(24 days)
hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, 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:
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produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH);
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produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones, if equipped with 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 (PAN, 2D), cephalometric (CEPH, 2D) and tomographic (CBCT, 3D) radiological system, that acquires radiological images by rotating around the patient. The rotating arm is attached to a support column capable of moving vertically through a motorized movement.
The system is equipped with X-ray tube generator and detectors (sensors) for dental panoramic (PAN), cephalometric radiography (CEPH) and cone beam computed tomography (CBCT).
The proposed device can be sold under three different product name and brands names for commercial needs, without changing any of the safety, electrical and functional features. The variants are:
1 hyperion X5 myray CEFLA S.C.
2 NewTom GO NewTom CEFLA S.C.
3 X-RADIUS COMPACT Castellini CEFLA S.C.
Wherever the proposed device is mentioned, it is intended the device with its three different trade/ device names: hyperion X5, NewTom GO and X-RADiUS COMPACT.
The provided document, a 510(k) Premarket Notification summary for the hyperion X5, NewTom GO, and X-RADiUS COMPACT dental X-ray systems, primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria for an AI/CADe system. Therefore, much of the requested information regarding AI acceptance criteria, ground truth establishment, expert adjudication, and MRMC studies is not present in this document.
The document discusses performance tests for image quality and geometrical accuracy, which are standard for X-ray imaging devices, but these are not framed as acceptance criteria for an AI or CADe output.
However, based on the information available, I can answer parts of your request concerning the overall device performance proof.
This device is an X-ray imaging system, not an AI/CADe system. Therefore, the questions related to AI-specific acceptance criteria, ground truth establishment for AI, expert adjudication for AI, and MRMC studies for AI assistance are not directly applicable to the information provided.
Here's what can be extracted and inferred from the document regarding the device's performance proof:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria in a table format for a pass/fail study, similar to how AI/CADe systems are evaluated. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance data" section describes the types of tests conducted and concludes that the results "demonstrated a substantial equivalence."
| Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Reported Device Performance (Summary) |
|---|---|
| Safety and EMC (Compliance with relevant standards) | Compliance demonstrated with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-63, IEC 60601-1-6, IEC 62366-1, IEC 62304, IEC 60825-1. |
| Spatial Resolution (Comparison with predicate/reference) | Demonstrated "substantial equivalence" in spatial resolution when compared to hyperion X5 3D version (K161900) for panoramic X-rays and hyperion X9 pro (K190496) for lateral ceph X-rays, using QUART Technical Phantom (DIN 6868-5). |
| Low Contrast Resolution (Comparison with predicate/reference) | Demonstrated "substantial equivalence" in low contrast resolution when compared to hyperion X5 3D version (K161900) for panoramic X-rays and hyperion X9 pro (K190496) for lateral ceph X-rays, using QUART Technical Phantom (DIN 6868-5). |
| Geometrical Performance (Comparison with predicate/reference) | For PAN and CEPH projections, "comparable in terms of distortion performance" with hyperion X5 3D version (K161900) and hyperion X9 pro (K190496). For CBCT, all measured parameters "fall between the acceptance range the same of reference device hyperion X5 3D version (K161900)," validating noise and geometric distortion. "Substantial equivalence" in geometrical performances demonstrated. |
| Overall Image Quality (Comparison with predicate/reference) | Qualitative comparison on anthropomorphic and technical phantoms (2D and 3D) against hyperion X5 3D version and hyperion X9 pro. QA analysis with a cylindrical phantom yielded positive results. Clinical image evaluation performed for 2D Panoramic, CBCT, and Tele-radiography images. Results "able to demonstrate the substantial equivalence in performance." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the sample size (number of images or patients) used for any of the clinical or non-clinical performance tests. For phantom studies, specific phantom names (e.g., DIN 6868-5, suitable cylindrical phantom) are mentioned, but not the number of phantom images acquired. For clinical evaluations, it mentions "different hyperion X5 and hyperion X9 pro," "different patient," and "Same Patient," but no specific patient counts.
- Data Provenance: Not specified in terms of country of origin. The document states that "On-field Clinical Evaluation of hyperion X5 and end-users feedback report" was conducted, implying real-world data collection, but does not specify if it was retrospective or prospective. Given the context of a 510(k) submission for an imaging device, the data is typically from internal company testing or external collaborations, but the source is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document briefly mentions "expert professionals" in the Indications for Use for a reference device (hyperion X5 3D version) but provides no details on their role or qualifications in establishing ground truth for the performance tests. The device is intended to be used by "physicians, dentists, x-ray technologists and other legally qualified professionals."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified. No adjudication method is mentioned for any of the performance evaluations.
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
- MRMC Study: No MRMC study is mentioned. This is expected as the device is an imaging system, not an AI-assisted diagnostic tool. The "Comparative Clinical Evaluation" mentioned (e.g., 2D Panoramic X-rays, CBCT) would typically involve comparisons of image characteristics by experts, but not a formal MRMC study on reader performance improvements with AI assistance.
- Effect Size of AI Assistance: Not applicable, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is an X-ray imaging device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance appears to be established through:
- Physical Phantom Measurements: For spatial resolution, low contrast resolution, noise, and geometric distortion using technical phantoms (e.g., QUART Technical Phantom, cylindrical phantom).
- Qualitative Expert Assessment of Clinical Images: In the "Comparative Clinical Evaluation" section, it implies expert review of images from different devices, assessing quality and "identification of main marker points." This is likely a qualitative assessment by an unnamed number of clinical professionals.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.