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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 DenTek™ Fresh Protect™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

The DenTek™ Fresh Protect™ Dental Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of an ethylene/vinyl acetate copolymer and utilizes a ready-to-wear, one-size-fits-all design. The fully occlusive guard is worn on the lower teeth, maintaining separation between the upper and lower teeth, thereby preventing the noise and damage associated with teeth grinding.

This document is a 510(k) Premarket Notification from the FDA for a dental guard, not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present.

The document discusses the substantial equivalence of the DenTek™ Fresh Protect™ Dental Guard to a predicate device based on non-clinical performance data and biocompatibility tests.

Here is a summary of the non-clinical performance data presented for the DenTek™ Fresh Protect™ Dental Guard:

Acceptance Criteria and Device Performance (Non-Clinical)

Regarding the other requested points (sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set size, training set GT):

• Sample sized used for the test set and the data provenance: Not explicitly stated as this is a non-clinical bench testing and biocompatibility assessment, not a clinical study with a patient test set. The tests involved "finished guards" or specific materials.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for bench tests would be the measured physical properties or biochemical reactions. For biocompatibility, established ISO standards define the endpoints.
• Adjudication method for the test set: Not applicable for non-clinical bench testing.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is not about an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI/ML device.
• The type of ground truth used: For the non-clinical tests, the ground truth is derived from the established physical and chemical measurements as per the referenced ISO standards and simulation studies.
• The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
• How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document is a 510(k) premarket notification for a physical medical device (dental guard) and thus does not contain the information relevant to an AI/ML device's acceptance criteria, study design, or ground truth establishment.

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The DenTek Ultimate™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

The DenTek Ultimate™ Dental Guard is a one-piece, posterior-occlusion dental guard consisting of two moldable bite-pads connected by a flexible band that rests behind the user's front teeth. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's maxillary pre-molars after the guard has been heated via submersion in boiled water. The DenTek Ultimate™ Dental Guard is supplied pre-loaded into a flexible molding tray that allows the user to accurately place and comfortably hold the heated device during the molding process. When in place, the guard maintains separation between upper and lower teeth, reducing noise and damage to the teeth associated with teeth grinding.

This document describes the regulatory submission for the DenTek Ultimate™ Dental Guard (K180933). The review confirms substantial equivalence to a predicate device, the DenTek™ Custom Comfort Nightguard Version 2 (K091660), for the indication of protecting against bruxism or nighttime teeth grinding.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerically-defined thresholds. Instead, it describes performance characteristics that the device was tested against to demonstrate substantial equivalence to its predicate. The "reported device performance" is essentially that the device performed sufficiently in these tests to meet the subjective goals of the tests and support its intended use.

Here's a breakdown of the performance data reported (which served as evidence of meeting implied "acceptance criteria" for substantial equivalence):

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

The document refers to "simulation studies" for the impression, separation, stability, and comparative wear tests. It does not explicitly state the sample size (e.g., number of guards tested, number of simulated applications) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that these were "simulation studies." For the biocompatibility tests, specific ISO standards are cited, which typically involve standardized methods and sample sizes for the biological material/animals used, but the specific number used in this particular study is not given.

Given the nature of the device (over-the-counter dental guard) and the type of submission (510(k) for substantial equivalence), in-depth clinical trials with large human test sets are often not required if technical and bench testing is sufficient to demonstrate similarity to a predicate.

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

The document does not mention the use of experts to establish a "ground truth" for the non-clinical performance tests. These were likely evaluated based on objective measurements or observations by trained technicians or engineers involved in the testing, adhering to predefined protocols for each simulation.

For the biocompatibility tests, the ground truth is established by the results of the standardized assays themselves, interpreted by qualified personnel in toxicology/biocompatibility, but their specific number or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

No adjudication method is described for the "test set" (which consists of bench tests and biocompatibility assays). The outcomes of these tests are direct results from the experimental setup, rather than subjective assessments requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. The DenTek Ultimate™ Dental Guard is a physical medical device for protection against bruxism, not a diagnostic tool requiring human reader interpretation in the same way.

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

This question is not applicable. The DenTek Ultimate™ Dental Guard is a physical medical device, not an algorithm or AI system. Therefore, "standalone" algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

For the impression, separation, stability, and comparative wear tests, the "ground truth" would be the objective physical performance observed during the simulation studies. For instance, whether an impression was "distinct" would be based on visual criteria, whether teeth were "separated" would be a physical measurement, and "durability" would be assessed against expected wear characteristics.

For the biocompatibility tests, the ground truth is established by the biological response of cells (cytotoxicity) or animals (sensitization, irritation) as measured and interpreted according to the specific ISO standards.

8. The Sample Size for the Training Set

This question is not applicable. The DenTek Ultimate™ Dental Guard is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This question is not applicable. As stated above, there is no "training set" for this device.

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Compound W® Nitro-Freeze is intended for over-the-counter treatment of common warts and plantar warts in adults and children four years of age or older.

Compound W® Nitro-Freeze is a pen-like cryogenic device that utilizes pressurized nitrous oxide (N,O, liquefied) to destroy wart tissue through evaporative cooling when the cryogen is delivered via a disposable foam applicator tip. Each Compound W® Nitro-Freeze device is supplied in an outer carton with an Instructions-for-Use leaflet and a bag containing replacement tips.

The document describes the device Compound W® Nitro-Freeze, an over-the-counter cryogenic wart remover. The following summarizes the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formalized table of acceptance criteria. Instead, substantial equivalence to legally marketed predicate devices (Wartner® Wart Removal System (K032271) and Wartie® Wart Remover (K140314)) is claimed based on comparable intended use, technological characteristics, and safety/effectiveness data. The performance is reported in terms of freezing temperature and clinical effectiveness.

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

• Sample Size (Clinical Study): 138 patients randomized, with 124 per-protocol.
  • Nitro-Freeze arm: 50 patients
  • Wartner arm: 38 patients
  • Wartie arm: 36 patients
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It mentions "a single-center... study," but the location of this center is not specified. The study is described as a "multi-arm study," indicating a prospective design (patients were enrolled and treated).

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

This information is not provided in the document. The document mentions "evaluator assessments" following treatments in the clinical study, but does not specify the number or qualifications of these evaluators or how "ground truth" (i.e., wart clearance) was established, aside from the term "cured."

4. Adjudication Method

This information is not provided in the document.

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

An MRMC comparative effectiveness study was not conducted for this device. The clinical study was a direct comparison of the device's effectiveness against predicate devices in treating warts in human subjects, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study

A standalone, algorithm-only performance study was not conducted as this is a physical medical device (cryogenic wart remover), not an AI/software as a medical device.

7. Type of Ground Truth Used

For the clinical performance data, the ground truth was based on clinical assessment of wart clearance, described as "cured" after a certain number of treatments.

8. Sample Size for the Training Set

This information is not applicable/not provided. The device is an over-the-counter physical cryogenic wart remover, not a machine learning algorithm that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age or older.

The Nix® Ultra Lice Treatment Kit consists of two components: Nix® Ultra Lice Killing Solution and Nix® Ultra Lice Removal Comb. The kit also includes an Instructions for Use Leaflet.

Nix® Ultra Lice Killing Solution is a formulated device containing dimethicone and isoparaffin. The product kills lice and their eggs by physically coating the lice and clogging the spiracles through which they breathe and conduct water exchange; the solution also lubricates the hair to facilitate removal of dead lice and nits with the supplied comb. The Nix® Ultra Lice Treatment Kit is intended for over-the-counter use.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Nix® Ultra Lice Treatment Kit:

Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission for the Nix® Ultra Lice Treatment Kit does not explicitly state pre-defined quantitative acceptance criteria in the typical sense (e.g., "The device must achieve X% sensitivity and Y% specificity"). Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Clear™ Lice Egg Remover System (K981147).

The closest equivalent to "acceptance criteria" and "reported device performance" in this document is the demonstration of effectiveness against lice and nits and safety through in-vitro studies and a clinical study. The primary endpoints in the clinical study focused on "cure rates" (no infestation) at different time points.

Here's a table summarizing the relevant performance metrics from the studies:

Study Details

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

   • In-vitro studies: The document details the subjects as "adult lice, nits, and lice genetically confirmed to be permethrin- and DDT-resistant (BR-HL strain)". The exact numerical sample size (e.g., number of lice or nits per test) is not provided, only the resulting mortality rates.
   • Clinical Study (Ref# NUHL001-10/15): The tables show results for 25-26 subjects for "Reference" and 25-26 subjects for "Test" in the "All baseline infestations" category. For "Mild and Moderate Baseline Infestation," it's 19 subjects for "Reference" and 17-18 subjects for "Test". The specific country of origin is not explicitly stated, but the mention of a European marketer for post-marketing data suggests the clinical trial could have been conducted in Europe. The study is described as a "randomized, controlled, investigator- and assessor-blinded study," indicating it was a prospective clinical trial.
   • Post-marketing adverse event data: This involved 518,095 units sold in Europe from June 2007 to December 2015, making it retrospective observational data.

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

   • In-vitro studies: Not explicitly stated. The ground truth (live vs. dead lice/nits) would typically be assessed by laboratory technicians trained in entomology, potentially under the supervision of experts in parasitology. Specific qualification details are not provided.
   • Clinical Study: The study involved an "investigator" to assess the baseline infestation and presumably monitor for cure or presence of lice. The document does not specify the number of investigators or their qualifications beyond the term "investigator." For Head Lice studies, these are often medical professionals or trained personnel experienced in examining scalps for lice and nits.

3. Adjudication method for the test set:

   • In-vitro studies: Not specified, but generally, clear criteria for "mortality" in entomological studies are pre-defined and applied consistently by trained observers.
   • Clinical Study: Not explicitly described. Given it was an "investigator- and assessor-blinded study," it implies that at least two independent parties were involved in assessments, one of whom was blinded. However, the specific adjudication process (e.g., if there were discrepancies between assessors) is not detailed.

4. 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:

   This is not an AI/imaging device. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable to this device. The clinical study was a comparison of the Nix® Ultra product against a "Reference" product in terms of cure rates.

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

   This is not an AI/algorithm-driven device. Therefore, a standalone algorithm-only performance study is not applicable. The "device" in this context is a physical lice treatment kit.

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

   • In-vitro studies: Biological endpoint (mortality/viability of lice and nits) observed directly by trained personnel. This could be considered a form of direct biological observation, which is highly objective.
   • Clinical Study: Clinical outcome (presence or absence of head lice infestation), assessed by an "investigator" based on visual examination, likely aided by comb-out procedures. This would implicitly involve a form of expert assessment or consensus if multiple investigators were involved, but the document doesn't detail this.
   • Post-marketing adverse event data: Self-reported adverse events from users and classified by the marketer. This is outcomes data based on user experience.

7. The sample size for the training set:

   This device is a chemical and mechanical treatment for lice, not a machine learning model. Therefore, the concept of a "training set" for an algorithm is not applicable.

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

   As this is not a machine learning device, the concept of a "training set" and its associated ground truth establishment is not applicable.

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For the over-the-counter removal of common and plantar warts.

The Compound W® Wart Removal System Dual Power is a cryosurgical system for the over-the-counter removal of common and plantar warts. Compound W® Wart Removal System Dual Power consists of the following:

• O Pressurized aerosol spray canister with a mixture of dimethyl ether and propane (K032271)
• o Reusable actuator/cap that releases the cryogen onto the disposable applicators
• Disposable foam applicators O
• Salicylic acid gel wart remover provided in a squeeze tube (in compliance with OTC O monograph 21 CFR 358 subpart B)
• O Comfort pads
• Instruction Leaflet o

This document is a 510(k) premarket notification for the "Compound W® Wart Removal System Dual Power." It primarily establishes substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of clinical performance.

While the document details comparisons between the new device and a predicate device (Dr Scholl's® Dual Action Freeze Away™ Wart Remover) to demonstrate substantial equivalence, it does not contain information about:

1. A table of acceptance criteria and reported device performance: The document compares technical characteristics and indications for use, but there are no specific numerical acceptance criteria (e.g., success rates, cure rates) or corresponding performance data from a clinical study for the new device.
2. Sample size used for the test set and data provenance: No clinical test set data is provided.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set data is discussed.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a direct-to-consumer product, not typically requiring comparative effectiveness studies against human readers for diagnostic tasks.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm trained on data.
9. How ground truth for the training set was established: Not applicable.

However, based on the provided text, we can infer the "acceptance criteria" through the lens of "substantial equivalence" to the predicate device. The primary acceptance criterion for the FDA 510(k) pathway is that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if it has different technological characteristics, it does not raise new questions of safety or effectiveness and is as safe and effective as the predicate device.

Here's an attempt to structure the answer based on the provided document, interpreting the "acceptance criteria" as meeting substantial equivalence to the predicate:

The provided document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting a de novo clinical study with specific performance acceptance criteria. Therefore, the "acceptance criteria" are implied by the FDA's regulatory standard for 510(k) clearance, which means the device must be as safe and effective as a predicate device and not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
The document does not describe a clinical performance study with a test set. The basis for clearance is substantial equivalence to a predicate device based on comparison of characteristics and technological features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set data is presented.

4. Adjudication method for the test set:
Not applicable, as no clinical test set data is presented.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done or reported in this document. This type of study is typically conducted for diagnostic devices where human interpretation of images or signals is involved. The device is a therapeutic cryosurgical unit.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used:
Not applicable, as no clinical data with ground truth is discussed for the device's performance. The "ground truth" in the context of a 510(k) is effectively the established safety and effectiveness of the identified predicate device that the new device is compared against.

8. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device, not an AI algorithm.

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