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The CryoDose H indications for use as follows: CryoDose H is indicated for use in the treatment of actinic keratosis, genital warts, lentigo, mulluscum contagiosum, sebortheic keratosis, skin tags, verruca vulgaris, and verruca plana.

The proposed device, CryoDose H, is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. The device consists of an aerosol-filled canister and parts within the canister. The canister is sold within a kit with accessories including: Directions for Use, swabs, and packaging materials. The aerosol is sprayed onto a foam covered cotton swab that is then placed upon the benign lesion (e.g. wart) for 15-40 seconds.

The provided document describes the acceptance criteria and study for the Nuance Medical, LLC CryoDose H device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state a specific numerical sample size for each test (e.g., number of foam tips tested for biocompatibility, number of cans for chemical composition, number of devices for temperature testing). The description indicates "Tests were performed" and "Studies were conducted" which implies samples were used.
• Data Provenance: Not explicitly stated. However, given this is an FDA 510(k) submission, the studies would have been conducted by or for Nuance Medical, LLC, likely in a controlled laboratory setting. There is no mention of country of origin for data, nor if it was retrospective or prospective in a clinical sense, as the studies are primarily bench and lab-based (biocompatibility, chemical, structural, temperature performance).

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

• Number of Experts: Not applicable or not specified. The tests described are primarily objective, bench-top engineering, chemical, and biological assessments, not requiring expert human interpretation of observational data to establish ground truth in the typical clinical sense.
• Qualifications of Experts: Not applicable or not specified for these types of tests. The tests would be performed by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests involve objective measurements (e.g., chemical analysis, temperature readings, visual inspections, biological assay results) and comparisons to predetermined criteria or the predicate device, rather than subjective assessments 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

• MRMC Study: No. This device is a cryosurgical unit (cryogen spray and applicators), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this submission.

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

• Standalone Performance: Not applicable. This is a physical medical device for cryosurgical treatment and does not involve an algorithm or AI.

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

• Type of Ground Truth: The ground truth for this device is primarily established by:
  • Predicate Device Equivalence: The safety and effectiveness of CryoDose H are established by demonstrating substantial equivalence to the legally marketed predicate device, Histofreezer. This means the predicate device's established safety and efficacy serve as the "ground truth" for the new device.
  • Objective Criteria: For specific tests, the ground truth is based on objective, measurable criteria:
    • Biocompatibility: Established ISO 10993 standards and pass/fail criteria for cytotoxicity, sensitization, and irritation.
    • Chemical Composition: Quantitative chemical analysis results matching the specified formula.
    • Structural/Functional Equivalence: Engineering specifications, measurements, and visual inspection confirming identity or substantial equivalence.
    • Temperature Performance: Objective temperature measurements and visual confirmation of physical effects (ice ball).

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of algorithm development.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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The Compound W® Freeze Off™ Plantar Wart Removal System is indicated for over-the-counter treatment of common and plantar warts.

The Compound W® Freeze Off™ Plantar Wart Removal System is a cryosurgical system for the treatment of common warts and plantar warts. It consists of:

• A canister filled with a liquid mixture of the compressed gases dimethyl O ether, propane and isobutane
• 12 Disposable Applicators O
• 1 Pumice Stone o
• o 12 Foot Comfort Pads
• 1 Reusable Activator that releases the cryogen into the applicator O
• An illustrated description of how to use the product with common and o plantar warts

This device is a portable cryosurgical system comprised of a canister containing cryogen and an applicator that is saturated with cryogen and then applied tan the wart to be treated.

The provided text is a 510(k) summary for the Compound W® Freeze Off™ Plantar Wart Removal System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study report. Therefore, much of the requested information about acceptance criteria, detailed study design, and performance metrics for this specific device is not available in the provided text.

Here's an attempt to address the points based on the available information:

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

The document does not specify quantitative acceptance criteria or a direct performance study for the new device (Compound W® Freeze Off™ Plantar Wart Removal System). Instead, it relies on demonstrating substantial equivalence to previously approved devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a specific "test set" for the new device. The submission relies on the established safety and effectiveness data of the predicate devices. Therefore, no information on sample size, data provenance, or study type for a test set of this specific device is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No specific test set for the new device is described, and thus no expert ground truthing process is mentioned in this submission.

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

Not applicable. No specific test set for the new device is described, and thus no adjudication method is mentioned.

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 a cryosurgical device for wart removal, not an imaging or diagnostic AI device. Therefore, MRMC studies and AI assistance metrics are not relevant or mentioned.

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

Not applicable. This is a medical device, not an algorithm, and its use inherently involves human interaction for application.

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

For the predicate devices, the ground truth for establishing safety and effectiveness would have been based on clinical outcomes data (e.g., wart clearance rates, adverse events) from their original clinical studies. However, the provided document does not detail these for the predicates, only states that their safety and effectiveness were established.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device that utilizes a training set in the conventional sense.

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

Not applicable. This is not an AI/algorithm-based device.

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