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The Fotona XD Diode Laser System, and its accessories, are intended for use in

• Periodontology for
  • Laser soft tissue curettage r
  • Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
  • Oral Soft Tissue surgery for
    • Gingivectomy
    • Gingivoplasty
    • Fibroma removal
    • Treatment of Aphthous Ulcers
    • Crown Lenghtening
    • Frenectomy
    • Papillectomy
    • Photocoagulation
• Cosmetic Dentistry for
  • Light activation for bleaching materials for teeth whitening -
  • Lasers-assisted bleaching/whitening of the teeth -

The Fotona XD Diode Laser System is based on a semiconductor laser that operates in the nearinfrared range of the electromagnetic spectrum. The laser source consists of a compact semiconductor laser diode module that emits laser light at a wavelength of 810 nm in continuous wave mode or pulse operation mode from 20 Hz to 10 kHz. The output power can be set from 250 m W to 7.0W. A red diode aiming beam (650 nm) is combined with the therapeutic laser beam and , both beams are guided through an optical fiber delivery unit and an optical handpiece to the treatment site.

The provided text describes a 510(k) submission for the Fotona XD Diode Laser System, seeking substantial equivalence to existing predicate devices. This type of submission relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria and a study to prove device performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document. The document focuses on regulatory clearance through substantial equivalence.

Here's an explanation of what can be extracted and why other parts are not available:

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

Not applicable. The 510(k) summary does not present specific acceptance criteria in terms of quantitative performance metrics for the Fotona XD Diode Laser System itself. Instead, it relies on demonstrating substantial equivalence to predicate devices that have already met safety and effectiveness standards. The "device performance" is implicitly considered to be equivalent to the predicate devices for the specified indications for use.

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

Not applicable. No new clinical trials or performance studies with test sets are described in this 510(k) summary. 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)

Not applicable. No new test set requiring expert ground truth establishment is described.

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

Not applicable. No new 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

Not applicable. This document pertains to a medical device (laser system), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-related performance improvements are irrelevant.

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

Not applicable. This is a medical device, not an algorithm.

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

Not applicable to this 510(k) submission directly. The "ground truth" for the Fotona XD Diode Laser System's approval is based on the established safety and effectiveness of the legally marketed predicate devices for their approved indications.

8. The sample size for the training set

Not applicable. No machine learning or AI component requiring a training set is part of this device or its submission.

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

Not applicable. No machine learning or AI component requiring a training set is part of this device or its submission.

Summary of Relevant Information from the Provided Text:

The essence of this 510(k) submission is to demonstrate substantial equivalence to existing devices, specifically:

• Predicate Device 1: Odyssey 2.4G Diode Laser (K050453)
• Predicate Device 2: Opus 10 Dental Diode Laser System (With Tooth Whitening Application) (K011769)

The Fotona XD Diode Laser System shares the same indications for use and similar design and functional features with these predicate devices. The approval letter from the FDA (FEB - 4 2009) confirms that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market. This indicates that the device met the regulatory requirements for 510(k) clearance by proving its similarity to already approved devices, rather than through a de novo performance study against specific acceptance criteria.

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