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The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) 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 PICOSECOND Nd:YAG Laser System (PICO PREMIUM ) 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 532nm wavelength of the PICOSECOND Nd: YAG Laser System (PICO PREMIUM ) is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzparick skin types I-III.

The PICOSECOND Nd: YAG Laser System (PICO PREMIUM) is comprised of the Main Body which includes an optics laser generator, power supply, cooling system, operation panel, etc., and the Articulated Arm, Handpiece, Foot Switch, Protective Goggles, Power Supply Cord, etc. and by applying high voltage to the laser generator 1064nm and 532nm wavelength and emission wavelength of the laser, the maximum output is 5 00mJ. This device is comprised of an Optical Laser Generator (Optics), power supply, chiller, touch LCD panel and switching mode power supply, main control board, air pump, etc., and is operated by microprocessor software.

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 energy.

After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Foot Switch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. A cooling system controls the febrility caused by the laser output.

The provided text is a 510(k) summary for the PICOSECOND Nd:YAG Laser System (PICO PREMIUM). It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, the document does not describe a clinical study with human subjects, nor does it present acceptance criteria and performance metrics in the context of an AI/algorithm-based diagnostic or therapeutic device.

The "Performance Data (Non-clinical)" section (Page 6, Section 8) explicitly states that "All acceptance criteria were met," but these listed criteria are for engineering and safety standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993 for biocompatibility, and FDA guidance for software verification and validation). These are not performance metrics related to diagnostic accuracy, sensitivity, specificity, or the improvement of human reader performance, as would be expected for an AI-enabled device that requires such rigorous clinical validation.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/algorithm-based device and its clinical performance. The provided document concerns a laser system device that is evaluated against established safety, electrical, and biocompatibility standards, not an AI or algorithm that would undergo the type of performance evaluation you've outlined.

Based on the provided document, the following information is either not applicable or not available:

1. A table of acceptance criteria and the reported device performance: The acceptance criteria mentioned are engineering standards (e.g., IEC, ISO) and the document states they "were met." No specific quantitative performance data for the device's clinical effectiveness (e.g., in terms of tattoo removal efficiency or safety in human subjects against specific metrics) is provided in a comparative table.

2. Sample sizes used for the test set and the data provenance: No test set for clinical performance is described. The "test set" here refers to the engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical ground truth establishment is described.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not mentioned. The device is a laser system, not a diagnostic AI that would typically undergo such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable, as there's no mention of an algorithm 'training set'.

9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to demonstrate substantial equivalence to a predicate laser device based on technical characteristics and compliance with safety and performance standards, not clinical efficacy measured through a study design typically associated with AI/ML products.

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The IDS SHINY IPL system is intended for use in Surgical, Aesthetic applications in Dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV.

• Wavelengths: Conditions: 415nm - 950nm Acne, Vulgaris 560nm - 950nm Melasma, Ephelides 640nm - 950nm Acne, Hair Reduction 640nm - 1200nm Hair Reduction 695nm - 1200nm Hair Reduction 755nm - 1200nm Hair Reduction

The SHINY IPL System, using visible rays created by Xenon Lamp through Sapphire which are installed on Hand-piece, and composed Main board, LCD screen, Hand-piece, Cooling system. This device uses computer controlled power supply and filter to generate visible ray pulses of prescribed duration and intensity. This device also equipped the Cooling systems to maintain both the Treatment head / Systems at appropriate and safe temperatures. The visible ray pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the system. This system has two hand-pieces and each hand-piece has 3 wavelengths to choose from at the end of the Hand-piece there is a sapphire filter. Visible rays are emitted when the button is pressed.

The provided document is a 510(k) summary for the SHINY IPL System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not include detailed information on acceptance criteria for device performance studies or the specific studies conducted to prove the device meets these criteria in the context of clinical effectiveness or algorithm performance (e.g., studies involving human readers or standalone AI performance).

The "Summary of Performance and Safety Testing" section (Page 4, Section 7) broadly states:
"The SHINY IPL System performs as intended based on performance data provided in this submission.
Software: Verification and validation testing of the software confirm that the software version is appropriate for release.
Electrical Safety and Electromagnetic Compatibility: The SHINY IPL System has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2)."

This section focuses on general performance, software validation, and electrical safety/EMC, which are standard engineering and regulatory compliance tests. It does not refer to clinical studies or AI algorithm performance validation.

Therefore, I cannot extract the specific details requested in your prompt regarding acceptance criteria and performance studies related to clinical effectiveness, AI algorithm performance, human reader improvement, or ground truth establishment. The document suggests that the substantial equivalence determination for this IPL system is based on its similarity in design, operational features, and intended use to the predicate device, along with meeting general safety and performance standards, rather than specific clinical trial data demonstrating effectiveness against a predefined acceptance criterion for a medical outcome or AI accuracy.

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The SMAXEL (formally the MX-7000 MICROXEL) Fractional C02 Laser System is indicated for use in non-fractional mode is incision, excision, ablation, vaporization of human soft tissue. Intended for use in Dermatology, Plastic and General Surgery, Gynecology, Neurosurgery, and Podiatry.

When used in fractional mode, the SMAXEL Fractional C02 Laser System indications for use in ablative skin resurfacing, wrinkles, fine lines, rhylides, and furrows in Dermatology, Plastic and General Surgerv,

SMAXEL CO2 Surgical Laser System

This is a 510(k) clearance letter for the SMAXEL CO2 Surgical Laser System. It is an administrative document and does not contain the specific technical study details needed to answer your questions regarding acceptance criteria and performance data.

The letter confirms that the FDA has reviewed the device and determined it is substantially equivalent to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would include performance data, but that data is not part of this public letter.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: This letter does not specify any performance criteria or reported results.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not available in this document.
4. Adjudication method: Not available in this document.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not available in this document. This device is a surgical laser, not an AI diagnostic tool, so such a study would likely not be relevant.
6. Standalone performance: Not applicable in the context of a surgical laser as described here.
7. Type of ground truth used: Not applicable or available.
8. Training set sample size: Not applicable or available.
9. How the ground truth for the training set was established: Not applicable or available.

The document only states the device's indications for use and confirms its regulatory status. To find the detailed clinical and performance data, one would typically need to review the full 510(k) submission, which is generally not publicly available beyond a summary.

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The Q10 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 pigmented and vascular lesions, such as, but not limited 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 vascular lesions including, but not limited to:
• port wine birthmarks
• telangiectasias
• spider angioma
• cherry angioma
• spider nevus
• Treatment of 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 is a 510(k) premarket notification for a laser surgical instrument, and as such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for a novel AI or diagnostic device. Therefore, a direct response to your detailed questions regarding acceptance criteria and study design (as might be found for a new diagnostic algorithm) is not present in the provided document.

However, I can extract the relevant information from the document and explain why other requested details are not applicable here.

Here's a breakdown based on the provided text:

Pertaining to the Device:

• Trade/Device Name: Q-Switched Nd:YAG Laser System / IDS Model Q10 Q-Switched Nd: YAG Laser
• Regulation Number: 21 CFR 878.4810
• Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
• Regulatory Class: Class II
• Product Code: GEX

Analysis of your specific questions:

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

   • Not Applicable. This document is a 510(k) summary, which establishes substantial equivalence, not novel performance against specific acceptance criteria for a new diagnostic device. The device is a physical laser system, not an AI or diagnostic tool that would have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its performance is inherent in its physical specifications and intended use, which are deemed equivalent to a predicate. The "Indications for Use" section outlines what the device is cleared to do, not its diagnostic performance.

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

   • Not Applicable. As this is a 510(k) for a physical laser device, it doesn't typically involve a "test set" in the context of evaluating an AI or diagnostic algorithm. Clinical data to support the indications may have been generated, but the specific details of a test set, its size, and provenance are not outlined in this 510(k) clearance letter. The FDA's review for substantial equivalence generally focuses on technological characteristics, safety, and effectiveness compared to a predicate, which might include relying on established literature or predicate device's safety record rather than a new clinical study with a "test set" for performance evaluation.

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 "ground truth" establishment in the context of evaluating a diagnostic algorithm mentioned. The effectiveness of the laser for its stated indications (e.g., "removal of dark ink tattoos," "treatment of wrinkles") is generally supported by the predicate device's history and the understanding of laser-tissue interaction for these applications.

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

   • Not Applicable. No test set requiring expert adjudication is discussed in this document.

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 physical laser device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant here.

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

   • Not Applicable. This device is not an algorithm.

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

   • Not Applicable. As explained, the concept of "ground truth" as applied to evaluating a diagnostic algorithm doesn't apply to this type of device and submission. Efficacy is generally demonstrated by clinical observations and comparisons to predicate devices over time, rather than a single "ground truth" metric.

8. The sample size for the training set:

   • Not Applicable. Training sets are relevant for machine learning algorithms, which this device is not.

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

   • Not Applicable. This device does not have a training set or associated ground truth.

In summary, the provided document is a 510(k) clearance letter for a Q-Switched Nd:YAG Laser System, indicating that the FDA has determined it is substantially equivalent to legally marketed predicate devices. The nature of this submission (a physical device, not a diagnostic or AI product) means that the requested details regarding acceptance criteria, test/training sets, ground truth, and expert evaluations in the context of diagnostic performance are not applicable or provided within this type of regulatory document.

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