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hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:

(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMD), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The Proposed device is a panoramic, cephalometric and tomographic radiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084). Like the predicate device the proposed device can be sold under three different proprietary product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features:
1 hyperion X9 pro myray CEFLA S.C.
2 NewTom GIANO HR NewTom CEFLA S.C.
3 X-RADIUS TRIO PLUS Castellini CEFLA S.C.
Wherever the Proposed device is mentioned the device with its three different trade/ proprietary names: hyperion X9 pro, New Tom GiANO HR and X-RADiUS TRiO PLUS.
Like the predicate device hyperion X9 pro, NewTom GIANO HR, X-RADIUS TRIO PLUS (K214084) the proposed device is equipped with X-ray tube generator and X-ray sensors (Solid State X-ray Imaging Detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and computed tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C.

This document describes a 510(k) premarket notification for a dental X-ray system. The key aspect of this submission is that the Proposed Device is a modification of an existing, legally marketed Predicate Device. The modifications primarily involve the availability of alternative 2D X-ray detectors. Therefore, the study presented here focuses on demonstrating substantial equivalence to the predicate device, rather than proving novel performance against a clinical ground truth.

1. Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to an existing device, the "acceptance criteria" are predominantly the adherence to various medical device standards and the maintenance of comparable performance to the predicate device. The "reported device performance" is largely framed in terms of "no significant difference" or "comparable" to the predicate, as the goal is to show the new version is as safe and effective as the old.

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

The document does not specify a traditional "test set" sample size in terms of clinical cases or patient images. This submission relies on a comparison against the predicate device's established performance and adherence to engineering and safety standards. The testing described is primarily non-clinical performance testing to verify conformity with various IEC standards (electrical safety, EMC, radiation protection, software lifecycle, usability, dental x-ray specific requirements).

• Sample Size: Not specified in terms of clinical images or patient data, as the study is not based on a new clinical performance claim but on equivalence to a predicate. It indicates "Verification activities for confirmation of the image quality of the proposed device has been performed." This implies technical tests on samples, phantoms, or test patterns, rather than a large human-read image dataset.
• Data Provenance: Not explicitly stated for specific test data, but the manufacturer is CEFLA S.C. based in Imola, Italy. The testing would have been conducted as part of their device development and validation processes, likely at their facilities or certified labs. The study is a non-clinical validation comparing the proposed device's technical specifications and test results to those of the predicate device and relevant standards. It is retrospective in the sense that it relies on existing data/standards for the predicate and engineering tests for the new device.

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

This type of submission (510(k) for substantial equivalence based on non-clinical performance and direct comparison to a predicate) typically does not involve establishing ground truth through multiple expert clinical readers for a test set. The "ground truth" here is the established safety and performance of the predicate device and the adherence to relevant international standards.

If image quality was assessed, it would likely be through technical metrics (e.g., MTF, contrast, noise) rather than subjective clinical readings by multiple radiologists. The document references "image quality review," which could involve internal engineering and quality experts. No specific number or qualifications of experts for image review are provided in this summary.

4. Adjudication Method for the Test Set

Not applicable for this type of submission. There is no multi-reader, multi-case study or a need for clinical adjudication to establish ground truth for a diagnostic accuracy claim. The comparison is based on engineering specifications and adherence to standards.

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: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." This means the submission relies on non-clinical performance data and a direct comparison of features and technical specifications to the legally marketed predicate device.

Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance, as AI assistance is not the subject of this submission, nor is a human-in-the-loop performance study.

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

This device is an X-ray imaging system, not an AI software algorithm. Therefore, "standalone" algorithm performance testing is not applicable in this context. The core function is image acquisition, not algorithmic analysis of images.

7. The Type of Ground Truth Used

The "ground truth" for this submission is implicitly the already established and FDA-cleared performance and safety of the predicate device (K214084), combined with compliance with relevant international and national standards (e.g., IEC 60601 series, IEC 62304). The study aims to demonstrate that the small changes introduced do not alter this established 'ground truth' of safety and fundamental performance. It is not based on expert consensus for disease detection, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (X-ray system), not an AI algorithm that requires a "training set."

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

Not applicable, as there is no AI algorithm training set involved.

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hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:

(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dentomaxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

The Proposed device is a panoramic, cephalometric andiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro (K190496). Like the predicate device the proposed device can be sold under three different product name and brands for commercial needs, without changing any of the basic safety, essential performances and functional features:

Like the predicate device hyperion X9 pro (K190496) the proposed device is equipped with X-ray tube generator and X-ray sensors (solid state X-ray imaging detectors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT). The proposed device permits to acquire radiological images (panoramic images, cephalometric images and 3D volumes) at varying radiographic angles by rotating around the patient following different trajectories depending on the selected examination. The exposed area can be adapted to a specific region of interest to keep the radiation dose as low as possible for the patient. This is achieved by collimating the x-ray beam and the adjustment of starting and ending points of the x-ray source and sensor movement. Furthermore, the radiation dose can be adapted by various parameters such as examination types and exposure technique factors. Class I lasers pointers are utilized to define reference lines for the patient position. The patient, stabilized through adjustable patient supports, can sit or stand. Control panel allows user actions as: height adjustment, selection of examination, and exposure parameters and delivers information about the unit status. The obtained digital image data are processed to provide a reconstructed image. The images are transferred to a computer, in real time or later depending on the needs and choice of the operator. The software used to manage the images, essential for CBCT acquisitions, is NNT/iRYS, a radiological imaging software developed by CEFLA S.C.

The provided text describes a 510(k) premarket notification for a dental X-ray system, comparing a proposed device (hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS) to a predicate device (hyperion X9 pro, K190496). The submission focuses on demonstrating substantial equivalence, particularly related to the introduction of new 2D X-ray sensors.

Based on the provided text, the device in question is not an AI-powered device; it is a general dental X-ray imaging system. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML-based medical devices (such as MRMC studies, sample sizes for test/training sets, expert adjudication, or ground truth establishment for AI performance) are not applicable or reported in this document.

The "acceptance criteria" discussed in this document relate to the performance and safety standards that the medical device must meet to demonstrate substantial equivalence to a legally marketed predicate device. The text does not detail specific performance thresholds or how the device as an AI would be evaluated. Instead, it confirms compliance with general medical device standards.

Here's a breakdown of what is available and what is not for the requested points, given that this is not an AI device:

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

• Acceptance Criteria (as implied by the document for a general medical device): Compliance with recognized consensus standards for medical electrical equipment, radiation protection, and software.
  • IEC 60601-1: Medical electrical equipment (basic safety and essential performance)
  • IEC 60601-1-2: Electromagnetic compatibility
  • IEC 60825-1: Safety of laser products
  • IEC 60601-1-3: Radiation protection in diagnostic X-ray equipment
  • IEC 62366: Application of usability engineering
  • IEC 62304: Medical device software Software lifecycle processes
  • IEC 60601-2-63: Dental extra-oral X-ray equipment (particular requirements)
  • IEC 60601-1-6: Usability
  • Demonstration of equivalent or lower radiation dose (DAP values).
  • Demonstration of equivalent image quality.
• Reported Device Performance (against these criteria):
  • Radiation Dose: The Proposed Device showed "similar or lower measured DAP values than Predicate Device for the same selected exams."
    • Proposed Device (Sensors with scintillator): 11 mGy*cm2 to 126 mGy*cm2
    • Proposed Device (Direct conversion sensors): 7 mGy*cm2 to 103 mGy*cm2
    • Predicate Device (Sensor with scintillator): 13.01 mGy*cm2 to 229.81 mGy*cm2
  • Mechanical & Technical Features: Largely identical or with justified differences that do not negatively affect safety or performance (e.g., new direct conversion sensors, updated firmware/software to manage new sensors, but conforming to standards).
  • Image Quality: "The results of the image quality review have demonstrated that the device is substantially equivalent to the predicate device." (No specific metrics or quantitative values are provided for image quality beyond this statement).
  • Software Validation: Updated firmware and viewing software for new sensors were managed according to IEC 62304 and FDA Guidance on Medical Device Software.
  • Electrical Safety & EMC: Complies with IEC 60601-1:2012 and IEC 60601-1-2:2014.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not specified for AI performance. This document describes non-clinical performance testing (e.g., electrical safety, EMC, radiation output, image quality review) of the X-ray system itself, not a test set for an AI algorithm.
• The document states "The results of the Non-clinical performance testing support substantial equivalence." No specific "test set" sample size in the context of diagnostic performance (e.g., number of patient images) is mentioned.
• Data Provenance: Not explicitly stated, but the testing would likely have been conducted by the manufacturer (CEFLA S.C.) in Italy, given their location. The nature of the testing (bench testing, phantom imaging, etc.) suggests it's not patient data for an algorithm.

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):

• Not applicable. There is no mention of a "test set" requiring expert-established ground truth for diagnostic performance, as this is not an AI device. The "image quality review" is mentioned, but without details on experts or methodology.

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

• Not applicable. No adjudication method is mentioned as this is not an AI device or a study involving human reader performance evaluation in a diagnostic context.

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. The document explicitly states: "Given the differences from the predicate device, no human clinical studies have been considered necessary to support substantial equivalence." Therefore, no MRMC study was performed, and no AI assistance is part of this device.

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

• Not applicable. This device does not feature a standalone algorithm in the context of AI. It is an X-ray imaging system.

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

• Not applicable in the AI context. Ground truth in this submission pertains to the physical and technical specifications of the device, confirmed through engineering measurements, compliance with standards, and comparison to the predicate device's established performance parameters. For image quality, it's inferred that the review was against expected image characteristics for such a system, rather than diagnostic outcomes.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so no training set for an algorithm is mentioned or relevant.

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

• Not applicable. As above, no training set for an AI/ML algorithm is involved.

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hyperion X9 pro, NewTom Giano HR, X-RADiUS TRiO PLUS is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to:

(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;

(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH):

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option.

Not Found

This FDA clearance letter does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use.

Specifically, the following information is not provided in the given text:

• A table of acceptance criteria and the reported device performance: This document does not include any performance metrics, thresholds, or a direct comparison to acceptance criteria.
• Sample size used for the test set and the data provenance: There is no mention of the number of cases or patients used for testing, nor the origin (country, retrospective/prospective) of any data.
• Number of experts used to establish the ground truth for the test set and their qualifications: The document does not discuss expert involvement in ground truth establishment.
• Adjudication method: There is no information regarding how disagreements among experts (if any were used) were resolved.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not mention whether such a study was performed or any effect size related to AI assistance.
• Standalone (algorithm-only) performance: While the device is an X-ray system, it's not an AI-driven diagnostic algorithm whose standalone performance would typically be reported.
• Type of ground truth used: The document does not specify if expert consensus, pathology, or outcomes data was used for validation.
• Sample size for the training set: As there's no mention of an AI algorithm or a training process, this information is absent.
• How the ground truth for the training set was established: Similarly, this information is not applicable or provided.

The document indicates that the devices (hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS) are digital panoramic, cephalometric, and tomographic extra-oral X-ray systems, and it describes their intended uses, such as producing images of the maxillofacial region, jaws, skull, and for cephalometric and tomographic examinations. The substantial equivalence determination is based on the comparison to predicate devices, but the specific performance data for this equivalence is not detailed in this FDA letter.

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Hyperion X9 is a digital panoramic, cephalometric and tomographic extra-oral X-ray system. indicated for use in:

• (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and
• (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH);
• (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition (teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option.

The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings. This technique is known as CBCT or CB3D.

Hyperion X9 is a digital panoramic, cephalometric and tomographic extra-oral X-ray system.

This FDA 510(k) clearance letter for the Cefla S.C. Hyperion X9 does not contain the detailed study information or acceptance criteria you've requested.

The document is a clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use. It outlines general regulatory requirements and contact information for further inquiries.

Specifically, the following information is NOT present in this document:

• A table of acceptance criteria and the reported device performance: This document only provides the indications for use.
• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and this device is an X-ray system, not typically an AI algorithm in the context you're asking about.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

To obtain this kind of detailed performance and study data, you would typically need to look for:

• The actual 510(k) submission document itself (which is often much more extensive than this clearance letter).
• Published clinical studies or technical reports related to the device.
• The manufacturer's official documentation or website.

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