(78 days)
The Chromos 694 (MEHL) Ruby Laser, Mark I, is indicated for the removal of unwanted body and facial hair.
The Mark I Chromos 694 Ruby Laser is a laser instrument used in medical practice for the removal of unwanted body and facial hair.
The provided text describes a 510(k) premarket notification for the "Chromos 694 Ruby Laser for Hair Removal," seeking substantial equivalence to a predicate device, the "MEHL Ruby Laser for Hair Removal." It does not contain information about specific quantitative acceptance criteria or a dedicated study designed to prove the device meets these criteria in the way typically expected for a new medical device approval with performance metrics like sensitivity, specificity, or accuracy.
Instead, the submission focuses on demonstrating substantial equivalence through:
- Engineering data: Showing similarity in light delivery characteristics.
- Calculations: Proving essentially equivalent fluences for the different spot sizes (5mm vs. 7mm).
- Thermographic profiles: Comparing the optical fiber (new device) to the articulated arm (predicate device).
- Improvements in safety and reliability: Listing features like the elimination of the Q-switched option, replacement of the articulated arm with optical fiber, larger spot size, and software-directed controls with shutdown provisions.
The clinical data mentioned refers to studies performed on the predicate device, not the new Chromos 694 Ruby Laser. The conclusion is that "With the similarity in technical characteristics between the MEHL Ruby Laser and the Chromos 694 Ruby Laser, equivalence in clinical performance can therefore be assured, with more safeguards, better control and increased reliability intrinsic to the newer model."
Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria is not present in the provided document, as the submission strategy relies on demonstrating substantial equivalence to a previously approved device, rather than new, independent clinical efficacy/safety trials with pre-defined performance endpoints.
Here's a breakdown of what can be extracted and what is not available based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from K971814) |
|---|---|
| Safety: No unexpected safety issues | Predicate Device (MEHL Ruby Laser): "In clinical studies with the MEHL Ruby Laser, no unexpected safety issues were identified. No scarring or purpuric reactions were observed. Though hyper- and hypopigmentation were seen infrequently, these effects resolved predictably within a few months." |
| New Device (Chromos 694 Ruby Laser): "With the similarity in technical characteristics... equivalence in clinical performance can therefore be assured, with more safeguards, better control and increased reliability intrinsic to the newer model." | |
| Improvements: Eliminated Q-switched option, replaced articulated arm with optical fiber (eliminates Gaussian hot spots), software-directed controls and safeguards (including shutdown for 7 fault conditions). | |
| Effectiveness (Hair Removal): Equivalent to predicate device | Predicate Device (MEHL Ruby Laser): Used for "removal of unwanted body and facial hair." |
| New Device (Chromos 694 Ruby Laser): "Substantially equivalent to its predecessor... Both use the same wavelength, deliver the same energies to the skin, and are constructed of similar components for the removal of unwanted body and facial hair." | |
| Technical Similarity Assessments: Engineering data showing similarity in light delivery, calculations proving essentially equivalent fluences (for 5mm and 7mm spots), thermographic profiles (optical fiber vs. articulated arm). | |
| Reliability: Improved or maintained | New Device (Chromos 694 Ruby Laser): "Reliability is improved... Reliability of the newer laser also was assured with a preponderance of quality control and validation information." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The clinical safety data mentioned refers to studies with the predicate device ("In clinical studies with the MEHL Ruby Laser..."), but the number of subjects or cases is not provided.
- Data Provenance: Not specified. It's implied to be clinical data from the predicate device, but no details on country, retrospective/prospective nature are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This information is not provided. The document relies on technical similarity and historical clinical safety data of the predicate, not a new clinical study with a ground truth established by experts specifically for the Chromos 694 Ruby Laser.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. No new clinical trial with expert adjudication is described for the Chromos 694 Ruby Laser.
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 for hair removal, not an AI-assisted diagnostic tool involving human "readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the predicate device's clinical safety, the "ground truth" implicitly referred to observed clinical outcomes (e.g., "no scarring or purpuric reactions were observed," "hyper- and hypopigmentation... resolved predictably"). For the new device, the "ground truth" for its equivalence claim relies on engineering and technical data demonstrating similarity to the predicate, ensuring comparable performance.
8. The sample size for the training set
- Not applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.