(19 days)
DIGITAL RADIOGRAPHY CXDI-60C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-60C is a solid state x-ray imager which has 23x28cm imaging area. The DIGITAL RADIOGRAPHY CXDI-60C intercepts x-ray photons and the scintillator of the CXDI-60C emits visible spectrum photons that illuminate an array of photo-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.
The provided text describes a 510(k) premarket notification for the Canon CXDI-60C digital radiography device, comparing it to two predicate devices, CXDI-60G and CXDI-50C. The primary focus of the submission is to demonstrate substantial equivalence, particularly highlighting improvements in the fluorescent screen material leading to better image quality at lower X-ray dosages.
However, the document does not contain information about a specific study or acceptance criteria for device performance in the context of clinical accuracy or diagnostic efficacy that is typically associated with AI/CADe devices. The submission primarily addresses the technical performance of the imaging device itself (e.g., DQE, physical dimensions, materials) rather than evaluating its diagnostic performance on a test set against ground truth.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not explicitly present in the provided text. The "acceptance criteria" discussed are largely related to technical specifications and comparison to the predicate device's DQE (Detective Quantum Efficiency).
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Providing digital image capture for conventional film/screen radiographic examinations, replacing film/screen systems in all general purpose diagnostic procedures (excluding mammography). | CXDI-60C's intended use is stated to be the same as that of the predicate devices CXDI-60G and CXDI-50C, indicating it meets this criterion. |
| Diagnostic image quality with reduced X-ray dosage compared to predicate (CXDI-60G). | CXDI-60C uses CsI (Cesium Iodide) as the fluorescent screen, which provides high X-ray absorption. This allows it to deliver diagnostic images with an X-ray dosage less than that required by CXDI-60G. |
| Improved DQE (Detective Quantum Efficiency) compared to predicate (CXDI-60G). | CXDI-60C's DQE approximately doubles compared to CXDI-60G due to the use of CsI. |
| Substantial equivalence in safety and effectiveness to predicate device (CXDI-60G). | The "Performance Data" and "design control activities and non-clinical testing" are cited as demonstrating that CXDI-60C is "as safe and effective as CXDI-60G." |
| External dimensions and weight changes (compared to CXDI-50C). | External dimensions changed from 491x477x23mm to 344x380x22.5mm. Weight changed from 4.8Kg to 2.5Kg. (While these are "differences", they are presented as part of the new model's specifications, implying they meet design objectives). |
Detailed breakdown of other requested information (based only on the provided text):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated. The document refers to "Performance Data" and "non-clinical testing" but does not specify the sample size, type of test data (e.g., patient cases), or its provenance for evaluating diagnostic performance. This submission focuses on the technical performance of an imaging sensor, not a diagnostic AI algorithm.
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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 / Not explicitly stated. Ground truth, in the context of diagnostic performance evaluation, is not mentioned. The device is a digital X-ray imager, not an AI algorithm requiring a ground truth for diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not explicitly stated. Adjudication methods are typically used when establishing ground truth for diagnostic studies, which is not described here.
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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. This is not an AI/CADe device. The document describes a digital X-ray imager.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an imager, not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not explicitly stated. Ground truth, in the context of diagnostic studies, is not described in this submission. The "ground truth" for evaluating this device would be its physical and technical performance parameters (e.g., DQE measurements) rather than diagnostic accuracy against a clinical reference standard.
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The sample size for the training set:
- Not applicable. This device is a hardware imager, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for a machine learning model is mentioned.
§ 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.