(284 days)
The CS 1600 is indicated for use by health professionals as an aid in the detection of dental caries.
It is also indicated for use in viewing and capturing intraoral color video images for the purpose of:
- Allowing practitioners to view and magnify all regions of the oral cavity
- Assisting in communication with the patient by providing a view of treatment areas before and after a procedure
- Providing images for documentation in patient records.
The CS 1600 Intraoral Camera (CS 1600) is an intraoral camera system that also includes an optical caries detection system based on fluorescence imaging with reflectance enhancement. The system is intended for use by healthcare professionals in dental and dental sub-specialty clinical settings.
The system consists of an intraoral camera assembly which is connected via USB connection to a PC, and associated image acquisition software and accessories. Accessories include hygienic barrier sheaths and a collar attachment for the camera assembly that is used for maintaining an optimal working distance in either caries detection mode.
The provided text describes the Carestream CS 1600 Intraoral Camera and its intended use as an aid in detecting dental caries. However, it does not contain the detailed clinical study information or acceptance criteria that would allow for a comprehensive answer to your request.
Specifically, the document states:
- "Clinical testing of the system in each caries detection mode has been completed. The conclusion of the study verified the efficacy for the intended use of the device under clinical conditions." (Section 9. Clinical Testing)
- "Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use." (Section 8. Non-Clinical testing)
These statements confirm that clinical testing was performed and concluded the device was effective, but they do not provide any of the quantitative details you requested.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, sample sizes, ground truth establishment, MRMC studies, or standalone performance. The document focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices, rather than presenting detailed clinical performance data.
§ 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.