(72 days)
Dr. Yglo Wart Remover is indicated for the over-the-counter treatment of common warts and plantar warts.
The Dr. Yglo Wart Remover is effective in the treatment of warts by providing an over the counter cryosurgery product (for the treatment of warts), to be used at home.
Dr. Yglo Wart Remover consists of:
- A pressurized canister filled with 50ml of the compressed liquid gas dimethyl ether.
- A custom application unit used to administer the cold delivered by the cryogen to the wart.
- Instructions for use in which you can read about the product how it works, how to use the product to treat warts, warnings and limitations.
This document is a 510(k) Premarket Notification for the Dr. Yglo Wart Remover. It details the device's characteristics and demonstrates its substantial equivalence to a predicate device, the Wartie Wart Remover.
The document does not describe a study to prove the device meets acceptance criteria in the manner typically associated with clinical performance studies for AI/ML medical devices. Instead, it focuses on demonstrating substantial equivalence through non-clinical testing, primarily bench testing, and comparisons of technological characteristics, intended use, and safety profiles with a predicate device.
Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the type of information presented in this 510(k) summary. The information provided is for a cryosurgical unit, which is a physical device, not an AI/ML algorithm.
However, I can extract information related to the acceptance criteria and supporting studies as presented for this specific type of medical device submission.
Here's the closest interpretation of the requested information based on the provided text:
Acceptance Criteria and Device Performance (as demonstrated for substantial equivalence)
Since this is not an AI/ML device, the "acceptance criteria" are related to demonstrating equivalent safety and efficacy through non-clinical means compared to a legally marketed predicate. There isn't a table of quantitative performance metrics like sensitivity/specificity for disease detection.
| Acceptance Criterion (Demonstrating Equivalence) | Reported Device Performance/Evidence |
|---|---|
| Intended Use Equivalence | Dr. Yglo Wart Remover is indicated for over-the-counter treatment of common warts and plantar warts, identical to the predicate device (Wartie Wart Remover K140314). |
| Technological Equivalence (Mechanism) | Both devices are portable cryosurgical systems using dimethyl ether (DME) as the cryogen and a metal applicator for focused application. Both remove thermal energy from skin. |
| Technological Equivalence (Materials) | Both use DME from an aerosol can applied via a metal core with a Nickel tip. |
| Biocompatibility | Established according to ISO 10993, similar to the predicate. |
| Performance Equivalence (Bench Testing) | Comparative performance bench testing with predicate and other competitive devices demonstrated equivalent freezing performance and skin adherence. This supports the safety and efficacy. |
| Safety and Labeling Equivalence | Dr. Yglo Wart Remover has substantially similar warnings, contraindications, and safety statements as the predicate, ensuring consumer safety. It also has a secured locking ring for mechanical safety, similar to the predicate. |
| Usability | "Concept and Product Testing with 23 patients for In-Home Use" was performed. (No specific acceptance criterion or quantitative results are provided in this summary, but the test was performed). |
Study Details (based on the provided 510(k) Summary)
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A table of acceptance criteria and the reported device performance:
- See the table above. Note that "acceptance criteria" here refer to the points of comparison for demonstrating substantial equivalence, not quantitative performance thresholds for an AI algorithm.
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Sample sizes used for the test set and the data provenance:
- Test Set (Human Use/Usability): 23 patients for the "Usability Study—'Concept and Product Testing with 23 patients for In-Home Use'".
- Data Provenance: The document does not specify the country of origin for the usability study. It is implied to be a prospective study ("Concept and Product Testing").
- Test Set (Bench Testing): Not specified. Bench testing involved comparing the device to the predicate and other competitive devices regarding "freezing performance and skin adherence testing." The exact number of tests or samples is not provided in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this cryosurgical device's 510(k) submission. Ground truth, in this case, would relate to device proper functioning, safety, and equivalence to established cryosurgery. The effectiveness of wart removal is assessed through clinical outcomes and comparison to established methods, not by expert consensus on image interpretation.
- For the usability study, "patients" were involved, but their role was in using the device, not establishing a medical "ground truth."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an image interpretation or diagnostic AI device.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, a cryosurgical unit, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical studies supporting substantial equivalence, the "ground truth" is implied by the established performance of the predicate device and accepted standards for cryosurgical units (e.g., ability to freeze tissue, material compatibility, safety in use).
- For the usability study, the "ground truth" would be actual user experience and ability to correctly follow instructions and operate the device safely for its intended purpose.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.