(151 days)
Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.
The provided text is a 510(k) summary for a dental handpiece. It details the device's equivalence to a predicate device but does not describe an AI medical device or a study involving AI performance metrics like sensitivity, specificity, or reader studies. Instead, it focuses on the engineering and biocompatibility testing of a physical dental instrument.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance for an AI model, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the content provided.
The document discusses the following types of tests for the dental handpiece:
Design Verification & Performance Data:
- Appearance Test
- Operation Test
- Rotational Speed Test
- Noise Test
- Spray Test
- Light Test
- Serviceable Year/Shelf-Life Test
Biocompatibility Testing (applicable from the predicate device):
- ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
- ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts)
- ISO Intracutaneous Irritation Test (GLP 2 Extracts)
- ISO Materials Mediated Rabbit Pyrogen (GLP)
- ISO Acute Systemic Injection Test (GLP 2 Extracts)
The document concludes that the proposed device is substantially equivalent to the predicate device based on these tests and that no new questions of safety or effectiveness are raised.
§ 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.