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The Fox Q-980 Diode Laser is indicated for surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, thoracic surgery and laser assisted lipolysis.

Fox Q-980 is a standard diode medical laser with 980nm wavelength and quartz fibers

This document describes a 510(k) submission for the Fox Q-980 Laser. The submission is primarily focused on demonstrating substantial equivalence to predicate devices, particularly for the added indication of laser-assisted lipolysis.

Here's an analysis of the provided text in relation to your questions:

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

Based on the provided text, there are no specific performance acceptance criteria or reported device performance metrics in the format of a clinical study or performance data table. The submission relies solely on demonstrating compliance with recognized standards and equivalence to predicate devices, rather than establishing de novo performance targets.

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. The document does not describe a clinical study with a test set.

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. The document does not describe a clinical study with ground truth established by experts.

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

Not applicable. The document does not describe a clinical study with an adjudication method.

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-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance in a diagnostic capacity.

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

Not applicable. This device is a laser surgical instrument, not an algorithm.

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

Not applicable. The document does not describe a clinical study requiring ground truth. The primary ground for approval is substantial equivalence to legally marketed predicate devices and compliance with recognized performance standards. In this context, the "ground truth" for the device's safety and effectiveness is implicitly established by the predicate devices and their successful market history, as well as adherence to safety standards.

8. The sample size for the training set

Not applicable. The document does not describe a machine learning algorithm or a training set.

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

Not applicable. The document does not describe a machine learning algorithm or a training set.

Summary of the 510(k) Submission for Fox Q-980 Laser:

This 510(k) submission for the Fox Q-980 Laser is a declaration of substantial equivalence to previously cleared devices (K073322 and K082721). The key arguments for equivalence are:

• Identical Core Device: The Fox Q-980 is stated to be the "same 980 nm laser cleared under K073322."
• Added Indication Equivalence: The added indication for laser-assisted lipolysis is justified by the fact that the predicate device LaserPro980 (K082721) also has this indication.
• Technological Characteristics: The device utilizes a 980nm diode laser and quartz fibers, similar to the predicate devices.
• Compliance with Standards: The device complies with relevant electrical and laser safety standards (21CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, IEC 60825-1) and sterilization standards (ISO 11135-1 and 2).

The 510(k) process for devices like this typically relies heavily on demonstrating that the new device does not raise new questions of safety or efficacy compared to legally marketed predicate devices, rather than presenting new clinical study data with specific acceptance criteria.

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