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The StarWalker Laser System Family is indicated for:

1064 nm wavelength in Q-switched mode:

-Removal of dark (black, blue, brown) tattoo ink

-Treatment of nevus of ota

-Treatment of common nevi

-Removal and lightening of unwanted hair

-Skin resurfacing procedures for the treatment of acne scars and wrinkles

-Treatment of melasma

-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

1064 nm wavelength in long pulse 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 benign pigmented and benign vascular lesions, such as, but not limited to,

port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins

-Coagulation and hemostasis of soft tissue

-Treatment of wrinkles

-Treatment of mild to moderate inflammatory acne vulgaris

1064 nm wavelength in PICO mode:

-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple

-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV

-Treatment of acne scars in Fitzpatrick Skin Types II-V

-Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV

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

-Red, tan, purple and orange tattoo ink removal

-Sky blue (light) tattoo ink removal

-Green tattoo tattoo ink removal

-Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus

-Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi

-Seborrheic Keratosis

-Treatment of post-inflammatory hyperpigmentation

-Skin resurfacing procedures for the treatment of acne scars and wrinkles

-Removal of epidermal pigmented lesions

532 nm wavelength in long pulse mode:

-Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

-The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

532 nm wavelength in PICO mode:

-Tattoo removal in Skin Types I - III

-Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV

The Fotona StarWalker Laser System Family is based on the previously cleared Fotona StarWalker Laser System Family (K171227).The device 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: Y AG 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 nm or a 650 nm wavelength, correspondingly. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size.

The provided text is a 510(k) premarket notification for a medical device, specifically a laser system. It details the device's indications for use, technological characteristics, and comparison to predicate devices, along with the non-clinical tests performed.

However, the document states "Clinical Summary: Not Applicable." This means that no clinical studies were performed, and therefore, there is no information regarding acceptance criteria for device performance based on human reader studies, an AI algorithm's standalone performance, ground truth establishment, or sample sizes related to clinical data.

The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and adherence to relevant safety and performance standards (EN, IEC, ISO).

Therefore, I cannot provide the requested information, particularly points 1 through 9, as they pertain to clinical studies that were explicitly stated as "Not Applicable" in this submission.

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The StarWalker Laser System Family is indicated for:

Specific Indications:

1064 nm wavelength in Q-switched mode:

• Removal of dark (black, blue, brown) tattoo ink l
• Treatment of nevus of ota -
• Treatment of common nevi -
• Removal and lightening of unwanted hair —
• Skin resurfacing procedures for the treatment of acne scars and wrinkles —

1064 nm wavelength in long pulse 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 benign pigmented and benign vascular lesions, । such as, but not limited to,
  • port wine stains, ।
  • hemaongiomae,
  • warts.
  • telangiectasiae, —
  • rosacea. -
  • 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 nm dye converter handpieces):

• Red, tan, purple and orange tattoo ink removal -
• Sky blue (light) tattoo ink removal -
• Green tattoo tattoo ink removal -
• Treatment of benign pigmented lesions including, but not limited to: —
  • cafe-au-lait birthmarks
  • solar lentigines -
  • senile lentigines
  • senile lentigines -
  • Becker's nevi —
  • freckles
  • common nevi -
  • nevus spilus

Treatment of benign vascular lesion including, but not limited to:
- port wine birthmarks
- । telangiectasias
- spider angioma -
- cherry angioma
- spider nevi ।

• Seborrheic Keratosis -
• Treatment of post-inflammatory hyperpigmentation -
• -Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Sky blue (light) tattoo ink removal
• -Green tattoo tattoo ink removal

532 nm wavelength in long pulse mode:

• The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

The Fotona StarWalker 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 nm or a 650 nm wavelength, correspondingly. Both lasers are used in non-contact mode. The user activates laser emission by means of a footswitch.

This document is a 510(k) premarket notification for the Fotona StarWalker Laser System Family. 510(k) submissions demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of regulatory submission.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

No explicit "acceptance criteria" table with corresponding "reported device performance" is provided in the context of a clinical study for this 510(k) submission. Instead, the document establishes substantial equivalence by comparing the technological characteristics of the StarWalker Laser System Family to predicate devices. The "performance" is considered equivalent if the technological characteristics are similar and the intended uses are the same.

The document provides tables of technical specifications for the Nd:YAG laser and Nd:YAG KTP laser of the StarWalker, comparing them to predicate devices (Tables A and B on pages 6-7). These tables outline various technical parameters such as:

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

• No clinical test set information is provided. The document explicitly states: "No clinical testing was needed." (Page 8). This is typical for a 510(k) submission where substantial equivalence is demonstrated through technological comparison and adherence to standards, rather than new clinical trials.

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 testing was performed, there was no test set requiring ground truth established by experts.

4. Adjudication method for the test set:

• Not applicable. 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:

• No. This is not an AI-enabled device. This is a laser system for dermatological and surgical applications.

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

• No. This is not an AI-enabled device.

7. The type of ground truth used:

• Not applicable for clinical efficacy. For regulatory clearance, the "ground truth" used for this 510(k) submission is the established safety and efficacy profiles of the predicate devices. The StarWalker system aims to demonstrate that its technical specifications and intended uses are substantially equivalent to these already-cleared devices, implying a similar safety and efficacy profile. "Ground truth" in this context would implicitly refer to the validated performance of the predicate devices.

8. The sample size for the training set:

• Not applicable. No training set for an algorithm was used as this is not an AI-enabled device and no clinical studies were performed.

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

• Not applicable.

Summary of the Study (or lack thereof) for this 510(k) Submission:

The Fotona StarWalker Laser System Family received 510(k) clearance based on demonstrating substantial equivalence to existing legally marketed predicate devices, not through a formal clinical comparative effectiveness study against specific acceptance criteria.

The "study" or evidence provided is primarily:

• A detailed description of the device's technological characteristics.
• A comparison of these characteristics to those of three predicate devices (Fotona QX ND:YAG/KTP Laser System Family (K083889), Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939), and Fotona Dynamis Pro Family (K143723)).
• A statement that the intended uses are the same as the predicate devices.
• A list of recognized national and international consensus standards (e.g., EN 60601 series, EN ISO 14971, IEC 60825 series) to which the device complies, indicating safety and performance validation through non-clinical testing.
• Explicit statement: "No clinical testing was needed."

This approach is common for traditional medical devices under the 510(k) pathway, where a new device is shown to be as safe and effective as a legally marketed predicate device without requiring new clinical trials, especially if its technology and intended use are similar.

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