(370 days)
The Orion Series Surgical Laser System (Q-Switched Nd:YAG configuration) is intended for the removal and reduction of unwanted hair.
The Crion Series Surgical Laser System and the Lyra Surgical Laser System are intended for the lightening and removal of unwanted body hair in Fitzgatrick Skin Ty I to VI using 1064 nm, Nd:YAG.
The Orion Series Surgical Laser System consists of a movable console containing power supplies, a treatment laser on a solid optical deck, and a cooling system to dissipate the heat generated by the system. A keypad control panel with CRT enables the user to control the laser system operating parameters. Surgical power is controlled via a footswitch. Laser power is emitted only when the footswitch is depressed. The delivery system is through fiber optics.
Here's an analysis of the provided text to extract the requested information about acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Success defined as) | Reported Device Performance |
|---|---|
| Investigator estimate of ≥ 30% hair reduction AND patient satisfaction ranking of "Fair" or better | Overall Success Rates: |
- 38% at 7 days post-treatment
- 86% at 30 days post-treatment
- 58% at 90 days post-treatment |
| Safety: No adverse events or complications reported beyond the time of treatment | Safety: One adverse event (extended erythema and burning sensation resolved within 10 minutes of treatment) reported at the time of treatment (1.4%). No adverse events or complications reported beyond the time of treatment. |
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 (Test Set): 70 patients, with 139 treated sites among them.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was described as "multi-center" with "three geographically dispersed investigational centers," and the 510(k) summary is submitted to the US FDA, implying US-based data.
- Retrospective or Prospective: Prospective (described as a "multi-center, randomized, unblinded design with an active, parallel control" and treatments were performed between specific dates: June 8 and October 12, 1998).
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)
- Number of Experts: At least one "investigator" at each of the three study centers. The text refers to "the investigator" (singular) in the context of effectiveness evaluation, implying a single expert per site making the primary visual assessment.
- Qualifications of Experts: Not specified. The text only refers to "the investigator" without detailing their professional background or experience (e.g., dermatologist, physician, etc.).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: None explicitly described for the "investigator" estimates. The text primarily relies on the investigator's visual estimation and the patient's self-reported satisfaction/estimate. The success criteria combine these two subjective measures. There is no mention of an independent panel or multiple expert readers for agreement.
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
- MRMC Study: No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done.
- Effect Size of AI Assistance: Not applicable, as this is a device study for a surgical laser, not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This study evaluates a physical laser device operated by a human, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for effectiveness was a combination of:
- Expert Visual Estimation: "The investigator was to visually estimate percent reduction in hair density." (Subjective)
- Patient Self-Reported Visual Estimation: "The patient was also queried as to her or his visual estimate of percent reduction in hair density." (Subjective)
- Patient Satisfaction Ranking: "The patients were asked to rank their treatments on a scale from 1 to 5." (Subjective outcomes data)
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This study describes a clinical trial for a physical medical device, not a machine learning model that requires a training set. The 70 patients used are for the prospective clinical study itself.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set in the context of this device evaluation.
§ 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.