(196 days)
Digital image scanner of dental is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.
Digital image scanner of dental is a dental device that scans IP Imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on the screen and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size S0, S1, S2 and S3. The intraoral plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with 630-645 nm laser. The laser beam is moved across the surface of the plate by an oscillating mirror. The laser beam stimulates the top coating of the plates, which consists of X-rays sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier tube/ PMT) and transferred into an electrical output signal. This signal is digitalized and is the data for the digital X-ray image. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the screen, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.
The provided document is a 510(k) summary for a dental image scanner. It describes the device, compares it to a predicate device, and outlines the non-clinical testing performed to demonstrate substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the way medical imaging AI/CAD performance studies typically do, nor does it refer to a multi-reader multi-case (MRMC) study. The testing described focuses on device performance characteristics rather than diagnostic accuracy with human readers.
Therefore, many of the requested criteria cannot be directly extracted from this document, as they pertain to clinical or human performance studies, which are explicitly stated as "not required for this submission."
Here's the information that can be extracted or inferred, with explanations for what cannot be found:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of general acceptance criteria with performance results in the context of diagnostic accuracy. Instead, it lists technical performance tests and states that the "Imaging standard requirements were met" and "Laser products have passed safety test."
| Acceptance Criteria Category | Specific Test/Parameter (if applicable) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Passed (does not raise questions about safety effectiveness) |
| Electromagnetic Compatibility | IEC 60601-1-2 | Passed (does not raise questions about safety effectiveness) |
| Imaging Performance | Imaging standard requirements (dental X-ray), IEC 61223-3-4 | Met X-ray equipment imaging standard requirements |
| Laser Safety | IEC 60825-1 | Passed safety test |
| Software Verification & Validation | FDA Guidance for Software in Medical Devices | All functions supporting system specification are proper; verification and validation properly accomplished. |
| Image Plate Test | Imaging area, degree of attenuation, uniformity, image contrast, bit depth, spatial resolution/MTF | Verified by testing |
| Image Accuracy & Fidelity Test | Accuracy, uniformity, image contrast, spatial resolution/MTF, image fidelity | Verified by testing |
| Theoretical Resolutions | Not explicitly an acceptance criterion, but mentioned | 17 LP/mm (compared to predicate's 10 or 33 LP/mm) |
| MTF (Modulation Transfer Function) | Not explicitly an acceptance criterion, but mentioned | More than 45% at 3 lp/mm |
| DQE (Detective Quantum Efficiency) | Not explicitly an acceptance criterion, but mentioned | More than 21.0% at 3 lp/mm |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "image plates test" and "image accuracy and fidelity test," which are laboratory/technical performance tests, not clinical performance tests with a specific patient dataset.
- Data Provenance: Not applicable, as no patient data (images from humans) was used for performance testing (clinical testing was not required). The tests appear to be conducted on the device itself using phantom or test patterns.
- Retrospective/Prospective: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided because diagnostic ground truth from expert readers was not established or used, as clinical testing was not required. The "ground truth" for the technical tests would be the known properties of the phantoms/test patterns used.
4. Adjudication method for the test set
- Not applicable, as no expert reading or adjudication of diagnostic findings was involved.
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, an MRMC comparative effectiveness study was not done. The document explicitly states under section 7, "Clinical Testing: Clinical testing was not required for this submission." This type of study would fall under clinical testing.
- Effect Size: Not applicable as no such study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is a hardware scanner, not an AI/CAD algorithm. The "Image Reading and Checking Testing" falls under standalone performance, as it assesses the device's ability to accurately scan and process images. However, this is about the quality of the image output from the scanner, not the diagnostic performance of an AI algorithm on those images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the technical performance tests ("Image Reading and Checking Testing"), the ground truth would be established by the known characteristics of the test patterns, phantoms, and calibrated equipment used for measurement. It is not expert consensus, pathology, or outcomes data, as these relate to clinical diagnostic accuracy, which was not assessed.
8. The sample size for the training set
- Not applicable. This device is a scanner, not an AI or machine learning algorithm that requires a training set. The "software verification and validation testing" refers to typical software engineering V&V processes, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device (it's not an AI/ML algorithm).
§ 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.