(94 days)
The Cefla MyRay Hyperion is intended for use in producing panoramic-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.
The MyRay Hyperion is a panoramic dental X-ray system which consists of a telescopic column, an overhead frame with a horizontal arm where an X-ray source and collimator and an X-ray image detector are mounted, and a console with a keyboard and display. The device includes a patient positioning system that consists of two handles which the patient grasps during exposures, a bite block, a frame for holding the head in the proper position and alignment with laser guide lights. The x-ray source and collimator generate a fan shaped x-ray beam which is projected through the patient's skull by the rotation of the imaging unit. The x-ray image detector allows reconstruction of the diagnostic image, storage of the image in the buffer memory, and transfer of the image to an external PC (not provided by Cefla).
Here's an analysis of the provided text regarding the Cefla MyRay Hyperion, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for the Cefla MyRay Hyperion, a dental panoramic X-ray system. This type of device is an imaging modality. The typical "acceptance criteria" and "studies" you're asking about (e.g., performance metrics like sensitivity/specificity, comparison to ground truth, reader studies) are primarily relevant for AI/CAD devices that provide diagnostic interpretations or assistance.
For a standard X-ray imaging system like the Cefla MyRay Hyperion, the "acceptance criteria" are generally related to its ability to produce clear, diagnostically acceptable images and its functional characteristics meeting established safety and performance standards for medical devices. The "study" for such a device is typically a demonstration of substantial equivalence to existing predicate devices, focusing on technical specifications, image quality, and safety rather than a clinical efficacy trial with human readers.
Therefore, many of your requested points will not be directly applicable or explicitly stated in this type of submission.
Acceptance Criteria and Device Performance for Cefla MyRay Hyperion
Based on the provided 510(k) summary, the device's "acceptance criteria" for regulatory clearance are primarily demonstrating substantial equivalence to predicate devices in terms of intended use, operational characteristics, and technological characteristics, as well as meeting general safety and performance standards. The "study" proving this is the 510(k) submission itself, which compares the new device to established predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied by 510(k)) | Desired Performance (Implied from Predicate Comparison) | Reported Cefla MyRay Hyperion Performance (from Table 5-1) |
|---|---|---|
| Intended Use Equivalence | For producing panoramic X-ray images of the maxillofacial region for examination of teeth, jaw, and oral structures. | Same intended use: production of panoramic X-ray images of the maxillofacial region for examination of teeth, jaw, and oral structures. |
| Imaging Principle | Fan beam, High-Frequency Constant Potential X-ray source, CCD detector. | Fan beam, High-Frequency Constant Potential X-ray source, CCD detector. |
| X-ray Source Parameters | Focal spot (0.5mm), max energy (e.g., ~85-90 kVp). | Focal spot: 0.5mm, Max Energy: 85 kVp. |
| Detector Characteristics | CCD pixel size (e.g., ~48 microns), 12-bit grayscale. | CCD pixel size: 48 microns, Detector area: 147 x 6 mm, Grayscale: 12 bit. |
| Image Pixel Size | Typical for panoramic systems (e.g., ~96 x 96 microns). | Image pixel size: 96 x 96 microns. |
| Patient Positioning | Utilizes laser lines for accurate patient positioning. | 3 laser lines for patient positioning. |
| Safety Standards | Compliance with relevant electrical safety, radiation safety, and electromagnetic compatibility standards (implied by general controls and submission for class II device). | Not explicitly detailed in the summary, but required for 510(k) clearance and covered under general controls provisions of the Act. |
| Image Quality (Diagnostic Acceptability) | Images produced by the device must be diagnostically acceptable for the intended use. | Not quantified in the provided text. Demonstrated by comparison to accepted predicate devices and implied by technical specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: This 510(k) pertains to a medical imaging device itself, not an AI or diagnostic software. Therefore, there isn't a "test set" in the sense of a dataset of images used to evaluate diagnostic performance. The "test" for this device involved comparing its technical specifications and image acquisition capabilities to legally marketed predicate devices.
- Provenance: Not applicable in the context of diagnostic performance data. The device was manufactured in Italy.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable (N/A): For a panoramic X-ray machine itself, "ground truth" as it applies to diagnostic accuracy of an AI algorithm is not relevant. The device's "ground truth" is its ability to produce images that are physically accurate representations of the maxillofacial anatomy, which is assessed through engineering testing and comparison to functional specifications, not expert consensus on diagnostic findings.
4. Adjudication Method for the Test Set
- N/A: No "adjudication method" for diagnostic interpretation of a test set was performed as this is an imaging device, not a diagnostic AI.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: An MRMC comparative effectiveness study was not done. These studies are typically conducted for AI/CAD systems to demonstrate improvement in human reader performance with aid. This submission is for an imaging acquisition device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- N/A: This is an imaging device, not a standalone diagnostic algorithm. Its "performance" is its ability to acquire images, not to interpret them without human intervention.
7. Type of Ground Truth Used
- Physical and Technical Specifications: The "ground truth" for this device's evaluation is primarily its adherence to established engineering, safety, and performance specifications for dental panoramic X-ray systems, as well as its ability to produce images comparable in quality to predicate devices. This includes measurements of factors like focal spot size, kVp output, detector characteristics, and image resolution.
8. Sample Size for the Training Set
- N/A: The concept of a "training set" is relevant for machine learning algorithms. This is a medical device for image acquisition, not an AI algorithm, so no training set was used.
9. How the Ground Truth for the Training Set Was Established
- N/A: As there's no training set, this question is not applicable.
§ 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.