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810 nm Diode Laser System:

• · Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
  • 。 Gingival troughing for crown impression
  • · Gingivectomy
  • · Gingivoplasty
  • 。 Gingival incision and excision
  • 。 Hemostasis and coagulation
  • · Excisional and incisional biopsies
  • Fibroma removal
  • · Frenectomy and frenotomy
  • · Oral papillectomies
  • · Soft tissue crown lengthening
  • 。 Treatment of aphthous ulcers
  • · Treatment of herpetic lesions
• · Periodontology:
  • · Laser soft tissue curettage.
  • · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
• Cosmetic Dentistry:
  • · Laser-assisted bleaching/whitening of the teeth,
  • · Light activation for bleaching materials for teeth whitening
• · Implant recovery
• · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology

810 nm Diode Laser Module:
· Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:

• 。 Gingival troughing for crown impression
• · Gingivoplasty
• · Soft tissue crown lengthening
• 。 Treatment of aphthous ulcers
• 。 Treatment of herpetic lesions

810 nm Diode Laser System & Module in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

980 nm Diode Laser:

• · Gingival troughing
• · Crown lengthening
• · Gingivoplasty
• · Coagulation
• Hemostasis of donor site
• Implant recovery
• Implant uncovery
• · Soft tissue curettage
• · Sulcular debridement
• Biopsy
• · Frenectomy
• Operculectomy
• Exposure of unerupted teeth
• Pulpotomy
• Treatment of aphthous ulcers
• · Excision of lesions
• · Light activation of bleaching materials for teeth whitening
  · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, and thoracic surgery.

445 nm Diode Laser:
· Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue

The Fotona XPulse Pro Laser Platform is a multi-application, multi-technology platform that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.

The Fotona XPulse Pro Laser Platform consists of a console, a footswitch and attachable laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.

A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse platform: 445 nm, 810 mm and 980 nm.

Following handpieces are to be used with Fotona Xpulse Pro Laser Platform: R21-SHP, R26 (variants: black, green, blue, silver and red), R24, R30, Genova and MarcCo (variants S, M & L).

Please note: The provided text describes a medical device submission (510(k) Premarket Notification) for the Fotona XPulse Pro Laser Platform. This document focuses on demonstrating substantial equivalence to predicate devices and does not present a typical study with acceptance criteria and results in the way one might expect for a new diagnostic or AI-powered device.

Therefore, the requested information elements related to AI-specific study design (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not available in this document because this is a laser surgical instrument, not an AI diagnostic device. The document states "Clinical testing: No clinical testing was needed."

Here's the information that can be extracted from the provided text, structured to address your request where possible, and indicating where information is not applicable (N/A) or not provided:

Acceptance Criteria and Device Performance Study for Fotona XPulse Pro Laser Platform

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a laser surgical instrument, and not an AI or diagnostic device with quantifiable performance metrics like sensitivity/specificity, the "acceptance criteria" are based on demonstrating substantial equivalence to existing predicate devices. The performance is assessed through technical specifications and adherence to standards rather than clinical endpoints in this 510(k) summary.

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

• Sample Size for Test Set: Not applicable. The document states "Clinical testing: No clinical testing was needed." Performance was assessed through engineering and bench testing against specifications and standards, and by comparison of technical characteristics to predicate devices.
• Data Provenance: Not applicable for clinical data. For technical comparison, the data is derived from the specifications of the Fotona XPulse Pro Laser Platform and the nominated predicate devices (Fotona SkyPulse Laser Platform K193656, FOX 1-980, FOX Q-1064, FOX-Q-810 K073322, Wolf445nm K192272, SIROLaser Blue K180044, XD Diode Laser System K083034).

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

• Not applicable. As a laser surgical instrument requiring no clinical testing for its 510(k) clearance, ground truth established by medical experts for a test set is not part of this submission type.

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

• Not applicable.

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 decision-support tool.

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 (expert consensus, pathology, outcomes data, etc.)

• Not applicable for clinical ground truth. The "ground truth" for this device's performance demonstration lies in its adherence to recognized consensus standards (e.g., IEC 60601 series, ISO 14971) and its technical specifications matching or being similar to legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. There is no AI component or training set involved in this medical device submission.

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

• Not applicable.

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