The Myoscience Cryo-Touch III 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 III is not indicated for treatment of central nervous system tissue.

Device Description

The Myoscience Cryo-Touch III 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 needle probe, "Tip" cooled by the cryogenic fluid (liguid nitrous oxide, N₂O) to a selected area. The Tip is cooled by the Joule-Thomson effect and/or Latent Heat of Vaporization. The Cryo-Touch III may be used in conjunction with a standard off-the-shelf nerve stimulator device in applications where precise nerve location is desired.

AI/ML Overview

The provided text describes the Myoscience Cryo-Touch III, a cryogenic surgical device. Since this is a medical device and not an AI/ML-based system, many of your requested criteria (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable. The device's performance is demonstrated through various engineering and preclinical tests, not through studies involving human or imaging data analysis.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria Implicitly Met	Reported Device Performance
Temperature reproducibility	Device consistently achieves target temperatures for cryoablation.	PASS, Substantially equivalent to predicate
Mechanical Integrity for system	Device components maintain structural integrity during use.	PASS, Substantially equivalent to predicate
Disable valve reliability	Safety mechanism reliably prevents unintended operation.	PASS, Substantially equivalent to predicate
Thermal fuse testing	Thermal fuse functions correctly to prevent overheating.	PASS, Substantially equivalent to predicate
Nitrous exposure	N₂O leakage or exposure is within safe limits.	PASS, Substantially equivalent to predicate
Cryozone size	The size and shape of the cryoablation zone are consistent and predictable.	PASS, Substantially equivalent to predicate
Needle Integrity	The needle probe maintains structural integrity and functionality.	PASS, Substantially equivalent to predicate
Device Durability	Device withstands repeated use and sterilization procedures.	PASS, Substantially equivalent to predicate
Sterilization and Shelf Life Testing	Device can be effectively sterilized and maintains sterility and functionality over its shelf life.	PASS, Substantially equivalent to predicate
Electrical Safety Testing	Device meets electrical safety standards (e.g., preventing shock, electromagnetic compatibility).	PASS, Substantially equivalent to predicate
Software Testing	Device software functions as intended and does not introduce hazards.	PASS, Substantially equivalent to predicate
Safety Testing	Overall device operation is safe for patients and users.	PASS, Substantially equivalent to predicate
Biocompatibility Testing	Device materials are compatible with biological tissues to minimize adverse reactions.	PASS, Substantially equivalent to predicate

Implicit Acceptance Criteria: The phrase "Substantially equivalent to predicate" indicates that the Cryo-Touch III met the same performance standards and safety profiles as the previously cleared Cryo-Touch and Cryo-Touch II devices. This implies that the acceptance criteria are based on the established performance of the predicate devices and relevant industry standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11137-1, ISO 11607, and ASTM F882-84).

2. Sample size used for the test set and the data provenance

Since this is a physical medical device and not a data-driven AI system, there is no "test set" in the context of data. The "tests performed" refer to laboratory and engineering evaluations. The sample size for these tests would typically involve a predefined number of devices or components to be tested according to design verification and validation protocols (e.g., a certain number of units for durability testing, or a specific number of cycles for reliability tests). This specific number is not provided in the summary. Data provenance is not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant for this type of medical device's performance evaluation. The "ground truth" for the device's technical specifications and safety would be established through engineering specifications, regulatory standards, and established scientific principles.

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

Not applicable. Adjudication methods are typically used for resolving discrepancies in expert labeling or diagnoses, which is not relevant for the technical performance testing of this device.

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 device is a cryogenic surgical tool, not an AI-assisted diagnostic or treatment planning system. Therefore, MRMC studies are not relevant.

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

Not applicable. This is a physical device, not an algorithm.

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: The design parameters and target performance metrics defined by the manufacturer.
International Standards: Adherence to recognized medical device standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11137-1, ISO 11607, and ASTM F882-84).
Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices (Cryo-Touch and Cryo-Touch II).

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the AI/ML sense.

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

Not applicable. There is no training set for this device.

Summary

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myoscience

Cryo-Touch III

Premarket Notification

Section 5: 510(k) Summary

Device Information:

Category	Comments
Sponsor / Submitter:	Myoscience, Inc525 Chesapeake DriveRedwood City, CA 94063(650) 474-2600(650) 474-2700
Correspondent ContactInformation:	Tracey HenryVice President RAQA, Clinical Compliance525 Chesapeake DriveRedwood City, CA 94063(650) 474-2600(650) 474-2900
Device Common Name:	Cryogenic Surgical device
Device Classification & Code:	Class II, GXH
Device Classification Name:	Cryosurgical unit and accessories (21 CFR 882.4250)
Device Proprietary Name:	Myoscience Cryo-Touch III

a. Predicate Device Information:

The Cryo-Touch III is substantially equivalent to the following currently legally marketed devices:

510(k) Number	Product	Sponsor
K083493	Cryo-Touch	Myoscience, Inc
K102021	Cryo-Touch II	Myoscience, Inc

b. Date Summary Prepared

February 8, 2012

c. Description of Device

Device Design

The device is comprised of four main components:

1. a re-usable Control Unit,
1. a re-usable Handpiece,
a single patient use Tip, and 3.

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myoscience

Test Performed	Result
Temperaturereproducibility	PASS, Substantially equivalent to predicate
MechanicalIntegrity for system	PASS, Substantially equivalent to predicate
Disable valvereliability	PASS, Substantially equivalent to predicate
Thermal fusetesting	PASS, Substantially equivalent to predicate
Nitrous exposure	PASS, Substantially equivalent to predicate
Cryozone size	PASS, Substantially equivalent to predicate
Needle Integrity	PASS, Substantially equivalent to predicate
Device Durability	PASS, Substantially equivalent to predicate
Sterilization andShelf Life Testing	PASS, Substantially equivalent to predicate
Electrical SafetyTesting	PASS, Substantially equivalent to predicate
Software Testing	PASS, Substantially equivalent to predicate
Safety Testing	PASS, Substantially equivalent to predicate
BiocompatibilityTesting	PASS, Substantially equivalent to predicate

This performance testing demonstrated that the device is in compliance with pertinent standards (IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 11137-1, ISO 11607, and ASTM F882-84), the product labeling, and is substantially equivalent to the predicates.

Clinical Testing Submitted: None

g. Conclusion

Myoscience concludes that the Cryo-Touch III described in this submission is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol, with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MyoScience, Incorporated % Ms. Tracey Henry Sr. Director, Regulatory Affairs and Quality Assurance 525 Chesapeake Drive Redwood City, CA 94063

JUN 2 2 2012

Re: K120415

Trade/Device Name: Myoscience Cryo-touch III Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: II Product Code: GXH Dated: June 13, 2012 Received: June 15, 2012

Dear Ms. Henry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for answer to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease now u, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 toure be actived a determination that your device complies with other requirements of the Act that I DA has made a actoring administered by other Federal agencies. You must

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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you attp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 1000 the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Health Center for Devices and Radiological Health

Enclosure

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Cryo-Touch III Premarket Notification

Section 4: Indications for Use Statement

510(k) Number:

Device Name: Myoscience Cryo-Touch III

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Daryl Kausin

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear. Nose and Throat Devices

K120415 510(k) Number.

Regulation Number and Section

§ 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).