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The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.

The cold light sources of the PS series consist of short arc metal-halide or xenon lamps, driven by electronic ballasts. Optical components such as mirrors, lenses, filters and coatings focus the light to a very small diameter of typically 1.5-3mm, Fiber light guides (single or bundles) transmit the light to the application such as headlights, endoscopes or other lighted tools.

Based on the provided text, the device described is a "Xenon/Metal halide light source with fiber and headlight" (PS series) intended as an "AC-powered dental operating light." The document explicitly states:

"No performance data is required for this Class I device nor requested by FDA (ODE)."

Therefore, a detailed study proving the device meets specific acceptance criteria, as one might find for a more complex medical device, was not necessary or provided in this 510(k) submission. The submission primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.

Here's an breakdown based on your requested information, acknowledging the limitations due to the device's classification:

Acceptance Criteria and Device Performance

Study Details (or lack thereof)

Since "No performance data is required" for this Class I device, the following points are largely not applicable or indicate that a specific "study" as you might define it for a complex AI/diagnostic device was not performed.

1. Sample size used for the test set and the data provenance: Not applicable. No performance data was required.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance data was required.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance data was required.
4. 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 light source, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a light source, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for performance data as it was not required.
7. The sample size for the training set: Not applicable. This device is a light source, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of the "Proof"

The "proof" that this device meets its "acceptance criteria" (which in this case are primarily substantial equivalence and safety compliance) is demonstrated through:

• Comparison to Predicate Devices: The submission argues that the PS series light source is "similar in use, design and function" to several legally marketed predicate devices (Cogent/WelchAllyn Solartec Source ST270, Micro Link endoscopic fiber cable; Isolux America 1300 XSBP, 1125 XSB, Fiber optic surgical headlight, fiberoptic cable).
• Adherence to Safety Standards: The document lists a comprehensive set of international and national safety standards that the device "fully meets." This is a critical component for FDA clearance, especially for devices where extensive performance testing might not be mandated.
• Technological Description: The detailed description of how the device produces and channels light (e.g., short arc lamps, optical components, improved focusing into small fibers) serves to explain how it achieves its intended illumination function, and implicitly, how it is equivalent or even potentially an improvement in focusing effectiveness compared to older technologies (though this isn't framed as a strict performance claim with quantitative data).

In essence, for this Class I device, the regulatory pathway did not require the type of extensive performance study you've outlined for AI or diagnostic devices. The acceptance criteria were primarily met through demonstrating safety compliance and substantial equivalence to established predicate devices.

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