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The Flight Dental Systems A-Series Operative Units are intended to supply power und serve as a base for dental devices and accessories. The use intended is in the treatment of dental patients in the dental clinic/office environment. The units are for use only by trained dentists, dental hygienists, dental technicians and dental assistants.

The Flight A-Series Dental Operative Unit is a dental operating system. The device includes a patient chair, dentist's element, utility center and a floor box. The unit may also include a cuspidor, an assistant's element and a dental operating light. The doctor's element may be mounted on the patient chair or on a mobile cart. The unit is used to position the patient in a comfortable position and to provide the power to the dentist's instruments including dental handpieces.

This document describes the Flight Dental Systems A-Series Dental Operative Unit, cleared under K070196. This device is a dental operating system comprising a patient chair, dentist's element, utility center, and floor box, intended to supply power and serve as a base for dental devices and accessories in a dental clinic/office environment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Sirona C8+ Dental Operative unit - K983242) rather than defining explicit, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly met by demonstrating conformance to relevant standards and direct equivalence to the predicate.

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

• Sample Size for Test Set: The submission states that "Bench testing has been performed on a sample that is in all respects the same as the device to be marketed." This indicates a single device sample (or a very small number representing the manufactured article) was used for physical bench testing.
• Data Provenance: The bench testing was performed against local GB standards in China. Additional independent laboratory testing was performed by Intertek Testing of Mississauga, Ontario, Canada. This is prospective testing of the device itself.

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

• This submission does not involve clinical data or expert evaluations for establishing ground truth in the context of image interpretation or diagnostic performance. Instead, ground truth is established by the compliance of the device with recognized international and national standards as assessed by engineering and testing professionals at the designated testing laboratories. Therefore, the "experts" are the qualified personnel at the testing facilities (e.g., Intertek Testing) who conducted the specified tests and verified compliance. Their specific qualifications are not detailed beyond their affiliation with the testing labs.

4. Adjudication Method for the Test Set:

• Not applicable. The testing described is objective bench testing against engineering standards, not subjective evaluation requiring adjudication among multiple human assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted devices that impact human clinical decision-making. This device is a physical dental operative unit.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This device is a physical medical device, not an algorithm or software-only device. Its performance is inherent in its physical and electrical characteristics conforming to safety and performance standards.

7. Type of Ground Truth Used:

• The "ground truth" used for this submission is conformance to established engineering and safety standards (e.g., ISO, UL, CSA, GB standards), combined with direct comparison of technological characteristics to a legally marketed predicate device.

8. Sample Size for the Training Set:

• Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

• Not applicable, as there is no training set.

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