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VALO X curing light is a source of illumination for curing photo-active materials and adhesives. It is also intended to provide illumination to aid in visualization during oral procedures. VALO X curing light accessory/ diffusor lenses are not intended for complete cure of photo-activated materials and adhesives.

VALO™ X:
With its broadband spectrum, VALO™ X curing light is designed to polymerize all light-cured products in the wavelength range of 380-515 nm per ISO 10650:2018.
The VALO X curing light can be used in a corded or cordless configuration using the Ultradent VALO rechargeable batteries or provided VALO X cord adapter. The curing light is designed to rest in a standard dental unit bracket or can be custom-mounted using the VALO surface mounting bracket included with the kit.

VALO™ X Accessory Lenses:
Accessory: PointCure Lens, Mode: Curing Mode, Description: Augments the VALO X curing light to polymerize composite through a translucent prosthetic.
Accessory: ProxiCure Ball, Mode: Curing Mode, Description: Augments the VALO X curing light to polymerize composite and help shape contact area matrix of an interproximal restoration.
Accessory: Diffuser Lens, Mode: White Light Diagnostic Aid Mode, Description: Augments the VALO X curing light to provide a visual aid for accurate color/shade comparison or whenever natural light is needed.
Accessory: Diffuser Lens, Mode: Black Light Diagnostic Aid Mode, Description: Augments the VALO X curing light to provide visualization of fluorescing chemicals in dental resins.
Accessory: Interproximal Lens, Mode: White Light Diagnostic Aid Mode, Description: Augments the VALO X curing light in visualization of teeth and dental prostheses.
Accessory: Translume, Mode: Curing or Diagnostic Aid Modes, Description: Augments the VALO X curing light in visualization by providing longer wavelength light to transilluminate teeth and dental prostheses.

I am unable to provide the detailed information requested regarding the acceptance criteria and study proving device performance for the VALO X and VALO X Accessory Lenses.

The provided text is a 510(k) Summary and FDA clearance letter for a dental curing light. While it describes the device, its intended use, and a comparison to a predicate device, it does not contain the specific acceptance criteria or the detailed results of performance studies that prove the device meets those criteria.

Medical device submissions to the FDA, particularly 510(k)s seeking substantial equivalence, generally involve performance data, but the public summary (like the one provided) often only broadly states that testing was performed and confirms that the device is substantially equivalent to a predicate. It typically references standards applied and types of tests conducted (e.g., radiant exitance, biocompatibility, EMC), but does not present the granular data, acceptance criteria tables, sample sizes, or expert review details that you are asking for.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance values.
• Sample sizes used for test sets or data provenance (beyond mentioning "internal testing protocols").
• Information on ground truth establishment, including the number and qualifications of experts or adjudication methods.
• Any details about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance (as this is not an AI/software device).
• Details on training set sample sizes or how their ground truth was established.

The document states that "Device design validation and verification activities have been performed to FDA Guidance Document... and recognized standards and via internal testing protocols." It lists several ISO and IEC standards that were applied during non-clinical testing. This general statement, however, does not provide the specific performance results or acceptance thresholds.

Therefore, I cannot fulfill your request based solely on the provided text. To get such detailed information, one would typically need access to the full 510(k) submission not just the public summary or clearance letter.

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