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 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 Histofreezer V indications for use as follows: l, 1,1,2-tetrafluoroethane, pentafluoroethane, and l, 1,1-tri fluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

The Histofreezer V device utilizes extreme cold to facilitate the removal of benign topical lesions. The device utilizes a combination of 1.1.1.2-Tetrafluoroethane. Pentafluoroethane, and 1,1,1-Trifluoroethane delivered from the cannister of gas into a foam bud or cone which acts as a reservoir for the cryogen gas. To perform the treatment the bud or cone facilitates freezing the targeted lesion for up to 40 seconds .. The frozen lesion falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

The provided text is a 510(k) Premarket Notification from the U.S. FDA for the Histofreezer V device. This document does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study that proves a device meets such criteria. Instead, it focuses on demonstrating substantial equivalence of the Histofreezer V, a cryosurgical unit, to a predicate device (CryoDose/McKesson) based on its technological characteristics and performance (specifically temperature attainment).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, MRMC studies, or standalone performance for an AI/ML device, as this information is not present in the provided text.

The text does include:

• A comparison of the Histofreezer V with its predicate device, CryoDose/McKesson (K130995), highlighting similarities in intended use, cryogen, cryogen gas boiling point, cone materials, mode of use, mechanism of action, safety, operation, and defined operators.
• A brief mention of "bench testing" that focused on "demonstrating the equivalency of temperatures over their treatment times while using cone or applicators from the CryoDose/McKesson device and Histofreezer V."
• A statement that the product was tested for biocompatibility according to FDA's guidance and ISO 10993 requirements.

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The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.

The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product utilizes extreme cold to facilitate the removal of warts and skin tags by freezing. Each kit contains a container of cryogen gas, foam applicators, tweezers and instructions for use. The device is for OTC use and utilizes a combination of dimethyl ether, propane and isobutane delivered from the canister into a foam applicator which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to approximately -55°C. The applicator is then placed against the wart or skin tag for 40 seconds which freezes the targeted tissue. The frozen skin tag or wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

The provided text describes the Freeze 'n Clear Skin Clinic for Warts and Skin Tags device (K211099), a cryosurgical unit intended for the over-the-counter (OTC) treatment of common warts, plantar warts, and skin tags.

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

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and fulfilling safety and usability requirements for an OTC product.

However, based on the performance data section, implicit criteria and reported performance can be inferred:

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

• Clinical Study Test Set: Over 300 subjects.
• Data Provenance: Conducted at 3 US dermatology offices (prospective clinical study). Historical data on complaints and adverse events was also considered, which would be retrospective data from outside the US.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study's subjects (e.g., confirming the nature of warts or skin tags). It mentions that the study was performed at dermatology offices, implying clinical oversight, but details on expert review for ground truth are not provided. For the "self-diagnosis" aspect, the ground truth would presumably be the dermatologists' diagnoses compared to the subjects' self-diagnoses.

4. Adjudication method for the test set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). It states a clinical study was performed at dermatology offices, which implies physician oversight and potentially consensus on diagnoses if multiple practitioners were involved, but details are not given.

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, an MRMC comparative effectiveness study was not done. This device is a cryosurgical unit, not an AI-assisted diagnostic tool for human readers.

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

Yes, aspects of "standalone" performance were assessed through bench testing.

• Bench Testing (Temperature): Compared temperatures attained by the subject device and a predicate device.
• Bench Testing (Cell Destruction): Used an in vitro model to compare the ability of the subject device and a predicate device to freeze and destroy target cells.

7. The type of ground truth used

• Biocompatibility: Established by adherence to ISO 10993 standards.
• Cryogenic Efficacy (Bench Testing): Ground truth was based on objective physical measurements (temperature) and in vitro cell destruction models.
• Clinical Study: Ground truth for self-diagnosis and self-selection would likely be the dermatologists' clinical diagnoses of warts and skin tags, against which subject self-assessments were compared. Usability and label comprehension ground truth would be based on subjects' ability to follow instructions and correctly operate the device.
• Post-Market Safety: Ground truth derived from historical complaint and adverse event data.

8. The sample size for the training set

The document does not refer to a "training set" as this device is a physical cryosurgical unit and not an AI/machine learning algorithm requiring a distinct training phase.

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

Not applicable, as there is no training set in the context of this device.

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The CryoLab® is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures.

The List below shows examples of the types of lesions that may be treated:

• Molluscum Contagiosum ●
• Skin Tags ●
• Actinic Keratosis ●
• Lentigo
• Verruca Plana ●
• Verruca Vulgaris ●
• Verruca Plantaris
• Genital Lesions ●
• Seborrheic Keratosis

The CryoLab® device is designed to electronically control a timed dispense of cryogen gas when actuated. The device contains no software and uses a cylinder of nitrous oxide or carbon dioxide. Licensed Practitioners can dispense the gas for use in procedures requiring the surgical destruction of target tissue using the extreme cold of nitrous oxide, N2O (-89°C) or carbon dioxide, CO2 (-79°).

The document does not explicitly state acceptance criteria in a quantitative table or a study proving that the device meets specific performance thresholds. Instead, it demonstrates substantial equivalence through comparative bench testing against predicate devices.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with explicit acceptance criteria (e.g., "Device must maintain a temperature of X for Y duration") and corresponding reported performance values for each criterion in the way typical for software or diagnostic device evaluations.

Instead, the performance data section focuses on demonstrating equivalency to predicate devices. The key performance indicators mentioned and their comparative results are:

With Carbon Dioxide: Bench testing showed "equivalent delivery of cryogen gas" when comparing the CryoLab® and CryoClear. The "amount dispensed" was "substantially the same." |
| Temperature Attained (Open Spray) | Equivalent to predicate devices. | With Nitrous Oxide: Bench testing showed that the "temperatures attained" were "substantially the same" when comparing the CryoLab® and CryOmega Flexx.

With Carbon Dioxide: Bench testing showed that the "temperatures attained" were "substantially the same" when comparing the CryoLab® and CryoClear. |
| Ability to Destroy Red Blood Cells | Equivalent to predicate device. | A second bench test comparing CryOmega Flexx and CryoLab® (both using N2O) demonstrated their "ability to destroy red blood cells immobilized in agar" was equivalent. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2. | CryoConcepts conducted testing on the CryoLab® to verify compliance with IEC 60601-1:2005 3ed. +A1:2012 and IEC 60601-1-2:2015. Compliance was declared. |
| ASTM Compliance | Compliance with ASTM: F882-84 (96) for Cryosurgical Medical Instruments. | CryoLab® "Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments." |

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

• Sample Size: Not explicitly stated in terms of a "test set" with a specific number of instances. The performance evaluation was based on bench testing rather than a typical clinical patient-based test set. The document refers to testing "liquid Nitrous Oxide or Carbon Dioxide" and "comparing the CryOmega Flexx and CryoLab® with Nitrous Oxide" and "CryoClear...compared to the CryoLab® with Carbon Dioxide." This implies a series of laboratory experiments but the number of repetitions or samples tested is not quantified.
• Data Provenance: The data is from "bench testing" conducted by CryoConcepts LP. It is not patient or country-specific data. It is prospective in the sense that the tests were conducted specifically for this submission.

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

• Not Applicable. Since the performance evaluation involved bench testing of physical characteristics (gas dispense, temperature, red blood cell destruction) rather than a diagnostic interpretation, there was no "ground truth" to be established by clinical experts in the traditional sense. The accuracy of measurements would be validated by standard laboratory practices.

4. Adjudication Method for the Test Set:

• Not Applicable. No human interpretation or diagnostic assessment requiring adjudication was performed.

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

• No. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the device. Instead, substantial equivalence is based upon benchtop performance testing." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed, as the device is a cryosurgical unit, not an AI diagnostic tool.

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

• Not Applicable. This is a physical medical device (cryosurgical unit) and does not involve an algorithm or AI. Its performance is inherent in its mechanical and thermodynamic function.

7. The Type of Ground Truth Used:

• Bench Testing Data / Physical Measurements: The "ground truth" for the performance claims (e.g., temperature attained, gas dispensed) was established through direct physical measurements and observations during bench testing. For example, temperature was measured, and the destruction of red blood cells in agar was observed.
• Not: Expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use machine learning or AI algorithms, so there is no concept of a "training set."

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

• Not Applicable. (No training set).

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The CryoTouch™ is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures.

The list below shows examples of the types of lesions that may be treated:

• Verruca (warts) ●
• Plantar warts
• Seborrheic Keratoses
• Actinic Keratoses
• Achrochordon ●
• Molluscum Contagiosum ●
• Age Spots
• Dermafibroma
• Small Keloids ●
• Granuloma Annulare ●
• Porokeratosis Plantaris ●
• Angiomas
• Lentigo Maligna
• Keratoacanthoma
• Basal Cell Carcinomas ●
• Bowen's Disease
• Lentigo Discrete
• Chondrodermatitis
• Epithelial Nevus
• Leukoplakia ●
• Granuloma Pyogenicum ●
• Kaposi's Sarcoma ●
• o Pyogenic Granuloma

The CryoTouch™ device gently dispenses cryogen gas into an applicator or a uniquely designed cone. The applicator or cone is then used to apply the extreme cold to the lesion being treated to effect cryosurgical treatment.

The CryoTouch™ device is a cryosurgical unit intended for the destruction of various lesions by applying cryogenic gases at low temperatures. The submission aims to demonstrate substantial equivalence to the predicate device, Verruca Freeze K982506.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., a specific temperature range to be achieved with a defined tolerance). Instead, the performance objective is to demonstrate equivalency of temperature and cryosurgical effect compared to the predicate device.

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

• Sample Size: Not explicitly stated. The study involved "bench testing" and "a second bench test." The quantity of devices, cones/applicators, or agar samples used is not detailed.
• Data Provenance: The data is generated from bench testing, meaning it was conducted in a laboratory setting. There is no information about country of origin of the data as it's a technical bench study. It is inherently prospective as the tests were designed and executed to compare the devices.

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

This type of information is generally not applicable to the bench testing described. The "ground truth" here is objective physical measurements (temperature, red blood cell destruction) rather than expert interpretation of medical images or clinical outcomes. There is no mention of experts being used in this capacity for the bench tests.

4. Adjudication Method for the Test Set

Not applicable. The bench tests involved objective measurements, not subjective evaluations requiring adjudication.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images. This submission describes a cryosurgical device, and its performance evaluation focused on its physical characteristics and direct effect on biological material in a lab setting. It does not involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI/algorithm-driven device. Its performance is assessed physically.

7. Type of Ground Truth Used

The ground truth used in the bench testing was:

• Physical Measurements: Primarily temperature profiles attained by the device.
• Direct Biological Effect: The device's ability to destroy red blood cells immobilized in agar, serving as a simplified model for tissue destruction.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/ML model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The CryOmega Flexx is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.

The List below shows examples of the types of lesions that may be treated:

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

The CryOmega Flexx device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses a 16g or 25g cartridge of nitrous oxide that is sprayed once the gas cartridge has been screwed onto the applicator. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N2O (-89ºC).

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CryOmega Flexx device:

The document is a 510(k) premarket notification summary for the CryOmega Flexx, a cryosurgical unit. It focuses on demonstrating substantial equivalence to a predicate device (CryOmega-K102006) rather than defining and proving new acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" here are essentially the performance characteristics of the predicate device, which the new device must meet or be substantially equivalent to.

1. Table of Acceptance Criteria and Reported Device Performance

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