(75 days)
The DIGITAL RADIOGRAPHY CXDI-701G Wireless, CXDI-701C Wireless, CXDI-801G Wireless and CXDI-801C Wireless provide digital image capture for conventional film/screen rudiographic examinations. These devices are intended to replace radiographic film!screen systems in all general purpose diagnostic procedures are not intended for mammography applications.
The four models of detectors included in this submission are solid state x-ray imagers. Models CXDI-701C Wireless and CXDI-701G Wireless have an approximate imaging area of 35.0 x 42.6 cm, while models CXDI-801C Wireless and CXDI-801G Wireless have an approximate imaging arca of 35.0 x 27.4 cm For all models, the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values and the images will be displayed on monitors. The digital value can be communicated to the operator console via wiring connection or wireless. For all four of the proposed models, the dynamic range has been increased to allow for improved tonal precision. In addition, these models can detect x-ray irradiation without direct electrical connection to the x-rav generator. referred to as the Non-Generator Connection Mode. The x-ray flat panel detector integrates a real-time x-ray irradiation sensor as well as an imaging detector on the same detector surface. During the Non-Generator Connection Mode. the irradiation sensor is activated to detect the start of irradiation while the imaging detector is in the idling status. The detection of irradiation shifts the imaging detector to the image acquisition status instantaneously to obtain the x-ray image.
The provided text describes a Canon Digital Radiography system (CXDI-701C Wireless, CXDI-701G Wireless, CXDI-801C Wireless, and CXDI-801G Wireless) and its substantial equivalence to predicate devices, rather than an AI-powered device with specific acceptance criteria related to AI performance. Therefore, many of the requested fields about AI-specific studies, ground truth establishment, reader studies, and sample sizes for training/test sets cannot be extracted from this document.
However, I can extract information related to the device's functional and performance characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness.
Here's the available information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance table (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, it focuses on demonstrating substantial equivalence to predicate devices and compliance with regulatory standards.
| Feature/Criterion | Reported Device Performance/Comparison |
|---|---|
| Intended Use | Digital image capture for conventional film/screen radiographic examinations; intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (excluding mammography). Performance is considered equivalent to predicate devices for this intended use. |
| Technological Characteristics | Functionally identical and substantially equivalent to predicate devices. |
| Dynamic Range | Increased from approximately 4 digits with 14-bit Linear A/D and 12-bit Output Data (predicate) to approximately 4 digits with 16-bit Linear A/D and 16-bit Output Data (new device). This modification allows for improved tonal precision and product performance. |
| Non-Generator Connection Mode | New feature: Detects x-ray irradiation without direct electrical connection to the x-ray generator. The x-ray flat panel detector integrates a real-time x-ray irradiation sensor as well as an imaging detector on the same detector surface. Activates to detect start of irradiation and instantaneously shifts to image acquisition status. Testing demonstrated device performs comparably to predicate devices and is equivalent, despite this new feature. |
| Safety and Effectiveness | Tests demonstrated the device is safe and effective, performs comparably to the predicate device(s), and is equivalent. Specifically, it complies with the U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards: IEC 60601-1, 60601-1-2, 60601-1-3, and 60601-2-32. |
| Software Compliance | Documentation provided demonstrating compliance to all FDA requirements stated in "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," including verification/validation results and traceability of verification/validation tests to software requirements and software risk hazards. |
| Image Quality | Non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s) were performed. The conclusion states no new questions regarding safety or effectiveness when compared to predicate, implying comparable image 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 document does not specify a "test set" in terms of patient cases or images for evaluating diagnostic performance. The testing described is primarily non-clinical, focusing on functional specifications, software verification/validation, and image comparisons.
- Sample Size: Not specified for image comparisons, functional tests, or software validation.
- Data Provenance: Not specified. The submitter is Canon, Inc. - Medical Equipment Group, Tokyo, Japan. The lack of clinical trial details makes it impossible to determine retrospective/prospective or country of origin for any "data."
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. The document describes non-clinical testing and image comparisons, not clinical performance studies requiring expert ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no diagnostic "test set" and corresponding ground truth adjudication are described for this type of non-clinical submission.
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 MRMC study was mentioned. This device is a digital radiography detector system, not an AI-powered diagnostic tool. The submission focuses on hardware and associated software functionalities for image acquisition and display, demonstrating equivalence to previous versions and predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. It is a hardware system for X-ray image acquisition.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as the testing was non-clinical focusing on device functionality, safety, and equivalence to predicate devices, not diagnostic accuracy requiring a clinical ground truth.
8. The sample size for the training set
Not applicable. This document is for a digital radiography system, not an AI device that typically requires a training set for machine learning. The "training" here refers to manufacturing and software development processes, not data-driven model training.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI device with a distinct training set and associated ground truth.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.