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The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years or older.

The CryoFreeze Wart and Skin Taq Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common, plantar warts, and skin tags. The device includes:

• A pressurized aerosol canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
• Applicator swabs
• Detailed instructions, including illustrated descriptions

To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds.

The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.

The provided document is a 510(k) summary for the CryoFreeze Wart and Skin Tag Remover, which is a cryosurgical unit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria in the same way a PMA (Pre-Market Approval) or de novo submission might.

Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, specifically regarding clinical studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance. The device described is a physical medical device, not an AI/software as a medical device (SaMD).

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial for performance outcomes (e.g., cure rates, recurrence). Instead, substantial equivalence is demonstrated through technological comparison and non-clinical performance testing against a reference device.

• Use (OTC)
• Mechanism of action (extreme cold destroys tissue)
• Cryogen material (dimethyl ether, propane, isobutane)
• Freeze temperature (-55°C)
• Design (canister, applicators, tweezers)
• Treatment procedure
• Storage & safety conditions
• Disposal
• Defined operators (consumer use) |
  | Output Temperature of Cryogen | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |
  | Freeze Charge Hold Time | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |
  | Visual Confirmation of Ice Ball | Equivalent to reference device (Verruca-Freeze H) | Confirmed equivalent to reference device |

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) for a physical cryosurgical device. The document mentions "comparative performance testing against the reference device," but it does not specify sample sizes for these non-clinical tests (e.g., how many times temperature was measured, or how many freeze cycles were observed).
• Data Provenance: Not specified, but generally, non-clinical tests for 510(k) devices are conducted by the manufacturer or a contract research organization.

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):

• This information is not provided because the device is a physical cryosurgical unit, and the testing described is non-clinical performance testing rather than clinical evaluation against an expert-determined ground truth for diagnostic accuracy, for example.

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

• Not applicable/Not provided as the testing described is non-clinical performance testing, not a clinical trial requiring adjudication of patient outcomes or diagnostic readings by experts.

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 MRMC study was done. This device is a direct-to-consumer physical cryosurgical tool, not an AI or imaging device that would involve human readers or AI assistance.

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

• No standalone algorithm performance study was done. This device does not involve an algorithm.

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

• For the non-clinical performance tests, the "ground truth" would be the measured physical properties (e.g., temperature) as determined by calibrated instruments, and visual observations (e.g., ice ball formation). This is not a "ground truth" in the clinical or diagnostic sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML product and does not have a "training set."

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

• Not applicable. This device is not an AI/ML product and does not have a "training set."

In summary, the provided 510(k) letter and summary establish substantial equivalence for the CryoFreeze Wart and Skin Tag Remover based on its technological characteristics and non-clinical performance being comparable to previously cleared predicate and reference devices. It does not involve AI or clinical studies with expert-adjudicated ground truth as would be relevant for software/AI-based medical devices.

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The Verruca-Freeze® H cryosurgical system is indicated for use in the treatment of the following skin lesions:

• · Actinic Keratosis
• · Genital Warts
• · Lentigo
• · Molluscum Contagiosum
• · Seborrheic Keratosis
• · Skin Tags
• · Verruca Plantaris
• · Verruca Vulgaris
• · Verruca Plana

The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions. The device consists of:
• Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
• Polyurethane foam swabs
• Detailed instructions including illustrated descriptions

The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion.

The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thaw time is 20-40 seconds.

This treatment methodology is simple and has been an accepted by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.

The provided document is a 510(k) premarket notification letter and summary for a medical device called "Verruca-Freeze H," a cryosurgical unit. It establishes substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, or accuracy), or details of a study that proves the device meets specific performance criteria beyond stability testing for the product's shelf life.

The 510(k) process for this device, a cryosurgical unit, primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through technological characteristics, materials, and intended use. It is not an AI/ML medical device submission, which typically requires rigorous performance studies to demonstrate the algorithm's effectiveness in diagnosis or treatment.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details related to AI/ML device performance from the provided text. The document explicitly states:

• "The subject device has the same technological characteristics as the same design, energy source, materials, and other features." (Page 5)
• "A stability protocol was developed to ensure that the product is maintained throughout its labeled dating period. Testing conducted under controlled conditions at room temperature and under accelerated conditions." (Page 5)

These statements indicate that the "study" conducted was related to stability and comparison to a predicate device, not an evaluation of an AI algorithm's diagnostic or therapeutic performance using patient data, ground truth, and expert adjudications.

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The Verruca-Freeze® H cryosurgical system is indicated for use in the following skin lesions:

• · Actinic Keratosis
• · Genital Warts
• Lentigo
• Molluscum Contaqiosum
• Seborrheic Keratosis
• Skin Tags
• · Verruca Plantaris
• · Verruca Vulgaris • Verruca Plana
• Verruca Plana

The Verruca-Freeze® H cryosurgical system is used for treatment of benign skin lesions.
The device consists of:

• Canister filled with a liquid mixture of the compressed gases dimethyl ether, propane, and isobutane
• . Polyurethane foam swabs
• . Detailed instructions including illustrated descriptions
  The main component of the device is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed after each use. The foam swabs allow the cryogen to be localized to a target lesion.
  The one- to two-minute procedure begins by spraying cryogen onto a foam swab, which is then placed directly onto the lesion and held for 15-40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thawing. The typical thaw time is 20-40 seconds.
  This treatment methodology is simple and has been an accepted practice used by physicians for decades. It utilizes a standard cryogen composition profile to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation are occurring.

The provided document is a 510(k) summary for the Verruca-Freeze® H cryosurgical system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria through a machine learning or AI algorithm's performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML powered device. The "performance data" mentioned refers to non-clinical tests of the cryosurgical process itself, not an algorithm's performance.

Here's why the document cannot answer the prompt's specific questions about AI/ML device performance:

• Device Type: The Verruca-Freeze® H is a cryosurgical system, a physical medical device that applies cold to treat skin lesions. It is not an AI-powered or software-based medical device.
• "Study" Context: The "performance testing" described in Section 6.2 ("Non-Clinical Performance Data") is about measuring the output temperature and effectiveness of the cryogen and applicators, and visually confirming ice ball formation. This is physical hardware performance testing, not an algorithmic study.
• Absence of AI/ML Specifics: There is no mention of algorithms, training sets, test sets, ground truth establishment by experts, adjudication methods, or MRMC studies, all of which are relevant to evaluating AI/ML-based medical devices.
• "Clinical Performance Data": Section 6.3 explicitly states, "There was no clinical testing required to support the medical device as the indications for use are equivalent to those of the predicate device. These types of devices have been on the market for decades and their clinical safety and efficacy has been established." This further confirms that no new clinical study was conducted for this submission, let alone one focused on AI/ML performance.

In summary, the provided document is a regulatory submission for a traditional medical device demonstrating substantial equivalence, not an AI/ML device showing performance against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about the study design (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, training set details) because this information is not present in the provided text.

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1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratoses, achrochordon, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna, keratoacanthoma, basal cell, bowen's disease, lentigo discreta, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi's sarcoma, and pyogenic granuloma.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Verruca-Freeze Cryosurgery Delivery System™." It does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, or detailed ground truth methodologies for an AI/algorithm-driven device.

The FDA 510(k) clearance process primarily establishes substantial equivalence of a new device to a legally marketed predicate device. While it may involve performance testing, the provided letter summarizes the administrative decision by the FDA, not the detailed study results.

Therefore, I cannot extract the information you've asked for from this document. The document simply states the device is substantially equivalent for the indications for use listed, allowing it to be marketed.

Ask a specific question about this device

Ask a specific question about this device