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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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