(161 days)
The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia.
Fractional Effects:
The UltraClear Fractional Laser System with its accessories when used in Ultra mode is intended to produce fractional effects during skin resurfacing.
UltraClear Fractional 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 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 medical device, the UltraClear Fractional Laser System, and its 510(k) premarket notification to the FDA. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific clinical study with acceptance criteria for device performance in a clinical context.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results for an AI algorithm is NOT present in this document.
The document discusses non-clinical performance studies to confirm functional specifications and biocompatibility, as well as software verification and validation. However, these are engineering and regulatory compliance tests, not clinical efficacy or performance studies with specific statistical acceptance criteria for clinical outcomes.
The document does not provide the information requested in terms of acceptance criteria for clinical performance or details of a study proving such criteria are met.
Here's a breakdown of what is and is not in the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document outlines technical specifications for the device and compares them to predicate devices, but no clinical acceptance criteria or performance metrics against such criteria are mentioned.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. No clinical test set or data provenance is mentioned.
- 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): Not provided. This is relevant for clinical studies, which are not detailed here.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. This is relevant for clinical studies, which are not detailed here.
- 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 provided. This device is a laser system, not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm in the context of diagnostic AI.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the context of clinical performance. The "ground truth" for the non-clinical tests would be the design specifications and recognized standards.
- 8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable. This is a physical medical device, not an AI algorithm.
Summary of what the document does provide regarding device "performance":
The document states that "Acclaro Corporation conducted non-clinical performance studies to confirm the overall functional specification testing of the UltraClear Fractional Laser System against its design specifications and intended use."
The specific non-clinical tests mentioned are:
- Biocompatibility Testing: Conducted in accordance with ISO-10993-1 to demonstrate the patient-contacting material of the handpiece is safe for transient use (≤24 hours of contact).
- Electromagnetic Compatibility & Electrical Safety: Underwent testing with passing results according to recognized standards:
- IEC 60825-1, 2007
- IEC 60601-1, 2005+A1:2012
- IEC 60601-1-2 Ed. 3, 2007-03
- IEC 60601-2-22 Third Edition, 2007-05
- Software Verification and Validation Testing: Demonstrated the software is appropriate for release and that the system performed as intended, verifying energy outputs meet design specifications.
These are standard regulatory compliance tests for medical devices, confirming safety and adherence to technical specifications, but they do not describe clinical efficacy or performance against clinical acceptance criteria.
§ 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.