Search Results

[Indications for use of Q-switched Nd:YAG Laser]
1064 nm (including RTP 1064 mode):

• Incision, excision, ablation, vaporization of soft tissue for general dermatology
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Treatment melasma
• Treatment of Pigmented Lesions
• · nevus of ota
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Tattoo Removal
• dark ink: black, blue and brown

532 nm:

• Treatment of Vascular Lesions
• · port wine birthmarks
• · telangiectaias
• · spider angioma
• · cherry angioma
• · spider nevi
• Treatment of Pigmented Lesions
• · café-au-lait birthmarks
• · solar lentiginos
• · senile lentiginos
• · becker's nevi
• · freckles
• nevus spilus
• nevus of ota
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Tattoo Removal
• · light ink: red, sky blue, green, tan, purple, and orange

[Indications for use of FR mode in Nd:YAG Laser]

• Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
  [Indications for use of Ti:Sapphire Laser]
  785nm:
• Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
  *Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *

The flash lamp as a laser pumping source converts electric energy to light energy when a high voltage is applied. Nd:YAG crystal with the specific resonator emits an 1064nm single wavelength laser by absorbing light energy from the flash lamp. Q-switching mode is applied to the 1064nm laser resonator to amplify the 1064nm laser with about 10ns short pulse width.
The amplified O-switched 1064nm laser is secondarily amplified by an another Nd: YAG crystal and, then is converted to a second harmonic 532nm laser by passing through KTP crystal.
Finally a 785nm laser is emitted by the 785nm cavity with Ti:Sapphire crystal using the 532nm laser as a laser pumping source.
HELIOS 785 Pico Laser System can emit 1064nm, 532nm, and 785nm laser selectively by switching the wavelength conversion optical modules. The 1064nm laser is emitted by only Nd: Y AG crystal resonator and the 532nm laser can be emitted with the 1064nm laser and KTP crystal. The 785nm laser can be emitted by all optical modules.
The Q-switch mode normally produces polarized light, but it is also possible to set the FR(Free Running) mode, which emits light in all directions by removing the optics of the Q-switch module. Additionally, the RTP(Real Twin Pulse) mode can be set to generate two identical pulses with a very short interval instead of a single pulse.
The HELIOS 785 Pico laser system consists of:
a) A high voltage power supply, which converts and rectifies Alternating Current (AC) to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.
c) The micro processor based controller unit, which regulates the functions of both lasers and allows parameter selection by the user.
d) The Nd: YAG laser + Ti:sapphire laser head.

This document is a 510(k) summary for the HELIOS 785 Pico (1754V2) laser system. It describes the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain explicit acceptance criteria, performance data from a specific study to prove the device meets acceptance criteria, or details regarding ground truth establishment, expert adjudication, or sample sizes for training and test sets in the context of an AI/algorithm performance study.

The "Performance Data" section (page 13) refers to non-clinical tests for safety and performance according to consensus standards, but these are general engineering and safety standards for laser products, not typical performance metrics for an AI medical device like sensitivity, specificity, or accuracy derived from clinical data.

Therefore, many requested points cannot be extracted from the provided text.

Here is the information that can be extracted, with notes for the missing information:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document refers to non-clinical safety and performance tests against consensus standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, IEC 60601-1-6, IEC 60601-2-22) for the laser device itself, but it does not specify quantitative acceptance criteria or clinical performance metrics (like accuracy, sensitivity, specificity) for a specific medical indication, which would typically be included for an AI/algorithm-based device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document details the laser device's technical specifications and intended uses, but it does not mention a test set or data related to any clinical evaluation for performance.

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)

This information is not provided. As there's no mention of a test set or clinical performance evaluation, there's no information on experts for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This information is not provided. The document is for a laser surgical instrument, not an AI-assisted diagnostic or treatment planning system that would typically undergo an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. The device is a laser system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided.

8. The sample size for the training set

This information is not provided.

9. How the ground truth for the training set was established

This information is not provided.

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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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PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

This device consists of a power supply unit, a cooling system, a controller, and a laser resonator, and is controlled by a microprocessor. When electric energy pumping is applied to the flash lamp, the laser is emitted through a device laser module that oscillates a laser with a wavelength of 311mm, and the laser is radiated through the end of the optical fiber, which is a laser carrier.

The provided text is a 510(k) Summary for the PALLAS Premium device, a Solid-State Ultraviolet laser system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance studies typical for novel AI/ML medical devices.

Therefore, the information required to answer your prompt, specifically concerning acceptance criteria and detailed study performance (like MRMC studies, specific performance metrics, ground truth establishment for test/training sets, and expert qualifications for data annotation), is not present in the provided text.

The "Performance Data" section discusses compliance with various electrical safety, electromagnetic compatibility, laser safety, and software validation standards, but it does not include any clinical performance data or acceptance criteria related to the device's efficacy or accuracy in treating the specified conditions (psoriasis, vitiligo, atopic dermatitis, and leukoderma). The document asserts equivalency based on technical characteristics and intended use, implying that clinical performance is expected to be similar to the predicates.

This type of 510(k) submission generally relies on the established safety and effectiveness of the predicate devices. The device described, PALLAS Premium, is a physical laser system, not an AI/ML algorithm requiring studies to demonstrate diagnostic or prognostic accuracy.

If this were an AI/ML device, the detail you requested would be crucial for determining its clinical utility and safety. However, for a laser surgical instrument, the focus of the 510(k) submission is on demonstrating safety through adherence to recognized standards and technical similarity to legally marketed devices.

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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 (1064mm)
• Tattoo Removal (1064nm, 532nm)
• dark ink : blue and black (1064nm)
• · light ink : red, sky blue, green (532nm)
• Treatment of Vascular Lesions (532nm)
• · port wine birthmarks
• · telangiectaias
• · spider angioma
• · cherry angioma
• · spider nevi
• Treatment of 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)

• O-switched Nd: Y AG Laser and Ti:Sapphire Laser cannot be used simultaneously *

HELIOS IV 785 consist of a set of Q-switched Nd: YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm), and controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

This is a 510(k) premarket notification for the Laseroptek Co., Ltd. HELIOS IV 785, a laser surgical instrument for use in general and plastic surgery and in dermatology. The document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, the typical acceptance criteria and study design elements for AI/ML device performance are not applicable or described in this document.

The document does not describe the acceptance criteria and a study that proves a device meets them in the context of an AI/ML algorithm. Instead, it is a Premarket Notification (510(k)) for a medical device (a laser system), demonstrating substantial equivalence to already legally marketed predicate devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance for an AI device is not present in this document. The document focuses on the technical characteristics and intended use of the laser system.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Not applicable in the context of AI/ML performance. This document describes a laser system. The "performance data" section refers to compliance with safety standards and electrical/mechanical performance, not diagnostic accuracy or AI model performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. There is no mention of a test set, data (images/signals), or data provenance in the context of an AI/ML algorithm.

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. There is no discussion of ground truth establishment by experts for an AI/ML output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No test set or adjudication method is described for an AI/ML algorithm.

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 is a hardware device (laser system), not an AI/ML diagnostic or assistive device. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a laser system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable. There is no AI/ML component discussed that would require ground truth.

8. The sample size for the training set:

• Not applicable. No AI/ML training set is mentioned.

9. How the ground truth for the training set was established:

• Not applicable. No AI/ML training set or ground truth process is mentioned.

Summary of what the document does describe (relevant to device performance, but not AI performance):

The document details the technical characteristics of the HELIOS IV 785 laser system and compares them to two predicate devices (Helios III Q-Switched Nd:YAG Laser System and PicoWay Laser System) to demonstrate substantial equivalence.

Performance Data (Non-clinical tests mentioned):

The device underwent non-clinical testing to ensure compliance with various standards related to laser products, general safety, electromagnetic compatibility, usability, and biocompatibility.

• 21 CFR 1040.10 and 1040.11 (mandatory performance standards for laser products)
• IEC 60601-1:2005+A1:2012 (general requirements for basic safety and essential performance)
• IEC 60601-1-2:2014 (electromagnetic disturbances)
• IEC 60601-1-6:2010+AMD1:2013 (usability)
• IEC 60601-2-22:2019 (particular requirements for surgical, cosmetic, therapeutic and diagnostic laser equipment)
• IEC 60825-1:2014 (safety of laser products, classification and requirements)
• ISO 14971:2012 (risk management)
• IEC 62366:2008 (usability engineering)
• ISO 10993-5:2009 and ISO 10993-10:2013 (biocompatibility)

The "reported device performance" in this context is the successful evaluation and compliance with these non-clinical standards, which are considered sufficient to establish substantial equivalence for the safety and effectiveness of the laser device.

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PicoLO Premium is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064nm

The 1064nm wavelength of the PicoLO Premium is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

532nm

The 532nm wavelength of the PicoLO Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

PicoLO Premium is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Premium consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

Based on the provided text, the device in question is the PicoLO Premium, a multi-wavelength pulsed laser system intended for use in dermatology, general, and plastic surgery. The approval is based on a 510(k) submission, specifically demonstrating substantial equivalence to a predicate device, not through a clinical study that proves the device meets specific performance acceptance criteria in terms of accuracy or effectiveness in a typical AI/diagnostic device sense.

Therefore, the requested information regarding acceptance criteria and a study proving performance in the context of an AI/diagnostic device (e.g., sensitivity, specificity, MRMC study, expert ground truth) cannot be found in this document. This document focuses on demonstrating the substantial equivalence of the PicoLO Premium to a previously cleared laser system (PicoLO Nd:YAG Picosecond Laser System, K203491) based on technical characteristics and safety standards.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical tests demonstrating compliance with recognized safety and performance standards for laser products, not a study evaluating diagnostic accuracy or human reader performance.

Here's a breakdown of what can be extracted and what is missing based on the prompt:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Safety and Technical Performance – Not Clinical Efficacy):
The acceptance criteria are not presented in a table format with specific thresholds for clinical efficacy measures (like sensitivity or specificity). Instead, they are compliance with recognized consensus standards for laser devices. The "reported device performance" is that it was tested and found to be compliant with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This type of information is not provided in the document, as it describes a 510(k) clearance based on substantial equivalence to a predicate device, relying on non-clinical performance and safety testing, not a clinical trial with patient data.

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):
This information is not applicable/not provided. The "ground truth" here is compliance with engineering and safety standards, not clinical diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. No clinical ground truth adjudication process is described.

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:
This information is not applicable/not provided. This is not an AI-assisted diagnostic device, but a therapeutic laser system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. This is a physical laser device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission focuses on compliance with established international and FDA-recognized consensus standards for medical device safety, electrical performance, laser specific requirements, usability, and risk management. No clinical ground truth (like pathology or outcomes data) for efficacy is required for this type of 510(k) submission, as it relies on equivalence to a predicate device.

8. The sample size for the training set:
This information is not applicable/not provided. This is a physical laser device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:
This information is not applicable/not provided. As above, no training set for a machine learning model is involved.

Summary of the "Study" (Non-Clinical Testing for Substantial Equivalence):

The "study" in this context refers to non-clinical performance and safety testing to demonstrate that the PicoLO Premium is equivalent in terms of safety and effectiveness to the predicate device, PicoLO Nd:YAG Picosecond Laser System (K203491).

• Test Set: The device itself and its components were the "test set" for various engineering and safety evaluations. The "data" are the results of these tests (e.g., electrical measurements, laser energy output, adherence to design specifications).
• Data Provenance: The tests were conducted internally or by accredited labs as part of the manufacturer's (Laseroptek Co., Ltd.) regulatory submission process. The country of origin for the device manufacturing and testing would be South Korea, where the applicant is located. The process is inherently prospective as it involves creating a new device and then testing its compliance.
• Experts/Ground Truth Establishment: The "experts" involved are likely engineers and quality assurance professionals responsible for device design, manufacturing, and testing, ensuring compliance with the specified standards. The "ground truth" is defined by the technical specifications outlined in the consensus standards themselves, against which the device's performance is measured.
• Adjudication Method: Not applicable for this type of compliance testing.
• MRMC Study/Standalone AI Performance: Not applicable as it's not an AI device.

In essence, the document confirms that the PicoLO Premium underwent a series of technical and safety evaluations to ensure it meets the established benchmarks for laser surgical instruments and is substantially equivalent to its predicate device, rather than providing data from a clinical trial demonstrating its efficacy on a patient population.

Ask a specific question about this device

PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064nm

The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

532nm

The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd: YAG Picosecond Laser System consists of a set of O-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

Based on the provided document, the device in question is a PicoLO Nd:YAG Picosecond Laser System, and the document is a 510(k) summary for its premarket notification (K203491). This type of FDA submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through a full clinical trial with acceptance criteria for specific performance metrics like those for an AI/ML device.

Therefore, the document does not contain the acceptance criteria and study details typically associated with proving a device (especially an AI/ML device) meets specific performance metrics. Instead, it demonstrates performance by showing compliance with recognized standards and technical characteristics comparable to a predicate device.

Here's why the requested information cannot be fully provided from this document:

• This is not an AI/ML device: The PicoLO Nd:YAG Picosecond Laser System is a laser for surgical and aesthetic applications. It's a hardware device, not a software algorithm that performs diagnostic or prognostic tasks.
• 510(k) pathway: The 510(k) clearance pathway is about demonstrating substantial equivalence to a predicate device, not about establishing novel performance benchmarks. The performance data provided are primarily non-clinical (electrical safety, EMC, usability, risk management, biocompatibility, and laser safety standards), confirming the device's build quality and operation within established safety parameters, not its efficacy compared to a numerical performance target.
• No "acceptance criteria" in the AI/ML sense: The "acceptance criteria" for this device are its compliance with various consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, ISO 10993). There are no performance metrics like sensitivity, specificity, or AUC that would involve a test set, ground truth experts, or MRMC studies.

However, I can extract and present the
information that is available in the document, framed in the context of device safety and effectiveness as demonstrated for this type of medical device clearance:

Device Type: PicoLO Nd:YAG Picosecond Laser System (Hardware device, not AI/ML)
FDA Submission Type: 510(k) Premarket Notification (K203491)

Given that this is a 510(k) submission for a laser device (not an AI/ML product), the "acceptance criteria" and "study" are not presented in terms of AI/ML performance metrics (e.g., sensitivity, specificity, F1-score) or comparative effectiveness studies with human readers. Instead, the "acceptance criteria" are compliance with relevant safety and performance standards, and the "study" involves non-clinical testing to demonstrate this compliance and substantial equivalence to a predicate device.

Here's the relevant information from the document:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for a device cleared through the 510(k) pathway primarily relate to its compliance with recognized standards and its comparable performance to the predicate device. These are qualitative rather than quantitative performance metrics for a diagnostic algorithm.

2. Sample size used for the test set and the data provenance

• Test set sample size: Not applicable in the context of an AI/ML algorithm's performance study. The "testing" here refers to engineering and safety validation, not a clinical test set of patient data.
• Data provenance: Not applicable. The "data" are measurements from non-clinical laboratory tests and engineering evaluations of the device, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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 device is a laser system, not an AI assistance tool for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a hardware device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" equivalent for this device's clearance pertains to compliance with engineering standards and safety requirements.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires training data.

9. How the ground truth for the training set was established

• Not applicable.

Summary regarding this specific document:

This document is a 510(k) summary for a laser medical device. It demonstrates safety and effectiveness through compliance with recognized consensus standards and by showing substantial equivalence to a previously cleared predicate device and a reference device for new indications. It does not provide information relevant to the types of studies and acceptance criteria typically associated with AI/ML-based medical devices or comparative effectiveness studies involving human readers and AI assistance.

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The indication for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.

Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.

The provided text is a 510(k) Summary for a medical device, the PALLAS 308/311 Solid-State UV Laser System. It outlines the device's technical characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence for FDA clearance.

However, this document does not contain information about a study that proves the device meets specific acceptance criteria based on AI/algorithm performance, human reader improvement with AI assistance, or expert consensus on a test set. The performance data section refers to non-clinical tests (measurement of wavelength, output power, energy fluence) and compliance with various consensus standards related to electrical safety, electromagnetic compatibility, usability, risk management, and software validation for a laser system, not an AI-driven medical device.

Therefore, I cannot provide the requested information related to acceptance criteria and study details for an AI-driven device, as the provided document concerns a UV laser system and its substantial equivalence to a predicate device, based on engineering and safety standards, not AI-specific performance.

Specifically, the document does not mention:

• A table of acceptance criteria with reported device performance for an AI/algorithm.
• Sample sizes for a test set or data provenance for AI model validation.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods for a test set.
• A multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• The type of ground truth (e.g., pathology, outcomes data).
• Sample size for a training set or how its ground truth was established.

The "Performance Data" section details non-clinical tests of the laser's physical parameters and compliance with electrical and safety standards, which are typical for laser devices seeking 510(k) clearance via substantial equivalence.

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PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064nm

The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

532nm

The 532nm wavelength of the PicoLO laser system is indicated for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd: YAG Picosecond Laser System consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

This document describes the PicoLO Nd:YAG Picosecond Laser System, a device intended for surgical and aesthetic applications in dermatology and general and plastic surgery, specifically for tattoo removal.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for the device's performance in terms of clinical outcomes (e.g., percentage of tattoo clearance). Instead, it focuses on demonstrating substantial equivalence to a predicate device (PicoWay Laser System) through technical performance data and adherence to regulatory standards.

Therefore, the "acceptance criteria" are implied by the equivalency claims and adherence to safety and performance standards. The reported device performance is presented as compliance with these standards and technical specifications comparable to the predicate.

2. Sample size used for the test set and the data provenance:

The document focuses on non-clinical (engineering and regulatory standard) testing and explicitly states: "Non-clinical tests: Testing conducted on the PicoLO Nd:YAG Picosecond Laser System shows that it refers to the relevant mandatory performance standards for laser products..."

• Sample Size: The document does not specify a "sample size" in the context of human subjects or clinical data for performance testing. The "tests" described are related to the device itself and its compliance with engineering and safety standards (e.g., electrical safety, EMC, laser safety).
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based evaluations of the device's physical and electronic characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the submission relies on demonstrating substantial equivalence through technical testing and adherence to recognized consensus standards, rather than a clinical study requiring expert-established ground truth for a test set. The "ground truth" for the non-clinical tests is defined by the requirements of the standards themselves.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided and is not applicable to the non-clinical testing performed. Adjudication methods are typically used in clinical studies where human interpretation or assessment of an outcome is required.

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:

This is not applicable. The device is a laser system for tattoo removal, not an AI-assisted diagnostic or interpretative tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical laser system, not an algorithm, and its use inherently involves a human operator (a medical professional).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance data presented, the "ground truth" is established by adherence to and measurement against the requirements and specifications detailed in the cited FDA-recognized consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971, ISO 10993).

8. The sample size for the training set:

This is not applicable. There is no mention of a "training set" as the submission is for a physical laser device and its substantial equivalence, not a machine learning or AI-based product.

9. How the ground truth for the training set was established:

This is not applicable for the reasons stated above.

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The LOTUS III Multi-Pulsed Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

Laseroptek Co. Ltd.'s LOTUS III Pulsed Er:YAG Laser System is an Erbrium:YAG laser with a wavelength of 2940 nm. A set of Er: YAG lasers is controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

Based on the provided text, the device in question is the "LOTUS III Multi-Pulsed Er:YAG Laser System," which is a medical laser system. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria for a new AI/imaging device.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of AI performance metrics like sensitivity, specificity, human reader improvement, ground truth establishment, training sets, etc.) is not present in this type of regulatory submission for this particular device.

This document is for a traditional medical device (a laser system) and primarily relies on non-clinical performance testing and comparison of technical characteristics to predicate devices to establish substantial equivalence. It does not involve a study of the kind typically performed for AI-powered diagnostic devices that would have the specific performance metrics and study design details requested in your prompt.

Here's why the requested information cannot be found in the provided text:

• Device Type: This is a laser system (Er:YAG laser) for general and plastic surgery and dermatology. It is a physical medical device, not an AI/software device that analyzes images or data.
• Regulatory Pathway: This is a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or performance against new, specific clinical acceptance criteria through a full-scale clinical trial like a PMA, or a clinical validation study for an AI algorithm.
• Performance Data (Section 6): The "Performance Data" section explicitly states that "Non-clinical tests" were conducted, referring to compliance with mandatory performance standards for laser products (e.g., 21 CFR 1040.10 and 1040.11), electromagnetic compliance (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366), safety of laser products (IEC 60825-1, IEC 60601-2-22), risk management (ISO 14971), and biocompatibility (ISO 10993). These are engineering and safety standards, not clinical performance metrics for a diagnostic AI.
• Absence of Clinical Study Details: There is no mention of:
  • Sensitivity, specificity, AUC, or other diagnostic performance metrics.
  • Test sets, training sets, or data provenance (countries, retrospective/prospective).
  • Experts establishing ground truth, adjudication methods, or MRMC studies.
  • Standalone algorithm performance or human-in-the-loop improvement metrics.

In summary, as this document pertains to a traditional laser medical device obtaining 510(k) clearance, the requested details for AI/imaging device performance criteria and studies are not applicable and thus not present in the provided text.

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Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) port wine birthmarks (532 nm) telangiectasias (532 nm) spider angioma (532 nm) cherry angioma (532 nm) spider nevi (532 nm) cafe-au-lait birthmarks (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles, nevus spilus (532 mm) nevus of ota (1064 nm)

The Helios III laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. Three basic elements of operations are as follows: 1) A Nd:YAG crystal is used as a gain medium which produces a laser beam. 2) A resonator then amplifies the beam. 3) A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Nd–YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit. The regulation of laser output and repetition rate can be set by the user via GUI (Graphic User Interface) and controlled by microprocessor, which interfaces with the power supply.

The provided text is a 510(k) summary for the Helios III Q-Switched Nd:YAG Laser System. It is an FDA submission seeking substantial equivalence to existing predicate devices, not a study proving the device meets specific acceptance criteria through clinical or AI-driven performance metrics.

The document primarily focuses on bench testing and comparison of technical specifications and intended uses with predicate devices to demonstrate substantial equivalence, rather than providing the kind of performance data you are asking for regarding AI/human reader studies.

Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are not applicable (N/A) because this is not a submission for an AI/ML medical device or a clinical outcome study in the traditional sense you have described.

Here's a breakdown of the information that is available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide explicit "acceptance criteria" in the format of pass/fail thresholds for clinical or AI performance. Instead, it presents a comparison of the Helios III's technical specifications and intended uses against two predicate devices recognized as legally marketed. The "performance" is demonstrated by showing that these specifications are comparable to or within acceptable ranges of the predicates.

Table 1: Approved Indication of Uses for Helios III Predicate Devices (Comparative)

Table 2: Performance Specification Comparison with Predicate Devices (Comparative)

Regarding the Study:

The document states:

• Performance Data: "Non-clinical testing of Helios III included visual and mechanical inspection, electrical and mechanical safety testing, functional performance testing, etc., in bench. Some of these tests include visual inspection, earthbond testing, software testing, transit testing, leakage current testing and measurements. Test reports have been submitted."
• This refers to bench testing for safety and functional performance as a laser device, not a comparative clinical study or AI performance evaluation.

Specific Answers to Your Questions (based on the provided text):

2. Sample sizes used for the test set and the data provenance: N/A. This document describes non-clinical bench testing of a laser device, not performance on a test set of medical images or patient data. Data provenance (country, retrospective/prospective) is also N/A for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth establishment by experts is not described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A. No adjudication process for a test set is mentioned.
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: N/A. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A. For the bench testing, "ground truth" would be the engineering specifications and safety standards met by the device.
8. The sample size for the training set: N/A. This device does not involve a training set as it is not an AI/ML product.
9. How the ground truth for the training set was established: N/A. Not an AI/ML product.

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