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The Claritag Advanced is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The Claritag Kit contains the Claritag handheld device and the Claritag Base. The Claritag device houses the Claritag "squeeze and freeze" heads with foam treatment pads and liquid cooling gas. A spare set of treatment heads is included. The Claritag Base will activate the freezing once the heads are placed into the base. Pressing down on the base sends the liquid cooling gas to the Claritag "squeeze and freeze heads." Instructions for Use are included.

AI/ML Overview

The provided text describes the Claritag Advanced device, an over-the-counter (OTC) cryosurgical unit for skin tag removal. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study for acceptance criteria.

Based on the provided information, I can extract the following details regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily uses a comparison to predicate devices to establish substantial equivalence. It does not explicitly state numerical acceptance criteria for performance metrics (e.g., success rate, safety endpoints) for the Claritag Advanced. Instead, the "performance" is demonstrated by showing similar technological characteristics and safety profiles to legally marketed devices.

Acceptance Criteria Category (Implied from comparison)	Reported Device Performance (Claritag Advanced)
Intended Use	OTC treatment of skin tags in adults age 21 years or older. (Matches predicate for skin tags, and aligns with OTC classification).
Mechanism of Action	Extreme cold freezes skin tag. (Same as predicate).
Cryogen	HP152a. (Different from primary predicate's DMEP, but stated as having "safety characteristics as compared with DMEP," and matches secondary predicate).
Time to freeze skin tag	20 seconds, 2 times. (Different from primary predicate's 40 seconds, but matches secondary predicate).
Visible safety indicator of freezing temperature	Blue tint in foam pads. (Present, unlike primary predicate).
Safety Conditions	Similar warnings regarding flammability, pressurization, heat exposure, and use near open flame, matching or being a superset of predicate warnings. No new issues of safety or effectiveness are deemed to be raised.
Treatment Procedure	Push down on canister until hissing sound starts and stops and foam tips turn blue. Place tips around tag and squeeze for 20 sec. Repeat. (Matches secondary predicate, different from primary).
Number of Treatments	10 (Different from primary predicate's 8, but matches secondary predicate).
Disposal	Entire unit is disposable after emptied of cryogen. (Same as predicate).
Exclusion Criteria (Outer Box Label)	Do not use if diabetic, have poor blood circulation, or diagnosed with blood conditions affected by extreme cold or if younger than 18 years old. (Differs from primary predicate's "younger than 21," aligning with the device's OTC indication for adults 21+ but the exclusion criteria state 18, which is slightly inconsistent. However, the clearance is for age 21 or older).
Biocompatibility	Meets ISO 10993 Requirements. (Stated to meet, same as predicate). This implies specific tests were passed, but the actual acceptance criteria for these tests (e.g., absence of cytotoxicity) are not detailed.
Performance Testing (Mechanical, Effective Duration, Temperature)	Tests performed and "test results show that the subject device is substantially equivalent to the predicate Device." Specific criteria are not provided.
Human Factors	Human factors validation test performed and "test results show that the subject device is substantially equivalent to the predicate Device." Specific criteria are not provided.
Safety/Effectiveness	"raises no new issues of safety or effectiveness." This is the ultimate "acceptance criterion" for 510(k) clearance based on substantial equivalence.

2. Sample Size for Test Set and Data Provenance:

The document mentions "Non-Clinical Test Reports" and lists:

Biocompatibility: Cytotoxicity, Sensitization, Irritation
Performance testing: Mechanical Integrity Testing (ASTM F882-84(2002)), Effective Duration Test, Temperature Testing
Human Factors: Human factors validation test

However, it does not provide any details about the sample size (number of devices tested, number of human subjects, etc.) for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These appear to be lab-based or simulated tests, as no clinical trial data is referenced.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The document describes non-clinical and human factors testing, and relies on comparison to predicate devices, not on expert-established ground truth for a test set in a diagnostic or clinical performance study.

4. Adjudication Method for Test Set:

Not applicable, as no expert review or adjudication process for a test set (e.g., image interpretation) is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. This type of study is typically for evaluating AI-assisted diagnostic devices, which is not the nature of the Claritag Advanced.

6. Standalone Performance:

Standalone performance (algorithm only) is not relevant for this device as it is a physical cryosurgical unit, not a software algorithm. Its "performance" is tied to its physical characteristics and how it compares to predicate devices in achieving the intended cryotherapeutic effect. The non-clinical tests (mechanical, temperature, effective duration) contribute to demonstrating its standalone functional performance, but specific metrics beyond "substantially equivalent" are not provided.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be established by the specifications or standards against which the device was tested (e.g., ISO 10993 for biocompatibility, ASTM F882-84(2002) for mechanical integrity). For the overall substantial equivalence, the "ground truth" implicitly relies on the safety and effectiveness profile of the cleared predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is a physical cryosurgical unit, not a machine learning or AI model that requires a training set.

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

Not applicable, for the same reason as above.

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