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The APOZA LED Curing Light is a dental curing light that is designed for use in the optical polymerization of dental resins.

APOZA LED Curing Light (Family: Model# E-Morl.it , D-2000 , TOP 3W, TOP 5W) is non-invasive medical device and is designed for use in the optical polymerization of dental resins. APOZA LED Curiing Light deliver 440-490nm blue light. APOZA LED Curing Light is also called APOZA Dental Curing Light. it includes the following models: . E-MorLit consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger) , () D-2000 consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger) () TOP 3W consist of a handy unit and a switching power adaptor. () TOP 5W consist of a handy unit and a switching power adaptor. The handy unit contains a programmed control circuit, high intensity dental blue LEI》 light source, a light quide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.

The provided text is a 510(k) premarket notification for a medical device, specifically a dental curing light. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the kind of information typically found in a study proving a device meets acceptance criteria, especially for AI/ML devices.

Here's why and what information is missing:

• Type of Device: This is a hardware device (LED Curing Light) used for polymerization of dental resins. The acceptance criteria and performance evaluation for such a device focus on electrical safety, light output specifications, and biocompatibility, not on diagnostic performance against a ground truth as would be the case for an AI/powered diagnostic tool.
• 510(k) Summary Nature: A 510(k) summary primarily aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to independently prove specific performance metrics beyond what's relevant for equivalence.

Therefore, I cannot provide the requested information in the format of acceptance criteria and a study for an AI device. The document states:

"7. Performance In terms of operating specification, Safety & EMC requirements, Summary: the device conforms to applicable standards included IEC 60601-1 and IEC 6060 -1-2 requirements."

This is the extent of the performance claim, referring to compliance with general electrical safety and electromagnetic compatibility standards, not clinical performance or diagnostic accuracy.

Missing Information (for an AI/ML device context, which is not applicable here):

• Table of Acceptance Criteria and Reported Device Performance: Not provided as it's not a diagnostic AI device. The performance summary refers to compliance with safety and EMC standards.
• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, this document is for a hardware dental device and does not contain the information requested about acceptance criteria and studies typical for AI/ML diagnostic devices. Its primary purpose is to establish substantial equivalence to a predicate device based on similar intended use and technological characteristics, and compliance with general safety standards.

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