(54 days)
The Digora Optime imaging system is indicated for capturing, digitization and The Digora Optime Images stored in imaging plate recording media.
A digital radiography system for intra oral imaging plates located in disposable bags. The system may be used with all x-ray equipment which is designed for intra oral radiography. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photo electronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spatial Resolution (Predicate Device: Digora) | 8 lp/mm |
| Spatial Resolution (Subject Device: Digora Optime) | 10 lp/mm |
| Dose required for a certain pixel-value (compared to Digora) | Equivalent |
| Bit Depth (Predicate Device: Digora) | 8 bits |
| Bit Depth (Subject Device: Digora Optime) | 14 bits |
| Ability to read imaging plates of sizes: 0, 1, 2, 3 intraoral films | Confirmed |
| Diagnostic capability (compared to Digora) | Equivalent or slightly better |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for a test set. It mentions a "comparison between a pixel-value of a known object and the spatial resolution," which suggests some form of testing, but details on the number of images or cases are absent.
The data provenance is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The statement about "diagnostic capability" implies some form of assessment, but the methodology is not detailed.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not mention an MRMC comparative effectiveness study. It states that "Digora Optime has also been shown to be able to provide images of equivalent or slightly better diagnostic capability to the predicate device Digora." However, it does not elaborate on the study design or report any effect size.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device described is an "imaging plate reader" that processes digital electronic signals and relies on "auxiliary software (such as Digora for Windows K983267), a PC" for further image processing, display, and archiving. While the device itself is a piece of hardware, the term "standalone" in the context of an algorithm or AI typically refers to the performance of the software processing. The document focuses on the technical performance of the imaging plate reader and its output quality, rather than the standalone performance of an AI algorithm in isolation. Therefore, a standalone algorithm-only performance study as typically understood in AI is not described. The performance described is of the entire system as an image acquisition and digitization device.
7. The Type of Ground Truth Used
The ground truth appears to be based on:
- Known object characteristics: For spatial resolution and pixel-value.
- Comparison to a predicate device's performance: For dose and diagnostic capability.
There is no mention of pathology, expert consensus, or outcomes data being explicitly used as ground truth.
8. The Sample Size for the Training Set
The document does not mention any "training set" or "training data" as
this is not an AI/ML device per se but a medical device for image acquisition.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned in the context of this device.
§ 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.