(391 days)
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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Self-Selection | Percentage of participants able to properly self-select themselves using the box labeling | Study 1: 98.3% |
| Study 2: 95% | ||
| Device Operation | Percentage of participants able to correctly use the device by reading the User's Guide (without assistance) | Study 1 (without final labeling): 86.4% |
| Study 1 (with final labeling): 97.2% | ||
| Study 2 (with final labeling): 93% | ||
| Study 3 (with final labeling): 100% |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.