(4 days)
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.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards Conformance) | Reported Device Performance |
|---|---|
| Safety: Device electrical safety, mechanical integrity, and biocompatibility. | Bench testing against various standards: |
| - Electrical Safety: Comply with IEC 60601-1 / UL 60601-1 and CAN/CSA-C22.2 No. 601.1 M90 for electrical medical equipment. | - Independent laboratory testing by Intertek Testing confirmed conformity with UL 60601-1 and CAN/CSA-C22.2 No. 601.1 M90. |
| - Mechanical Safety/Functional Standards: Comply with ISO 7494-1:1996 (Dentistry - Dental units - Part 1: General requirements and test methods) and ISO 7494-2:2003 (Dentistry - Dental units - Part 2: Water and air supply). | - Bench testing against local GB standards (GB9706.1-1995 and Y Y/T1043-2004) which are near equivalent to ISO 7494-2:2003 and ISO 7494-1:1996. Additional testing performed where local standards were not equivalent. |
| - Compatibility with Handpieces: Comply with ISO 9168:1991 (Dental handpieces - Coupling dimensions). | - Tested against ISO 9168:1991 and found to be in compliance. Device uses industry-standard 4-Hole handpiece tubings. |
| - Biocompatibility (Patient/Operator Contact Surfaces): Comply with ISO 7405:1997 (Dentistry - Evaluation of biocompatibility of medical and dental devices). | - Patient and operator contact surfaces tested and found to be in compliance with ISO 7405:1997. Device composed of materials with a long history of use. |
| Effectiveness/Performance: Ability to supply power and act as a base for dental devices and accessories, and to position the patient. | - Device description and comparison table assert "Equivalent" performance in all functional aspects (control of air and water, installation, components, accessories, power/utility supply, water system, cleaning system, activation, place of use, intended users) to the predicate Sirona C8. |
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.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.