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ROLENCE Dental High Speed Handpiece, model: RHP is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

According to ISO7785-1:1997, Dental Handpiece . -- Part 1: High-speed air turbine handpieces; and ISO13485:2003, Medical Device Quality Management System to complete the device design steps.

The provided document is a 510(k) summary and FDA clearance letter for the ROLENCE Dental High Speed Handpiece, Model: RHP. It does not describe an AI/ML medical device, but rather a traditional medical device (a dental handpiece). Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the information provided, addressing the questions where relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The submission refers to international standards for device design and performance verification, rather than specific numerical acceptance criteria and reported device performance values.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for this type of traditional medical device. The "test set" here refers to the physical device prototypes being tested against engineering standards. The data provenance would be the manufacturing site (Taiwan R.O.C.) where the verification tests were conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of an AI/ML device. For this traditional device, the "ground truth" is defined by the technical specifications and performance requirements established in the referenced ISO standards. The individuals conducting the tests would be qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI/ML device. Device testing against standards doesn't typically involve adjudication.

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 is a traditional dental handpiece, not an AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a manual device operated by a human professional.

7. The Type of Ground Truth Used

For this traditional medical device, the "ground truth" for demonstrating substantial equivalence and performance relies on:

• Conformance to International Standards: Specifically, ISO7785-1 for functional verification, ISO13485 for design processes, and ISO14971 for risk management.
• Comparison to Predicate Device: The primary method for establishing substantial equivalence was a comparison of formulations and intended uses with the JINDELL High Speed Air Turbine Handpiece (K062740).

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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THE ULTRA-LITE 200E IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.

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This is an FDA Premarket Notification (510(k)) letter for a dental device, specifically a light cure unit. Based on the provided text, the document focuses on the regulatory aspects of the device's clearance and does NOT contain information about performance acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The 510(k) process primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical studies with specific performance metrics as might be seen for novel or higher-risk devices.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design verification and validation report, or a clinical study report.

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THE EXCELLITE IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS .

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The provided document is an FDA 510(k) clearance letter for a dental light cure unit. It is not a study report or a document describing the acceptance criteria and performance of a device based on a study.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, training set details) because this document does not contain that level of detailed study information.

The letter primarily confirms that the "Excellite Light Cure Unit" is substantially equivalent to legally marketed predicate devices. It states its intended use for "polymerization of light cured material by dental professionals" but does not provide any performance metrics or study specifics.

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THE ULTRA-LITE 5 TURBO IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS .

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I am sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a dental light cure unit. It confirms that the device is substantially equivalent to a legally marketed predicate device and allows it to be marketed.

However, this document does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or clinical performance data as you have requested. These details would typically be found in the 510(k) submission itself, which is a much more extensive document than the clearance letter.

Therefore, I cannot extract the information you are looking for from the given text.

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THE EXCELLITE TURBO IS A.LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.

EXCELLITE TURBO LIGHT CURE UNIT

This looks like a 510(k) clearance letter for a dental light cure unit, not a study report for an AI device. The document does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

Specifically, the device is the "Excellite Turbo Light Cure Unit" and its indication for use is "for polymerization of light cured material by dental professionals." This is a physical device used for dental procedures, not an AI or software-as-a-medical-device (SaMD).

Therefore, I cannot provide the requested information based on the provided text. The questions you've asked are relevant for AI/SaMD submissions, but not for this type of traditional medical device clearance.

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