(110 days)
The Ti2200 Transillumination Cable is a diagnostic aid used to locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures underneath the tooth surface utilizing a fiber optic cable and handle attached to a light source.
The Ti2200 Transillumination Cable is a fiber optic transilluminator connected directly to a light source. The Ti2200 Transillumination Cable uses a 2.1mm fiber-optic bundle with a 45 degree stainless steel end-tip. The end-tip, when placed on the tooth surface (and when other sources of light are minimized), creates an illuminated tooth structure to help locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures. These clinical entities reduce the ability to transmit light and therefore show up as dark areas in an otherwise bright structure thus aiding in diagnosis.
The provided text describes a 510(k) submission for the Ti2200 Transillumination Cable. This device is a fiber optic transilluminator intended to help locate dental issues like decay, calculus, and cracks by illuminating the tooth structure.
The document discusses the device description, intended use, and claims substantial equivalence to a predicate device (Addent Inc., Microlux Transilluminator). The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence rather than reporting a detailed clinical or performance study.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided input.
§ 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.