(143 days)
HYPERION X5 is an extraoral X-ray system for digital panoramic X-rays suitable for production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity.
Hyperion X5 allows the following projections:
- Standard or pediatric panoramic views (PAN);
- i Full or partial views of the dentition selected by the user (DENT);
- Frontal and lateral view of the maxillary sinuses (SIN); .
- Lateral and posteroanterior view of the temporomandibular joints (TMJ) from several angles. -
The HYPERION X5 shall not be used on patients (child) less than approximately 1045mm in height and less than 19Kg in weight. These height and weight measurements approximately correspond to that of an average 4 year old. Furthermore the device shall not be used with patients not vigilant and cooperative, since the patient must be able to understand and follow the operator's instructions for a correct positioning
The Hyperion X5 apparatus consists of one rotating arm attached to the support column. The powered rotating arm is capable of rotating for about 210° and translating thereby allowing the x-ray emission system and image detector to be moved around the patient according to complex orbits that follow the morphological profile. The rotating arm is attached to a support column capable of moving vertically through a motorized movement in order to allow it to perform the panoramic exposition.
The system provides patient positioning means such as handles and bite point with chin rest. The correct patient positioning is guided by 3 LASER positioning lights. The x-ray generator provides up to 85 kV, 15 mA to the x-ray tube, and the scanning process is performed by an independent axes cinematic unit. The system is equipped with CMOS solid state x-ray image detector, with associated electronics. The solid state CMOS detector contain a Cs(Tl) scintillator able to capture the radiation emitted by the x-ray generator, converting it in fluorescence and then in electric charge, accumulated by each pixel according to the light intensity. The accumulated charge in each row is sequentially selected by vertical shift registers for row scan, transferred to the amplifier and converted in voltage signal and than converted in a 14bit digital signal that transfered to the PC, trough the Ethernet connection, allow to create a set of by dimensional images acquired during the movement of the rotating arm along the designed orbits. These set of images suitably interconnected, allow at the software to create the panoramic standard image in order to show the exam result, store and evaluate it.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Hyperion X5 device:
Important Note: The provided document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily providing a full, detailed clinical study with pre-defined acceptance criteria and statistical power calculations typically found in a clinical trial report. Therefore, some information requested (like specific numerical acceptance criteria for clinical outcomes, sample sizes for test/training sets with data provenance, and details about expert ground truth establishment for AI performance) is not explicitly present because the document describes a benchmarking/comparison study against a predicate device, rather than a standalone clinical efficacy study with strict performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) Summary (demonstrating substantial equivalence), the "acceptance criteria" are implicitly defined by the predicate device's performance and compliance with relevant standards. The "reported device performance" refers to how the Hyperion X5 compares to the predicate.
| Feature / Performance Metric | Acceptance Criteria (Implicitly, equivalent to Predicate) | Reported Device Performance (Hyperion X5) |
|---|---|---|
| Indications for Use | Subset of predicate's 2D indications | Meets subset of predicate's 2D indications |
| Panoramic Image Resolution | Comparable to predicate (Hyperion X9) using QUART Phantom | Comparable to predicate (Hyperion X9) |
| Geometrical Performance (Magnification, Orthogonality) | Comparable to predicate (Hyperion X9) using CEFLA Phantom | Comparable to predicate (Hyperion X9) |
| Image Information Level (Under/Over-Exposition) | Similar to predicate (Hyperion X9) in extreme conditions | Similar to predicate (Hyperion X9) |
| MTF (Modulation Transfer Function) | 60% @ 1lp/mm, 10% @ 4lp/mm (Predicate) | 58% @ 1lp/mm, 8% @ 4 lp/mm (Hyperion X5) |
| DQE (Detective Quantum Efficiency) | 80% @ 0lp/mm, 20% @ 3lp/mm (Predicate) | 70% @ 0lp/mm, 18% @ 3lp/mm (Hyperion X5) |
| Patient Population | Adult & pediatric | Adult & pediatric |
| Selectable Expositions | PAN, DENT, SIN, TMJ (2D mode) | PAN, DENT, SIN, TMJ |
| Compliance to Standards | IEC 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 62366, 60601-2-63, 62304; FDA Guidance on Solid State X-ray Imaging Devices; FDA Guidance on MD SW | Compliant with all mentioned standards and guidances |
2. Sample Size for Test Set and Data Provenance
The document describes non-clinical bench tests using phantoms rather than a clinical test set with patient data.
- Sample Size for Test Set: Not applicable in the context of human patient data. The "test set" consists of phantom images. The number of images or runs with the phantoms is not specified.
- Data Provenance: Not applicable, as no human patient data was used. The tests were performed internally by the manufacturer (CEFLA S.C.).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. As non-clinical bench tests with phantoms were used, the "ground truth" is based on the known physical properties and measurements of the phantoms themselves, not expert interpretation of clinical images.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Bench tests with phantoms rely on objective measurements against known phantom characteristics, not subjective human adjudication of clinical findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The submission focuses on direct technical comparison using phantoms and compliance with standards. There is no mention of human readers evaluating images or a comparative effectiveness study with or without AI assistance.
- Effect Size: Not applicable, as no MRMC study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in a sense. The described "non clinical performance tests" (comparison with QUART Technical Phantom, Geometrical Comparison with CEFLA Phantom, and comparison during under/over-exposition) assess the device's image acquisition and reconstruction capabilities independent of human interpretation or intervention for diagnostic tasks. These are technical performance evaluations of the imaging system.
7. Type of Ground Truth Used
- Type of Ground Truth: Phantom-based objective measurements. The "ground truth" for these non-clinical tests refers to the known characteristics and values designed into the QUART Technical Phantom (DIN 6868-5) and the Standard Technical CEFLA Phantom for evaluating resolution, magnification, and orthogonality.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Hyperion X5 is an X-ray imaging system, not an AI or machine learning algorithm in the context of this submission. There is no mention of a "training set" for an AI component. The software mentioned (firmware, VKB, NNT/IRYS) controls the device and processes images, but the document does not describe it as an AI system requiring a training set in the modern sense.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as no training set for an AI component is mentioned.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.