(287 days)
Dental High-speed Turbine Handpiece is intended for removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
The Dental High-speed Turbine Handpiece is the dental treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and and efficiency can be improved. Cartidges have high precision when rotating, cartiridges have low noise and high efficiency. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type "PANA SPRAY Plus" manufactured by NAKANISHI INC (cleared in K163483).
The provided document describes a 510(k) premarket notification for a Class I medical device, the Dental High-speed Turbine Handpiece. The document details the device's substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding detailed acceptance criteria and a study to prove them is not applicable in this context.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific numerical acceptance criteria for performance in a clinical sense. Instead, it compares the subject device's specifications and performance to predicate devices and adherence to relevant standards.
| Acceptance Criteria (Inferred from comparison to predicates and standards) | Reported Device Performance (Subject Device) | Predicate Device Performance (K152146) | Note on Comparison |
|---|---|---|---|
| Indications for Use | Removing carious material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. | Removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. | Substantially Equivalent (SE) |
| Operational Modes | Air-powered | Air-powered | SE |
| Water Spray | Single/Triple | Single/Triple | SE |
| Type of Chuck | Push button, Screw | Push button | SE (Predicate K141886 includes both types, and both are mechanically safe) |
| Composition of Main Materials | Stainless Steel, Brass, Titanium | Stainless steel, Brass, Aluminum, Titanium | SE (Differences are compliant with ISO 10993-1) |
| Bur Extraction Force | 28N | 22N~45N | SE (Compliant with ISO 14457) |
| Operating Pressure | 177KPa ~ 301KPa | 200KPa | SE (Compliant with ISO 14457) |
| Rotation Speed | 300,000rpm ~ 400,000rpm | 350,000rpm ~ 400,000rpm | SE (Compliant with ISO 14457) |
| Sterilization | Steam autoclave method | Steam autoclave method | SE |
| Compliance Standards | ISO 10993-5, ISO 10993-10, ISO 14457 | Not explicitly listed for predicate, but generally compliant. | SE (Subject device complies) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This is not a clinical study assessing patient outcomes or device performance on a test set of data/patients. The "test set" here refers to the physical device being tested against engineering standards.
- Data Provenance: Not applicable in the context of clinical data. The performance claims are based on engineering tests and comparisons to predicate devices, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on diagnostic images) is not relevant for this type of device submission. The "ground truth" for this device is established through compliance with recognized standards and successful engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical adjudication of results for a test set.
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 device is a dental handpiece, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for the device's safety and effectiveness is established through adherence to ISO standards (ISO 14457 for performance, ISO 10993-1 for biocompatibility, ISO 17665:2006 and ISO 11134:2003 for sterilization), and reprocessing validation according to FDA guidance. It is also based on demonstrating substantial equivalence to existing legally marketed devices.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.