone" evaluation would refer to its own functional standalone performance as measured by the nonclinical tests listed, which were indeed performed.

7. The Type of Ground Truth Used:

The ground truth for these nonclinical tests appears to be based on:

Engineering specifications and design requirements: The document states the tests "demonstrate that the product met the design requirements for system performance."
Pertinent consensus standards: Compliance with standards like IEC 60601-1, IEC 60601-1-2, ISO 10993-1, and ISO 11137-1 serves as a form of ground truth or benchmark.
Performance of legally marketed predicate devices: The "substantially equivalent to predicate" outcome for many tests indicates that the performance of existing, approved devices served as a critical benchmark or ground truth for acceptable performance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The Cryo-Touch IV is a physical cryogenic surgical device. There is no mention or indication of any AI/ML components that would require a "training set" in the context of machine learning. The nonclinical tests described are for device validation, not algorithm training.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided for the same reasons as point 8.

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