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The R2 Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. It is intended for use in a healthcare facility such as a clinic or doctor's office.

The Dermal Cooling System is comprised of the following components:

control unit - houses the user interface, the system controller, and the power source
handpiece – contains the TEC, thermistors, and the aluminum cooling plate in a thermoplastic housing
chiller - provides circulating water to the handpiece to remove heat extracted by the TEC
isolation transformer – isolates system from AC power

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the R2 Dermal Cooling System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance (as stated in document)
Biocompatibility	Skin contacting, surface device for limited duration (< 24 hours): cytotoxicity, sensitization, and irritation.	Passed. Considered compliant with ISO-10993 and recognized by FDA.
Electrical Safety	Compliance with IEC 60601-1 (2005+A1:2012).	Passed.
EMC (Electromagnetic Compatibility)	Compliance with IEC 60601-1-2 (2007).	Passed.
Usability	Compliance with IEC 60601-1-6 (2010); ability of users with no prior experience to read operating guide and perform mock cooling procedure multiple times on a simulated test system.	Passed. All users successfully completed the mock procedure and demonstrated understanding of device features.
Thermistor & Timer Accuracy	Implicit: devices accurately measure and display temperature and time.	Passed. Demonstrated through verification testing.
Thermal Performance & Range	Implicit: ability to achieve and maintain specified cooling temperatures (minimum -30°C, maximum treatment duration 300 seconds); sufficient thermal power to cool aluminum contact plate to pre-set temperature.	Passed. Demonstrated through verification testing.
Reuse	Implicit: withstand repeated use as intended.	Passed. Demonstrated through verification testing.
Physical Specifications	Implicit: device dimensions, weight, material integrity, etc., meet design requirements.	Passed. Demonstrated through verification testing.
Compatibility with Use Environment	Implicit: device functions properly in healthcare facility settings.	Passed. Demonstrated through verification testing.
Treatment Parameters	Minimum/maximum temperature settings, treatment duration, active warming, auto-recipe control.	Passed. Demonstrated through verification testing.
Power and Operational Control	Implicit: system initiates and controls operational modes correctly, user interface functions as designed.	Passed. Demonstrated through verification testing.
Labeling, Interface, and Support Requirements	Implicit: clear and accurate labeling, user-friendly interface, proper support mechanisms.	Passed. Demonstrated through verification testing.
Cryoablation Zone Equivalence	Creation of a cryoablation zone substantially equivalent to the predicate (CryoPen® Surgical System).	Passed. Measurements documented with an in vitro model verified the creation of a substantially equivalent cryoablation zone with both devices.
Software Verification & Validation	Compliance with FDA's "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January 2002); device software considered "moderate level of concern."	All tests were successfully passed by meeting the acceptance criteria.
Safety and Effectiveness Equivalence	Expected to be equivalent to predicates in safety and effectiveness for specified use conditions.	Performance data demonstrate the device performs to specification and is expected to be equivalent to the predicates. All testing, including substantial equivalence testing with the primary predicate, was passed. The Dermal Cooling System is determined to be substantially equivalent.

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

Sample Size: Not explicitly stated for specific tests beyond "multiple times" for usability testing. For the cryoablation zone equivalence, an "in vitro simulated model" was used.
Data Provenance: All testing appears to be retrospective bench testing and usability testing conducted by the manufacturer, R2 Dermatology, Inc. There is no indication of country of origin for the data; it's assumed to be domestic (USA) given the FDA submission.
No preclinical or clinical testing was performed.

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

Not applicable. The document does not describe the use of human experts to establish ground truth for the test set. Ground truth was established through technical specifications, bench testing, and comparison with a predicate device in an in vitro model.

4. Adjudication Method for the Test Set

Not applicable. There was no explicit adjudication method described as there were no human-read studies or subjective assessments requiring adjudication. The performance was assessed against predefined technical specifications and comparison to a predicate device via objective measurements.

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

No. This device is a cryosurgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Yes, in a sense. The core "performance data" and "substantial equivalence testing" were standalone in that they evaluated the device's physical and functional capabilities (thermal performance, accuracy, software operation) and its ability to create a cryoablation zone equivalent to a predicate in an in vitro model, without a human operator's diagnostic or interpretative input being part of the primary performance metric. The usability testing, while involving humans, focused on their ability to operate the device, not on their diagnostic effectiveness.

7. The Type of Ground Truth Used

Bench Test Specifications: For thermal performance, accuracy, physical specifications, power control, etc., the ground truth was the pre-defined engineering and design specifications of the device.
Predicate Device Performance: For the cryoablation zone equivalence, the ground truth was the established performance of the predicate CryoPen® Surgical System in creating a cryoablation zone, as measured in an in vitro model.
Regulatory Standards: For biocompatibility, electrical safety, EMC, and usability, the ground truth was compliance with recognized international and FDA standards (ISO-10993, IEC 60601 series, FDA software validation guidance).

8. The Sample Size for the Training Set

Not applicable. This document describes the testing and validation of a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set mentioned or implied for an AI/ML model, the establishment of ground truth for such a set is not relevant to this document.

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