(26 days)
The Intraoral Dental Digital Imaging Sensor is aimed at the acquisition of intra-oral medical images from teeth, jaw and oral structure, only for exclusive dental use and must be handled by trained and qualified health professionals.
This Intraoral Dental Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. There are three names proposed for this device: EAGLE S/ SAEVO SLIM/D700 SLIM. The three models are all identical except for the name. This sensor was developed to obtain a high-quality x-ray image from the human arch and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital sign and transfers it to a computer through USB connection (Universal Serial Bus). The device performs the acquisition by positioning the sensor inside of the patient's mouth, behind the structure to be examined. The structure should be exposed to a dose of x-rays, using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and then transfers it to a computer via a Universal Serial Bus (USB) connection. The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device.
The provided text describes the marketing submission for an Intraoral Dental Digital Imaging Sensor (Eagle S/Saevo Slim/D700 Slim) and its claim of substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria or a comprehensive study demonstrating performance against specific numerical or qualitative endpoints. The document primarily focuses on non-clinical testing (safety, EMC, biocompatibility) and a general statement about clinical images.
Here's an analysis of what information is available and what is missing, structured according to your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics. Instead, it presents a comparison table and discusses general improvements over the predicate device.
| Acceptance Criteria (Implicit/Derived) | Reported Device Performance (vs. Predicate) |
|---|---|
| Resolution (Line pairs/mm) | 25 lp/mm (Predicate: 15 lp/mm) |
| Pixel Size | 20 µm (Predicate: 33 µm) |
| Number of Pixels (Size 1) | 1000 x 1500 (Predicate: 600 x 900) |
| Number of Pixels (Size 2) | 1300 x 1800 (Predicate: 800 x 1000) |
| MTF (Modulation Transfer Function) | >70% @ 1.47 lp/mm (at RQA5) (Predicate: Not specified) |
| DQE (Detective Quantum Efficiency) | >61.3% @ 0 lp/mm (at RQA5) (Predicate: Not specified) |
| Contrast | 12 bits (Same as Predicate) |
| Gray Level | 4096 (Same as Predicate) |
| Clinical Acceptability | Images are of "good quality, clinically acceptable, and better than the predicate images." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the "clinical images" or "submitted intra-oral radiographs."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "submitted intra-oral radiographs" and "adequate clinical images."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One expert was mentioned for the image quality analysis.
- Qualifications: "USA Board Certified Radiologist." No mention of years of experience.
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Adjudication method for the test set:
- Adjudication Method: Not specified. It mentions a single "USA Board Certified Radiologist" performed an "image quality analysis" comparing the predicate to the new device. This suggests a sole expert review rather than a multi-reader adjudication process (e.g., 2+1 or 3+1).
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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:
- MRMC Study: No. The device is an imaging sensor, not an AI-assisted diagnostic tool for humans, so an MRMC study related to AI assistance for human readers is not relevant in this context. The clinical evaluation mentioned focused on inherent image quality of the sensor itself.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in the sense that the sensor's technical performance (resolution, MTF, DQE) was evaluated through bench testing, which is an algorithm/device-only evaluation. The "adequate clinical images" and radiologist review also reflect the standalone performance of the imaging sensor.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth (for image quality): Expert opinion/comparison. The "USA Board Certified Radiologist" compared images from the predicate and the new device. For the technical metrics (MTF, DQE, resolution), these are physical measurements rather than clinical ground truth established by pathology or outcomes.
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The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document describes an imaging sensor, not a machine learning or AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable (as above).
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.