(23 days)
The CLEAR + BRILLIANT TOUCH® System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
The CLEAR + BRILLIANT TOUCH® Laser System is the second generation of the Clear+Brilliant line of products. Clear+Brilliant products use non-ablative laser designed for use in dermatological procedures intended to improve the appearance of a patient's skin. The system incorporates self-diagnostic algorithms to ensure its correct operation. The CLEAR + BRILLIANT TOUCH® Laser System is part of the family of Solta Medical products using the fractional photothermolysis principle to resurface the skin.
CLEAR + BRILLIANT TOUCH® Laser System is comprised of four sub-systems:
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- Console
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- Handpieces: 1440nm and 1927nm (Perméa) handpieces
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- Treatment Tip
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- Credit Key
The console and up to two handpieces are connected mechanically and electrically by an umbilical cable. The treatment tip is mechanically and magnetically secured to the handpiece. All components must be properly connected and fully functional for the system to be operable. The system will not permit laser energy output until the treatment tip is in contact with the patient's skin.
The embedded processor and software control the precise delivery of the fractional laser treatment by directing the electrical and mechanical components that determine the position, spacing, and focus of the optical output. The processor and software also monitor the status of a treatment and the system and present this information to the operator on the touchscreen.
The Credit Key is the replaceable accessory allowing access to treatment credits and is attachable to the console. It is removable and is disposed of after the credit balance reaches zero.
The solid-state design of CLEAR + BRILLIANT TOUCH® Laser System limits maintenance and minimizes utility requirements.
The provided document does not contain information about specific acceptance criteria, reported device performance, or a clinical study for the CLEAR+BRILLIANT TOUCH® Laser System as it would for an AI/ML powered device. This document is a 510(k) premarket notification for a medical device that utilizes laser technology for dermatological procedures, not an AI/ML diagnostic or prognostic tool.
Here's a breakdown of why the requested information cannot be fully provided based on the input text:
- Type of Device: The CLEAR+BRILLIANT TOUCH® Laser System is a physical laser device, not a software algorithm that performs diagnostics or prognostics. Therefore, the typical acceptance criteria and study designs (like standalone performance, MRMC studies, ground truth establishment) for AI/ML devices do not apply.
- 510(k) Clearance: This is a 510(k) submission, which aims to demonstrate substantial equivalence to a legally marketed predicate device. The focus is on comparing technological characteristics, safety standards compliance, and non-clinical performance (like electrical safety, electromagnetic compatibility, biocompatibility, and software validation), rather than a clinical effectiveness study with specific diagnostic performance metrics like sensitivity or specificity.
However, I can extract the relevant information that is present in the document.
Information Present in the Document:
1. A table of acceptance criteria and the reported device performance:
The document lists various non-clinical performance tests and standards to which the device must conform, and it states that the device "passed all the above applicable standards testing." These standards serve as the "acceptance criteria" for safety and basic performance.
| Document No. | Document Title | Reported Device Performance |
|---|---|---|
| ANSI/AAMI ES 60601-1(2005) + AMD (2012) and AAMI STD ES60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | Passed, demonstrating compliance |
| IEC/EN 60601-1-2 Ed.4.0 (2014) | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Passed, demonstrating compliance |
| IEC 60601-2-22:2012, Edition 3.1 | Medical Electrical Equipment—Part 2-2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. | Passed, demonstrating compliance |
| IEC 60825-1:2014 Edition 3.0 | Safety of laser products - Part 1: Equipment classification and requirements. | Passed, demonstrating compliance |
| ISO 10993-1:2018 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | Passed, demonstrating compliance (for biocompatibility of materials) |
| EN/ISO-10993-5: 2009 | International Organization for Standardization (ISO) 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. | Passed, demonstrating compliance (for biocompatibility of materials) |
| ISO 10993-10:2013 | International Organization for Standardization (ISO) 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (2010). | Passed, demonstrating compliance (for biocompatibility of materials) |
| 21 CFR Part 820 | FDA Quality Systems Regulation | Compliance indicated by 510(k) submission implying adherence to QSR |
| ISO 13485 | Medical Devices – Quality Management Systems | Compliance indicated by 510(k) submission implying adherence to QMS |
| EN ISO 13485:2016 | Medical devices—Quality management systems—Requirements for regulatory purposes | Compliance indicated by 510(k) submission implying adherence to QMS |
| EN ISO 14971:2019 | Medical Devices—Application of risk management to medical devices | Compliance indicated by 510(k) submission implying adherence to risk management |
| EN 62304:2015 | Medical device software—Software life cycle processes | Compliance indicated by inclusion of software in the device |
| EN/IEC 62366-1 b: 2015 Edition 1.0 b cor.1: 2016 | Medical devices - Application of usability engineering to medical devices | Compliance indicated by documentation |
| IEC 60601-1-6:2013, Edition 3.1 | Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. | Compliance indicated by documentation |
| ANSI/AAMI HE75: 2009 (R)2018 (Reference Standard) | Human factors engineering - Design of medical devices | Compliance indicated by documentation |
| ISTA testing standards | International Safe Transit Association; Packaging integrity performance tests; General test standards are ISTA 1A, 2A, and 3A per transport environment. | Passed, demonstrating packaging integrity |
The overall performance evaluation states: "The product performance testing demonstrates that the functional requirements have been met and that CLEAR+BRILLIANT TOUCH® Laser System is equivalent to the predicate device."
The following requested information is NOT applicable or NOT found in the provided document, as it pertains to AI/ML or clinical efficacy studies that are typically not part of a 510(k) submission for this type of laser device:
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a laser device's non-clinical performance testing.
- 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 applicable. Ground truth for a laser device's safety and performance involves engineering and standards compliance, not medical expert interpretation of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a laser device, not an AI/ML-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device. For this laser device, the "ground truth" for non-clinical testing is adherence to established engineering, electrical, biocompatibility, and safety standards.
- The sample size for the training set: Not applicable (no AI/ML training set).
- How the ground truth for the training set was established: Not applicable (no AI/ML training set).
§ 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.