(117 days)
755 nm:
The PicoSure workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 3mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
532 nm:
The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I-III.
The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, an optional 532 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. This 532 nm Laser Delivery System converts the 755 nm laser energy into a 532 nm wavelength and is available in multiple spot sizes.
The provided document describes the Cynosure PicoSure™ Workstation with 532 nm Laser Delivery System (K143105) for tattoo removal. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with specific thresholds for device performance. Instead, it describes a comparative clinical study where the PicoSure device was deemed "as effective as" a predicate device (RevLite Q-Switched Nd:YAG Laser System K133254) based on a qualitative scoring scale.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness in tattoo removal comparable to predicate device | Mean score of 3.8/6 overall efficacy for PicoSure, compared to 3.7/6 overall efficacy for the predicate device (RevLite). The study concluded that "PicoSure to be as effective as the predicate device RevLite." |
| Safety (absence of serious adverse events) | "There were no deaths, serious adverse events (SAEs) or unanticipated adverse device effects (UADEs) reported in this study." |
| Software Verification and Validation | "Software verification and validation testing to support the 532 nm Laser Delivery System was successfully completed." (No specific metrics provided for this, but implies it met internal acceptance criteria for functionality and reliability). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 18 subjects with a total of 23 tattoos.
- Data Provenance: Not explicitly stated, but clinical trials for FDA submissions are typically conducted in the US or in countries with comparable regulatory standards. The document doesn't specify if it was retrospective or prospective, but clinical studies for regulatory approval are generally prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three (3) blinded reviewers.
- Qualifications of Experts: Not specified in the document.
4. Adjudication Method for the Test Set
- Adjudication Method: "Mean scores for all three evaluators were calculated per subject to determine overall mean scores." This indicates that the scores from the three reviewers were averaged. It's not a 2+1 or 3+1 method, but rather a direct averaging.
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
- No, an MRMC comparative effectiveness study involving AI assistance was not done. This study solely compared the PicoSure device to a predicate laser device (RevLite) in the context of human-conducted laser treatments. AI assistance is not mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. The device in question is a laser system, not an AI algorithm. The performance evaluation was for the laser system's ability to remove tattoos when operated by humans.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus based on a "6 point categorical efficacy scoring scale" applied to photographs. This is a form of clinical assessment/subjective evaluation.
8. The Sample Size for the Training Set
- Not applicable. The device is a physical laser system, not a machine learning algorithm that requires a training set in the conventional sense. The "training" for this device would be its engineering design, development, and manufacturing processes, which are informed by scientific principles and prior knowledge of laser-tissue interaction, not a data training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained above, this is a physical device, not an AI/ML algorithm that uses a training set with established ground truth.
§ 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.