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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 submission (K222661), consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C Wireless, DIGITAL RADIOGRAPHY CXDI-Pro (CXDI-703C Wireless and CXDI-403C Wireless), and DIGITAL RADIOGRAPHY CXDI-Elite (CXDI-720C 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 the changes to the predicate CXDI-CS01, which include the addition of the DIGITAL RADIOGRAPHY CXDI-Pro detector (CXDI-803C Wireless) and the DIGITAL RADIOGRAPHY CXDI-Elite detectors (CXDI-820C Wireless and CXDI-420C Wireless) to the CXDI-CS01 series of detectors, a firmware update of the DIGITAL RADIOGRAPHY CXDI-Pro and DIGITAL RADIOGRAPHY CXDI-Elite detectors from 01.01.03.00 to 01.02.00.01 and from F2.00.03.00 to 02.01.04.00 respectively, and a CXDI Control Software version update from V3.10.2.2 to V3.10.2.6 to fix bugs. Together, these changes make up the CXDI-CS01.

Here's a breakdown of the acceptance criteria and study information for the DIGITAL RADIOGRAPHY CXDI-CS01, based on the provided FDA 510(k) summary:

This device (DIGITAL RADIOGRAPHY CXDI-CS01) is a digital X-ray imager, and this 510(k) submission (K230175) is a Special 510(k) for changes to a previously cleared predicate device (K222661). The changes primarily involve adding new detectors and a firmware update, along with a minor software bug fix. Therefore, the information related to clinical studies and ground truth establishment will be limited, as determined by the FDA's decision that clinical testing was "not necessary" due to the minor nature of the changes and the device's substantial equivalence to the predicate. Most of the "performance" described here relates to engineering and regulatory compliance rather than clinical diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a Special 510(k) for minor changes and not a novel device requiring extensive clinical performance validation, the "acceptance criteria" are primarily related to maintaining or demonstrating equivalence in technical specifications and adherence to safety and performance standards. The document primarily focuses on demonstrating that the changes do not negatively impact safety or effectiveness.

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

The document explicitly states: "Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device." Therefore, there is no explicit clinical "test set" in the traditional sense of human patient data for diagnostic accuracy evaluation.

The "test set" for this submission refers to the detectors and software changes themselves, and the testing performed was primarily "detector bench testing" and evaluations against engineering and regulatory standards.

• Sample Size for Test Set: Not applicable in the context of clinical images or patient data. The "sample" would be the specific new detector models (CXDI-803C Wireless, CXDI-820C Wireless, CXDI-420C Wireless) and the updated firmware/software.
• Data Provenance: Not applicable for a clinical test set. The validation data would come from internal Canon testing (bench testing, engineering tests) to ensure the new components perform as expected and meet regulatory standards. This is typically prospective in nature, as new components are being evaluated for the first time. The manufacturing origin is Japan (Canon Inc., Japan).

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

Not applicable. Since no clinical testing with patient images was deemed necessary, no experts (like radiologists) were used for establishing ground truth on a clinical test set. The "ground truth" for this submission relates to the functional and safety performance of the hardware and software, established through engineering validation and adherence to technical standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical case review requiring adjudication by multiple experts was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. The submission explicitly states "Clinical testing is not necessary." This type of study would be performed to evaluate the human-in-the-loop performance of an AI-assisted device, which is not the nature of this submission.

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

While the device itself is a digital radiography system (which essentially is a standalone imaging algorithm/device), there isn't a separate "AI algorithm" being evaluated independently in this submission. The device's performance is fundamental to its imaging capabilities, not an additional AI feature. The "performance" assessment focuses on the image quality metrics and safety standards of the detector and its processing, which are inherent to its "standalone" operation as an X-ray imager.

7. The Type of Ground Truth Used

The "ground truth" for this submission is:

• Engineering Specifications and Performance Standards: The device's performance (e.g., spatial resolution, DQE, IP level, wireless communication) is measured against predetermined technical specifications and international standards (IEC).
• Predicate Device Equivalence: The primary "ground truth" for this Special 510(k) is the demonstrated safety and effectiveness of the previously cleared predicate device (K222661). The new submission aims to prove that the changes do not alter this established equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a digital X-ray detector and associated software, not an AI model that requires a "training set" of medical images 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 model in this submission.

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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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