(90 days)
755mm:
The Elite iQ Laser System is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064nm:
The Elite iQ Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is indicated for the treatment of pseudo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin.
The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.
The provided FDA 510(k) summary for the Cynosure Elite iQ laser system primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing. It does not involve an AI/ML-driven device, clinical studies to evaluate diagnostic performance (like those for AI-driven image analysis), or human-in-the-loop performance studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, expert ground truth adjudication for AI, MRMC studies) are not applicable to this submission.
The "Performance Testing - Bench" section describes a validation study related to the "Hair Removal Treatment Guidance Mode" (which provides starting settings based on user input, not an AI algorithm) for safety. This is the closest aspect to "acceptance criteria and study that proves the device meets acceptance criteria" within the provided text, but it's not an AI/ML context.
Here's a breakdown based on the provided document, acknowledging the non-AI/ML context:
Device: Cynosure Elite iQ Laser System
Purpose of Submission (K193426): To demonstrate substantial equivalence to legally marketed predicate devices for indications related to hair reduction, vascular lesions, pigmented lesions, and wrinkle treatment, and for the Skintel Reader which measures skin melanin content.
1. A table of acceptance criteria and the reported device performance:
The document states that "Performance testing showed no complications from using the recommended settings, thus confirming the treatment parameters set forth in the Hair Removal Treatment Guidance Mode are a safe starting point for practitioners performing test spots." It also mentions "Results showed no undesirable or unexpected AEs from test spots."
While explicit numerical acceptance criteria (e.g., "no more than X% of patients experience AE") are not presented in this summary section, the implicit acceptance criterion for the "Hair Removal Treatment Guidance Mode" validation was that the recommended settings would lead to no undesirable or unexpected adverse events (AEs) when applied as test spots.
| Acceptance Criteria (Implicit for Hair Removal Treatment Guidance Mode) | Reported Device Performance |
|---|---|
| Recommended test spot settings are a safe starting point. | No undesirable or unexpected AEs from test spots. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of subjects. The document refers to "The subjects chosen were at the high end of the recommended skin type range."
- Data Provenance: The validation study was performed by E. Victor Ross MD, affiliated with Scripps Green Hospital in San Diego, CA (USA). It appears to be a prospective validation study, as it describes patients being "evaluated 48-72 hours post treatment."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One expert is explicitly mentioned: E. Victor Ross MD.
- Qualifications of Experts: Affiliated with Scripps Green Hospital in San Diego, CA. (Specific domain experience like "dermatologist with X years experience" is not detailed in this summary).
4. Adjudication method for the test set:
Not applicable in the context of this safety validation. The expert (E. Victor Ross MD) performed the study and evaluated the outcomes. There's no mention of multiple reviewers or an adjudication process for what would typically be an AI ground truth dataset in an AI/ML context.
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 system and a skin melanin reader; it does not involve AI assistance for human readers or interpretation of medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of AI/ML. The "Hair Removal Treatment Guidance Mode" provides recommendations, but those are based on pre-programmed settings and user inputs, not an AI algorithm performing alone.
7. The type of ground truth used:
For the "Hair Removal Treatment Guidance Mode" validation, the "ground truth" was the observed absence of undesirable or unexpected adverse events (AEs) on patients following treatment with the system's recommended settings. This is akin to outcomes data related to safety.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. The "Hair Removal Treatment Guidance Mode" settings were "created based on previous user experience with the Elite+ Laser System," rather than being derived from a formal training dataset for an AI model.
9. How the ground truth for the training set was established:
Not applicable, as there was no formal "training set" in the context of an AI/ML algorithm. The settings were derived from "previous user experience" with an earlier product (Elite+ Laser System), suggesting historical clinical observations and expert consensus from practical application over time.
§ 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.