(392 days)
C50 is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to magnification).
The C50 is an intraoral video camera equipped with LEDs to illuminate the inspection site. The C50 optics and its complementary metal oxide semiconductor (CMOS) sensor capture the natural fluorescence of the site under observation and convert the images into a video signal that is sent to the computer via a USB interface. The dental practitioner can use the images displayed on the computer screen as an aid in diagnosis. A USB Type-C (camera) to USB-A cable is provided to connect the C50 to a computer. The C50 provides the following functions: Aid in the detection of pit and fissure caries Information about patient dental hygiene Highlighting of dental plaque Highlighting of gingival inflammations (restricted to gingival inflammation that leads to bleeding upon probing) Showing the difference between "before" and "after" care (follow-up). In CARIO mode (blue mode), the camera assists the dental practitioner by highlighting potential carious areas in pits and fissures on the occlusal surface of the teeth. In DAYLIGHT mode (white mode), the camera enables visualization of anatomical details invisible to the naked eye or with a mirror (thanks to its magnification). DAYLIGHT+ mode (white mode) is a shortcut version of DAYLIGHT mode where the contrast has been pushed from 20 to 70. In PERIO mode (yellow mode), the camera helps the dental practitioner to visualize dental plaque, in addition to highlighting areas of gingival inflammation (restricted to gingival inflammation that leads to bleeding upon probing).
The C50 is an intraoral camera intended for use in general dentistry. Its indications for use include aid in the diagnosis of pit and fissure caries, highlighting dental plaque and gingival inflammations (restricted to those leading to bleeding upon probing), and functioning as an intra-oral camera for magnified visualization of anatomical details.
Here's the breakdown of acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes comparison testing and other verification and validation tests rather than specific quantitative acceptance criteria for clinical performance metrics (e.g., sensitivity, specificity for caries detection). Instead, the performance testing focuses on demonstrating substantial equivalence to the predicate device and compliance with relevant safety and technical standards.
| Acceptance Criteria Category | Specific Test/Performance Aspect | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Clinical Modes (CARIO, DAYLIGHT, PERIO) | Demonstrated to be identical to the predicate device. |
| New Mode (DAYLIGHT+) | Functions similarly to DAYLIGHT mode but offers higher contrast. | |
| Image Quality (sharpness, size, resolution, focus position) | Comparison testing showed substantial equivalence to the predicate device, even with the Full HD resolution enhancement of the C50. | |
| Safety and Performance | Temperature elevation in target tissue | Comparison testing showed substantial equivalence to the predicate device. |
| Mechanical performance of reprocessed C50TIPS (maintains position, blocks external light) | Testing ensured the device maintains its position and completely blocks external light. | |
| Fit of third-party protective sheath with C50 and C50TIPS | Mechanical testing confirmed appropriate fit. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Electrical Safety (IEC 60601-1 and 60601-1-2) | Testing was conducted, and the device was found to be consistent with appropriate sections of the standards. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| EMC (IEC 60601-1-2, IEC/TR 60601-4-2) | Testing was conducted, and the device was found to be consistent with appropriate sections of the standards. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Photobiological Safety (IEC 62471) | Testing was conducted, and the device was found to be consistent with the appropriate section of the standard. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Software Validation (IEC 62304) | Validation was performed on the C50's firmware, consistent with the appropriate section of the standard. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Reprocessing Validation (FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings") | Validation was conducted on the C50, C50TIPS, and USB cable in accordance with FDA guidance. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | |
| Biocompatibility (ISO 10993-1, FDA Guidance Document "Use of International Standard ISO 10993-1") (C50TIPS) | Chemical characterization, cytotoxicity, and acute systemic toxicity tests were considered, and acceptance criteria were met for all. The patient contact materials are identical in formulation, manufacturing, processing, and geometry to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a test set in the traditional sense of a clinical diagnostic study with patient data used for accuracy evaluation. Instead, it refers to "comparison testing of image quality" and "mechanical performance testing" conducted on the device and its accessories (C50, C50TIPS, protective sheath, USB cable).
- Sample Size: Not specified in terms of number of patients or cases. The testing appears to have been performed on the devices themselves and associated accessories.
- Data Provenance: Not applicable in the context of device performance testing. The "data" generated comes from direct laboratory and safety testing of the device hardware and software. No patient or human subject data is mentioned for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As described above, the testing performed was focused on device characteristics and substantial equivalence to a predicate, not on a diagnostic accuracy study requiring expert ground truth establishment for patient cases.
4. Adjudication Method for the Test Set
Not applicable, as no clinical diagnostic test set with multiple reader interpretations requiring adjudication is described.
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 is described. The C50 is an intraoral camera and not an AI-powered diagnostic algorithm that assists human readers in interpretation. It provides visual information to the dental practitioner.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The C50 is a hardware device (intraoral camera with different illumination modes) that provides visual information. It is not an algorithm, and therefore, a standalone algorithm performance study is not applicable. The device's "diagnosis aid" function relies on the visual information it provides to the human practitioner.
7. The Type of Ground Truth Used
The ground truth used for relevant testing was based on:
- Comparison to a predicate device (SOPROCARE): Many aspects of the C50's performance (image quality, temperature elevation, functional modes) were evaluated against the known performance of the predicate device to establish substantial equivalence.
- Compliance with established standards: Electrical safety, EMC, photobiological safety, software validation, reprocessing validation, and biocompatibility were evaluated against recognized international and FDA standards.
- Engineering specifications/functional requirements: Mechanical tests ensured specific physical functionalities like the fit of accessories and light blocking.
8. The Sample Size for the Training Set
Not applicable. The C50 is a medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.