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510(k) Data Aggregation
(216 days)
High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
High Speed Air Turbine Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations, root canal preparations and polishing teeth.
The proposed devices, High Speed Air Turbine Handpiece, is a dental abrasive device that rotates at high speed air as the driving force. It has 11 models: G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800 and G800L. The cooling system includes air/water spray or only water spray. The head types include standard head and miniature head. The angle of the head and shaft include 45℃ and 90°. High Speed Handpieces are able to run from 320,000rmp to 430,000rmp. G450, G700L and G800L have optic light guide for light function, other models don't have the optic light guide. Coupling is the accessory for the some models of the proposed handpiece to connect with tubes of dental unit.
The provided text describes the regulatory clearance of a dental handpiece and references a non-clinical study to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and performance data for a device that typically accompanies a study proving the device meets those criteria, as one would expect for an AI/ML powered device.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device was tested per ISO 14457:2017 Dentistry - Handpieces and motors and that "the test result demonstrated that the proposed device complies with the standard requirements." However, the specific acceptance criteria and the quantified reported device performance values are not provided in the text.
The text lists the following parameters that were evaluated, implying these are the areas where acceptance criteria from ISO 14457:2017 were applied:
| Parameter Evaluated (Implied Acceptance Criteria from ISO 14457:2017) | Reported Device Performance (Not provided in the text) |
|---|---|
| Noise level @ Background noise level 56 dB(A) | "complies with the standard requirements" |
| Flow rate of air supply @ 400kPa | "complies with the standard requirements" |
| Flow rate of spray air @ 200kPa(2.0 bar) | "complies with the standard requirements" |
| Flow rate of water supply @ 200kPa(2.0 bar) | "complies with the standard requirements" |
| The force required to extract the test mandrels from the chuck system for Type 5 test mandrels | "complies with the standard requirements" |
| Torque @ Type 5 test mandrels | "complies with the standard requirements" |
| Speed of handpiece @ 0.22MPa | "complies with the standard requirements" |
| Dynamic eccentricity | "complies with the standard requirements" |
| Stall torque | "complies with the standard requirements" |
| The light at the output side of the handpiece (for models with optic light guide) | "complies with the standard requirements" |
Missing Information: The specific numerical acceptance limits for each parameter as defined by ISO 14457:2017 and the actual measured performance values of the device for each of these parameters are not detailed in this document.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "the proposed device" was tested, implying at least one unit of each of the 11 models (G100, G200, G300, G400, G450, G500, G600, G700, G700L, G800, G800L). However, the specific number of units tested for each parameter is not disclosed.
- Data Provenance: Not explicitly stated, but based on the applicant's address (Zhongshan, Guangdong, China), the testing was likely performed in China. The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as this is a non-clinical performance test for a mechanical dental device, not an AI/ML powered device requiring expert ground truth for interpretation. The "ground truth" for this device's performance comes from physical measurements against an international standard (ISO 14457:2017).
4. Adjudication method for the test set
- This information is not applicable for the same reasons as point 3.
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
- No, a MRMC comparative effectiveness study was not done. This is a clearance for a physical dental handpiece, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is not an AI/ML software device.
7. The type of ground truth used
- For this device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the international standard ISO 14457:2017 Dentistry - Handpieces and motors. The device's performance is measured against these established engineering and safety standards.
8. The sample size for the training set
- This information is not applicable as this is a physical device, not an AI/ML "algorithm" that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable as this is a physical device, not an AI/ML "algorithm."
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