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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 submission (K221876) consists of the CXDI-703C Wireless and CXDI-403C Wireless detectors, also called the AR-D3543W and AR-D4343W detectors respectively. The detectors intercept 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-Pro are not a part of this submission. The proposed changes to the predicate device, CXDI-Pro, includes the addition of the new detector, CXDI-803C Wireless (also called the AR-D2735W) to the CXDI-Pro series; a firmware update from 01.01.03.00 to 01.02.00.01; and a CXDI Control Software version update from 3.10.2.2 to 3.10.2.6. The new detector, CXDI-803C Wireless, which differs in pixel count, imaging area, external dimensions, and weight, has the same image performance as the predicate detectors. None of the CXDI-Pro detectors have any dynamic functions (such as fluoroscopy).

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the format of a table with thresholds and corresponding performance values. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technological characteristics and ensuring continued conformance with safety and performance standards.

The closest to "reported device performance" are the shared technical specifications and the statement that the new detector has the "same image performance as the predicate detectors."

2. Sample size used for the test set and the data provenance

The document states: "Adequate detector bench testing should be sufficient to demonstrate that the subject detector. CXDI-Pro, works as intended."
It also mentions "verification/validation activities" which included "detector bench testing."

• Sample Size for Test Set: Not explicitly stated in terms of number of images or cases. The testing appears to be primarily at the component level (detector, firmware, software) through bench testing and conformance to standards, rather than a clinical study with a specific number of patient cases.
• Data Provenance: Not specified, but given the nature of "bench testing" and "conformance with U.S. Performance Standard," it would likely involve laboratory test data and manufactured test images, rather than patient data from specific countries. This is a "Special 510(k) Submission" for modifications, so extensive new clinical data is often not required if substantial equivalence can be demonstrated through non-clinical means.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a non-clinical submission focused on technical equivalency, safety, and performance standards. There was no clinical ground truth established by experts.

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

Not applicable. This was a non-clinical submission; no adjudication method for a clinical test set was required or mentioned.

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. The device described is a digital radiography detector system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not relevant or reported.

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

Not applicable. The device is a hardware component (detector) and associated software/firmware for image acquisition and display, not an algorithm providing a standalone diagnostic output.

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

Not applicable. For this specific submission, the "ground truth" was established against technical specifications, engineering performance metrics (e.g., MTF, DQE), and conformance to internationally recognized safety and performance standards (e.g., IEC 60601 series). There was no clinical ground truth (expert consensus, pathology, outcomes data) as this was a non-clinical submission for device modifications.

8. The sample size for the training set

Not applicable. This device is a diagnostic imaging system component, not a machine learning algorithm that requires a "training set."

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

Not applicable. There was no training set for a machine learning algorithm.

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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 (K220098) consists of the CXDI-703C Wireless and CXDI-403C Wireless detectors, also called the AR-D3543W and AR-D4343W detectors respectively. The detectors intercept 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-Pro are not a part of this submission.

The subject of this Special 510(k) submission is a change to the predicate device, including compatibility with the Multi Box and Status Indicator, DIGITAL RADIOGRAPHY CXDI-Elite components that were cleared under K213780. The Status Indicator can be used when the proposed device is used in combination with the Multi Box. In addition, the CXDI Control Software has been updated from V3.10.0.8 to V3.10.2.2 to fix some bugs. Together, these changes make up the CXDI-Pro.

Based on the provided text, the device in question, DIGITAL RADIOGRAPHY CXDI-Pro / D1, is a digital radiography system, and the submission (K221876) is a Special 510(k). This means the submission focuses on modifications to an already cleared predicate device (K220098) rather than a completely new device. Therefore, the clinical testing section is deemed "not necessary" due to "minor differences from the predicate device."

This significantly limits the type of performance study and acceptance criteria information available. Special 510(k) submissions typically rely heavily on non-clinical bench testing and verification/validation activities to demonstrate that changes do not adversely affect safety or effectiveness, rather than large-scale clinical trials measuring diagnostic accuracy.

Here's an analysis based on the constraint that "clinical testing is not necessary" for this specific submission:

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

Since clinical testing was not performed for this submission, there are no acceptance criteria related to diagnostic accuracy or human-in-the-loop performance. The acceptance criteria and performance reported are focused on demonstrating that the modifications (addition of Multi Box and Status Indicator, software update, and firmware update) do not negatively impact the fundamental scientific technology and existing safety/performance standards of the predicate device.

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

The document explicitly states: "Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate verification and validation activities should be sufficient to demonstrate that the CXDI-Pro works as intended."

Therefore, there is no human patient "test set" or related sample size or data provenance information. The "test set" here refers to the bench tests and engineering validations performed on the device and its components to ensure compliance with the mentioned technical standards and functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as human clinical evaluation or ground truth adjudication by experts (e.g., radiologists) for diagnostic performance was not part of this "Special 510(k)" submission. The "ground truth" for the non-clinical tests would be established through engineering specifications, calibration standards, and regulatory requirements.

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

Not applicable, as there was no test set requiring human expert adjudication for diagnostic performance.

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 done. This device is a digital radiography system; the submission focuses on hardware and software updates to the imaging system itself, not an AI feature that assists human readers.

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

No standalone performance evaluation of a diagnostic algorithm was done. This is a review of a general-purpose digital X-ray system, not an AI diagnostic algorithm. The software update mentioned is for the CXDI Control Software, which governs the imaging process and display, not for an AI interpretation algorithm.

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

The "ground truth" for this submission's evaluation is based on engineering specifications, regulatory standards (e.g., IEC 60601 series, U.S. Performance Standard for radiographic equipment), and the performance characteristics of the predicate device. It's not clinical ground truth (like pathology or patient outcomes) because clinical testing was not required.

8. The sample size for the training set:

Not applicable. This submission is for modifications to a general radiography system, not for an AI algorithm. There is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI algorithm.

Ask a specific question about this device

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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