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The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling. inflammation, and hematoma from minor surgical procedures.

The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.

The Dermal Cooling System is intended to be used by trained healthcare professionals.

The 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 and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips.

The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dermal Cooling System:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Information about the Study:

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

The document states, "No other performance testing was performed for the subject device for this Traditional 510(k)..." and "No preclinical or clinical testing was performed." The only reported test is a "System Performance Test" described as "Bench testing." This implies the "test set" for this specific performance criteria was likely a single or a small number of physical devices tested in a lab setting, rather than a clinical dataset. No information on data provenance (country of origin, retrospective/prospective) is applicable as it's not a clinical study involving patient data.

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

Not applicable. The reported test is a bench test, and the "ground truth" is established by the device's ability to maintain a specific coldplate temperature, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set:

Not applicable, as it's a bench test against an objective temperature criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No preclinical or clinical testing was performed."

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

This question is not applicable to the Dermal Cooling System. This device is a physical cryosurgical instrument, not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not relevant.

7. The Type of Ground Truth Used:

The ground truth for the "System Performance Test" was the pre-defined target temperature range for the internal coldplate (-16.0°C ± 0.5°C) maintained over a specific duration (20 minutes). This is a physical performance specification, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

Not applicable, as there is no training set mentioned or implied.

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The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.

When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.

The Dermal Cooling System is intended to be used by trained healthcare professionals.

The 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 and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. For dermabrasion, the Dermal Cooling System handpiece is intended to serve as a handle to facilitate manual movement of the R2 Dermabrasion Tips.

The R2 Dermabrasion Tips are optional accessories for the Dermal Cooling System that may be attached to the distal end of the handpiece to facilitate manual dermabrasion. The R2 Dermabrasion Tips may be used with a commercially available topical or water to facilitate movement of the handpiece across the treatment area.

This document describes a 510(k) premarket notification for the Dermal Cooling System and its accessory, R2 Dermabrasion Tips. The primary purpose of the submission is to expand the indications for use of the Dermal Cooling System to include general dermabrasion, scar revision, acne scar revision, and tattoo removal when used with the R2 Dermabrasion Tips.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Dermabrasion Performance Test: 6 subjects (3 at 20 Amps EDM, 3 at 80 Amps EDM)
• Thermal Insulation Test: 6 subjects (3 at 20 Amps EDM, 3 at 80 Amps EDM)
• Data Provenance: The document does not specify the country of origin of the data. It appears to be a prospective study as tests were conducted on subjects.

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

The document does not mention the use of experts to establish a ground truth for the test set. The acceptance criteria for the performance tests (e.g., "no unexpected side effects observed") would likely have been evaluated by the researchers or medical staff conducting the study.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study focused on the performance of the device (Dermal Cooling System with R2 Dermabrasion Tips) itself, not on the improvement of human readers with AI assistance.

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

This device is not an AI algorithm. It is a physical medical device (Dermal Cooling System with R2 Dermabrasion Tips). The performance tests described demonstrate the device's physical functionality and safety, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

The ground truth for the performance tests was based on direct observation of subjects for:

• Absence of unexpected side effects (Dermabrasion Performance Test).
• Maintenance of skin temperature above a certain threshold (Thermal Insulation Test).

This is akin to objective clinical observations rather than established "ground truth" in the context of image analysis or diagnostic AI.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. This device is not an AI/ML device that requires a training set.

Ask a specific question about this device

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.

The Dermal Cooling System is intended to be used by trained healthcare professionals.

The 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 and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. 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 user interface display, the system controller, and the power converters
• chiller – provides circulating coolant to the handpiece to remove heat from the TEC
• handpiece - contains the TEC, temperature sensors, the aluminum cooling plate, and user interface elements
• isolation transformer – isolates system from AC mains power
• cart – houses the isolation transformer, chiller, and control unit

The control unit initiates the treatment parameters and receives feedback from temperature sensors in the handpiece during the procedure. The user interface provides the mechanism for selection of the treatment plan, initiation of treatment, and display of treatment status.

The non-sterile, reusable handpiece contains the TEC which cools the aluminum contact plate to the treatment temperature, while the circulation of fluid past the TEC allows for the removal of heat. Thermistors affixed to the aluminum contact plate monitor the temperature at the treatment site.

The Dermal Cooling System has three operational modes: cooling off, pre-cool, and treatment. Cooling off represents the resting state; no power is supplied to the TEC in the handpiece. Pre-cool is the state during which the aluminum contact plate in the handpiece is cooled prior to treatment. Treatment is the normal treatment state in which the contact plate temperature is controlled to a pre-defined temperature defined in the treatment plan, as selected from the user interface on the control unit. The minimum temperature is -30°C and the maximum temperature is 40°C; the maximum treatment duration is 300 seconds.

The user interface is the means by which the user can view system status and state of each operational mode. The software provides three primary functions: allowing the user to select a treatment plan; establishing communications with the TEC controller and monitoring and displaying treatment progress.

Use of a TEC with closed-loop temperature feedback for cooling, as provided by the Dermal Cooling System, allows the selected temperature to be precisely and accurately maintained throughout the treatment. The TEC controller in the control unit communicates to the TEC module in the handpiece, maintaining the temperature defined in the treatment plan selected by the user. As heat is removed from the skin through contact with the aluminum plate, it is then transferred through the TEC module to the heat exchanger, which is fluid cooled. The chiller maintains a continuous flow of coolant which is circulated through the heat exchanger to carry heat way from the TEC module. The Dermal Cooling System generates sufficient thermal power to cool the aluminum contact plate to a pre-set temperature over a pre-set time. The temperature of the cooling surface, as measured by the thermistor affixed to the aluminum contact plate, is fed into the TEC controller which modulates power to the TEC such that the surface temperatures are precisely controlled. The Dermal Cooling System has an automatic shut-off feature if the temperature for the TEC and cooling plate are out of range.

The Dermal Cooling System operates from standard 120 VAC (60 Hz) power to provide controlled, active cooling at the skin interface throughout the procedure.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The document describes the Dermal Cooling System, a cryosurgical instrument. The information provided focuses on the substantial equivalence determination for an expanded indication, rather than a detailed study proving the device meets acceptance criteria in a traditional sense for a novel device's performance. Instead, it demonstrates that the device already meets performance necessary for the expanded indication by comparing it to predicate devices and inherent capabilities.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

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

The document does not specify a distinct "test set" with a particular sample size for the System Validation tests. The evaluation appears to be based on bench testing of the device itself rather than a study involving a cohort of subjects. Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable in the context of human subject 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 for the "System Validation" tests was established through direct measurement and observation of the device's physical performance (temperature, sticking, blanching) during bench testing, not through expert interpretation of data.

4. Adjudication method for the test set

Not applicable, as the evaluation was based on direct physical measurements and observations during bench testing, not subjective interpretation requiring adjudication.

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 physical cryosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to its evaluation.

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

Not applicable. This is a physical medical device, not an algorithm. Its "standalone" performance is its direct operational capability, as assessed by the bench tests.

7. The type of ground truth used

For the "System Validation" tests, the ground truth was based on direct physical measurements and observations of the device's temperature control capabilities and interaction with simulated tissue (implied by "varied contours and body geometries" and "handpiece does not stick to tissue and no visible blanching"). This is a form of engineering/performance validation rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

Not applicable. The document does not describe the development of a machine learning model or algorithm that would require a training set. The device's operation is based on established engineering principles (thermoelectric cooling with closed-loop temperature feedback).

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

Not applicable, as there is no training set for a machine learning model described.

Ask a specific question about this device

The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin.

The 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 user interface display, the system controller, and the power converters
• . chiller – provides circulating coolant to the handpiece to remove heat from the TEC
• . handpiece - contains the TEC, temperature sensors, the aluminum cooling plate, and user interface elements
• . isolation transformer – isolates system from AC mains power
• . cart – houses the isolation transformer, chiller, and control unit

This document describes a 510(k) premarket notification for a Dermal Cooling System, not an AI/ML device. Therefore, the specific questions related to AI/ML device acceptance criteria, training sets, and ground truth establishment are not directly applicable to the provided information.

However, I can extract and structure the information related to the device's acceptance criteria and performance as presented in the document.

Device: Dermal Cooling System (Cryosurgical Unit and Accessories)

Indications for Use: The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin. It is intended to be used by trained healthcare professionals.

Here's an analysis based on the provided document, addressing the relevant points:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:

• Sample Size:
  • For the usability testing, "individuals with varying degrees of experience" were used, including "novice and experienced users." The exact number is not specified.
  • For the in vitro simulated model for subsurface temperature testing, the sample size (number of tests or models) is not specified.
• Data Provenance: The tests were bench tests and in vitro simulations. There is no mention of country of origin for the data as it's not patient data. The study was performed to support a 510(k) submission, indicating a pre-market evaluation rather than a post-market study or retrospective analysis of clinical data. It is a prospective testing approach for regulatory approval.

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

This is a physical device, not an AI/ML system that requires expert-established ground truth in the same way. The "ground truth" for this device's performance is established by objective physical measurements (e.g., temperature, force, weight) and functional performance checks against engineering specifications (e.g., maintain temperature, cycle LEDs).

For usability testing, "individuals with varying degrees of experience" were used, but these were users (not necessarily experts establishing ground truth about the device's function, but rather testing its usability).

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

Not applicable. This is not an AI/ML system requiring image or data interpretation by multiple readers/experts. The tests described are objective engineering and performance validations.

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 is not an AI/ML device, and no MRMC study, human reader improvement, or comparative effectiveness with or without AI assistance was performed or is relevant.

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

Not applicable. This is a physical medical device. It has software control for its operation, but it's not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is based on:

• Engineering Specifications: Designed performance parameters (e.g., specific temperatures, power output, weight limits).
• Physical Measurements: Objective measurements using validated sensors and equipment (e.g., force sensors, thermistors, calibrated controls).
• Functional Verification: Demonstrating the device performs its intended actions (e.g., LEDs cycle, buzzer activates, pre-cool/cooling/warming modes work).
• Simulated Model Performance: An in vitro simulated model was used to verify the creation of a cryoablation zone.

The document explicitly states: "No preclinical or clinical testing was performed." and "There were no changes to patient contacting material and, as such, biocompatibility testing was not repeated." This indicates reliance on bench testing and in-vitro models rather than patient outcomes or pathology.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device; there is no "training set" in the context of machine learning. The device's software is rule-based control logic, not a machine learning model.

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

Not applicable, as there is no training set for an AI/ML model. The software's functionality is verified against design specifications and validated through testing (as noted in point 7). "Software verification and validation testing was conducted per FDA's 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff' (January 2002)." This guidance focuses on traditional software engineering best practices, not machine learning training.

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The R2 Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin.

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

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

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