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The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-CS01 (hereinafter referred to as CXDI-CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors, and in the predicate device (K203849) consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless.

The CXDI-CS01 intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-CS01 are not a part of this submission.

The subject of this Special 510(k) submission is a change to the CXDI-CS01 to add the DIGITAL RADIOGRAPHY CXDI-Pro (hereinafter referred to as CXDI-Pro) series and the DIGITAL RADIOGRAPHY CXDI-Elite (hereinafter referred to as CXDI-Elite) series detectors to the CXDI-CS01 series of detectors. In addition, the CXDI-Pro and CXDI-Elite components and features (Bluetooth connection and the Built-in AEC Assistance) have been added to the CXDI-CS01. The CXDI Control Software has been updated from V2.19.0.7 to V3.10.2.2 to add the Intelligent NR function (cleared under K212269), update the GPU driver, add several minor functional changes, and fix bugs. Together, these changes make up the CXDI-CS01.

The provided text is a 510(k) summary for a medical device called "DIGITAL RADIOGRAPHY CXDI-CS01". It describes the device, its intended use, and its similarities to a predicate device. However, it explicitly states that clinical testing was not necessary for this submission due to minor differences from the predicate device. Therefore, the document does not contain any information about acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, or expert involvement for a clinical study.

The document only discusses bench testing to demonstrate conformance with performance standards and safety standards.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided text. The document refers to conformance with various standards (e.g., IEC 60601-1) but does not provide specific acceptance criteria or reported performance data for these standards in a tabular format. The table provided in the 510(k) summary compares technological characteristics with the predicate, such as DQE, pixel pitch, and spatial resolution, but these are characteristics of the device, not performance benchmarks against acceptance criteria from a study demonstrating clinical effectiveness.

Technological Characteristics Comparison (from the provided text, not acceptance criteria/performance from a clinical study):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available. The document explicitly states: "Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate detector bench testing should be sufficient to demonstrate that the subject detector CXDI-CS01 works as intended."

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)

This information is not available due to the absence of a clinical study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available due to the absence of a clinical study.

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

This information is not available. The device is a "Solid State X-Ray Imager" and its primary function is digital image capture. There's no mention of AI assistance for human readers in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not available. The device is a digital radiography system, not an AI algorithm, and no clinical performance studies are mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available due to the absence of a clinical study.

8. The sample size for the training set

This information is not available. There is no mention of an AI algorithm requiring a training set in this submission.

9. How the ground truth for the training set was established

This information is not available due to the absence of a training set as no AI algorithm is detailed in this submission.

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The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, and in the predicate device consists of the CXDI-703C Wireless detector unit, also called the AR-D3543W detector. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors 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 image can be communicated to the operator console via a wired or wireless connection.
The subject of this Special 510(k) submission is a change to the CXDI-Pro add a detector, the CXDI-403C Wireless (also called AR-D4343W) to the CXDI-Pro series of detectors. In addition, a Detector Stand (DS-01) and a new Battery Charger (BC-01) have been added as optional components to be used with the proposed CXDI-Pro detectors (CXDI-703C Wireless and CXDI-403C Wireless), the sleep to ready cycle time for the proposed CXDI-Pro detectors has been decreased, and the CXDI Contro Software has been updated from V3.10.0.3 to V3.10.0.8 to add the Intelligent NR function (cleared under K212269) and apply some bug fixes. Together, these changes make up the CXDI-Pro.

Here's a breakdown of the acceptance criteria and study information for the Canon Inc. Digital Radiography CXDI-Pro / D1, based on the provided FDA 510(k) summary:

This submission (K220098) is a Special 510(k) submission, which indicates that the changes made to the device (new detector, accessories, reduced cycle time, software update) did not fundamentally alter its intended use or fundamental scientific technology. Therefore, the primary focus of the performance evaluation is to ensure that these changes do not negatively impact the device's conformance with relevant standards and do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for modifications to an already cleared device, the "acceptance criteria" are primarily related to maintaining conformance with existing performance and safety standards, rather than establishing new clinical performance targets. The reported device performance confirms that these standards are still met.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set sample size" in terms of patient images or clinical cases. The performance evaluation is described as "Verification/validation activities" which focused on technical performance and safety standards. This suggests that the testing involved:

• Engineering tests on the physical components (new detector, accessories).
• Software testing for the updated control software and firmware.
• Electromagnetic compatibility (EMC) testing.
• Electrical safety testing.

The data provenance is industrial and engineering testing, rather than clinical data from specific countries or retrospective/prospective studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable in the context of this Special 510(k). Ground truth for clinical diagnostic performance (e.g., presence/absence of disease) is not the focus of this submission. The "ground truth" here is adherence to engineering specifications and safety standards, which would be assessed by engineers and quality control personnel.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring reader adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to demonstrate the clinical performance of a diagnostic aid, which is not the scope of this Special 510(k) submission focused on hardware/software modifications and maintaining safety/performance standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document primarily describes the performance of the overall digital radiography system, which includes the detector and control software. While the software update includes an "Intelligent NR function" (cleared under K212269), this submission's performance evaluation focuses on the integrated system's safety and continued conformance, not a standalone algorithm's diagnostic performance. Its effectiveness would have been established in the K212269 submission.

7. The Type of Ground Truth Used

The ground truth used for these verification and validation activities is based on:

• Engineering specifications (for the new detector, cycle time, accessories).
• International standards (IEC 60601-1, 60601-1-2, 60601-2-54, 60601-1-6, IEC 60529).
• U.S. Performance Standard for radiographic equipment.
• Software testing protocols to verify bug fixes and the integration of the Intelligent NR function without introducing new issues.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe a machine learning model being developed or trained on a dataset. The software update includes an "Intelligent NR function" which would have involved a training set in its original K212269 submission, but that information is not provided here.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set described in this submission.

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