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The Fotona OX Nd: YAG/KTP Laser System Family is indicated for incision, excision, ablation and vaporization of soft tissue for general dermatology.

Specific Indications:

1064 nm wavelength in Q-switched mode:

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

1064 nm wavelength in non- Q-switched mode:

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
• Photocoagilation and hemostasis of pigmented and vascular lesions, such as, but not limited to. port wine stains, hemaongiomae, warts, telangiectasiae, venus lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

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

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

The Fotona QX laser system family is based on the 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 flashlamps. After the cavity, 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 variable spot handpiece. Optionally, the KTP Nd: YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 mm or a 650 nm wavelength, correspondingly. Both lasers are used in non-contact mode. The user activates laser emission by means of a footswitch.

The Nd:YAG (1064 nm) laser can be operated in a Q-switched (nominal pulse duration 5-20 nsec) and in a non-Qswitched mode (nominal pulse duration 0.25 msec) of operation. The KTP: YAG (532 nm) laser with optional 585 nm and 650 nm wavelengths can be operated only in a Q-switched mode (nominal pulse duration 5-20 nsec).

In the O-switched mode, the Nd: Y AG (1064 nm) laser is capable of delivering up to 1.6 J of laser energy. Spot sizes available range from 2 to 8 mm.

In the non-Q-switched mode, the Nd: YAG (1064 nm) laser is capable of delivering up to 5 J of laser energy. Spot sizes range from 2 to 8 mm.

The frequency doubled Nd:YAG (532 nm) KTP laser delivers up to 0.6 J of laser energy in 5-20 nanosecond pulses. Spot sizes available range from 2 to 8 mm.

All three modes of operation are intended to be used for incision/excision, ablation, vaporization of soft tissue in general dermatology and for the indications for use as stated below.

The provided document is a 510(k) summary for the Fotona QX Nd:YAG/KTP Laser System Family. This type of submission to the FDA focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the way a clinical trial might for a novel device.

Instead, the core of this submission is a comparison to predicate devices, asserting that the new device shares similar indications for use, technical specifications, operating performance features, and general design features with already cleared devices.

Based on the provided text, here's an analysis of the requested information:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of a clinical study demonstrating effectiveness. The acceptance criteria for a 510(k) submission are typically related to demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.

The document lists the indications for use for the Fotona QX Nd:YAG/KTP Laser System Family (pages 5-6). These are the intended uses for which the device is considered substantially equivalent to predicates. The "performance" is implicitly deemed acceptable because it is similar to the performance of the predicate devices for the same indications.

• Treatment of nevus of Ota
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles | Deemed similar to predicate devices. |
  | 1064 nm non-Q-switched mode | - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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, hemangiomae, warts, telangiectasiae, venus lake, leg veins and spider veins
• Coagulation and hemostasis of soft tissue
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris | Deemed similar to predicate devices. |
  | 532 nm Q-switched mode | - 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 nevi
• Treatment of pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles. | Deemed similar to predicate devices. |

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 in the document. As a 510(k) submission based on substantial equivalence, there is no mention of a "test set" in the context of a new clinical study. The submission relies on the established safety and effectiveness of the predicate devices.

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 in the document. No specific "test set" requiring ground truth establishment by experts is mentioned, as this is not a de novo clinical trial.

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

This information is not provided in the document. No "test set" or adjudication method 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

An MRMC comparative effectiveness study is not mentioned in the document. This type of study is not relevant for a laser device submission focused on substantial equivalence to existing laser systems, nor does the device involve AI assistance.

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

This information is not applicable as the device is a laser system, not an algorithm, and the concept of "standalone performance" for an algorithm is not relevant here.

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

This information is not provided in the document. The submission is based on the previously established ground truth (safety and effectiveness) of the predicate devices for their respective indications.

8. The sample size for the training set

This information is not provided in the document. There is no mention of a "training set" as this is not an algorithm being developed or validated.

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

This information is not provided in the document. Not applicable for the reasons stated above.

In summary:

The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It does not contain the details typically found in a clinical study report or a submission for a novel device that requires de novo clinical validation. The "acceptance criteria" and "performance" are implicitly linked to the existing cleared status and indications for use of the specified predicate devices.

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1. Incision, excision, ablation, vaporization of soft tissue for general dermatology.
2. 532 nm wavelength:

• removal of light ink (red, tan, purple, and orange) tatoos, "
• removal of pigmented lesions, removal of vascular lesions,
• treatment of Lentigines, treatment of Cafe-Au-Lait,
• treatment of Common Nevi,
• treatment of Seborrheic Kearotoses,
• treatment of Post Inflammatory Hyperpigmentation.

3. 1064 nm wavelength:

• removal of dark ink (black, blue and brown) tattoos, -
• treatment of Nevus of Ota, -
• removal or lightening of unwanted hair, -
• treatment of Common Nevi. -
• skin resurfacing with or without adjuvant preparation --

The Fotona QX laser system is based on the 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 flashlamps. After the cavity, 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 lasers are used in non-contact mode. Both laser wavelengths share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Nd: YAG head or the KTP Nd: YAG laser wavelength. When the laser is first turned on the physician is able to select the desired wavelength via control panel. The Fotona QX laser system consists of: a) A high voltage power supply, which converts and rectifies the a.c. mains current 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 microprocessor based controller, which regulates the functions of both lasers and allows parameter selection by the user. d) The Nd: YAG laser head. e) The frequency doubling crystal. g) The optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

The provided text does not contain information about acceptance criteria or a study that specifically proves the Fotona QX Nd:YAG/KTP Laser System meets acceptance criteria. The document is a 510(k) premarket notification for the device, which aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with specific performance metrics and acceptance criteria.

Therefore, I cannot extract the requested information. The document focuses on:

• General Information: Company, contact, device trade names, classification.
• Device Description: Technical specifications of the laser system (Nd:YAG and KTP Nd:YAG wavelengths, energy delivery, spot sizes).
• Intended Use: Clinical applications for both 1064 nm and 532 nm wavelengths (e.g., tattoo removal, pigmented lesions, hair removal, skin resurfacing, soft tissue ablation).
• Summary of Substantial Equivalence: Comparison of the Fotona QX system's design features and intended uses to three predicate devices (Spectra-VRM, Medlite C6, and Palomar Q-YAG) to argue that it raises no new questions of safety or effectiveness.
• FDA Correspondence: Letter from the FDA granting substantial equivalence.
• Indications for Use Statement: Formal list of approved clinical applications.

The document lacks information on:

1. Acceptance Criteria Table: There is no table defining specific performance metrics and their acceptance thresholds.
2. Reported Device Performance: No clinical study results or performance data (e.g., efficacy rates, side effect profiles, a specific measure of "success" for tattoo removal or lesion treatment) are presented.
3. Sample Size and Data Provenance: No mention of test set sample sizes, country of origin, or whether any data was retrospective or prospective.
4. Number and Qualifications of Experts: No experts are mentioned as establishing ground truth for any test set.
5. Adjudication Method: Not applicable as no ground truth establishment is described.
6. MRMC Comparative Effectiveness Study: No such study is described, nor any effect size of AI assistance.
7. Standalone Performance: Not applicable as this is not an AI/algorithm-only device.
8. Type of Ground Truth: No ground truth (expert consensus, pathology, outcomes data) is mentioned as being used for any study.
9. Training Set Sample Size: Not applicable as this is not an AI/machine learning model where a training set would be used.
10. How Training Set Ground Truth Was Established: Not applicable.

This 510(k) submission is primarily a regulatory document demonstrating similarity to existing devices, not a scientific publication detailing a new clinical study.

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