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The PICO LEGEND Nd: Y AG Laser System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

-The 1064nm wavelength of the PICO LEGEND Nd: Y AG Laser System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).

-The 532mm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

This device comprises the main body, including the optics laser generator, power supply, cooling system, operation panel, articulated arm, handpiece, foot-switch, protective goggles, power supply cord, etc. Applying a high voltage to the laser generator generates 1064nm and 532nm laser emission wavelengths. The maximum output is 500mJ.

The optical laser generator (optics), power supply, chiller, touch LCD panel, switching mode power supply, main control board, air pump, etc., are operated by a microprocessor.

The Optical Laser Generator (Optics) is comprised of Nd: YAG Rod, which is the solid laser medium, Flash lamp for optical generation, various Reflector for optical transmission, etc., and permits high voltage in flash lamp connected with power supply and operates to generate laser. After turning on the device, once the Wavelength, frequency, Frequency, Spot Size, etc., have been set, press the Foot Switch in the READY state; the laser energy will be produced and transferred through the Articulated Arm and handpiece.

The provided document is a 510(k) Premarket Notification for the PICO LEGEND Nd:YAG Laser System. This document does not describe a study involving an AI/Machine Learning device. Instead, it focuses on demonstrating substantial equivalence of a laser medical device to a predicate device.

Therefore, the specific information requested in the prompt regarding AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, is not present in this document.

The document states:

• "9. Clinical Testing: No clinical testing provided." This explicitly indicates that no human subject studies were conducted to prove the device's efficacy or safety.
• The performance data section (Section 8) describes non-clinical testing related to electrical safety, EMC, usability, laser safety, and biocompatibility, as well as bench testing to confirm energy output specifications. It also mentions "Software Verification and Validation Testing" but this refers to traditional software engineering V&V, not AI/ML model performance evaluation against clinical ground truth.

In summary, this document is irrelevant to the request for information on an AI/ML device's acceptance criteria and performance study. The device is a laser system, and its clearance is based on substantial equivalence to a predicate device and compliance with applicable non-clinical performance standards.

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The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractionated mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry.

The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractionated mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

The BIOXEL CO2 Surgical Laser System is used in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry.

This equipment consists of main body, Articulated Arm, hand-piece, protective goggles, foot switch and power cable. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD screen, which facilitates operation of this equipment at user's convenience. The laser output is initiated with the foot switch.

The provided text is a 510(k) premarket notification for a medical device, the BIOXEL Fractional CO2 Surgical Laser System. This document outlines the device's characteristics, indications for use, and a comparison to predicate devices, but it does not contain the detailed information typically found in a scientific study that proves the device meets specific acceptance criteria.

Instead, the document focuses on regulatory compliance and demonstrating substantial equivalence to previously marketed devices. Therefore, I cannot construct the requested table and answer the study-specific questions as the necessary information is not present in the provided text.

Here's what I can extract and what is missing:

Information Present:

• Device Name: BIOXEL Fractional CO2 Surgical Laser System
• Indications for Use:
  • Non-fractionated mode: Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry.
  • Fractionated mode: Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.
• Predicate Devices: K111831 MX-7000 MICROXEL and K180036 SMAXEL.
• Summary of Performance Testing (General):
  • Software: Verification and validation testing confirm appropriateness for release.
  • Electrical Safety and Electromagnetic Compatibility: Tested per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
  • Biocompatibility: Established per ISO 10993-5.
• Conclusion: The device was found substantially equivalent to predicate devices.

Information NOT Present (which would be required to answer your questions):

• Specific Acceptance Criteria: The document mentions general performance (e.g., "performs as intended") and compliance with recognized consensus standards (electrical, EMC, biocompatibility). However, it does not list measurable acceptance criteria (e.g., "power output must be within +/- 5% of target," "ablation depth will be X mm +/- Y mm in Z tissue after N pulses," "complication rate not to exceed X%").
• Reported Device Performance against specific criteria: Without specific criteria, there are no reported performance values to compare against them.
• Details of the "Study" (if it can be called that in this context): The document refers to "testing" (software verification, electrical safety, biocompatibility) but not to a clinical or comparative performance study in the way typically discussed for AI/diagnostic devices.
• Sample Size (test set, training set): Not mentioned for any type of performance data.
• Data Provenance (country, retrospective/prospective): Not mentioned.
• Number of experts and their qualifications: Not applicable, as there's no mention of expert-derived ground truth or human reader studies.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported.
• Standalone (algorithm only) performance: Not applicable, as this is a physical laser device, not an AI algorithm.
• Type of ground truth used: Not applicable, as there's no diagnostic or predictive algorithm being evaluated in a clinical context.
• How ground truth for training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device, not a research paper detailing the performance of a diagnostic algorithm against specific clinical acceptance criteria. It affirms compliance with general safety and performance standards for market authorization but does not delve into the kind of detailed performance metrics you've requested.

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The Q-MASTER Q-Switched Nd:YAG Laser System is indicated for incision, ablation and vaporization of soft tissue for general dermatology.

1064nm wavelength in Q-switched mode:

• Removal of dark ink (black, blue and brown) tattoos
• Treatment of nevus of Ota
• Treatment of common nevus
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064nm wavelength in non Q-switched mode:

• Removal of unwanted hair, for stable long term, reduced hair growth when measured at 6, 9 and 12 months and for treatment of PFB (Pseudo Folliculitis Barbae). The laser is indicated for all skin types including tanned skin
• Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not linited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venous lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532nm wavelength in Q-switched mode (nominal delivered energy of 585nm and 650mm with the optional 585nm and 650nm dye hand-piece):

• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• Treatment of benign vascular lesions including, but not limited to:
• port wine birthmarks
• telangiectasias
• spider angioma
• cherry angioma
• spider nevus
• Treatment of benign pigmented lesions including, but not limited to:
• café-au-lait birthmarks
• solar lentigines
• senile lentigines
• Becker's nevus
• freckles
• common nevus
• nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles

Not Found

This document is a 510(k) clearance letter for the Q-MASTER Q-Switched Nd:YAG Laser System. It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on presenting specific performance metrics against pre-defined acceptance criteria in the format requested. The document lists the indications for use for the device, but it does not include a clinical study design, results, or acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving device performance based on the provided text.

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