Search Results

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.

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.

Ask a specific question about this device