(182 days)
The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.
The TIA Tip is an optional interchangeable component tip assembly that works with the Dental CAD/CAM System Scanner. With the TIA Tip installed the system allows for the simultaneous side by side visualization of live transilluminated and color imaging of the patient's dental anatomy, as well as providing the user with the ability to capture and save transilluminated static images to a patient digital file. The system consists of:
- Dental Scanner .
- TIA Tip ●
- Computer with Software ●
With one of the other provided interchangeable scanning tips installed, the system is also used to process dental restorations that are regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM of Dental Restorations.
The Scanner is a hand-held electronic device that consists of three parts: the scanner body, the TIA Tip and a custom USB data cable that connects the scanner to the computer. The scanner contains the electrical and opto-mechanical components.
The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable.
The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light.
In operation the probes conform to dental anatomy to direct light into the desired area of inspection. The light penetrates the tooth surface due to the translucent nature of dental anatomy. This allows a user to visualize the inner structure of the tooth and specifically to detect irreqularities like caries that show up as dark areas or spots on the transilluminated image. The scattering light of the illuminated anatomy is reflected by the tip mirror and directed toward the camera in the scanner which allows for a digital image to be captured.
The tooth is illuminated with light from both the scanner's laser projection system (RGB) and the TIA Tip LED's. Timing of the light is controlled through the electronics and is divided into separate frames. Collecting and presenting these images at many frames per second allows simultaneous "live" views of transilluminated image and full color view to the system operator. This allows the user to better visualize caries that cannot be detected with standard color imaging. For example, a proximal dental cavity becomes visible as a dark region in the transilluminated image.
The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options.
The software operates on a laptop or desktop pc. A network connection is required for interoperability.
When the TIA Tip is installed, it is automatically detected by the scanner and the operator is presented with both a transilluminated view and a live view simultaneously. The operator is provided with controls on the scanner to start/stop and toggle TIA illumination from Both/Right/Left LEDs to enhance TIA viewing. Additionally, on screen controls allow for TIA illumination intensity control for further TIA view optimization. Image capture of simultaneous TIA and live view images is provided which can be used for later reference. No digitization occurs during TIA viewing.
The provided text describes the TIA Tip, Cariosity, Transillumination Accessory Tip, P/N 156930xx and its substantial equivalence to a predicate device. However, the document explicitly states that "Clinical testing is not required and has not been performed," and therefore it does not contain a study proving the device meets acceptance criteria.
Instead, the document focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text, noting where information is not available:
1. Table of acceptance criteria and the reported device performance
Since no clinical study was performed to establish acceptance criteria for detection performance, this table cannot be provided from the given text. The document refers to "Key performance attributes tested and compared include: a. LED illumination and output power, b. Image Quality" to demonstrate similar performance to the predicate device, not to meet specific acceptance criteria for caries detection.
2. Sample size used for the test set and the data provenance
Not applicable, as no clinical or comparative performance study using a test set was conducted for caries detection. The non-clinical tests relate to hardware performance and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical study or test set requiring expert ground truth was conducted.
4. Adjudication method for the test set
Not applicable, as no clinical study or test set requiring adjudication was conducted.
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
No MRMC comparative effectiveness study was done. The device does not incorporate AI; it is a transillumination accessory for direct visualization.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is a diagnostic aid for human viewing and does not involve a standalone algorithm for performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no ground truth for caries detection performance was established due to the absence of a clinical study for this purpose.
8. The sample size for the training set
Not applicable, as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as the device is not an AI/ML algorithm that requires a training set.
Summary of Non-Clinical Performance Testing (as described in the document):
The TIA Tip was evaluated through non-clinical performance testing to demonstrate substantial equivalence to the predicate device, the CamX Triton HD Proxi. The key aspects tested and compared were:
- LED illumination and output power: The comparison table indicates that while the TIA Tip uses 727nm wavelength LEDs and the predicate uses 850nm, the output power (Max 3.74mW/cm² for TIA Tip at 3.845 mm vs. Max 2.00 mW/cm² for predicate at 7mm) was considered "almost the same" when measured side-by-side using the same equipment and test environment, accounting for measuring distance differences.
- Image Quality: Specific metrics or quantitative results for image quality are not provided in this summary, but it states "image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and E4D's TIA Tip."
Additionally, the device complied with several safety and biocompatibility standards:
- IEC 60601-1 Edition 3.1 - Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 – Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ISO 17665-1 (Sterilization validation – Moist Heat)
- ISO 10993 series (Biocompatibility Testing), specifically ISO 10993-10 for Irritation and Delayed Hypersensitivity, and ISO 10993-5 for Cytotoxicity.
Conclusion stated in the document:
Based on similarities in indications for use and technological characteristics, together with results of non-clinical performance testing, it is concluded that the TIA Tip is substantially equivalent to the CamX Triton HD Proxi Head system. This substantial equivalence determination allows the device to be marketed without the need for a new clinical study demonstrating specific acceptance criteria for caries detection performance.
§ 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.