(131 days)
To be used with the MEHL Chromos 694 Ruby Laser for the removal of unwanted body and facial hair.
The ChromoScan is a scanner which is used with the Chromos 694 Ruby Laser for the removal of unwanted body and facial hair. The hand held ChromoScan attachment enables treatment of multiple, rather than single hairs, thereby increasing efficiency and adding to the safety of the parent laser. The unit lays down a mathematically precise treatment grid whereby overlap is reduced and thermal recovery time is optimized. It is expected to lessen potential operator error by diminishing the time and tedium associated with one-hair-at-a-time hair removal procedures. Moreover, safeguards within the Chromos 694's intrinsic software insure that the scanner's fluences do not exceed those of the basic laser, i.e., no more than 20J/cm . ChromoScan is substantially equivalent to the other laser delivery attachment, the fiber optic handpiece. Both produce the same spot size, 7mm, and energies, as shown by computergenerated thermographic profiles.
This document is a 510(k) summary for the ChromoScan Scanner, an attachment for a ruby laser used in hair removal. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or a comprehensive study report on device performance against specific metrics. Therefore, many of the requested details are not present in the provided text.
Here is an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produce the same spot size as the fiber optic handpiece. | 7mm spot size, same as predicate. |
| Produce the same energies as the fiber optic handpiece. | Same energies as predicate. |
| Fluences do not exceed those of the basic laser (20 J/cm²). | Intrinsic software ensures fluences do not exceed 20 J/cm². |
| Ensure reliability. | Assured by state-of-the-art validation procedures. |
| No concerns about safety during preliminary use. | Preliminary use in Europe produced no safety concerns. |
| Substantial equivalence to predicate device (fiber optic handpiece). | Achieved for spot size, energies, and overall function. |
2. Sample sized used for the test set and the data provenance
The document mentions "Preliminary use of the ChromoScan on subjects in Europe."
- Sample size: Not specified.
- Data provenance: Europe, prospective (implied, as it refers to "preliminary use").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document does not describe a formal ground truth establishment process by experts for performance metrics, but rather a general safety observation during preliminary use.
4. Adjudication method for the test set
Not applicable/Not specified. The preliminary use observation for safety does not describe an adjudication method for data.
5. 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 device is a laser scanner attachment for hair removal, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a physical medical device like a laser scanner. However, the document emphasizes the scanner's ability to "lessen potential operator error" and lay down a "mathematically precise treatment grid," suggesting that the device's design aims to standardize and improve consistency of treatment application, which could be considered an autonomous function of the device's mechanics/software. There is no specific standalone performance study described for this aspect.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety aspect, "no concerns about safety" from preliminary use serves as an informal "ground truth" derived from observation. For technical specifications (spot size, energy), computer-generated thermographic profiles are used for comparison, implying a technical ground truth. There is no mention of pathology or broader outcomes data for the scanner itself.
8. The sample size for the training set
Not applicable. This is a physical device and an attachment, not an AI model that requires a training set.
9. How the ground truth for the training set was established
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.