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Claritag is indicated for use in the treatment of achrochordons (skin tags).

The Claritag device is indicated for the treatment of skin tags. Claritag® is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The cryogen application methodology for skin tag removal is a widely accepted practice used by physicians for decades.

The Claritag device is provided in a kit containing the main device (canister containing aerosolized cryogen, fitted with two treatment head activation base, 20 disposal single use foam pads, tweezers (which are provided as an optional accessory) and Instructions for Use.

The mechanism of action for cryotherapy are the direct effects of freezing on the cells, and the vascular stasis which develops in the tissue after thawing.

The provided text is a 510(k) summary for the Claritag device, a cryosurgical unit for treating skin tags. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria for clinical performance (e.g., efficacy or safety in patients). The "Performance Data" section (page 4) exclusively details non-clinical performance testing, such as temperature measurements, depth of penetration in ballistic gel, shelf life, and package performance. These tests are primarily designed to show that the device functions as intended and safely, but not to measure its clinical effectiveness or human safety outcomes directly.

Therefore, I cannot fulfill your request for the following sections based on the provided text:

1. A table of acceptance criteria and the reported device performance: No clinical acceptance criteria are mentioned, nor is clinical performance reported.
2. Sample sizes used for the test set and the data provenance: No clinical test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
4. Adjudication method for the test set: Not applicable as no clinical test set is discussed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No clinical ground truth is discussed.
8. The sample size for the training set: Not applicable; this is a physical device, not a machine learning model with a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information regarding performance:

The document reports on non-clinical performance data:

• Claritag Predicate Comparison: Temperature of foam pads for both Claritag and the predicate device were measured ten times using a simulated skin model. Both met the minimum temperature requirement of -20°C.
• Claritag Ballistic Gel Test: Depth of temperature penetration was measured at 1, 2, and 3 mm from the outer face of ballistic gelatin to confirm cryogenic gas freezing effect decreases with depth.
• Shelf Life: Real-time data supports a one-year shelf life.
• Package Performance Testing: Passed ISTA 6 -Fed Ex-A.
• Claritag & Predicate Pad Temperature Comparison Test: Both achieved an average minimum temperature of -20°C.

Conclusion stated regarding performance:

The non-clinical performance data demonstrate that the Claritag device performs comparably to the predicate device. This data, along with comparison of technological characteristics, supports the substantial equivalence determination.

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