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The Medical 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 Medical Picosecond ND: YAG Laser System mainly consists of a host, a light guide arm, a treatment handle, a foot switch, a power cord, and other auxiliary treatment accessories. The host mainly includes laser power supply, laser, water circulation cooling system, control board, and display screen. Accessories include a foot switch, laser protective glasses, power cords, and a water filling funnel.

The Medical Picosecond ND: YAG 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).

I am sorry, but the provided FDA 510(k) clearance letter for the Medical Picosecond ND: YAG Laser System (PZ-6) does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "No clinical study is included in this submission." (Page 11, Section 8.0 Clinical Test Conclusion)
• The "Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device." (Page 11, Section 7.0 Non-Clinical Test Conclusion) These non-clinical tests relate to compliance with various IEC and ISO standards for medical electrical equipment, laser safety, and biocompatibility, as well as software validation. These are not performance acceptance criteria for the intended use (tattoo and lesion removal) in the way you are asking.

Therefore, I cannot provide the detailed information requested in your prompt as it is not present in the provided text.

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The Reepot laser system is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

532nm Wavelength :

• Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Treatment of Lentigines
• Treatment of Cafe-Au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyper-Pigmentation
• Treatment of Becker's Nevi, Freckles and Nevi Spilus

The reepot Nd;Y AG laser system is comprised of the following major components:

• 1. Laser system console
• 2. LCD control panel
• 3. VSLS handpieces (included camera and LCD display)
• 4. Footswitch.
• 5. Accessories

This document is a 510(k) premarket notification for a laser surgical instrument, the reepot Nd:YAG laser system. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data for acceptance criteria against a specific medical condition. Therefore, the detailed information requested regarding clinical effectiveness studies, such as the use of test sets, expert adjudication, MRMC studies, or standalone algorithm performance, is not available in this document.

The document primarily addresses safety and technical equivalence, rather than clinical performance acceptance criteria.

However, I can extract the relevant information that is available:

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

The document doesn't provide specific quantitative "acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. Instead, it demonstrates technical performance and safety compliance by comparing its specifications to a predicate device and adhering to recognized standards.

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

• Not Applicable. No clinical test set data is presented in this 510(k) submission. The submission states, "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission."

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

• Not Applicable. No clinical test set and thus no ground truth established by experts is mentioned.

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

• Not Applicable. No clinical 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:

• Not Applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or is relevant to this submission.

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

• Not Applicable. This device is a laser surgical instrument, not an algorithm.

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

• Not Applicable. As no clinical studies were performed for this submission, no ground truth data from such studies is provided. The "ground truth" for this submission revolves around demonstrating that the device's technical specifications and intended use are substantially equivalent to a legally marketed predicate device, and that it adheres to relevant safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).

8. The sample size for the training set:

• Not Applicable. This submission is for a physical medical device (laser system), not a machine learning or AI model that requires a training set.

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

• Not Applicable. No training set for an AI/ML model is involved.

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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 PicoSecond Nd: YAG Laser System is a Nd: YAG solid state laser, which can deliver the energy at picosecond pulse bursts to the skin. The system is composed of laser generator, articulated arm, handpence, laser power supply, cooling system, display and control system.
The PicoSecond Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system.

The provided text is a 510(k) summary for the PicoSecond Nd: YAG Laser System. It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing. Crucially, it explicitly states "Clinical Testing: It is not applicable." This means that there was no clinical study conducted to prove the device's performance against specific acceptance criteria.

Therefore, I cannot provide the information requested in the prompt, as the provided document indicates that no such study was performed or needed for this 510(k) clearance.

Specifically, the following information cannot be extracted because no clinical study was conducted:

1. A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
2. Sample sized used for the test set and the data provenance: No test set due to the absence of a clinical study.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: "It is not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical laser system, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as this refers to training data for AI/ML models, which is not relevant here.
9. How the ground truth for the training set was established: Not applicable.

The document focuses solely on non-clinical testing to demonstrate substantial equivalence, specifically mentioning:

• Electrical safety and electromagnetic compatibility: Tested against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
• Performance characteristics: Implied through comparison of technical specifications with predicate devices (e.g., wavelengths, pulse energy, pulse duration, repetition rate, spot size). The conclusion states that the maximum pulse energy of the proposed device, while higher than one predicate and lower than another, "can be considered that the propose device can achieve its intended use and is safety." This is a declarative statement based on engineering comparison and non-clinical safety/performance tests, not clinical trial data.

In summary, for this particular 510(k) submission, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" were based on a comparison to legally marketed predicate devices and a battery of non-clinical, bench and lab-based engineering tests to ensure safety and performance equivalence, rather than a clinical trial.

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The Q-Switched Nd: Y AG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, incision, ablation, vaporization of soft tissue for general dermatology as follows:

532nm wavelength (nominal delivered energy of 585nm and 650mm with optional dye handpiece):

• Removal of light ink (red, sky blue, green, purple, and orange) tattoo
• Treatment of benign vascular lesions including, but not limited to: telangiectasias,
• Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses
• Treatment of Post Inflammatory Hyper-Pigmentation

1064nm wavelength:

• Removal dark ink (black, blue and brown) tattoo
• Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.

The Q-Switched Nd: YAG Laser System is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator, articulated arm, laser power supply, cooling system, display and control system,foot switch and others accessories.

The Q-Switched Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that concert the 532nm wavelength to 585nm and 650nm.

The Q-Switched Nd: YAG Laser System includes two models: HS-290K and HS-290EK.

I apologize, but the provided text from the FDA 510(k) summary for the Q-Switched Nd: YAG Laser System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based diagnostic AI.

Here's why and what the document does discuss:

• Device Type: The document describes a Q-Switched Nd: YAG Laser System, which is a physical laser device used for various dermatological and surgical applications (tattoo removal, pigmented lesions, etc.). It is not an artificial intelligence (AI) software or diagnostic imaging device.
• "Acceptance Criteria" in this context: For a physical medical device like a laser, "acceptance criteria" primarily refer to meeting technical specifications (e.g., laser power output accuracy, wavelength precision, pulse duration, electrical safety standards, electromagnetic compatibility). These are shown in the "VII Non-Clinical Testing" section by compliance with IEC standards.
• No AI Study: Since this is not an AI/software device, there is no discussion of:
  • A table of acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
  • Sample sizes for test sets or data provenance for AI validation.
  • Number of experts, qualifications, or adjudication methods for AI ground truth.
  • MRMC studies for human reader improvement with AI assistance.
  • Standalone algorithm performance.
  • Ground truth types like pathology or outcomes for diagnostic AI.
  • Training set details for an AI model.

The document explicitly states under "VIII Clinical Testing": "It is not applicable." This means that for the purposes of this 510(k) submission and establishing substantial equivalence for this laser device, a formal clinical study (which would be where you'd typically find performance data against clinical endpoints or, in the case of diagnostic AI, against expert ground truth) was not required by the FDA. The submission relies on non-clinical testing showing compliance with recognized standards and a comparison of technological characteristics to a predicate device.

Therefore, I cannot extract the information you requested based on the provided text. The questions are highly relevant for diagnostic AI medical devices, but the provided document describes a therapeutic laser device.

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755nm

The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser is indicated for temporary hair reduction.

Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains,

hemangiomas, telangiectasias).

1064nm

The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re growing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on 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, hemangioma, warts, telangiectasia, rosacea. Venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis. nevi, chloasma, verrucae, skin tags, keratos (signi flcant reduction in the intensity of black and/or blue-black tattoos) and plaques.

The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

The Nobleen Long pulsed Alexandrite & Nd: Y AG Laser System contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 mm, respectively. The output of each laser head is 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 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Rapid Cooling System (RCS) protects the upper layers of the skin with a cooling burst of cryogen.

The provided text describes the regulatory clearance of the "Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System" by the FDA. However, it explicitly states that no clinical studies were needed or performed to support this 510(k) Premarket Notification because of the device's substantial equivalence to a legally marketed predicate device (Candela GentleMax Family of Laser Systems K133283).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as these elements are typically part of clinical validation studies, which were not conducted for this specific device clearance.

The document focuses on non-clinical performance data to establish substantial equivalence, primarily through bench testing, electrical safety, electromagnetic compatibility (EMC), and software verification.

Here's what the document does provide in relation to "acceptance criteria" and "device performance" in the context of a 510(k) without clinical studies:

1. A table of pseudo-acceptance criteria (based on equivalence to predicate) and reported device performance:

• Same maximum delivered energy.
• Similar spot size.
• Identical 1000 µ optical fiber handpiece delivery system.
• Similar operating principles.
• Both use a short burst of cryogen spray (Rapid Cooling System - RCS) for skin cooling. Bench testing confirmed performance specifications were "identical to the predicate device" and that the Nobelenn system performs "according to specifications and functions as intended." |
  | - Software Performance | - Software verification testing conducted; results found acceptable for software release, performed per FDA guidance ("Guidance for the Content of Premarket Submission for Software Contained in Medical Devices"). |

Remaining points (2-9) cannot be answered from the provided text as they relate to clinical studies that were explicitly stated as not performed:

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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 laser system, not an AI diagnostic device, and no clinical studies were performed.
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 AI diagnostic device, and no clinical studies were performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical ground truth was established as no clinical studies were needed.
8. The sample size for the training set: Not applicable. No training set for clinical data was mentioned as no clinical studies were needed.
9. How the ground truth for the training set was established: Not applicable.

In summary, the FDA clearance for the "Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System" relied on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing and compliance with recognized standards, rather than new clinical efficacy or safety studies.

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Long pulse Nd:YAG Laser System is intended for use for :
• Benign pigmented lesions such as but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, sebortheic karatoses, nevi, chloasma, verucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques.
• Pigmented lesions to reduce lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The Long Pulse Nd:YAG Laser System is a flashlamp-excited, Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) laser system. Pulsed laser energy at a nominal wavelength of 10641m. This wavelength causes maximum energy absorption by targeting the treatment area and minimum absorption by surrounding skin structures. In addition, the laser pulse duration is controlled to be equal to or shorter than the thermal relaxation time of the target, to minimize heat transfer to surrounding tissues.
Deeper penetration and a more moderate hemoglobin absorption makes 1064 nm wavelength more useful for the deeper hair follicles and vessels. Further, with the right combination of parameters, the 1064 nm wavelength is also suitable for more superficial hair, telangiectasia and spider veins.
Base on this, Long Pulse Nd: Y AG Laser System is intended for 1) Benign pigmented lesions such as ,but not limited to , lemtigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss (significant reduction in the intensity of black and/or blue black tattoos) and plaques. 2) Pigmented lesion size, for patients with lesions that would potiently benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. 3) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Nd: Y AG Laser System consists of control system, user interface, power source , laser emission and delivery system, cooling system and safety features

The provided document is a 510(k) summary for a medical device called "Long Pulse Nd:YAG Laser System." It's a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document focuses on comparing the new device to existing ones rather than detailing a clinical study with acceptance criteria and device performance in the way a clinical trial report would.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in this 510(k) summary.

Here's what can be extracted and inferred from the document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics. The document focuses on showing substantial equivalence in intended use, technological characteristics, and principles of operation to a predicate device.
• Reported Device Performance: No clinical performance metrics (e.g., success rates, lesion reduction percentages, complication rates) are reported. The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." This implies performance was deemed acceptable if it matched the predicate's capabilities or standards, but specific numbers are absent.

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

• Sample Size for Test Set: Not applicable. This document refers to non-clinical tests (electrical safety, EMC, laser safety standards) and a comparison to a predicate device, not a human clinical test set.
• Data Provenance: Not applicable for a clinical test set. The non-clinical tests were presumably conducted by the manufacturer, Advanced Technology Laser Company, Ltd., based in Shanghai, China.

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)

• Number and Qualifications of Experts: Not applicable. No human expert-adjudicated ground truth data is presented.

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

• Adjudication Method: Not applicable. No human test set requiring adjudication 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a laser system, not an AI or diagnostic imaging device that would typically involve human readers interpreting results.

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

• Standalone Performance: Not applicable. This is a physical laser device, not a software algorithm.

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

• Type of Ground Truth: Not applicable for clinical performance. The "ground truth" for the non-clinical tests refers to compliance with established international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This a physical laser system, not an AI/machine learning device that would require or report a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of Information from the Document:

While the document does not contain the specific information requested, it does provide key details about the device and its regulatory submission:

• Device Name: Long Pulse Nd:YAG Laser System (Trade Name: SmoothTouch)
• Manufacturer: Advanced Technology Laser Company, Ltd. (Shanghai, China)
• Regulatory Number: K140249
• Intended Use:
  • Treatment of benign pigmented lesions (lentigos, solar lentigos, café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos - significant reduction in black/blue-black intensity, and plaques).
  • Reduction of pigmented lesion size for aggressive treatment or non-responsive lesions.
  • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is integral.
• Predicate Device: Gentle YAG Laser System (Candela Corporation), K022923
• Technological Characteristics Comparison (Proposed vs. Predicate):
  • Product Code: GEX (SAME)
  • Regulation Number: 21CFR 878.4810 (SAME)
  • Intended Use: SAME
  • Energy Source: ND:YAG Laser (SAME)
  • Waveform: 1064 nm (SAME)
  • Fluence energy range: up to 600J/cm2 (SAME)
  • Spot size: 1.5mm, 3mm, 8mm, 10mm, 12mm and 3mm*8mm (SIMILAR)
  • Aiming laser: 510nm diode laser (

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• · Tattoo Removal
• · Treatment of Vascular Lesions
• · Treatment of Pigmented Lesions,
• · Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

1064nm:
Tattoo Removal: Dark ink: blue and black
Treatment of Pigmented Lesions: Nevus of ota

532nm:
Tattoo Removal: Light ink: red, Light ink: sky blue and green
Treatment of Vascular Lesions: Port wine birthmarks, Telangiectasias, Spider angioma, Cherry angioma, Spider nevi
Treatment of Pigmented Lesions: Café-au-lait birthmarks, Solar lentiginos, Senile lentiginos, Becker's nevi, Freckles, Nevus spilus

The Nd: YAG Laser System is based on the Q-Switched Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser is activated by means of the use of flashlamp. A red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing handpiece.

Both laser wavelengths share a common power supply, control system, and cooling system. The internal microprocessor can be directed to select either the Nd:YAG or the KTP Nd:YAG laser wavelength. The physician is able to select the desired wavelength and the related output energy ,spot size ,fluence via control panel.

The provided text describes a 510(k) premarket notification for the Nd: YAG Laser System (Qmetrx 1000 (Victory 11)) and assesses its substantial equivalence to predicate devices. However, it does not include information about specific acceptance criteria related to device performance in a clinical context (e.g., efficacy rates for tattoo removal, lesion clearance), nor does it detail a study proving the device meets such criteria through clinical endpoints.

Instead, the document focuses on non-clinical testing to ensure safety and compliance with recognized standards.

Here's an analysis of the provided information, addressing your questions based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no specific performance acceptance criteria (e.g., target percentages for lesion clearance or tattoo fading) or a report of the device's clinical performance against such criteria. The "Testing" section focuses on compliance with international safety and electrical standards.

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

The document explicitly states: "No Clinical Information is required." Therefore, there was no clinical test set in the traditional sense of patient data. The testing mentioned refers to laboratory testing for safety and design specifications. There is no information about data provenance (country of origin, retrospective/prospective) for a clinical test set because none was used.

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

As no clinical test set was used, no experts were utilized to establish ground truth for a clinical test set. The grounding of the device's safety and effectiveness relies on compliance with engineering standards and comparison to previously approved predicate devices by the FDA.

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

Not applicable, as no clinical test set was used.

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-based diagnostic or assistive tool for human readers. No MRMC study was performed.

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

Not applicable. This is a physical medical device (laser system), not a software algorithm.

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

For the non-clinical testing, the "ground truth" was established by adherence to the specified international and national safety and performance standards (e.g., IEC 60825-1, IEC 60601 series, UL 60601-1). The device's "effectiveness" from the perspective of this 510(k) is primarily established through its substantial equivalence to the predicate devices, which means it shares similar indications for use, design, and functional features, implying similar efficacy outcomes based on the predicate's established history.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no mention of a training set.

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Intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic, laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonarythoracic surgery, podiatry and urology for surgical and aesthetic applications.

For intended use in Dermatology for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions, such as warts, scars and striae. Also intended for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

For intended use on all skin types (Fitzpatrick I-VI), including tanned skin.

For intended use in Podiatry for the ablation, vaporization, incision, excision, and coagulation of soft tissue, including Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.

For intended use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).

The FREEDOM Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the FREEDOM Laser System and contains the Nd: YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the LCD display.

The provided document, a 510(k) summary for the Lutronic Corporation FREEDOM Laser System, explicitly states "Performance Data None presented." Therefore, based solely on the provided text, there is no study described that proves the device meets acceptance criteria, nor are there any acceptance criteria defined within this document.

Consequently, I cannot fill out the requested table or answer the specific questions related to a study's methodology, sample sizes, expert involvement, or comparative effectiveness.

Without any performance data or acceptance criteria detailed in the submission, the table would be empty for the "Acceptance Criteria" and "Reported Device Performance" columns. All other points requesting information about a study would also be unanswerable from the provided text.

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Fotona XP Nd:YAG Laser System Family and its accessories are intended for use in the following procedures:

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

• Matrixectomy ー
• Radical nail excision -
• Periungual and subungual warts ー
• Plantar warts l
• Neuromas -
• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes ー Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

The Fotona XP Nd:YAG Laser System Family is based on thè Nd:YAG (1064 nm) laser technology. There is one optical cavity containing the Nd: YAG crystal. The Nd: YAG laser is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial bcam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by an optical fiber delivery system to an optical handpiece. Optionally, the laser beams can be guided through fiber having SMA905 connector on the proximal end and bare fiber on distal end. The user activates laser emission by means of a footswitch.

The Nd: YAG (1064 nm) laser can be operated with variable pulse durations in the range of 0.1-50 msec, with repetition rates up to 100 Hz and laser pulse energies up to 20 J. Depending on the type of treatment, the user can choose between a PULSE mode user interface, and a QCW (Quasi-Continuous Wave) mode user interface. The laser operation is the same for both modes, the difference is only in the laser parameters that can be directly selected from the keyboard.

The provided text describes a 510(k) premarket notification for the Fotona XP Nd:YAG Laser System Family. This is a submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a de novo submission that would typically involve a detailed clinical study with specific acceptance criteria and performance data.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (Cutera GenesisPlus and PinPointe FootLaser) based on:

• Identical technological and similar design characteristics.
• Similar indications for use.
• Comparable technical characteristics (e.g., laser source, wavelength, output mode, energy per pulse, pulse width, repetition rate, output power, beam delivery, spot sizes).

The table provided in the document is a comparison table of technical characteristics between the Fotona XP Nd:YAG Laser System Family and its predicate devices, not a table of acceptance criteria and reported device performance against those criteria.

To directly answer your request based on the provided text, the following information is NOT available:

• 1. A table of acceptance criteria and the reported device performance: This is not present. The document compares technical specifications to predicate devices.
• 2. Sample size used for the test set and the data provenance: Not applicable to this type of submission.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a surgical laser, not an AI algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The submission aims to show that the new device operates similarly and for the same intended uses as previously cleared devices, hence "substantially equivalent," without needing a new clinical trial to establish safety and effectiveness from scratch.

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Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology. Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:

• 1064 nm wavelength
• Tattoo Removal (dark ink: blue and black)
• Dermal Pigmented Lesions
• Nevus of Ota
• Removal or lightening of hair with or without adjuvant preparation.
• Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece)

• Tattoo removal (light ink: red, sky blue, green)
• Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
• Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus
• Skin Resurfacing for Acne Scars and Wrinkles
• Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength)
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor consists of a electrically powered Console in which laser energy produced within the system is delivered to the tissue by means of an articulated arm, Handpiece Adaptor and specially designed Handpieces. The user activates laser emission by means of a footswitch.

The provided 510(k) Premarket Notification for the Handpiece Adaptor RevLite Q-Switched Nd:YAG Laser System does not contain any information about acceptance criteria or a study proving the device meets said criteria.

Instead, the document focuses on establishing substantial equivalence to a predicate device (RevLite Q-Switched Nd:YAG Laser System with LCD, K083899). The key statement regarding performance is:

"The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor is comparable to its parent predicate device (RevLite Q-Switched Nd:YAG Laser System with LCD) in terms of its intended use, indications for use, technical specifications, operating performance features, and general design features."

Furthermore, it explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

This means that the submission relies entirely on the established safety and effectiveness of the predicate device, arguing that the new Handpiece Adaptor does not change the fundamental performance characteristics of the laser system. Therefore, I cannot extract the requested information as it is not present in the provided text.

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