(163 days)
The Inspektor™ Pro is intended to be used as an aid in the diagnosis of dental caries.
The Inspektor™ Pro is indicated as an aid in the diagnosis of dental caries.
The Inspektor™ Pro consists of a systembox equipped with a handpiece, mounted in a trolley together with a computer, a monitor, mouse, keyboard and footswitch.
While the provided document mentions the Inspektor™ Pro device, its intended use, and substantial equivalence to a predicate device, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for that specific information based on the given text.
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study results in the same way a clinical trial report would.
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.