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The PicoWay laser system is indicated for the following at the specified wavelength:

• · 532 mm: Removal of tattoos for Fitzpatrick Skin Types I-III to treat the following tattoo colors: red, yellow and orange.
• · 730 nm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
• · 785 mm: Removal of tattoos for Fitzpatrick Skin Types II-IV to treat the following tattoo colors: green and blue.
  · 1064 nm: Removal of tattoos for all Fitzpatrick Skin Types to treat the following tattoo colors: black, brown, green, blue and purple.

The Pico Way laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V and for treatment of Melasma for Fitzpatrick Skin Types I-IV.

The Resolve handpieces (532 nm, and 1064 nm) are also indicated for the treatment of wrinkles in Fitzpatrick Skin Types I-IV.

The Resolve Fusion handpiece (532 nm) is indicated for benign pigmented for Fitzpatrick Skin Types I-IV.

The PicoWay laser system is indicated for the following at the specified wavelengths:

532 nm :

· Treatment of Melasma for Fitzpatrick Skin Types I-IV.

· Treatment of café au lait macules (CALMs) for Fitzpatrick Skin Types I-IV.

• · Treatment of Lentigines for Fitzpatrick Skin Types I-IV.
  730 nm:

· Treatment of Lentigines for Fitzpatrick Skin Types I-IV.

1064 nm:

• · Treatment of Melasma for Fitzpatrick Skin Types I-IV.
• · Treatment of Nevus of Ota for Fitzpatrick Skin Types III-IV.

The PicoWay Laser System is a solid-state laser capable of delivering energy at wavelengths of 1064 nm, 532 nm, or 730 nm, at extremely short duration in the range of 240-500 (ps). The laser system contains one 755 nm (Alexandrite) laser head which is used to 'pump' (create) the 1064 / 532nm wavelengths. The outputs of the two lasers are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532nm or 1064nm wavelengths. The 532nm or 1064nm output energy is delivered to the skin through an Articulated Arm and Zoom Handpiece (HP) delivery system. There are also 3 hand pieces (Resolve), one for 1064nm and two for 532nm (low energy and high energy), which deliver a 10 x 10 array of focused spots to the skin and 1 Axicon hand piece (Resolve Fusion) for 532nm, which delivers a 10 x 10 array of focused and ring spots to the skin.

The provided document describes the Candela PicoWay Laser System (K220853) and its substantial equivalence to a predicate device (K191685). The primary difference is the addition of new indications for benign pigmented lesions. The document does not refer to the device as an "AI device" or an "algorithm," but rather a laser system. Therefore, some of the requested information regarding AI device testing (e.g., human-in-the-loop performance, effect size of human improvement with AI, training set details, expert qualifications for ground truth in a test set, adjudication methods) is not directly applicable.

However, based on the information provided, here's a summary of the acceptance criteria and the study that supports the expanded indications for the PicoWay Laser System, focusing on the clinical evidence for the new indications.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the expanded indications are implied by the clinical studies demonstrating the safety and effectiveness of the PicoWay Laser System for these conditions. The reported device performance is derived from the outcomes of these clinical studies.

Study Details (Relevant to Expanded Indications for Benign Pigmented Lesions)

1. Sample Size Used for the Test Set and Data Provenance:

   • Systematic Literature Search: Nine articles were identified, including randomized controlled, prospective, open-label, evaluator-blinded clinical trials or retrospective evaluator-blinded studies.
   • Total Subjects: 262 subjects across the identified studies.
     • Nevus of Ota: n=20
     • Café au lait macules (CALMs): n=32
     • Melasma: n=70
     • Lentigines: n=140
   • Data Provenance: Studies were conducted in the USA, UK, Asia (Thailand, China), and the Middle East (Israel). The studies appear to be retrospective and prospective clinical trials.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

   • The document mentions "evaluator-blinded" studies, implying assessments by experts, but it does not specify the number of experts or their qualifications used to establish ground truth for each specific study or the overall literature review. However, in the context of clinical trials for dermatological conditions, "evaluator-blinded" typically implies assessment by trained clinical personnel (e.g., dermatologists, physicians, or qualified study staff) who are blinded to the treatment arm or other study parameters to ensure unbiased evaluation of treatment outcomes.

3. Adjudication Method for the Test Set:

   • The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The use of "evaluator-blinded" suggests independent assessment, but the process for resolving disagreements or consolidating multiple evaluations is not detailed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done in the context of AI assistance. This device is a laser system, not an AI diagnostic device. The clinical studies described evaluate the effectiveness of the laser treatment itself.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Not applicable. This is a laser system, not an algorithm. Its performance is directly related to its physical operation and interaction with human tissue in a clinical setting, always with human involvement (a clinician operating the device).

6. Type of Ground Truth Used:

   • The ground truth was established through clinical evaluation of treatment outcomes by clinical investigators/evaluators (presumably physicians or trained medical staff).
   • For melasma, the "mean mMASI scores" (Melasma Area and Severity Index) were used, which is a standardized clinical assessment tool.
   • For other lesions, efficacy is implied by the reported treatment outcomes in the cited peer-reviewed literature.

7. Sample Size for the Training Set:

   • Not applicable. This is a laser device, not an AI system that undergoes training on a dataset. The "training" for such a device involves engineering design, manufacturing, and preclinical testing to ensure it meets performance specifications, followed by clinical studies to validate its safety and efficacy in humans.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. See point 7. The device's "performance" is based on its physical characteristics (wavelengths, fluence, pulse duration, spot size) and the clinical outcomes observed in human subjects.

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