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The Orthopantomograph OP300 panoramic, cephalometric and cone beam computed tomography x-ray device is intended to image the head and neck areas for diagnostic support. This includes temporomandibular Joints (TMJs) and dentomaxillofacial areas, and with the 13x15 cm field of view (FOV) this additionally includes the ear. nose and throat (ENT) regions. The x-ray device produces conventional 2D x-ray images and x-ray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

Orthopantomograph OP300 x-ray unit is a software controlled diagnostic dental X-ray equipment for producing panoramic, cephalometric and 3D images of the dentomaxillofacial complex, ENT and airway regions of the head and neck. The Orthopantomograph OP300 is available in different configurations (panoramic, cephalometric, 3D) with different 3D Field of View configurations (6X4 cm, 6X8 cm, 5X5 cm, 8X8 cm, 8X15 cm, and 13X15 cm). The components of the device include column, carriage, rotating unit (containing tube head, sensors and collimator), top-level hanger, patient head support, software for image reconstruction, and an optional software package for image reviewing. The proprietary name of the optional image reviewing software is CLINIVIEW.

Cone Beam Volumetric Tomography is a medical imaging technique that uses X-rays to obtain crosssectional images of the head or neck. The proposed device utilizes cone beam X-ray technology, which generates conical x-ray beams that rotate around the patient's head and incident upon the receptor that generate sufficiently contrasted images. Quality of the images depends on the level and amount of X-ray energy delivered to the tissue. When interpreted by a trained physician, these images provide useful diagnostic information.

The provided text describes the Orthopantomograph OP300, a dental X-ray device. The acceptance criteria and the study proving the device meets these criteria are mainly focused on demonstrating substantial equivalence to predicate devices, particularly the Scanora 3D (K110839), for expanded indications including ENT imaging.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for diagnostic accuracy or specific imaging quality metrics. Instead, it focuses on demonstrating substantial equivalence in diagnostic quality.

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

The text mentions an "image comparison study" and "clinical images acquired using Orthopantomograph OP300." However, it does not specify the sample size for the test set or the provenance (country of origin, retrospective/prospective) of the data used in these studies.

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)

The text states that "clinical images acquired using Orthopantomograph OP300 were reviewed by qualified clinicians" and that the image comparison study involved "images from ENT, airway and maxillofacial areas." However, it does not specify the number of experts used or their specific qualifications (e.g., number of years of experience, specific board certifications).

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

The text does not provide any information about the adjudication method used for establishing ground truth or evaluating images in the mentioned studies. It simply states that images were "reviewed by qualified clinicians."

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

The document describes an "image comparison study of predicate device Scanora 3D and proposed device Orthopantomograph OP300 images." This suggests a comparative study between devices rather than a human-in-the-loop study with AI assistance. The device is an X-ray imaging system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable and was not reported.

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

This point is not applicable as the Orthopantomograph OP300 is an imaging device, not an AI algorithm. Its performance is evaluated based on the quality of the images it produces for human interpretation, not as a standalone diagnostic algorithm.

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

The ground truth for the "acceptable quality" and "equivalent diagnostic quality" seems to be established through expert clinical review and comparison. There is no mention of pathology or outcomes data being used as ground truth for image quality assessments in the provided text.

8. The sample size for the training set

The document makes no mention of a "training set" as it describes an X-ray imaging device, not an AI model that requires training. The studies mentioned are focused on design verification, validation, and clinical image quality assessment.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

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The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination 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 is operated and used by qualified healthcare professionals.

The Orthopantomograph OP300 is an extra oral source dental x-ray device that is softwarecontrolled 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 provided text describes a 510(k) premarket notification for a modified dental X-ray device, the OP300. The submission aims to demonstrate substantial equivalence to a predicate device (also an OP300, K122018) rather than presenting a novel device that requires extensive clinical studies. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering and bench testing, demonstrating that the modifications do not negatively impact safety or effectiveness.

Here's an analysis based on the provided text, recognizing that this is a 510(k) submission for a modification, not a de novo device requiring broad clinical trials:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by complying with recognized consensus standards and demonstrating equivalent image quality and performance to the predicate device through bench testing.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • For image quality and sensor performance, the testing involved comparing the modified OP300 against the predicate OP300 (K122018). The specific number of images or runs is not explicitly stated, but it was "in-house Performance (bench) testing."
  • For the anthropomorphic phantom evaluation, it involved "images of an anthropomorphic phantom." The number of images is not specified.
  • Clinical images of patients were explicitly not used to support substantial equivalence.
• Data Provenance: The testing was "in-house" bench testing, conducted by the manufacturer (PaloDEx Group Oy) in Finland. This indicates internal, controlled testing, not necessarily independent third-party validation. The data is retrospective in the sense that it's comparing a new version to an existing (predicate) version's performance characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

No external experts or clinicians were explicitly stated as establishing ground truth for the bench test set. The evaluation of "image quality" and "sensor performance" likely relied on internal engineering and quality control staff, comparing objective metrics and potentially subjective assessments by qualified personnel. The statement "it was concluded that there is no significant differences in image quality" implies an internal assessment.

4. Adjudication Method for the Test Set

No formal adjudication method (like 2+1 or 3+1 by multiple experts) is mentioned, as clinical data was not used. The determination of "no significant differences" in image quality and sensor performance appears to be a conclusion drawn from the in-house bench testing results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was conducted. The submission explicitly states: "Sample clinical images of patients were not used to support substantial equivalence of the OP300 device." This means there was no human reader component to the "effect size of how much human readers improve with AI vs without AI assistance" as there is no AI assistance feature discussed in the submission, and no human reader study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an imaging system, not an algorithm being validated in isolation. The "standalone" performance relates to its ability to produce images compliant with standards and equivalent to the predicate, which was assessed through bench testing. The reconstruction software (FBP or ART) operates in a "standalone" fashion to generate the 3D view from 2D projections, but its performance was evaluated in terms of image quality metrics from the phantom, not through a separate algorithm-only study.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission primarily relies on:

• Engineering benchmarks and specifications: Adherence to the technical parameters and performance characteristics established for the predicate device.
• Consensus Standards: Compliance with recognized international standards (IEC 60601 series).
• Anthropomorphic phantom images: The "truth" for these images is the known anatomical/radiological features within the phantom, and the assessment looked for "severe defects" rather than diagnosing a specific condition.

8. The Sample Size for the Training Set

This submission is for a device modification (hardware and GUI changes), not a new algorithm that requires a separate training set. The device uses established image reconstruction techniques (FBP, ART) which do not involve deep learning or AI requiring a "training set" in the modern sense. Therefore, there is no mention of a training set sample size.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.

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The OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination 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 is operated and used by qualified healthcare professionals.

The Orthopantomograph OP300 is an extraoral source, software-controlled dental x-rav 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 provided text does not contain detailed information about specific acceptance criteria (performance metrics with thresholds) for the OP300 device, nor does it detail a comprehensive study designed to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the available text:

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

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics with specific thresholds (e.g., accuracy > 90%, sensitivity > 85%). Instead, it establishes "substantial equivalence" based on similar technological characteristics. The table provided focuses on comparing the design and function of the modified OP300 to its predicate (OP300 [K093683]).

The "acceptance criteria" here are largely based on the new device having "Same" or "similar" (within a specified range) technological and performance characteristics as the predicate device, which is a common approach for 510(k) submissions.

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

• Sample size: The document mentions a "Preference study as an image quality comparison." It states that "Same patient data was used for the reconstructions." It does not specify the number of patients or images used in this preference study.
• Data provenance: Not explicitly stated. The manufacturer is based in Finland. The study is referred to as a "preference study" implying image review, but the source of the patient data (country, retrospective/prospective) is not detailed.

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)

• Number of experts: The preference study involved "internal reviewers and external dental professionals." The exact number of these professionals is not specified.
• Qualifications of experts: The document only refers to them as "external dental professionals" and "internal reviewers." No specific qualifications (e.g., years of experience, specialization) are provided.

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

The document does not describe the adjudication method for the preference study. It simply states that images were "evaluated by internal reviewers and external dental professionals."

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, particularly one measuring the improvement of human readers with AI assistance, was not conducted. This device is a pure imaging system, not an AI diagnostic tool.
• The "preference study" compares images from the new OP300 with its predicate. It's a reader study, but not an MRMC for AI assistance. It aims to show equivalent image quality between the devices, not human performance improvement with AI.

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

• This question is less relevant to the OP300, as it is an imaging device, not an AI algorithm intended for standalone diagnostic performance.
• The "standalone" performance in this context would refer to the image quality produced by the system itself. The preference study was designed to compare the image quality of the modified OP300 to the predicate, effectively assessing its standalone imaging performance.

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

For the preference study, the "ground truth" was subjective expert preference/evaluation of image quality. It was not based on objective clinical ground truth like pathology or outcomes data. This is appropriate for an image quality comparison study rather than a diagnostic accuracy study.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning. It's an X-ray imaging device. Its algorithms (Filtered Back Projection or Algebraic Reconstruction Technique) are established methods, not 'trained' in the same way an AI model is.

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

Not applicable, as no machine learning training set is mentioned or implied for this device.

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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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