(15 days)
DIGITAL RADIOGRAPHY CXD1-55G 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 proceduros. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-55G is a solid state x-ray imager which has 35x 43cm imaging area. The DIGITAL RADIOGRAPHY CXDI-55G intercepts x-ray photons and the scintillator of the CXDI-55G emits visible spectrum photons that illuminate an array of photo-detectors that create an clectrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors.
This Canon CXDI-55G submission is a 510(k) for a new model of a digital radiography device. The submission explicitly states, "The Performance Data demonstrate that CXDI-55G is as safe and effective as CXDI-50G." This indicates that the study performed was a substantial equivalence study. Therefore, the acceptance criteria are not explicitly defined as they would be for a direct performance claim. Instead, the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate device, the CXDI-50G.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| As safe and effective as the predicate device (Canon CXDI-50G) | Performance data demonstrates CXDI-55G is as safe and effective as CXDI-50G. |
| Equivalent intended use to predicate device | CXDI-55G's intended use is the same as CXDI-50G. |
| Non-inferiority in imaging quality and diagnostic capability compared to predicate. | Not explicitly quantified in this summary, but implied by the overall conclusion of substantial equivalence based on "design control activities and non-clinical testing." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Performance Data" and "non-clinical testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide any information regarding experts used to establish ground truth or their qualifications. Given that this is a technological upgrade and not a diagnostic AI device, such expert review for ground truth might not have been a primary focus of this 510(k) summary.
4. Adjudication Method for the Test Set
No information is provided regarding adjudication methods. This type of detail is typically not found in summary documents for device upgrades.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No mention of an MRMC comparative effectiveness study is made in the provided text. This type of study is more common for AI-powered diagnostic aids, not for hardware upgrades of a digital radiography system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device, a solid-state X-ray imager, is a hardware component that captures images. Its performance is inherent in the image acquisition process, not an algorithm's standalone diagnostic ability. Therefore, the concept of "standalone performance" as typically applied to diagnostic algorithms is not directly applicable here. The performance is tied to the output image quality.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For a device like this, the "ground truth" for performance would generally relate to objective image quality metrics (e.g., DQE, MTF, SNR) established through physical testing and comparison to the predicate device. Clinical outcomes or pathology are unlikely to be direct ground truths for a basic image acquisition device.
8. The Sample Size for the Training Set
No training set is mentioned as this device is a hardware imager, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a hardware device like this.
§ 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.