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VALO Grand Corded: Source of illumination for curing photo-activated dental restorative materials and adhesives.

VALO Accessory Lenses: The VALO Accessory Lenses are multiple-use accessory lenses intended to provide illumination to aid in visualization during oral procedures and augment the VALO family of curing lights, which are a source of illumination for curing photo-activated dental restorative materials and adhesives. VALO Accessory Lenses are not intended for complete cure of photo-activated materials and adhesives.

VALO Grand Corded: With its broadband spectrum, VALO Grand Corded is designed to polymerize all light cured products in the wavelength range of 385-515nm per ISO 10650. VALO has a medical grade, international power supply and is suitable for power outlets from 100 to 240 volts. The handpiece is designed to rest in a standard dental unit bracket or can be custom mounted using the bracket included with the kit.

Accessory Lenses:

• . PointCure™ Lens - o Augments the VALO curing light to polymerize composite through a translucent prosthetic.
• . ProxiCure™ Ball Lens - o Augments the VALO curing light to polymerize composite and help shape contact area matrix of an interproximal restoration.
• TransLume™ Green Lens - Augments the VALO curing light to aid in visualization by providing longer wavelength light to o transilluminate teeth and dental prostheses.
• Black Light Lens - o Augments the VALO curing light to provide aid in visualization of fluorescing chemicals in dental resins.
• Interproximal Lens - Augments the VALO curing light to aid in visualization of teeth and dental prostheses. o
• White Light Lens - Augments the VALO curing light to provide a visual aid for accurate color/shade comparison or o whenever natural light is needed.

The provided text does not describe acceptance criteria for an AI/ML powered medical device, nor does it detail a study proving its performance. Instead, it is a 510(k) premarket notification for a dental curing light named "VALO Grand Corded and Accessory Lenses". This device is a traditional medical device, not an AI-powered one.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not applicable to the non-AI device described in the document.

The document discusses the substantial equivalence of the "VALO Grand Corded and Accessory Lenses" to predicate devices based on:

• Intended use: Illumination for curing photo-activated dental restorative materials and adhesives, and aid in visualization during oral procedures.
• Technological characteristics: Power source, light source (LED, blue and violet wavelengths), operational modes (for curing and diagnostic purposes with accessory lenses), accessories, material composition, and technical specifications (light intensity, peak wavelength, depth of cure).
• Recognized standards: ISO 10650, IEC 80601-2-60, ISO 14971, IEC 62366-1, ISO 10993-1.
• Non-clinical testing: Radiant exitance and emission spectrum testing (ISO 10650:2018), illuminance and color temperature testing, beam profile testing, duty cycle testing, and disinfection validation testing.

The conclusion is that the device is substantially equivalent to the predicate devices and does not raise new concerns of safety or efficacy, which is the standard for 510(k) clearance for conventional medical devices.

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