(177 days)
This HHC-Push button air turbine is intended for use with the Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine.
The Dental Handpiece with the HHC- replacement turbine is used by authorized persons in the practice of dentistry.
The HHC-replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
The HHC-Push button air turbine is a complete air turbine which will be offered as replacement turbine for Midwest Tradition original turbine.
High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's shank (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.
Acceptance Criteria and Device Performance Study for HHC-Push Button Replacement Turbine
This document outlines the acceptance criteria and the study that demonstrates the HHC-Push button replacement turbine’s performance, based on the provided 510(k) summary (K100389).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the HHC-Push button replacement turbine are established through direct comparison to a predicate device, the NSK- Replacement Turbine for Midwest Tradition Handpiece Products of NSK NAKANISHI INC. (K971774). The study aimed to demonstrate substantial equivalence by meeting or exceeding the predicate's performance specifications.
| Characteristic / Acceptance Criteria | Subject Device: HHC-Midwest Tradition Replacement Turbine Performance | Predicate: NSK-Midwest Tradition Replacement Turbine Performance |
|---|---|---|
| Operation Mode: | ||
| Intake air pressure | 35 psi - speed 420,000 rpm. Min. | 35 psi - speed 420,000 rpm Min. |
| Chuck: | ||
| Outside diameter | 0.125" | 0.125" |
| Chuck length | 0.425" | 0.435" |
| Actuator height | 0.034" | 0.038" |
| Bur extraction force | 5 lbs Min. push and pull forces/ 100 inspection using ONMI gauge/ per specification indicated on drawing | 5 lbs Min. push and pull forces- tested on predicate device |
| Air pressure | 35 psi. recommended | 35 psi. |
| Water pressure | 2 bar | 2 bar |
| Speed Rpm | 420,000 rpm. Min. | 420,000 rpm. Min. |
| Conformance standard for shanks | Meet I.S.O standard Shank diameter from 0.0625" to 0.0630" | Meet I.S.O standard shank |
Summary of Device Performance: "The HHC-Push button air turbine performance tests were carried out to evaluate it against the predicate device. In all instances the HHC-Push button air turbine functioned as intended, results observed were as expected, and was determined to have comparable performance and safety as compared to the predicate."
2. Sample Size and Data Provenance
- Sample Size for Test Set: The document states that "100 inspection using ONMI gauge" was performed for bur extraction force, implying a sample size of 100 units for this specific test. For other parameters, specific sample sizes are not explicitly mentioned, but the comparison implies testing was conducted on a sufficient number of units to establish equivalence.
- Data Provenance: The study was conducted by Handpiece Headquarters as part of their 510(k) submission. The data is retrospective, generated specifically for showing substantial equivalence to a legally marketed device. The country of origin of the data is not explicitly stated, but it can be inferred to be the United States, given the FDA submission.
3. Number of Experts and Qualifications for Ground Truth
- Experts: Not applicable. This study does not involve human expert interpretation of data to establish ground truth. It is a performance study comparing engineering specifications and functional output.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This study does not involve human adjudication. The performance metrics are objective and measurable engineering parameters.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of medical images or data. The HHC-Push button replacement turbine is a dental handpiece component, and its effectiveness is determined by its mechanical and operational performance, not by diagnostic accuracy or human interpretation.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: Not applicable. This device is a mechanical component, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through direct physical and functional testing.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this study is based on engineering specifications and established performance standards for dental handpiece turbines, as exemplified by the predicate device. The performance of the subject device was compared directly to these objective, measurable parameters.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.