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The Picosecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

• Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

• Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.

• Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The BL-C10 Picosecond ND:YAG Laser Systems is designed with a mains electricity (AC-powered) light amplification by stimulated emission of radiation (LASER) device assembly based on neodymium-doped yttrium-aluminium-garnet (Nd:YAG) and frequency-doubled Nd:YAG laser technology. The laser system generates ultra-short pulses in the picosecond range (1 picosecond = 10^-12 seconds). The pulses are then amplified within the Nd:YAG crystal. The system operates at two wavelengths: 1064nm and 532mm. These wavelengths are chosen to target different colors of pigments in tattoos and pigmented lesions.

• 1064nm Wavelength: Used for treating tattoos with colors like black, brown, green, blue, and purple, as well as for treating benign pigmented lesions.

• 532nm Wavelength: Used for removing tattoos with colors such as red, yellow, and for treating benign pigmented lesions. The ultra-short pulses have very high peak power, allowing them to interact with target (tattoos or pigmented lesions) in a precise and controlled manner. The short duration of the pulses helps minimize heat buildup in surrounding tissues.

I am sorry, but the provided text from the FDA 510(k) K240386 submission for the "Picosecond Nd: YAG Laser Systems (BL-C10)" does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.

The document primarily focuses on:

• Regulatory correspondence: FDA's substantial equivalence determination letter.
• Device description: Information about the Picosecond Nd:YAG Laser System (BL-C10), its wavelengths, and intended uses.
• Comparison to predicate devices: Discussion of technological similarities and minor differences between the BL-C10 and its predicates.
• Non-clinical testing: A list of international standards (IEC 60601-1, IEC 60601-1-2, etc.) that the device complies with, related to electrical safety and electromagnetic compatibility.
• Conclusion: Statement that the device is substantially equivalent to the predicate based on performance testing and validation studies which are not detailed in this public summary.

Specifically, the section "Non-Clinical and/or Clinical Tests Summary & Conclusions" states:

• "Non-Clinical Testing: A battery of tests was performed to verify that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards: [lists electrical safety and EMC standards]."
• "Clinical Testing: It is not applicable."

This clearly indicates that no clinical studies were performed or reported for this device in this submission, which means there would be no data on human-in-the-loop performance, standalone AI performance, or ground truth for such studies.

Therefore, I cannot fulfill your request for the information outlined in your prompt because the provided text does not contain it. The device in question is a laser system, not an AI/ML-driven diagnostic or therapeutic device for which such detailed performance study information would be typically found in a public 510(k) summary.

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[Indication for use of Q-switched Nd:YAG Laser]

• Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm)
• Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm)
• Tattoo Removal (1064nm, 532nm)
  dark ink : blue and black (1064nm)
  light ink : red, sky blue, green (532nm)
• Treatment of Benign Vascular Lesions (532nm)
  port wine birthmarks
  telangiectaias
  spider angioma
  cherry angioma
  spider nevi
• Treatment of Benign Pigmented Lesions (1064nm, 532nm)
  café-au-lait birthmarks (532nm)
  solar lentiginos (532nm)
  senile lentiginos (532nm)
  becker's nevi (532nm)
  freckles (532nm)
  nevus spilus (532nm)
  nevus of ota (1064nm)
  [Indication for use of Ti:Sapphire Laser]
  Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)
  Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously.

HELIOS 785 Pico consists of a Q-switched Nd:YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm). The device consists of a main body, color touch screen, articulated arm, foot switch and several handpieces, and is controlled by an embedded processor. The device uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis to achieve its intended purpose. It is for prescription use only.

The provided text is a 510(k) Premarket Notification submission for the HELIOS 785 Pico laser device. This document focuses on demonstrating substantial equivalence to existing predicate devices based on technical specifications and non-clinical testing, rather than presenting clinical study data to prove performance against specific acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the information requested in points 1-9 cannot be fully extracted or inferred from this document. This device is a laser surgical instrument, not an AI/SaMD, and its clearance pathway typically does not involve extensive clinical studies with human readers, ground truth consensus, or the specific types of performance metrics associated with AI algorithms.

Here's a breakdown of why the information is not present and what can be extracted:

Information Not Present in the Document:

• 1. Table of acceptance criteria and reported device performance (in the context of AI/SaMD): This document details technical specifications and non-clinical test validations (e.g., electrical safety, EMC, laser safety standards). It does not present acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or other measures typically used for AI/SaMD.
• 2. Sample size and data provenance for a test set: Not applicable as there's no clinical test set for AI performance. Non-clinical tests were conducted on the device itself.
• 3. Number of experts and qualifications for ground truth: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study or effect size for human reader improvement with AI assistance was performed or reported.
• 6. Standalone performance for an algorithm: Not applicable, as this is a hardware laser device, not a standalone algorithm.
• 7. Type of ground truth used: Not applicable.
• 8. Sample size for the training set: Not applicable, as there is no AI algorithm being trained.
• 9. How ground truth for the training set was established: Not applicable.

What can be extracted or inferred from the document:

• Device Type: Laser Surgical Instrument (specifically, a combination of Q-switched Nd:YAG and Ti:Sapphire lasers).
• Regulatory Class: Class II (Product Code: GEX).
• Indications for Use: Detailed for both Q-switched Nd:YAG Laser (incision, excision, ablation, vaporization of soft tissue; hair removal; tattoo removal of various colors; treatment of benign vascular lesions; treatment of benign pigmented lesions) and Ti:Sapphire Laser (removal of green and blue tattoos for Fitzpatrick skin types II-IV).
• Comparison to Predicate Devices: The submission is based on demonstrating substantial equivalence to the HELIOS IV 785 (K212663) as the primary predicate and PicoWay Laser System (K191685) as a reference predicate.
• Non-Clinical Testing: The document lists various non-clinical tests conducted to verify the device conforms to relevant mandatory performance standards and design specifications. These include:
  • IEC 60601-1:2005/A1:2012 (Medical Electrical Equipment General Requirements)
  • IEC 60601-1-2:2014 (Electromagnetic Compatibility)
  • IEC 60601-2-22:2012 (Specific Requirements for Laser Equipment)
  • IEC 60825-1: 2014 (Safety of laser products - Part 1: Equipment classification and requirements)
  • Biocompatibility evaluation per ISO 10993 and FDA guidance
  • Usability per IEC 60601-1-6 and IEC 62366
  • Risk management per ISO 14971
  • Software Validation & Verification Test
  • Bench Testing to verify the performance.
• No Clinical Study: The document explicitly states, "No clinical study is included in this submission." This indicates that the substantial equivalence determination for this device relies primarily on the demonstrated technical equivalence and non-clinical testing results, rather than clinical efficacy studies.

In summary, the provided document is a regulatory submission for a physical medical device (laser), not an AI/SaMD. Therefore, it does not contain the information typically associated with the acceptance criteria and study designs for proving AI device performance.

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