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DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 is indicated for use in generating radiographic images of human anatomy to replace the radiographic film/screen systems in all general purpose diagnostic procedures. It is also used for generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers.

Not intended for mammography applications.

The proposed CXDI-RF Wireless B1 is a solid state X-ray imager, which is capable of both fluoroscopic and spot radiographic imaging and has a common Thallium-doped Cesium Iodide (CsI:TI) scintillator. The CXDI-RF Wireless B1 will be integrated as a component into the Canon fluoroscopy x-ray system for fluoroscopic and radiographic imaging. The CXDI-RF Wireless B1 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 (CXDI Controller RF version 3.11), and then displayed on the PC/monitors. The PC/monitors used with the CXDI-RF Wireless B1 are not a part of this submission.

The provided document from the FDA 510(k) premarket notification for the Canon Inc. DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 does not contain information about acceptance criteria and a study proving that the device meets specific acceptance criteria related to AI/algorithm performance.

The document states that the device is a digital radiography and fluoroscopy system, which is hardware (a solid-state X-ray imager) with associated control software. It is not an AI/CADe (Computer-Aided Detection/Diagnosis) device with performance metrics like sensitivity, specificity, or AUC, which are typically evaluated against AI acceptance criteria.

The "Summary of Non-Clinical/Test Data" section primarily references adherence to technical standards, internal specifications, and FDA guidance documents for medical devices (e.g., biological evaluation, risk management, software life cycle, cybersecurity, electrical safety, radiation protection, usability, etc.). It emphasizes that "No clinical testing was required as non-clinical testing should be sufficient to demonstrate that the DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 works as intended."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets AI/algorithm-specific acceptance criteria, as the document does not describe such a study or performance metrics for AI.

If you have a document that specifically details the AI/CADe component of a different device, I would be happy to analyze it for the information you've requested.

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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-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-Elite / E1 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-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector (also called the AR-E3543W detector), the CXDI- 420C Wireless detector (also called the AR-E4343W detector), and the CXDI-420C Fixed detector (also called the AR-E4343S 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. 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-Elite are not a part of this submission. The proposed changes to the predicate device, DIGITAL RADIOGRAPHY CXDI-Elite (K221620), include the addition of a new detector, the CXDI-820C Wireless (also called the AR-E2735W), to the CXDI-Elite series; the standardization of the thickness of CXDI-720C Wireless and CXDI-420C Wireless; the firmware update from F2.00.03.00 to 02.01.04.00; the CXDI Control Software version update from 3.10.2.2 to 3.10.2.6; and the addition of a 25 m of the CXDI-420C Fixed detector cable and a 10 m of Wiring Cable (WC-01). Together, these changes make up the CXDI-Elite.

Here's a breakdown of the acceptance criteria and study information for the Digital Radiography CXDI-Elite / E1, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study of a novel device. Therefore, a traditional "study that proves the device meets the acceptance criteria" in terms of clinical outcomes or diagnostic accuracy with human-in-the-loop is expressly stated as not necessary for this submission. The "acceptance criteria" here are primarily about conformance to safety and performance standards after design changes, and the "study" is the verification/validation activities.

Acceptance Criteria and Reported Device Performance

Study Details:

This submission describes verification/validation activities rather than a clinical study.

1. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The submission refers to "adequate detector bench testing" and "verification/validation activities" which would involve testing the device itself against various parameters and standards. No specific number of images or patient data is mentioned for testing in the summary provided. The focus is on the device's technical performance and safety, not diagnostic accuracy based on a dataset.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic decision-making from expert interpretation is not relevant for this type of submission, as it's not a diagnostic AI device requiring human reader comparison. The "ground truth" here is compliance with engineering specifications and regulatory standards, established through technical testing.

3. Adjudication method for the test set: Not applicable. As there were no human readers establishing ground truth for diagnostic accuracy, no adjudication method was used.

4. 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: Not applicable. This device is a general-purpose digital radiography system, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in terms of product performance and safety, the device itself was evaluated in a standalone manner (through bench testing and compliance checks). The "device works as intended" conclusion stems from this.

6. The type of ground truth used:

   • Engineering specifications and performance standards: For parameters like pixel pitch, scintillator type, spatial resolution, IP level, wireless communication, and physical dimensions.
   • Regulatory standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 60601-1-6, and the U.S. Performance Standard for radiographic equipment.

7. The sample size for the training set: Not applicable. This document does not describe the development of an AI algorithm, so there is no "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI algorithm mentioned.

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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 (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.

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The DIGITAL RADIOGRAPHY CXDI-Elite / E1 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-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector unit, also called the AR-E3543W 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 value 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-Elite to add new detectors, the CXDI-420C Wireless (also called AR-E4343W) and the CXDI-420C Fixed (also called AR-E4343S), to the CXDI-Elite series of detectors. In addition, a Detector Stand (DS-01) has also been added as a component to be used with both the CXDI-720C Wireless and CXDI-420C Wireless. Compatibility with the Power Box (PB-01), a CXDI-Pro component that was cleared under K220098 has also been added. The CXDI Control Software has been updated from V3.10.0.4 to V3.10.2.2 to fix some bugs, update the GPU driver, and add several minor functional changes. Together, these changes make up the CXDI-Elite.

Upon review of the provided document, it is important to note that the submission is for an imaging device (Digital Radiography CXDI-Elite / E1), not an AI/Software as a Medical Device (SaMD) that performs diagnostic or assistive functions requiring performance studies with acceptance criteria based on accuracy metrics.

The document primarily addresses a Special 510(k) submission for changes to an existing, cleared device. These changes involve adding new detectors, an optional accessory, and software bug fixes/minor functional changes. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and safety performance, rather than clinical efficacy measured by AI model output and human reader performance.

The provided text does not contain information about:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample sizes for test sets (in the context of clinical performance evaluation).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device by confirming that the modifications do not raise new questions of safety or effectiveness. This is primarily achieved through non-clinical/bench testing and adherence to relevant standards.

Here's a summary of what the document does provide regarding acceptance criteria and performance, as it pertains to the hardware and basic software functionality of a digital radiography system:

Acceptance Criteria and Study for Digital Radiography CXDI-Elite / E1 (Hardware/Software Updates)

The acceptance criteria are implicitly met by demonstrating continued compliance with relevant international and FDA standards, and by showing that the changes (new detectors, accessory, software update) do not negatively impact the fundamental performance or safety characteristics of the device.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance (as stated in the document):

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

• The document states "Adequate detector bench testing should be sufficient to demonstrate that the subject detector CXDI-Elite / E1 works as intended." This implies physical testing of the devices, but does not specify sample sizes for "test sets" in the clinical performance sense, as this was not a clinical performance study. The testing appears to be primarily engineering verification and validation of hardware and software components.
• Data provenance: Not applicable in the context of clinical images or patient data. The testing is a validation of the device's technical specifications and compliance.

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

• Not applicable. This was not a study requiring expert readers to establish ground truth on clinical images, as it was not a diagnostic performance study for an AI algorithm.

4. Adjudication Method for the Test Set:

• Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This was not an AI-enabled diagnostic device or a comparative effectiveness study involving human readers.

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

• No. This device is a digital radiography system, not a standalone AI algorithm. Its function is to capture and display radiographic images.

7. The Type of Ground Truth Used:

• Not applicable in the clinical diagnostic sense. The "ground truth" for this submission are the established engineering specifications, safety standards (IEC 60601 series), and FDA guidance documents, against which the device's technical performance (e.g., MTF, DQE, IP level, functional modes) is verified via bench testing.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve machine learning or AI models with training sets.

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

• Not applicable for the reasons stated above.

In conclusion, the provided document is a 510(k) summary for a digital radiography hardware system with minor modifications. The "acceptance criteria" and "study" described pertain to engineering validation, safety testing, and demonstration of substantial equivalence by showing that the updated device continues to meet established performance and safety standards, and does not pose new risks. It is not an AI/SaMD performance study seeking to establish diagnostic accuracy against clinical ground truth.

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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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The DIGITAL RADIOGRAPHY CXDI-Elite / E1 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-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager using TFT (thin-film transistor) arrays. The CXDI-Elite is a series of detectors, currently consisting of the CXDI-720C Wireless detector unit, also called the AR- E3543W detector. The detector intercepts x-ray photons, and the Cesium-Iodide 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 a digital image, 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 monitors used with the CXDI-Elite are not a part of this submission.

The CXDI Control Software is updated from V2.16 to V3.10 in this submission. The update to the software includes bug fixes, modification to check-in function, modification to communication with X-ray emission devise, calibration support, addition of the Intelligent NR function (previously cleared under K212269), and the addition of Standard Synchronization Mode with Built in AEC Assistance.

The provided document K213780 is a 510(k) Pre-market Notification for a digital radiography device, the Canon DIGITAL RADIOGRAPHY CXDI-Elite / E1. This document establishes substantial equivalence to a predicate device, and as such, does not contain the detailed acceptance criteria for an AI/ML algorithm or the specific study that would prove the device meets such criteria.

The document makes a brief reference to an "Intelligent NR function (previously cleared under K212269)" in the section "Device Description," indicating that this specific function (likely an AI/ML noise reduction feature) has been previously cleared. However, the current 510(k) submission (K213780) is focused on the overall digital radiography system and its hardware/software updates, not specifically on the detailed performance of the "Intelligent NR function."

Therefore, based solely on the provided text, it is not possible to answer the requested questions about acceptance criteria and study details for an AI/ML device/algorithm, as this document does not provide that specific information.

To address the prompt, I will explain why the information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: Not present. This document is for a general digital radiography system, not specifically an AI/ML diagnostic or assistive algorithm. The "Intelligent NR function" is briefly mentioned as having been "previously cleared," meaning its performance data and acceptance criteria would be in the K212269 submission, not this one.
2. Sample sizes used for the test set and the data provenance: Not present. The document 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-Elite / E1 works as intended." This indicates that the substantial equivalence was based on bench testing and comparisons with predicate devices, not a clinical test set with human subject data for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present, as no clinical test set for an AI/ML algorithm is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present, as no clinical test set for an AI/ML algorithm is described.
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: Not present. The document explicitly states "Clinical testing is not necessary."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. The focus is on the complete system and its hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present, as no clinical test set for an AI/ML algorithm is described.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

In summary, the provided document (K213780) is a 510(k) Pre-market Notification for a general digital radiography system. It establishes substantial equivalence based on hardware and software updates, and bench testing, not on clinical performance studies of an AI/ML algorithm. While an "Intelligent NR function" (likely an AI/ML feature) is mentioned as previously cleared, the details of its specific acceptance criteria and the study proving it meets those criteria are not included in this particular submission.

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