(168 days)
The iTero Lumina Pro NRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.
The iTero Lumina Pro is an integrated intraoral imaging system capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. Scanning cycles are employed allowing the system to quickly alternate between the three modalities, creating a virtually simultaneous capture of the 3D optical impression, 2D color and NIR images.
The iTero Lumina Pro consists of the following main components:
- A. Scanning Wand used for intraoral scanning.
- B. Wand Cradle used to hold the Scanning Wand when not in use.
- C. Application Software that includes Graphical User Interface ("GUI").
- D. Computer platform
The scanning wand houses electronic, mechanical, and optical components, including projectors, LEDs and cameras which enables capturing 3D impression data as well as 2D color and NIRI images. The wand body is made of Aluminum, Copolyester and Glass. When not in use, it is stored in the Wand Cradle.
The iTero Lumina Pro features proprietary software that can be installed on the various configurations of the computer platform. The software is designed to manage the GUI, control the scanning process, display the scanned images, and connect to the stored patient data, including scanned data for display or export.
The iTero Lumina scanning wand is designed to be used with a single-use, non-sterile, disposable, wand barrier sleeve. The only patient-contacting materials are those contained within the wand barrier sleeve.
The provided text does not contain detailed information about specific acceptance criteria and a study that comprehensively proves the device meets these criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial report with specific performance metrics against pre-defined acceptance criteria.
However, I can extract information related to performance data and testing methods mentioned in the "Performance Data" section to infer some aspects of device performance and the types of studies conducted.
Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations of the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for NIRI functionality or specific performance targets. Instead, it states that "All testing showed similar performance to the predicate system." This implies that the acceptance criterion was likely comparable performance to the predicate device across various technical attributes.
| Acceptance Criterion (Inferred from testing performed) | Reported Device Performance (Summary) |
|---|---|
| Field of View (NIRI) | Similar performance to the predicate system |
| Image Sharpness (NIRI) | Similar performance to the predicate system |
| Depth of Field (NIRI) | Similar performance to the predicate system |
| Illumination Power (NIRI) | Similar performance to the predicate system |
| Wavelength and Spectral Bandwidth (NIRI) | Similar performance to the predicate system (uses 850nm, same as predicate) |
| Specular Reflection Suppression (NIRI) | Similar performance to the predicate system |
| Signal to Noise Ratio (NIRI) | Similar performance to the predicate system |
| Wand barrier sleeve material properties | Met requirements for dental barriers (e.g., tensile strength, tear resistance, puncture, penetration) |
| Wand barrier sleeve finished assembly | Met requirements (Microbial Ingress Testing, Pull testing) and showed equivalent performance to predicate |
| Basic Safety (IEC 60601-1, IEC 80601-2-60, etc.) | Complies with relevant standards |
| Electromagnetic Compatibility (IEC 60601-1-2, FDA Gdn) | Complies with relevant standards |
| Usability (IEC 60601-1-6, IEC 62366-1) | Complies with relevant standards |
| Software Life-Cycle (IEC 62304, FDA Gdn) | Designed and developed according to standards |
| Cybersecurity (UL ANSI 2900-1, UL ANSI 2900-2-1, FDA) | Ensured by compliance with requirements |
| Biocompatibility (ISO 10993-series) | Patient contacting components shown to be biocompatible |
| Cleaning/Reprocessing (ANSI/AAMI ST98:2022, FDA Gdn) | Found to be reliably cleaned and validated |
2. Sample size used for the test set and the data provenance
The document explicitly states that the company performed "bench testing" to support substantial equivalence. It does not provide details on sample sizes for the NIRI performance attributes (Field of View, Image Sharpness, etc.). It mentions ASTM standards for material testing of the wand barrier sleeve, which would imply defined sample sizes per those standards, but these are not enumerated in the text. There is no information provided about the origin or nature of the "test set" data in terms of patient population (e.g., country of origin, retrospective or prospective).
The testing described appears to be primarily non-clinical bench testing rather than clinical study data involving patient samples or diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe a process for establishing ground truth using human experts for diagnostic accuracy. The performance data presented focuses on technical and engineering performance characteristics of the device itself (e.g., optical properties, material strength, electrical safety).
4. Adjudication method for the test set
Not applicable, as there is no description of a test set involving human interpretation and adjudication of diagnostic results.
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
The document does not mention any MRMC study or AI assistance. The device is described as a "diagnostic aid" providing NIR images for a dentist's review. The NIRI functionality itself is the diagnostic aid, not an AI component assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe any standalone algorithm performance testing. The device's NIRI functionality generates images that are then reviewed by a dentist.
7. The type of ground truth used
For the technical and engineering tests described, the ground truth would be established by the specifications and performance characteristics of the predicate device and relevant international standards (e.g., for electrical safety, biocompatibility, material properties). For the NIRI imagery itself, the comparison is made against the predicate device's image output, not against a clinical "ground truth" like pathology for caries detection in this summary.
8. The sample size for the training set
Not applicable. The document describes a medical device generating images, not a 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 mention of a training set for a machine learning model.
§ 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.