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The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

The CLARO is a portable handheld intense pulse light (IPL) device powered by a rechargeable battery. The CLARO uses a Xenon flash lamp which delivers pulses of light with a wavelength range from 400-1100 nm at Imsec pulse duration and a fluence of 6 J/cm2. The spot size of the CLARO is 1cm2.

Here's a breakdown of the acceptance criteria and study information for the CLARO device, based on the provided text:

CLARO Device Performance Study Summary

1. Acceptance Criteria and Reported Device Performance

The provided document describes studies primarily focused on usability and self-selection for Over-The-Counter (OTC) use, rather than clinical efficacy studies with specific performance metrics like sensitivity or specificity for acne treatment. The acceptance criteria relate to the ability of users to understand labeling and operate the device correctly for OTC use.

2. Sample Size and Data Provenance

The provided document outlines the following sample sizes and provenance details:

• Test Set Sample Sizes:
  • Self-Selection Study 1: 61 subjects
  • Usability Study 1: 59 subjects (from Self-Selection Study 1)
  • Self-Selection and Usability Study 2: 165 subjects
  • Usability Study 3: 19 subjects
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for OTC clearance, these would most likely be prospective usability and self-selection studies conducted in a controlled environment.

3. Number and Qualifications of Experts for Ground Truth

The document does not specify the number or qualifications of experts used to establish ground truth for the usability and self-selection studies. For these types of studies, "ground truth" would typically be defined by whether participants followed instructions and operated the device as intended, assessed by study administrators or observers rather than medical experts.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test sets. This is expected given the nature of usability and self-selection studies, where the primary assessment is direct observation of user behavior compared to predefined correct actions.

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

No, an MRMC comparative effectiveness study was not done. The studies described are usability and self-selection studies for OTC device use, not clinical comparative effectiveness studies involving human readers (e.g., radiologists) and AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The CLARO is a physical device, and the described studies evaluate user interaction and understanding of labeling, not an algorithm's performance in isolation. The device itself is "identical in all technological respects" to a previously cleared prescription device (K080638), suggesting its standalone efficacy was previously established for a similar indication.

7. Type of Ground Truth Used

For the usability and self-selection studies, the "ground truth" was based on:

• Observed user behavior: Whether participants correctly followed instructions for self-selection from labeling.
• Observed device operation: Whether participants correctly operated the device based on the User's Guide.

This is a form of empirical observation and adherence to instructions, rather than expert consensus, pathology, or outcomes data related to an underlying medical condition.

8. Sample Size for the Training Set

The document does not mention a training set in the context of these usability and self-selection studies. These studies were intended to test the device and its labeling, not to train an algorithm or model.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned in the context of these studies, this question is not applicable.

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The CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

The CLARO is a portable handheld device that uses light energy from the blue to infra-red spectrum emitted by a Xenon flash lamp. The device is powered by a rechargeable battery. CLARO is intended to be a prescription device which will be used both in the doctor's office and in the home environment for the treamment of mild to moderate acne.

The provided text, a 510(k) summary for the CLARO device, does not contain specific acceptance criteria or details of a study proving the device meets particular performance metrics.

Instead, it states:

"Performance testing will be performed which will demonstrate compliance with IEC 60601-1-1 and IEC 60601-1-2. Testing was submitted which showed that the user was able to use the device in the home-use environment."

This indicates that general safety and essential performance standards (IEC 60601-1-1 and -1-2) would be addressed, and a user study demonstrated home-use feasibility. However, no specific performance criteria related to acne treatment efficacy, clinical outcomes, or comparative performance are detailed, nor are the results of any such study presented in this document.

Therefore, I cannot provide the requested information. The document focuses on regulatory submission and substantial equivalence to predicate devices, not on detailed performance study results against specific acceptance criteria for efficacy.

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