(61 days)
755mm:
The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I – IV.
532nm:
The PicoSure 532-nm delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-III.
1064nm:
The PicoSure 1064-nm delivery system is indicated for tattoo and benign pigmented lesions removal.
The PicoSure Workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.
The provided document is a 510(k) summary for the PicoSure Workstation, a laser surgical instrument. It details the device's indications for use and compares it to predicate devices. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance directly in the format you requested, especially regarding quantitative performance metrics, sample sizes for test sets, and details about expert involvement in establishing ground truth.
The document indicates that to support the expanded indications for use (Nevus of Ota, Hori macules, and Melasma), a literature search was conducted. This means the clinical evidence is based on existing published studies rather than a new, dedicated clinical trial performed for this 510(k) submission.
Here's an attempt to answer your questions based on the provided text, with clear indications where information is not available from this document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or specific improvement percentages) directly associated with this 510(k) submission. Instead, it relies on demonstrating substantial equivalence to a predicate device and supporting new indications through literature review. The reported "performance" is qualitative, focusing on whether the existing literature showed "acceptable clinical effectiveness and safety" for the new indications.
| Criteria (Hypothesized based on text) | Reported Device Performance (from literature review) |
|---|---|
| Clinical Effectiveness | Six identified articles reported acceptable clinical effectiveness for Nevus of Ota, Hori macules (nevus of Hori), and Melasma using the PicoSure at 755nm. |
| Safety Profile | Six identified articles reported acceptable safety. No serious adverse events were reported. Side effects were primarily transient and included common acceptable side effects for laser treatments as described in the product labeling. |
| Substantial Equivalence | The device is deemed substantially equivalent to the PicoSure Workstation (K173199) and RevLite Q-Switched Nd:YAG Laser System (K133254) which were legally marketed predicate devices, with no changes to the technological characteristics, only an expansion of indications based on clinical literature. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated as a single test set size. The document mentions "at least ten individuals" in each of the six identified articles. Thus, the total number of individuals across all six studies is at least 60. Individual study sizes are not detailed.
- Data provenance: The document states "peer reviewed, published articles." No specific countries of origin are mentioned.
- Retrospective or prospective: The articles were identified as "prospective studies."
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 Applicable / Not Available. Since the evidence is based on published clinical studies, the "ground truth" and its establishment would be inherent to the methodologies of those individual studies. The 510(k) summary does not provide details on how ground truth was established within these external studies or the qualifications of any experts involved in those studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. This information would pertain to the specific methodologies of the clinical studies identified in the literature search. The 510(k) summary does not provide these details.
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 document is for a laser workstation, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance effect size is relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (laser workstation), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Available. The "ground truth" would relate to the diagnosis of the benign pigmented lesions (Nevus of Ota, Hori macules, Melasma) and the success of their removal or clinical improvement. The specific method used to establish these in the surveyed literature is not detailed in this 510(k) summary. It likely involved clinical diagnosis by dermatologists and visual assessment of treatment outcomes.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this device. The device's operation is based on its physical properties and established laser physics, not on a machine learning model trained on data. The clinical literature reviewed supported the indications for use, not a training process for the device itself.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.