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Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery

Fox 940 is a diode laser with 940 nM wavelength and maximum 5 watt power output.

The provided 510(k) summary for the Fox 940 Laser focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with performance standards. It does not describe a study that involves clinical performance or the establishment of acceptance criteria related to diagnostic accuracy.

Therefore, I cannot provide the information requested in the prompt fields, as the document does not contain details about:

• A table of acceptance criteria and reported device performance (in terms of diagnostic metrics)
• Sample size used for a test set or data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication method
• MRMC comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for a training set
• How ground truth for a training set was established

Based on the provided document, the device's acceptance criteria and the "study" proving it meets them are primarily based on:

1. Technological Equivalence: The Fox 940 uses diodes to generate energy in the 940 nm range, similar to the predicate device LaserPro, which also produces energy in the 940 nm range. The Fox 810 Laser, another predicate, is the same system but generates energy in the 810 nm range. This demonstrates that the core technology and operating principle are consistent with legally marketed devices.
2. Compliance with Performance Standards: The Fox 940 Laser complies with established regulatory performance requirements:
   • 21 CFR 1040.10 and 1040.11 (with permissible deviations defined in Laser Notice 50, dated July 26, 2001) for laser products.
   • IEC 60601-1:1998 including amendment 1 (medical electrical equipment - general requirements for safety).
   • IEC 60601-2-22:1995 (particular requirements for the safety of surgical, therapeutic and diagnostic laser equipment).
   • IEC 60825-1:1993 including amendments 1 and 2 (safety of laser products - equipment classification requirements and user's guide).

The conclusion states that the Fox 940 Laser is substantially equivalent to the predicate devices because it has similar intended uses and complies with the same safety and performance standards. This type of regulatory submission (510(k)) typically relies on demonstrating equivalence rather than conducting new clinical performance studies for diagnostic accuracy, especially for devices like surgical lasers where safety and established physical principles are key.

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