(150 days)
The DIGORA® Optime imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
SOREDEX® DIGORA® Optime system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.
DIGORA® Optime (DXR-60) is 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 xray film or digital sensor. 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 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.
Further image processing, display and achieving are carried out with auxiliary software.
Here is an analysis of the provided text regarding the DIGORA® Optime (DXR-60) device, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the DIGORA® Optime (DXR-60) as substantially equivalent to its predicate device, the DXR-50, based on design, composition, and function. The acceptance criteria essentially revolves around demonstrating that the new device is as safe and effective as the predicate, with modifications having no adverse impact.
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance (DXR-60) | Notes |
|---|---|---|---|
| Material Changes | Equivalence in functionality to DXR-50 | Replaced machined aluminum with plastic components (chassis, plate carrier, door) providing equivalent functionality. | Verified/validated to have no impact on safety, effectiveness, image quality, or expected lifetime. |
| User Interface (UI) | Better visual communication and usability without affecting safety/efficacy | Modified control panel with relocated buttons, lighted numeric LEDs, and symbols for plate positioning, device status, and error codes. | Verified/validated to not affect safety or efficacy. |
| Image Processing Feature | Stitching two size 3 plates for occlusal view without affecting safety/effectiveness | "Comfort Occlusal 4C image processing ability" - two size 3 plates can be stitched; plates processed and supplied separately, then stitched. | Verified/validated to not affect safety or effectiveness, and makes the feature safe. |
| Safety and Effectiveness | No adverse impact on safety or efficacy from modifications | Design verification and validation demonstrated modifications did not affect safety and efficacy or raise new safety/efficacy questions. | Comprehensive testing on all applicable requirements per FDA guidance. |
| Image Quality | Diagnostic-quality images | Capable of providing diagnostic-quality images via anthropomorphic phantom images. | Considered appropriate due to primary target anatomy not involving moving or soft tissues of similar contrast. |
| Substantial Equivalence | Similar technological/performance characteristics to predicate | Deemed substantially equivalent to the predicate device (K041050) in clinical performance. | Based on similar characteristics and successful validation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For the non-clinical testing, anthropomorphic phantoms were used as the "test set" to demonstrate image quality and system capability. No specific number of phantoms or images is provided, but it states "Anthropomorphic phantom images of perianical and bitewing views were provided."
- No human patient images were used for clinical testing.
- Data Provenance: The testing was conducted by PaloDEx Group Oy (Manufacturer) in Tuusula, Finland. The data is non-clinical and derived from phantom images rather than retrospective or prospective human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience) used to establish "ground truth" for the phantom images. It implies that the manufacturer's internal team determined the images were "diagnostic-quality." Given the non-clinical nature and the product (an imaging plate reader), the "ground truth" for image quality would likely be assessed against established imaging standards and anatomical correctness within the phantom.
4. Adjudication Method for the Test Set
No multi-expert adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the primary test involved non-clinical phantom images. The assessment of "diagnostic-quality" appears to be an internal verification by the manufacturer.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not deemed necessary on DIGORA® Optime (DXR-60) device." Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported, as this study type was not performed and the device is an imaging plate reader, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The DIGORA® Optime (DXR-60) is an imaging plate reader, not an algorithm in the sense of a standalone AI diagnostic tool. Its performance is inherent in its ability to capture, digitize, and process x-ray images from imaging plates. The non-clinical tests on phantoms demonstrate this standalone functional performance (i.e., algorithm only in the sense of image processing capability, without human interpretation for diagnostic purposes as the primary outcome). The "algorithm" here refers to the system's image processing capabilities to produce an image, not an interpretative AI.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's performance was:
- Engineering/Technical Specification Comparisons: Comparing the DXR-60's specifications (e.g., theoretical resolution, pixel size, bit depth) against the predicate DXR-50 and demonstrating either equivalence or improvement where relevant.
- Physical Phantom Images: For image quality assessment, anthropomorphic phantom images were used, with the "ground truth" being the expected anatomical structures and image characteristics represented by the phantom for "diagnostic quality."
- Functional Verification/Validation: For material changes and UI modifications, the ground truth was that the changes had "no impact on safety, effectiveness, and overall performance."
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here in the context of machine learning. The DIGORA® Optime is a physical medical device (an imaging plate reader) and not an AI/ML algorithm that requires a training set of data. Its development involves traditional engineering design, testing, and validation processes, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" in the machine learning sense for this device. Therefore, no ground truth was established for a training set. The device's "training" refers to its design and manufacturing processes ensuring it meets its intended specifications and performance.
§ 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.