(98 days)
This system is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.
RIOSensor(Model RIS500) is intended to acquire real-time, clinical digital intraoral X-ray images using a solid-state imaging sensor. This system consists of the CMOS sensor and software for image display. This system senses the onset of the X-ray exposure and automatically acquires and save the image data to a PC (software).
Here's a breakdown of the acceptance criteria and study information for the RIO Sensor (RIS 500) based on the provided document:
This device is an intraoral imaging unit (dental X-ray sensor), and the focus of the performance evaluation is on its imaging characteristics, rather than diagnostic AI performance. Therefore, many typical AI-related criteria like MRMC studies, effect size of AI, and ground truth for disease detection are not applicable here. The evaluation centers on the physical and technical performance of the X-ray sensor itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Imaging Properties) | Reported Device Performance (RIS500) | Predicate Device-1 (EzSensor P) | Predicate Device-2 (EzSensor) |
|---|---|---|---|
| Theoretical Resolution (lp/mm) | 25 lp/mm | 25 lp/mm | 14.3 lp/mm |
| MTF (Modulation Transfer Function) | > 30% at 6 lp/mm | > 30% at 6 lp/mm | > 30% at 6 lp/mm |
| DQE (Detective Quantum Efficiency) | > 40% at 2.5 lp/mm | > 40% at 2.5 lp/mm | > 40% at 2.5 lp/mm |
| Pixel Size | 20x20 µm | 20x20 µm | 35x35 µm |
| Pixel Matrix (Size 1) | 1000x1500 pixel | 1200x1650 pixel (for Size 1.5) | 572x858 pixel (for Size 1) |
| Pixel Matrix (Size 2) | 1300x1700 pixel | 1300x1800 pixel (for Size 2.0) | 686x944 pixel (for Size 1.5) |
| Sensor Thickness | 5.6 mm | 4.95 mm | 4.95mm |
Note: The predicate devices have slightly different sizing conventions (e.g., "Size 1.5", "Size 2.0") which makes a direct pixel matrix comparison challenging without knowing the exact dimensions corresponding to "Size 1" and "Size 2" for RIS500 relative to the predicates. However, the theoretical resolution, MTF, and DQE are directly comparable and are the primary performance metrics. The RIS500 meets or exceeds the key imaging performance criteria of the predicate devices.
2. Sample Size for the Test Set and Data Provenance
The document primarily describes bench testing and non-clinical testing for evaluating the technical performance of the imaging device. It does not mention a "test set" in the context of clinical images for diagnostic evaluation, as there is no AI algorithm being evaluated for diagnostic efficacy.
- Bench Testing: Used to assess whether parameters related to imaging properties and patient dosage satisfy designated tolerances. The sample size for this is not explicitly stated but implies testing a sufficient number of devices or iterations to demonstrate compliance with standards.
- Non-Clinical Testing: Included MTF and DQE of the detector. No specific "sample size" of images is mentioned beyond the testing methodology itself.
- Clinical Considerations: "For clinical testing, two licensed practitioners/clinicians observed and verified that Intraoral Imaging Unit from RIOSensor (Model name: RIS500)." This suggests a qualitative observation by clinicians, not a quantitative study with a defined image test set.
- Data Provenance: Not applicable in the traditional sense for an AI model. The tests are on the device's hardware performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Ground Truth for Technical Performance: The "ground truth" for the technical performance metrics (MTF, DQE, theoretical resolution) is established by the performance testing standards themselves (e.g., IEC 61223-3-4). These are objective measurements against established physical standards.
- Clinical Observation: Two "licensed practitioners/clinicians" observed and verified the device. Their specific qualifications (e.g., years of experience, specialization) are not detailed beyond being "licensed practitioners/clinicians." This was for general verification, not for establishing diagnostic ground truth on a specific test set of cases.
4. Adjudication Method for the Test Set
Not applicable. There was no diagnostic test set requiring adjudication from multiple experts. The "clinical considerations" involved observation and verification by two practitioners, but not an adjudication process as understood in AI studies for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size
No, an MRMC comparative effectiveness study was not done. The device is a direct X-ray sensor, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is the X-ray sensor itself; it's not a standalone AI algorithm. Its performance is its ability to acquire and convert X-ray photons into electronic impulses for display.
7. The Type of Ground Truth Used
For the technical performance of the device (MTF, DQE, resolution), the ground truth is established by objective physical measurements against industry standards (e.g., IEC 61223-3-4). This is a form of scientific/engineering ground truth.
8. The Sample Size for the Training Set
Not applicable. This is an X-ray sensor, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI model or training set.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.