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The Satelec Mini LED AutoFocus is intended to be used by qualified dental practitioners as an ultraviolet activator for polymerization for:

• photo-polymerization in the 420-480 nm waveband of visible light cured A (VLC) dental materials
• A photo-polymerization in the 420-480 nm waveband of visible light cured (VLC) restorative composite materials, and
• photo-polymerization in the 420-480 nm waveband of visible light cured A (VLC) orthodontic brackets, and orthodontic bonding and sealing materials

The Satelec Mini LED AutoFocus is intended to be used by qualified dental practitioners as an ultraviolet activator for polymerizations intended for photopolymerization in the 420-480 nm waveband of visible light cured (VLC):

• . dental materials
• restorative composite materials, .
• orthodontic brackets, and orthodontic bonding and sealing materials t
  The Mini LED AutoFocus is available in two versions, a table top and an OEM (built-in). The table top uses a battery to power the handpiece and a base station for recharging the battery and storage of the handpiece and battery when not in use.
  The OEM version is intended to be built into a chair or cart. A cord connects the handpiece to a power module which is built into the chair. When not in use, the handpiece is placed in a handpiece holder on the chair or cart.
  The table top version consists of the following items:
• The Mini LED AutoFocus handpiece with its protective lid, incorporating the Light Emitting Diode and the backlit LCD screen
• The base station for recharging the device incorporating a wattmeter
• The mains adapter
• The Lithium Ion battery
• The sterilizable light guide and the control tip
• The protective light shield
• The user's manual and accompanying documentation.
  The OEM version consists of the following items:
• The Mini LED AutoFocus handpiece with its protective lid, incorporating the Light Emitting Diode and the backlit LCD screen
• Power module
• Handpiece cord (allows connection of handpiece to power module)
• The sterilizable light guide and the control tip
• The protective light shield
• The user's manual and accompanying documentation.

The provided text is a 510(k) summary for the Satelec Mini LED AutoFocus, specifically a notification of intent to market a device based on substantial equivalence to a predicate device. It is a regulatory document and does not describe a study involving acceptance criteria, device performance, or human readers as would be typical for an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document as it pertains to clinical performance studies, which are not detailed here for this type of device submission.

Here's what can be extracted based on the provided text, and where gaps exist:

1. A table of acceptance criteria and the reported device performance
This document does not contain specific acceptance criteria or reported device performance data in the context of a clinical study or benchmark performance testing with metrics like sensitivity, specificity, or AUC. The submission is based on substantial equivalence to a predicate device, meaning it asserts that the new device performs similarly to or better than the predicate without introducing new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a test set or data provenance for a clinical or performance study.

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. This document does not describe the establishment of a ground truth for a test set by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not mention an adjudication method for a test set.

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 document does not describe an MRMC study or any AI component. The device is an "ultraviolet activator for polymerization," not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no mention of a ground truth in the context of performance evaluation for this device. The "ground truth" for this submission is implicitly the performance and safety established for the predicate device.

8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth.

Summary based on the provided document:

The Satelec Mini LED AutoFocus is an ultraviolet activator for polymerization, a dental device used for curing dental materials. The submission to the FDA is a 510(k) premarket notification asserting substantial equivalence to a predicate device (Satelec Mini LED and Smartlite Mini, K032465) that was previously cleared.

The core argument for acceptance is the substantial equivalence to the predicate device. The document states:

• "The Satelec Mini LED AutoFocus is substantially equivalent to the predicate device by Satelec, Mini LED and Smartlite Mini (K032465) previously cleared by the FDA and currently marketed."
• "Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the Min LED AutoFocus."

Therefore, the "study" proving the device meets the "acceptance criteria" is essentially the comparison to the legally marketed predicate device, demonstrating that its intended use, technological characteristics, and performance are substantially similar to the predicate, such that it raises no new questions of safety or effectiveness. The FDA's clearance letter confirms this finding of substantial equivalence.

This type of submission does not typically involve the extensive clinical trials or performance metrics (like sensitivity/specificity) common for AI/ML devices or novel high-risk medical devices. Instead, safety and effectiveness are established by showing the new device is as safe and effective as a device already on the market.

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