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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.

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.

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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

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.

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