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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 Orthopantomograph® OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.

Orthopantomograph® OP300 is an extraoral source dental x-ray device, which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software. The name Orthopantomograph® OP300 is used when the device can produce panoramic, TMJ and optionally 3D images. The name Orthoceph® OC300 is used when the cephalometric option for cephalometric x-ray images is added to the device. Furthermore, the device can be equipped with the Volumetric Tomography device (K063773).

The provided text is a 510(k) summary for the Orthopantomograph® OP300, a dental X-ray device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, and adjudication methods for a specific study proving device performance against acceptance criteria is not present in the provided text. The document primarily identifies the device, its intended use, technological characteristics, and claims substantial equivalence to predicate devices.

Here's a breakdown of why each specific piece of information cannot be extracted:

• 1. A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the new device (e.g., minimum diagnostic accuracy, image quality scores). It doesn't report any direct performance metrics for the Orthopantomograph® OP300 in a study.
• 2. Sample size used for the test set and the data provenance: There is no mention of a test set, studies, or clinical data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set or study is described, this information is not available.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or study is described.
• 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: This document is for an X-ray device, not an AI-powered diagnostic tool, and no MRMC studies or AI involvement are mentioned.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned as no study is described.
• 8. The sample size for the training set: Not applicable as this is not an AI algorithm or a study involving a training set.
• 9. How the ground truth for the training set was established: Not applicable for the same reasons as above.

In summary, the provided 510(k) summary (K093683) for the Orthopantomograph® OP300 is a regulatory document focused on establishing substantial equivalence based on intended use and technological characteristics rather than providing detailed clinical study results with performance metrics and acceptance criteria.

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The Orthopantomograph® OP30 dental panoramic x-ray equipment is indented for dental radiographic examinations by producing digital radiographs of teeth. TM-joints and other oral structures by dentists and other legally qualified professionals.

Orthopantomograph® OP30 is an extraoral source dental x-ray equipment, which produces dental panoramic and TMJ images on its digital x-rav image receptor. The technique factor settings are: 66, 70, 73 or 77 kV, 10 mA and max 10 sec.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Orthopantomograph® OP30, focusing on its intended use, technological characteristics, and substantial equivalence to a predicate device. It confirms FDA clearance but does not include details on specific performance metrics, studies, sample sizes, or ground truth establishment.

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Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Snapshot is a digital intraoral sensor system that can be connected to a workstation PC via USB connection. The essential function and purpose of the system in a dental clinic is to capture intraoral digital dental x-ray images. The system can be used with general intraoral X-ray units. Snapshot utilizes existing designs and share parts with the predicate Sigma M sensor. The sensor is the same CMOS sensor as that of the predicate device. USB 2.0 High speed connection is used for image transfer to a PC. The basic system consists of Sensor, which is available in two sizes, Workstation software, Sensor holders and hygienic covers.

The provided document is a 510(k) summary for the Snapshot digital intraoral sensor system. It focuses on demonstrating substantial equivalence to a predicate device (Sigma M) rather than presenting a standalone study with acceptance criteria and performance data. Therefore, many of the requested details are not present in this document.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided document. The 510(k) summary primarily focuses on demonstrating substantial equivalence based on design, composition, and function compared to a predicate device, rather than quantitative performance against specific acceptance criteria. It states: "As conclusion Snapshot is as safe, as effective, and performs as well as or better than the predicate device." This is a qualitative statement of equivalence, not a presentation of performance data against defined metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document. There is no mention of a specific test set or data provenance for a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document. As there's no mention of a test set or a study conducted to establish performance metrics, there's no information on experts or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document.

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

There is no indication that an MRMC comparative effectiveness study was done, or that the device involves AI assistance. The document describes a "digital intraoral sensor system" which is a hardware component for capturing X-ray images, not an AI-powered diagnostic tool. The focus is on the sensor's ability to capture images, not on assisting human readers with interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/available. The "Snapshot" is a digital intraoral sensor system, essentially a hardware component for image acquisition, not an algorithm that functions in a standalone capacity for diagnosis. Its purpose is to "capture intraoral digital dental x-ray images."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided document, as no specific performance study with ground truth is detailed.

8. The sample size for the training set

This information is not available in the provided document. The device is a digital sensor, not a machine learning algorithm that requires a training set in the typical sense.

9. How the ground truth for the training set was established

This information is not available in the provided document, as it's not relevant to the described device type.

In summary:

The provided document is a 510(k) premarket notification that asserts substantial equivalence of the Snapshot device to a predicate device (Sigma M) based on design and functional similarities. It does not contain details about specific performance studies with acceptance criteria, test sets, or ground truth establishment, which are typical for studies evaluating diagnostic accuracy or AI software performance. The device is a hardware system for image capture, not an AI-driven diagnostic tool.

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