The Skin Clinic Freeze Point product is intended for the treatment of common warts, plantar warts, and skin tags by OTC consumers. Treat skin tags in adults age 22 years or older

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This 510(k) clearance letter details the clearance of a medical device, "Skin Clinic Freeze Point for Warts and Skin Tags," which is a cryosurgical unit. However, the provided document does not contain any information about the acceptance criteria or the study that proves the device meets the acceptance criteria.

The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the same way a PMA (Premarket Approval) application would. While a 510(k) submission does include performance data, this particular clearance letter only states that the device is substantially equivalent and provides regulatory information, such as:

• Device Name: Skin Clinic Freeze Point for Warts and Skin Tags
• Regulation Number: 21 CFR 878.4350
• Regulation Name: Cryosurgical Unit And Accessories
• Regulatory Class: Class II
• Product Code: GEH
• Indications for Use: Treatment of common warts, plantar warts, and skin tags by OTC consumers; treat skin tags in adults age 22 years or older.
• Type of Use: Over-The-Counter Use

Therefore, I cannot provide the requested information regarding acceptance criteria and study details based solely on this document.

To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a detailed study report that would typically be part of a 510(k) submission but is not included in the clearance letter itself.

Without that information, I cannot fill in the table or address the points about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, or ground truth establishment.

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The Skin Clinic Nitro Clear Wart Remover is intended for the OTC treatment of common warts and plantar warts in adults and children 4 years of age and older.

The Skin Clinic Nitro Clear Wart Remover device utilizes extreme cold to facilitate the removal of common and plantar warts by freezing. Each device contains a container of cryogen gas in a plastic holder along with instructions for use. The Skin Clinic Nitro Clear Wart Remover device is for OTC use and utilizes Nitrous Oxide cryogen delivered from the cartridge into a tip which acts as a reservoir for the cryogen gas. The applicator tip is cooled to as low as -89°C. Depending on the location and size, the applicator is placed against the common wart or plantar wart between 10-40 seconds which freezes the targeted area. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

Acceptance Criteria and Study Details for Skin Clinic NitroClear

Based on the provided FDA 510(k) clearance letter for the Skin Clinic NitroClear Wart Remover, here's a breakdown of the acceptance criteria and the studies conducted:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" for the device's performance in terms of efficacy (e.g., a specific percentage of wart clearance). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. This equivalence is established by:

• Comparable technological characteristics: The subject device operates on the same principle (cryotherapy to destroy tissue with extreme cold) and has similar design and safety features to its predicates.
• Achieving equivalent or lower temperatures: Through bench testing, the device demonstrated its ability to reach temperatures comparable to or lower than the predicate devices. This implies it can achieve the intended cryotherapeutic effect.
• Demonstrated cell killing efficacy (in vitro): The in vitro test showed that the device is capable of effectively destroying cells, aligning with its mechanism of action for wart removal.
• Human factors usability: The device's usability was deemed acceptable for over-the-counter use by consumers based on a dedicated study.

2. Sample Size for Test Set and Data Provenance

The document does not specify a quantitative "test set sample size" for a clinical efficacy study. The performance data primarily relies on:

• Bench Testing: This would involve laboratory setups to measure temperature, not human subjects.
• In vitro Test: This was conducted on cells in an agar matrix, not human subjects.
• Human Factors Usability Study: While not explicitly stated, this study would involve human participants to assess usability. The document does not provide the sample size, country of origin, or whether it was retrospective or prospective.

Given the nature of the clearance (510(k) for substantial equivalence), a large-scale clinical efficacy trial with a dedicated test set of patients for wart clearance is usually not required if the technology is deemed sufficiently similar to a predicate.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a clinical test set from a diagnostic or efficacy perspective. The testing described (bench, in vitro, usability) does not typically involve expert consensus for ground truth on patient outcomes.

• For Biocompatibility: Experts in biocompatibility testing (toxicologists, material scientists) would have been involved in the evaluation against ISO 10993 standards.
• For Human Factors: Experts in human factors engineering would have designed and evaluated the usability study.

No specific number or qualifications are provided in the document.

4. Adjudication Method for the Test Set

Since there is no mention of a clinical test set with patient outcomes requiring adjudication (e.g., for diagnostic accuracy of an AI or efficacy of treatment), there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is typically performed for diagnostic imaging devices involving multiple readers interpreting cases, often with and without AI assistance, to measure changes in diagnostic performance. The Skin Clinic NitroClear is a cryosurgical treatment device, not a diagnostic imaging AI.

6. Standalone Algorithm Performance Study

No standalone (algorithm only without human-in-the-loop) performance study was done. The device is a physical cryosurgical unit, not a software algorithm that operates independently. Its performance is inherent in its physical function and interaction with a user.

7. Type of Ground Truth Used

• For Biocompatibility: The ground truth would be established by the requirements of the ISO 10993 standard.
• For Temperature Attainment: The ground truth would be objective temperature measurements using calibrated equipment.
• For Cell Killing (in vitro): The ground truth would be the observed viability of cells in the agar matrix after treatment, typically assessed through laboratory methods.
• For Human Factors Usability: The ground truth would be observations of user interaction and performance against predefined usability objectives or tasks.

There is no mention of pathology, expert consensus on images, or long-term outcomes data as "ground truth" in the context of this 510(k) submission, as it focuses on substantial equivalence for a physical treatment device rather than a diagnostic or AI-driven system.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as the Skin Clinic NitroClear is a physical device, not an AI or machine learning model that requires training data.

9. How Ground Truth for the Training Set Was Established

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

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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 Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open. minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-Ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

In addition, the system is also intended for use in the following indications:

General Surgery

• · Destruction of warts or lesions.
• · Palliation of tumors of the oral cavity, rectum, and skin.
• · Ablation of breast fibroadenomas.
• Ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.

Urology
· Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia.

Gynecology

• · Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
  Oncology
• · Ablation of cancerous or malignant tissue.
• · Ablation of benign tumors.
• · Palliative intervention.
• Neurology
• · Freezing of nerve tissue in pain management/cryoanalgesia.

Dermatology
· Ablation or freezing of skin cancers and other cutaneous disorders.

Proctology

• · Ablation of benign or malignant growths of the anus and rectum.
• · Ablation of hemorrhoids.

Thoracic Surgery

• · Ablation of cancerous lesions.

The Co-Ablation System with Sterile Co-Ablation Probe is a device designed to freeze/ablate tissue. It utilizes phase change effect to generate extremely low temperature and high temperature to destroy lesion tissues with a combined working mode, to achieve better clinical efficacy, safety and efficiency.

Main components: Co-Ablation System, Sterile Co-Ablation Probe. Accessory: Sterile Temperature Probe.

The Co-Ablation System is a mobile medical equipment. The Co-Ablation System consists a host of Co-Ablation System including liquid nitrogen storage tank (referred to as cryotank), cryo-valve, warm working medium storage tank (referred to as warmtank), warm-valve, waste bottle,insulated pipe and control/display system, etc. The Co-Ablation System has model number with AI Epic S40U and AI Epic S20U.

The Sterile Co-Ablation Probe is a single-use sterile product, consisting of a handle, quick release connector, probe tip and probe shaft. It must be used in conjunction with the Co-Ablation System. During treatment, the Sterile Co-Ablation Probe is inserted into the lesion to be ablated. The freezing channel is opened, and the freeze working medium (liquid nitrogen) rapidly flows to the probe and evaporates to absorb heat, rapidly freezing and destroying tissue near the probe tip. When the system is switched from the freeze mode to warm mode, high temperature steam passes to the tip of the Sterile Co-Ablation Probe, rapidly heating the tip portion of the Sterile Co-Ablation Probe so that the frozen tissue around the Sterile Co-Ablation Probe is quickly melted, and the Sterile Co-Ablation Probe is easily pulled out. The Sterile Co-Ablation Probe consists of right-angle and straight configurations with model number Elite, and comprises 20 specifications as listed below:

The Sterile Temperature Probe is designed for use with the Co-Ablation System to monitor temperatures in the surrounding tissue. The Sterile Temperature Probe with model number Ease, and comprises 4 specifications: TSS08, TSL08, TMS15 and TML15.

The provided text is a 510(k) Summary for the Hygea Medical Technology Co., Ltd.'s Co-Ablation System with Sterile Co-Ablation Probe. It details comparisons to predicate devices and lists non-clinical performance data.

However, there is no information presented regarding acceptance criteria, reported device performance against those criteria, or a specific study proving the device meets those criteria in the context of an AI/algorithm's diagnostic performance. The document focuses on the substantial equivalence of the cryoablation system as a medical device based on its design, function, and non-clinical safety/effectiveness tests (electrical safety, EMC, usability, software, sterilization, biocompatibility, shelf life, ex-vivo, and animal testing).

Specifically, the document states:

• "No clinical data was necessary to determine the substantial equivalence of this device." This directly indicates that no clinical study, which would typically contain acceptance criteria and performance metrics for a diagnostic device, was conducted or submitted for this 510(k) clearance.
• The "Software Testing" section mentions "the software verification/validation met the acceptance criteria," but these acceptance criteria are related to general software development standards (IEC 62304, FDA guidance for software and cybersecurity) and not to the diagnostic performance of an AI/algorithm.

Therefore, I cannot provide the requested table and information because the provided text does not contain data related to:

1. A table of acceptance criteria and reported device performance for an AI/algorithm's diagnostic capability.
2. Sample size and data provenance for a test set for AI/algorithm performance.
3. Number and qualifications of experts for ground truth establishment for AI/algorithm performance.
4. Adjudication method for an AI/algorithm test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI/algorithm performance.
8. Sample size for the training set of an AI algorithm.
9. How the ground truth for an AI training set was established.

This 510(k) summary is for a cryoablation system, which is a therapeutic device, not an AI-powered diagnostic device. The performance data presented refers to the physical and software functionalities of the system in performing cryoablation, not to the diagnostic accuracy of an AI.

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The Advanced Cryo Wart Remover is designed as an over-the-counter (OTC) self-care device indicated for adults and children from the age of four years and older for the treatment of common and plantar warts.

The Advanced Cryo Wart Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common and plantar warts. The device includes:

• A 15 mL / 0.51 oz pressurized aerosol canister containing a freezing agent (1,1-Difluoroethane, Propane, and Isopentane).
• A metal tip that applies the cryogen directly to the wart
• Detailed instructions, including illustrated descriptions.
  To activate the product, the lay user must, while holding the device facing downward, press the side buttons firmly five times in a row. Apply the cold metal tip for 20 seconds on warts located on the hands, tops of feet, and toes. Apply for 40 seconds on plantar warts in areas with thicker or calloused skin.
  The device is non-sterile, reusable, and intended for home use by laypersons. No special training or sterilization is required for operation.

The provided text is a 510(k) premarket notification for the "Advanced Cryo Wart Remover." It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about a study that establishes acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) or the results of such a study.

The document details:

• Non-clinical Performance Data (Section 9):
  • Biocompatibility Testing (ISO 10993 series)
  • Shelf Life Testing (ASTM D3090-72)
  • Transportation Testing (ASTM D4169)
  • Bench Testing (comparative thermal performance, freeze temperature extremes, plateau, and duration)
  • Label and IFU Comprehension Study (Flesch test)
  • Human Factors Study (usability study compliant with EN ISO 8317:2004, secondary usability study on timing, self-assessment study on wart identification)

These studies are primarily focused on safety, usability, and the physical characteristics of the device (such as its ability to freeze at certain temperatures or its shelf life). They do not involve a clinical study with a test set, ground truth experts, or metrics like sensitivity/specificity for wart removal effectiveness. The "self assessment study" mentioned under Human Factors is related to label comprehension, not the device's efficacy.

Therefore, I cannot provide the requested table or answer the questions related to clinical performance, as the provided text does not contain that information. The 510(k) pathway for this device relied on demonstrating substantial equivalence primarily through non-clinical performance data and comparison to legally marketed predicate devices, rather than a new clinical efficacy study with performance acceptance criteria like those often seen for AI/ML-driven 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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Compound W® Skin Tag Remover is intended for the OTC treatment of skin tags in adults age 22 years or older.

Compound W® Skin Tag Remover is a cryogenic device intended to remove acrochordons (skin tags) via epidermal cryotherapy, destroying target epidermal cells by using extremely cold temperatures. The device contains a non-replaceable, non-refillable aluminum canister holding the gases dimethyl ether and propane. Activation of the device ejects a dose of the gases into a disposable polyurethane foam applicator tip, resulting in freezing of the applicator to approximately -30°C. The cold applicator tip is placed on the skin tag, thus destroying the target tissue. Each Compound W® Skin Tag Remover device is supplied in a paperboard carton with eight disposable tips, plastic tweezers, adhesive "Tag Target" skin-protecting discs, and an Instructions-for-Use leaflet.

The provided document is a 510(k) premarket notification from Medtech Products Inc. to the FDA for their product "Compound W Skin Tag Remover." It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence.

Based on the information provided, here's a description of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Cryogenic Performance Study (in vitro): The document does not specify the exact sample size for the "product samples" tested. It only states "Product samples were tested."

  • Provenance: This was an in vitro experiment, meaning it was conducted in a lab setting, not on human subjects. The origin of the products themselves (Compound W device and predicate) would be from the respective manufacturers. There is no mention of country of origin for test data, but the submission is to the US FDA.
  • Retrospective/Prospective: This appears to be a prospective bench test designed specifically for this submission.

• Biocompatibility Testing: The document does not specify the sample size for the materials tested (canister, adhesive Tag Target discs).

  • Provenance: This is lab-based testing.
  • Retrospective/Prospective: This appears to be prospective lab testing.

• Human Factors Validation Testing:

  • Sample Size: 50 participant volunteers.
  • Data Provenance: The document states participants were from the "general population," including "15 intended users and 35 non-intended users." The location of this study (e.g., country, specific site) is not specified.
  • Retrospective/Prospective: This was a prospective usability study specifically conducted to validate the device's human factors.

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

• Cryogenic Performance: No external experts were used for ground truth establishment. The ground truth (temperature readings) was established directly by the measuring instrument (thermocouple sensor).
• Biocompatibility Testing: The ground truth for biocompatibility is established by the test results against the criteria of ISO 10993. This would typically be conducted by certified lab personnel, but "experts" in the sense of adjudicating human-generated data are not applicable here.
• Human Factors Validation Testing: No explicit mention of external experts establishing a "ground truth" for the test set. The study aimed to assess if users could safely and effectively use the device, and the findings are reported at a high level. Human factors studies are more about observing user interaction and identifying potential use errors rather than adjudicating a "truth" like a medical diagnosis. The "ground truth" here is the observed user behavior and the successful completion of tasks based on the product's design and labeling.

4. Adjudication Method for the Test Set

• Cryogenic Performance & Biocompatibility: Not applicable, as these were objective bench/lab tests with quantifiable outputs from measurements or standard protocols.
• Human Factors Validation Testing: The document does not describe a specific adjudication method like "2+1" or "3+1." Human factors studies involve direct observation, task analysis, and error collection. The assessment of whether the user interface "supports safe and effective use" would be based on the data collected during these observations and the analysis by the human factors specialists conducting the study.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging AI, where multiple readers interpret cases with and without AI assistance to measure improvement in diagnostic accuracy. The "Compound W Skin Tag Remover" is a cryogenic device for physical removal of skin tags, not a diagnostic imaging device. The studies focused on physical performance, biocompatibility, and usability.

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

• Not applicable in the context of an AI algorithm. This device does not contain an AI algorithm. Its "performance" is mechanical/chemical (freezing capacity) and user interface design. The cryogenic performance and biocompatibility tests can be considered "standalone" in the sense that they assess the device's physical properties independently of human interaction during the test, but this refers to the product's physical function, not an AI algorithm.

7. The Type of Ground Truth Used

• Cryogenic Performance: Objective physical measurement (temperature, in degrees Celsius) using a thermocouple sensor.
• Biocompatibility Testing: Results compared against established ISO 10993 standards and criteria for cytotoxicity, skin irritation, and sensitization.
• Human Factors Validation Testing: Observed user behavior, success/failure in task completion, and identification of use errors based on pre-defined criteria.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product (cryosurgical unit), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI.

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

• Not applicable. As there is no AI/ML component, there is no training set or ground truth establishment for such a set.

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The Skin Clinic Freeze Point product is intended for the treatment of common and plantar warts by OTC consumers. May be used with children 4 years of age or older under adult supervision.

The Skin Clinic Freeze Point device utilizes extreme cold to facilitate the removal of warts and by freezing. Each kit contains a container of cryogen gas in a plastic holder and instructions for use. The device is for OTC use and utilizes difluoroethane cryogen delivered from the canister into a foam wrapped tip which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to as low as -50°C. The applicator is then placed against the wart for up to 40 seconds which freezes the targeted tissue. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

This document describes the FDA's 510(k) clearance for the Skin Clinic Freeze Point device. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria, particularly for a medical device that relies on AI/ML or complex diagnostic capabilities.

The provided text focuses on demonstrating substantial equivalence to predicate devices for a cryosurgical unit, which is typically cleared based on bench testing (temperature comparison, cell destruction), biocompatibility, and human factors usability for an OTC product. It does not involve performance metrics or study designs typically associated with AI/ML devices or diagnostic accuracy studies (e.g., sensitivity, specificity, MRMC studies, detailed ground truth establishment, or specific acceptance criteria for algorithm performance).

Therefore, I cannot provide a complete answer with all the requested details (especially points 1, 2, 3, 4, 5, 6, 7, 8, 9) because the information is not present in this kind of 510(k) summary for this type of device.

However, I can extract what is provided and explain why other points are not applicable or present:

Based on the provided document for the Skin Clinic Freeze Point device:

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

This 510(k) summary does not present specific quantitative acceptance criteria or detailed performance results in the format of a table as one would expect for a diagnostic or AI/ML device (e.g., sensitivity, specificity thresholds). Instead, "performance" is demonstrated by:

• Bench Testing:
  • Acceptance Criteria (Implied): Temperatures attained by the Skin Clinic Freeze Point product are comparable to the Wartie and Freeze n Clear Skin Clinic predicate devices.
  • Reported Performance: "Bench testing compared the temperatures attained by the Wartie and Freeze n Clear Skin Clinic predicate devices to the Skin Clinic Freeze Point product to demonstrate that they were comparable."
  • Acceptance Criteria (Implied): Ability to freeze and destroy target cells is comparable to predicate devices.
  • Reported Performance: "Additional bench testing using an in vitro method compared all the same products and showed they were comparable in their ability to freeze and destroy target cells."
• Biocompatibility:
  • Acceptance Criteria (Implied): Meets the requirements of ISO 10993.
  • Reported Performance: "product was tested for biocompatibility including cytotoxicity, sensitivity, irritation according to FDA's biocompatibility 2020 guidance and meets the requirements of ISO 10993."
• Human Factors Usability:
  • Acceptance Criteria (Implied): Consumers can comprehend and understand the labeling and use of the product for OTC indication.
  • Reported Performance: "The human factors usability testing evaluated consumers ability to comprehend and understand the labelling and use of the product."

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

• Bench Testing: Not specified as "sample size" in the context of clinical data. It refers to a comparison of devices rather than patient data. Data provenance is implied to be laboratory testing.
• Human Factors Usability Study: The specific sample size for the usability study is not provided in this summary. Data provenance would be prospective usability testing with human participants.

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

• Not applicable / Not provided. This device is a cryosurgical unit, not a diagnostic device requiring expert interpretation for ground truth. Its performance is evaluated through physical characteristics (temperature, cell destruction) and user comprehension.

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

• Not applicable / None specified. This concept is relevant for diagnostic accuracy studies involving multiple readers or assessors to establish a reference standard, which is not the primary mode of evaluation for 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:

• No, not done. This is a physical device (cryosurgical unit), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

• Not applicable. This device does not have an "algorithm" in the sense of AI/ML or image processing that performs standalone tasks.

7. The type of ground truth used:

• Bench Testing:
  • Temperature Measurement: The "ground truth" would be the measured temperature of the applicator or the frozen tissue, compared against the predicate devices' performance.
  • Cell Destruction: The "ground truth" would be the observed destruction of target cells in an in vitro model, compared against the predicate devices' performance.
• Human Factors Usability: The "ground truth" would be the observed user interactions and comprehension of instructions, typically assessed against pre-defined usability success criteria (e.g., successful task completion, correct answers to comprehension questions).

8. The sample size for the training set:

• Not applicable / Not provided. This device does not use a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and safety standards for medical devices.

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

• Not applicable. See point 8.

Summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence for a cryosurgical unit based on its physical characteristics, biocompatibility, and user-friendliness for over-the-counter use, not on complex diagnostic or AI-driven performance metrics. Therefore, many of the questions related to AI/ML device evaluation are not applicable or answered by this document.

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The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles) are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.

The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.

The CX Needles have the following specific indications:

· Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)

· Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.

· Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of the skin

• Gynecology – Ablation of malignant neoplasia or benign dysplasia of the female genitalia

· General surgery - Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas

• ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
• · Thoracic surgery (with the exception of cardiac tissue)
• Proctology Ablation of benign or malignant growths of the anus or rectum

Boston Scientific Corporation's (BSC) IceSeed 1.5 CX Straight Cryoablation Needle, IceSphere 1.5 CX Straight Cryoablation Needle, and IceRod 1.5 CX Straight Cryoablation Needle (hereafter referred collectively as the Straight Needles) are sterile, single use, disposable devices used in conjunction with a Boston Scientific cryoablation system for cryoablative destruction of tissue during surgical procedures under CT guidance. The Straight CX Needles are disposable 1.5 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The needles convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Active tissue thawing may also be achieved by activating the heating element inside the Straight CX Needles.

The provided document is a 510(k) summary for Boston Scientific's IceSeed 1.5 CX Straight Needle, IceSphere 1.5 CX Straight Needle, and IceRod 1.5 CX Straight Needle. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with acceptance criteria for a new device's performance.

Therefore, the specific information requested, such as acceptance criteria, reported device performance for these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment from a clinical effectiveness study, is not available in this document.

The document primarily describes engineering and functional verification testing to show that the new straight needles perform similarly to existing predicate bent-tip needles.

Here's a breakdown of what is available related to your request, and what is not:

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

• Acceptance Criteria (Implied by equivalence to predicate devices and functional requirements): The document states that "Verification testing was conducted on the Straight CX Cryoablation Needles to ensure that the design, functionality, and performance met all the specified requirements and that the features of the needle satisfy its intended use." It also notes that "Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications."

  • Specific performance parameters are mentioned as matching the predicate devices, such as:
    • Shaft working length: 175mm
    • Shaft Diameter: 1.5mm
    • Markings: Thin and Thick marks at specific distances
    • Length of low friction coating on shaft: Specific starts and ends from the tip
    • Active zone Indicator: Specific starts from the tip and band length
    • Freezing cryogen: Argon 99.995%
    • Thawing gas: Helium 99.998%
    • Isotherm diameter: (IceSeed: -40°C: 15 ± 3 mm, -20°C: 24 ± 3 mm, 0°C: 37.5 ± 3 mm; IceSphere: -40°C: 16 ± 3 mm, -20°C: 26 ± 3 mm, 0°C: 39 ± 3 mm; IceRod: -40°C: 17 ± 3 mm, -20°C: 28 ± 3 mm, 0°C: 43 ± 3 mm)
    • Isotherm height: (IceSeed: -40°C: 21 ± 4 mm, -20°C: 28 ± 4 mm, 0°C: 41 ± 4 mm; IceSphere: -40°C: 24 ± 4 mm, -20°C: 32 ± 4 mm, 0°C: 45 ± 4 mm; IceRod: -40°C: 41 ± 4 mm, -20°C: 47 ± 4 mm, 0°C: 60 ± 4 mm)

• Reported Device Performance: The document generally states that "Test results demonstrated that the Straight CX Cryoablation Needles meets defined specifications, is substantially equivalent to the predicate devices, and does not raise any new issues of safety and effectiveness for its intended use." It implicitly means the new devices performed within the acceptable ranges for the parameters listed above, matching the predicate devices. No specific raw data or numerical results of the functional tests are provided.

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

• Not Available. The document refers to "verification testing" and "functional testing" but does not specify sample sizes for these tests. There is no mention of a "test set" in the context of clinical data or patient studies. The provenance of any data is not mentioned, as it's primarily bench testing.

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

• Not Applicable / Not Available. This information relates to clinical studies and expert review for ground truth, which is not described in this 510(k) summary.

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

• Not Applicable / Not Available. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not detailed here.

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 / Not Available. This device is a cryoablation needle, a surgical tool. It is not an AI-assisted diagnostic or decision-support system, so an MRMC study with AI assistance is irrelevant.

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

• Not Applicable / Not Available. As above, this is a physical medical device, not a standalone algorithm.

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

• Not Applicable / Not Available (for clinical ground truth). The "ground truth" for the device's performance is established by industrial standards and in-house functional requirements, and comparison to the parameters of the predicate device. It's engineering and performance specifications, not clinical outcomes or expert consensus on diagnoses.

8. The sample size for the training set:

• Not Applicable / Not Available. There is no mention of a training set as this is about a physical medical device, not a machine learning model.

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

• Not Applicable / Not Available. As there is no training set, this question is not applicable.

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The Celsio Flexible Cryocatheter System is intended for cryoadhesion applications during interventional procedures such as the removal of tissue, foreign bodies, mucous plugs, blood clots, necrotic tissue, tumors and tissue biopsies, and for palliative devitalization (destruction) of tissue by the application of extreme cold.

The Celsio Flexible Cryocatheter System is a cryosurgical device with a disposable carbon dioxide (CO2) cartridge that is used with commercially available endoscopes with a minimum working channel diameter of 2mm and maximum working length of 1052 mm, in interventional endoscopic procedures. The Celsio Flexible Cryocatheter System is comprised of a Flexible Cryocatheter (sterile, single use), a CO2 Refrigerant Cartridge (non-sterile, single use) and a Refrigerant Dispenser (nonsterile, single use). The flexible cryocatheter is typically delivered using a compatible endoscope to the target location. Once the refrigerant dispenser is activated, pressurized refrigerant fluid is delivered to the catheter tip where it undergoes expansion to its lower temperature (the Joule-Thomson effect), causing surrounding tissue in contact with the catheter tip to freeze and adhere.

The provided text is a 510(k) summary for a medical device (Celsio Flexible Cryocatheter System). It details the device's intended use, comparison to a predicate device, and general performance data, but does not contain specific details about acceptance criteria or a study proving that an AI/Software device meets acceptance criteria.

The document discusses "performance data" and "Design Verification and Validation testing" for the cryocatheter system itself, including thermal characteristics (ice ball dimensions, temperature, cooling/thawing rates) and pre-clinical testing (ex-vivo, in-vivo, post-mortem). However, these are standard tests for a physical medical device and do not involve AI or software performance as would be relevant to the questions posed about AI acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information from the given text as it pertains to a physical medical device clearance, not an AI/software device clearance. The prompt explicitly asks for details related to a "device" meeting acceptance criteria, and then queries a series of points that are specifically relevant to AI/Software performance studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance). Since the provided document is for a physical cryosurgical unit, it does not contain the information necessary to answer those specific questions.

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