(263 days)
The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use: General skin resurfacing procedures. Ultra mode is further indicated for the following fractional applications: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).
UltraClear Laser System is a transportable device. The system includes the 15" touch screen, on/off switch, foot peddle, an emergency stop button, remote interlock, and calibration port. The device console houses most of the power consuming components, including the laser module, medical grade power supply, the scanner drivers, software, TEC cooling module, water pump, fans, software controls, and all other electrical control components. The laser system is a fiber laser device operating at a wavelength of 2,910nm. The system incorporates a fiber couple laser diode assembly pumping erbium doped fluoride glass fiber to generate laser emission. The laser energy is delivered during treatment via the handpiece. A 635 nm visible red laser diode aiming beam is used to visualize the location of the beam during laser treatment.
The provided text describes a 510(k) premarket notification for the UltraClear Laser System, a medical device for dermatological and plastic surgery applications. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/ML study.
Therefore, most of the information requested in your prompt (e.g., acceptance criteria for AI performance, sample size for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) is not present in the provided document, as it pertains to the clearance of a laser system, not an AI/ML-based device.
Here's an analysis based on the information that is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in a structured table format for performance metrics in the way one would for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device through a comparison of technical specifications and performance studies validating the laser's physical characteristics and safety.
The "Predicate Comparison Table" (Page 4) effectively serves as a comparison of specifications against a "substantial equivalence assessment." The acceptance criteria here are implicitly that the UltraClear Laser System's specifications are "Same," "Similar, within range," or "Substantially equivalent" to the predicate device.
| Specifications | UltraClear Fractional Laser System | JOULE ProFractional System | Substantial Equivalence Assessment |
|---|---|---|---|
| Manufacturer | FA International | Sciton, Inc. | Not Applicable |
| K Number | K210847 | K180508 | Not Applicable |
| Product Code | GEX, ONG | GEX, ONG | Same |
| Prescription Use | Yes | Yes | Same |
| Laser Energy Source | Er: YAG | Er: YAG | Same |
| Laser Delivery | Fiber & Handpiece | Fiber, Handpiece, Articulated arm | Substantially equivalent |
| Wavelength | 2910 nm | 2940 nm | Substantially equivalent |
| Aiming Beam | Red diode laser 5mW | Red diode laser 5mW | Same |
| Target Chromophore | Water | Water | Same |
| Fractional Technology | Yes | Yes | Same |
| Energy per Microbeam(mJ/mb) | 0.6-1.5 (Clear Mode), 1.5-3.0 (Silk Mode), 3.6-35.0 (Ultra Mode), 0.6-1.5, 3.6-35.0 (UltraClear-Mode) | Up to 70 | Similar, within range |
| Adjustable Spot Size | 2x2mm - 15x15mm | 1.3x1.3mm - 20x20mm | Substantially equivalent |
| Pulse/Repetition Rate | Up to 3 Hz | Up to 3 Hz | Same |
| Pulse Width/Duration | 0.1 to 3.0 msec (or 3000 usec) | 0.5 to 1.5 msec (or 1500 usec) | Substantially equivalent |
| Delivery System | Fiber optic arm with handpiece | Articulated arm and/or fiber optic arm with handpiece | Same |
| Cooling System | Water & Air | Water & Air | Same |
| Electrical Requirements | 100-240 VAC/8.5A, 50/60 Hz | 230 VAC/25A, 50/60 Hz | Substantially equivalent |
| Software/GUI/Touch Screen | Yes | Yes | Same |
| Energy Monitor | Display Indicates Energy Delivered to Tissue | Display Indicates Energy Delivered to Tissue | Same |
| Console Dimensions | w15.9" x d20.5" x h42.1" | w14" x d21" x h41" | Substantially equivalent |
| Weight | 80 Lbs | 200 Lbs | Substantially equivalent |
| Power Supply | Yes | Yes | Same |
The performance data mentioned in the document primarily relates to:
- Histology Study: "Human biopsies were taken and analyzed post laser treatment. Tissue samples were taken from three participants to establish the thermal damage and tissue effect of lasing." (Page 5) The specific "performance" results (e.g., degree of thermal damage, specific tissue effects) are not quantified or provided in this summary, but the study was conducted to confirm the expected effects.
- Biocompatibility: "The patient contacting material of the handpiece are identical to the reference device." (Page 5) This means the biocompatibility is implicitly accepted as equivalent to the predicate device.
- Electromagnetic Compatibility & Electrical Safety: "UltraClear Laser System underwent electrical safety and electromagnetic compatibility with passing results according to the following recognized standards." (Page 6) This indicates compliance with established safety standards.
- Software Validation and Verification Testing: "UltraClear Laser System underwent software verification and validation testing, which demonstrated the software is appropriate for release and that the system performed as intended. Furthermore, the testing verified the energy outputs of the system meet its design specifications." (Page 6) The performance is stated as "performed as intended" and "meet its design specifications," but no specific quantitative metrics or acceptance criteria for software performance are detailed.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For the histology study, "Tissue samples were taken from three participants." (Page 5). This is the only explicit "test set" mentioned.
- Data Provenance: The document does not specify the country of origin for the human biopsies. It does not mention if the data was retrospective or prospective, though the description implies prospective collection for the histology study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of this device and study. The "ground truth" for the histology study would be established by standard pathological analysis, but the number or qualifications of experts are not specified.
4. Adjudication method for the test set
Not applicable in the context of this device and study.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based device.
7. The type of ground truth used
For the histology study, the ground truth was derived from "human biopsies" and "thermal damage and tissue effect of lasing" (pathology/tissue effects).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical laser system.
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.