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DIGITAL RADIOGRAPHY CXD1-40G COMPACT 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 procedures. This device is not intended for mammography applications.

DIGITAL RADIOGRAPHY CXDI-40G COMPACT, designed for easy installation in bucky unit, is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The provided text is a 510(k) summary for the Canon CXDI-40G COMPACT digital radiography device. It describes the device, its intended use, and compares it to a predicate device (Canon CXDI-40EG). However, it does not contain information about acceptance criteria, detailed performance metrics, specific studies conducted, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications.

The summary primarily focuses on demonstrating substantial equivalence to a predicate device, highlighting changes in physical dimensions and housing for easier installation. It concludes that "The Performance Data demonstrate that CXDI-40G COMPACT is as safe and effective as CXDI-40EG," but it does not present this performance data.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer the questions regarding sample sizes, ground truth, experts, or comparative effectiveness studies based on the provided text.

The available information is limited to:

• Proposed Device: Canon CXDI-40G COMPACT
• Predicate Device: Canon CXDI-40EG (K050987)
• Intended Use: Digital image capture for conventional film/screen radiographic examinations, intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (not for mammography).
• Comparison: Same intended use, differences in external dimensions and housing for easier installation.
• Conclusion: Substantially equivalent to predicate based on "Performance Data" and "design control activities and non-clinical testing" (the details of which are not included in this summary).

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PACS Software Solution 2003 is intended to be used by radiologists and other medical professionals for purposes of diagnosis, or for clinical review, by viewing medical images on digital display devices or hard copy printouts. PSS03 provides an efficient interface to medical images and manages the archiving of medical images for short and long term storage. PSS03 is intended to be used with imaging equipment (e.g., Magnetic Resonance Imaging (MRI), Computerized Tomography (CT), Digital Radiography (DR), Ultrasound (US), etc.) and patient information systems (e.g., Hospital Information Systems (HIS), Radiology Information Systems (RIS)) approved for medical use.

PACS Software Solution 2003 is used to acquire, process, display, evaluate, archive, print and distribute DICOM compliant images for clinical purposes. Images may be acquired from imaging modalities such as CR, CT, MR, X-Ray, and other devices.

PACS Software Solution 2003 (PSS03)' is proprietary software used in conjunction with computer hardware to provide a Picture Archiving and Communication System. PSS03 has been designed to manage medical imaging data from various imaging devices (e.g. Magnetic Resonance Imaging, Computerized Tomography, Digital Radiography, Ultrasound, etc.). Management of medical imaging data from these devices, enabled by PSS03, includes display tools, the support of industry standard communication protocols (e.g. Transfer Control Protocol/Internet Protocol, Digital Communication in Medicine, Ethernet, etc.) and archiving of data using hierarchical protocols. The system provides redundant storage of the exam data.

PSS03 accommodates individual user preferences by automatically displaying medical images in a presentation format unique to the user and to the type of exam selected.

PSS03 is highly scalable, providing a small facility or a large enterprise of facilities the same functionality.

This 510(k) submission for "PACS Software Solution 2003" is a traditional clearance based on substantial equivalence to a predicate device, "Paper Film - PACS". As such, it does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment that would be present in a submission for a novel AI/ML medical device.

Therefore, many of the requested categories of information cannot be provided from this document. The device in question is a Picture Archiving and Communication System (PACS) software, which is infrastructure for managing medical images, not a diagnostic algorithm itself.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission for a PACS software, not a diagnostic algorithm. Performance is assessed against the predicate device's capabilities.
• Reported Device Performance: The document states that the new system has "equivalent design features, methods of use, and equivalent functional characteristics as the predicate device" and "raises no new safety or effectiveness issues." It highlights improvements like "newer faster systems such as monitor resolution and tape drives as well as allowing for multiple external storage devices." It also mentions "smooth" and "sharp" filtering of images using a low-pass blurring kernel, and 8-bit and 12-bit JPEG compression, similar to the predicate.

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

• Not applicable/Not provided. This is a PACS software, not a device that runs diagnostic algorithms on a test set of medical images in the way an AI/ML device would. The evaluation is functional and comparative to a predicate PACS.

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

• Not applicable/Not provided. No "ground truth" in the diagnostic sense is established for this PACS software.

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

• Not applicable/Not provided.

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. This is a PACS software, not an AI-assisted diagnostic tool.

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

• No. This is a PACS software. Its function is to facilitate human review and management of images, not to perform standalone diagnostic tasks.

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

• Not applicable/Not provided.

8. The sample size for the training set:

• Not applicable/Not provided. This is PACS software, not a machine learning model requiring a training set.

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

• Not applicable/Not provided.

Summary based on provided text:

This 510(k) submission for "PACS Software Solution 2003" asserts substantial equivalence to a previously cleared PACS known as "Paper Film - PACS" (K940664). The primary argument for equivalence is based on:

• Same Indications for Use: Both systems are intended for radiologists and other medical professionals to view medical images, for diagnosis or clinical review, and manage the archiving of medical images.
• Equivalent Design Features: Both operate under Open Windows on a Unix-based operating system and consist of image servers, database servers, and workstations for image acquisition, processing, rendering, archiving, printing, and distribution.
• Technological Characteristics: Both provide "smooth" and "sharp" filtering, and utilize 8-bit and 12-bit JPEG compression.
• Improvements: The new system takes advantage of "newer faster systems such as monitor resolution and tape drives as well as allowing for multiple external storage devices." It also enhances patient integrity by assigning a Radiology Information System key in addition to the Medical Record Number and patient's name.
• Calibration: Display devices for both are calibrated using standard SMPTE patterns and/or graphics card software.

The submission confirms that the device "raises no new safety or effectiveness issues" compared to its predicate. The evaluation focuses on functional equivalence and updated technological capabilities of the PACS system rather than diagnostic performance metrics or clinical study outcomes typical for AI/ML diagnostic tools.

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CANON DIGITAL RADIOGRAPHY CXDI-40C 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 procedures.

The Canon digital radiography CXDI-40C is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. The CXDI-40C uses CsI (Cesium Iodide) as the fluorescent screen deposited on the amorphous silicon array, while the predicate CXDI-40G uses GOS (Gadolium Oxy-Sulfide). The CXDI-40C delivers diagnostic images with approximately half the xray dosage required by CXDI-40G and CXDI-40C's DQE approximately doubles compared to CXDI-40G. The CXDI-40C's imaging size, number of pixels and pixel pitch are the same as those of CXDI-40G. CXDI-40C operates in conjunction with an upright stand, table, and universal stand. CXDI-40C's housing size and shape are almost as same as those of CXDI-40G. A Control PC is required to operate the CXDI-40C.

The provided text is a 510(k) summary for a medical device (Canon CXDI-40C digital radiography system) seeking clearance from the FDA. It declares substantial equivalence to a predicate device (Canon CXDI-40G).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Key Takeaway: The provided 510(k) summary does not contain information about acceptance criteria or specific studies that prove the device meets those criteria in the way typically required for AI/CAD-based devices. This document is from 2003 and for a digital radiography system replacing film/screen, not a system with advanced analytics or AI. The FDA clearance is based on substantial equivalence to an existing device, primarily focusing on hardware differences (fluorescent screen material) and the impact on image quality (DQE, dosage).

Therefore, many of the requested fields below will be marked as "Not Applicable" or "Not Provided" because the nature of this submission is different from one for an AI/CAD device.

Acceptance Criteria and Device Performance

Study Details

1. Sample sized used for the test set and the data provenance:

   • Not Provided. The document relies on similarity to a predicate device and improved technical specifications (like DQE and reduced dosage), rather than a clinical test set with patient data for performance evaluation in the context of an AI/CAD system.

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

   • Not Applicable / Not Provided. This type of evaluation (expert-established ground truth) is typical for AI/CAD devices, not for a fundamental digital X-ray capture system like this, where the primary evaluation is technical equivalence and imaging characteristics.

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

   • Not Applicable / Not Provided.

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 / Not Done. This is not an AI-assisted device. The primary comparison is between the proposed device and a predicate digital radiography device, focusing on hardware and image acquisition characteristics.

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

   • Not Applicable / Not Done. This device is a digital X-ray capture system, not an algorithm.

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

   • Not Applicable / Not Provided. The "ground truth" in this context would be the successful capture of diagnostic-quality X-ray images, as demonstrated by technical metrics (DQE, dosage) and clinical history/usage of the predicate device. It's not about disease detection performance.

7. The sample size for the training set:

   • Not Applicable / Not Provided. This is a hardware device submission, not an AI model submission. There is no concept of a "training set" for the device itself in this context.

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

   • Not Applicable / Not Provided.

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Canon Non-Mydriatic Retinal Camera CR-DGi is intended to be used for taking pictures of retina of human eye without a mydriatic.

CR-DGi is an improved model of CR5-45NM.

The provided text describes Canon's CR-DGi Non-Mydriatic Retinal Camera. The device is an updated model of the Canon CR 45 NM, and its primary purpose is to capture images of the human retina without the need for pupil dilation. The 510(k) submission (K031629) focuses on demonstrating substantial equivalence to the predicate device.

However, the provided text does not contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, sample sizes used, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details about training set size and ground truth establishment for an AI/algorithm-based device.

The document is a 510(k) summary for a medical device that appears to be a hardware product (a camera), not an AI/algorithm. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance are not applicable here. The "performance" section in the comparison table refers to physical specifications and features (e.g., angle of view, working distance, focusing mechanism) rather than diagnostic accuracy metrics.

The FDA 510(k) clearance in this case is for a medical device (camera) demonstrating substantial equivalence in its specifications and intended use to a previously cleared predicate device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, expert involvement, or AI-specific performance metrics as this information is not present in the provided text.

The document primarily states:

• Proposed Device: Canon CR-DGi HKI, Ophthalmic camera
• Predicate Device: Canon CR 45 NM 86HKI, Ophthalmic cameras (K980246)
• Intended Use: Taking pictures of retina of human eye without a mydriatic.
• Performance Comparison: A table comparing specifications between the proposed and predicate devices, showing "Same" for most critical imaging parameters (Angle of view, Min. diameter of pupil required, Working distance, Light source for photography). The primary change noted is the image unit shifting from supporting multiple options (EOS Digital Camera, 35mm film, Polaroid, 3CCD TV Camera) to solely EOS Digital Camera.
• Regulatory Clearance: The FDA found the device substantially equivalent to the predicate device.

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CANON DIGITAL RADIOGRAPHY CXDI-40G 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 procedures.

The Canon digital radiography CXDI-40G is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The provided text is a 510(k) Summary for the Canon Digital Radiography CXDI-40G. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about a study proving the device meets acceptance criteria in the way typically expected for a medical device efficacy study (e.g., clinical trials, performance benchmarks against specific metrics).

Instead, the submission focuses on substantial equivalence to previously cleared predicate devices (CXDI-11 and CXDI-22). The "proof" that the CXDI-40G meets acceptance criteria is implicitly based on its technical characteristics being similar to or the same as the predicate devices, which were already deemed safe and effective.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state acceptance criteria in terms of performance thresholds for a new study. Instead, it relies on the technical specifications and performance of the predicate devices as the de facto "acceptance criteria." The new device is presented as having "Same" or comparable performance characteristics to the cleared predicate devices.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Based on Substantial Equivalence Claim)

The document does not describe an independent study to "prove the device meets acceptance criteria" in a typical clinical performance study sense. Instead, the "study" is implicitly the comparison of the CXDI-40G's specifications against those of its predicate devices.

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

• Not Applicable (N/A): No specific test set or clinical study data is presented. The submission relies on a descriptive comparison to predicate devices, not a new performance study with a test set of images or patients.

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

• N/A: No test set with ground truth established by experts is described.

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

• N/A: No test set or adjudication process 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

• N/A: No MRMC study was conducted or reported. This device is an imaging capture system, not an AI-assisted diagnostic tool.

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

• N/A: This submission is for a digital radiography capture device, not a standalone AI algorithm. Its performance is assessed through technical specifications consistent with existing radiography systems.

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

• N/A: No explicit ground truth data is used in this submission, as it focuses on substantial equivalence based on technical specifications and intended use. The "ground truth" for the predicate devices' performance would have been established during their respective clearance processes.

8. The sample size for the training set

• N/A: This is not an AI/machine learning device submission; therefore, there is no concept of a "training set."

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

• N/A: No training set is involved.

Conclusion from the Document:

The Canon Digital Radiography CXDI-40G is deemed substantially equivalent to its predicate devices (CXDI-11 and CXDI-22) based on a detailed comparison of their technical characteristics (image size, pixel pitch, number of pixels, imaging principle, materials, intended use, etc.), physical characteristics, and software. The primary differences noted relate to mechanical structure, compatibility with different stands/tables, and the type of grid used, which are presented as not raising new questions of safety or effectiveness. The software update (V5.0) is also discussed, highlighting that main changes are related to controlling the CXDI-40G sensor and GUI updates, and is compared to a previously cleared version (V4.1). The FDA's letter concurs with the substantial equivalence finding based on the information provided.

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The DR-ER version of Canon's X-ray Digital Cameras 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 procedures.

The Canon X-ray digital camera model CXDI-11 DR-ER add. version is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The Canon X-ray digital camcra model CXDI-22 DR-ER add. version is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capure for conventional film/screen radiographic examinations.

The Canon X-ray digital camera model CXDI-31 DR-ER add. version is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The provided text describes three different Canon X-ray Digital Camera models (CXDI-11 DR-ER, CXDI-22 DR-ER, and CXDI-31 DR-ER), all referenced under K023586. However, the documentation does not contain specific acceptance criteria or details of a study proving the devices meet such criteria. It primarily focuses on demonstrating substantial equivalence to their respective predicate devices.

The documents are 510(k) summaries for new versions of existing X-ray digital cameras, stating their intended use is to replace film/screen systems in general diagnostic procedures. The FDA's letter (Document 3 and 4) confirms the substantial equivalence determination but does not provide details of performance studies or acceptance criteria beyond regulatory compliance.

Therefore, I cannot provide the requested information from the given text. The provided documents are administrative in nature for FDA clearance and do not contain the technical study details needed to answer the prompt.

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Canon Laser Blood Flowmeter CLBF model 100 is intended for use in observing patient's fundus (retina) with the information of blood flow (velocity) in a retinal vessel. The information of blood flow is also obtained by CLBF model 100, and it is intended to help doctors' reading of retinal images.

The Canon Laser Blood Flowmeter (CLBF) Model 100 allows for fundus observation with velocity measurement of retinal blood flow.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. However, it does highlight that a published clinical study was included to support a claim of substantial equivalence to a predicate device.

Based on the available information, here's an attempt to answer your questions, with significant limitations due to the lack of explicit detail:

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

The document does not explicitly state acceptance criteria or provide a table of performance metrics against such criteria. The closest information is a comparison between the proposed device (Canon Laser Blood Flowmeter CLBF Model 100) and its predicate device (Heidelberg Retina Flowmeter). This comparison focuses on technical specifications and intended use rather than specific a priori acceptance criteria for performance.

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

The document mentions "A published clinical study was included to support a claim of substantial equivalence." However, it does not provide any details regarding:

• The sample size of patients or images in this clinical study.
• The country of origin of the data.
• Whether the study was retrospective or prospective.

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 provided in the document. The nature of "blood flow information" provided by the device (velocity, flow rate, vessel diameter, time variation) suggests that ground truth would likely involve direct measurement techniques or other validated methods, rather than expert interpretation of images for initial validation. However, the document states the device "is intended to help doctor's reading of retinal images," implying some level of clinical assessment. Without details of the clinical study, the role of experts in establishing ground truth is unknown.

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

This information is not provided in the document.

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

The document does not indicate that an MRMC comparative effectiveness study was conducted. The claim of "substantial equivalence" is based on comparing the device's technical characteristics and intended use to a predicate device, and a "published clinical study" without further detail. There's no mention of AI assistance or human reader improvement.

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

The device is a "Canon Laser Blood Flowmeter CLBF Model 100" which performs "fundus observation with velocity measurement of retinal blood flow." Its output includes numerical values for velocity, flow rate, and vessel diameter, and graphical representations of time variation. The document states "The information of blood flow is also obtained by CLBF Model 100, and it is intended to help doctor's reading of retinal images." This implies the device provides quantitative measurements directly; it is not described as an "AI algorithm" in the modern sense that processes images for interpretation by humans. Therefore, the concept of "standalone performance" for an AI algorithm for diagnosis or detection doesn't directly apply here. The device itself is a measurement tool, and its "standalone performance" would relate to the accuracy and precision of its blood flow measurements. The document does not provide such detailed performance data.

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

The document does not explicitly state the type of ground truth. Given the nature of a blood flowmeter, ground truth for its measurements (velocity, flow rate) would most likely come from:

• Direct physical measurements in controlled settings.
• Comparison to other established, validated blood flow measurement techniques (if applicable for retinal vessels).
• Clinical correlation with known physiological states or conditions related to blood flow (e.g., changes in flow in response to stimuli or in disease states).

The mention of a "published clinical study" suggests that some form of clinical validation or comparison was performed.

8. The sample size for the training set

The device is a measurement system (Laser Blood Flowmeter) and not described as an AI/machine learning model in the modern sense that requires a "training set" of data to learn from. Therefore, the concept of a training set sample size is not applicable to the information provided.

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

As there is no mention of a "training set" in the context of an AI/machine learning model, this question is not applicable based on the provided text.

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CANON X-RAY DIGITAL CAMERA CXDI-22 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 procedures.

The Canon X-ray digital camera model CXDI-22 is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.

The provided 510(k) summary for the Canon CXDI-22 X-ray Digital Camera focuses on establishing substantial equivalence to a predicate device (Canon CXDI-11) rather than presenting a performance study with specific acceptance criteria and detailed results.

Therefore, much of the requested information regarding specific acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. The document primarily details the hardware specifications and intended use of the device and its predicate.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria: The document implies that the CXDI-22 meets "acceptance criteria" by demonstrating that its technical characteristics are "Same" as the predicate device (CXDI-11) or by detailing the specific physical changes (e.g., sensor unit dimensions, power supply, table integration) without indicating any degradation in core imaging performance metrics like MTF or Dynamic Range. The performance metrics listed for CXDI-11 are implicitly the acceptance criteria for CXDI-22 for substantial equivalence.

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

• Not available. The document does not describe a performance study with a specific test set. The submission is based on comparison to a predicate device.

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

• Not available. As there is no described test set or performance study, there is no mention of experts establishing ground truth.

4. Adjudication method for the test set:

• Not available.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. The document does not describe an MRMC comparative effectiveness study.

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

• Yes, implicitly. The device itself is an image capture system; its performance metrics (MTF, dynamic range) are inherent to the hardware and are evaluated as "standalone" technical specifications rather than in a human-in-the-loop context for this type of 510(k) submission. However, a formal "standalone study" report is not provided. The comparison chart indicates that the CXDI-22 shares the "Same" performance characteristics as the predicate CXDI-11, which would have undergone similar standalone technical evaluations.

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

• Not applicable / Not available. For demonstrating substantial equivalence for an X-ray digital camera, the "ground truth" often refers to physical measurements of image quality (e.g., MTF, DQE) rather than clinical diagnostic accuracy against pathology or outcomes. The provided document relies on demonstrating equivalent technical specifications to a previously cleared device.

8. The sample size for the training set:

• Not applicable / Not available. This device is a hardware digital X-ray capture system, not an AI or algorithm-driven diagnostic tool in the sense of requiring a "training set" of data to learn from.

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

• Not applicable / Not available. Similar to point 8, this question is not relevant for this type of device and submission.

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CANON X-RAY DIGITAL CAMERA CXDI-11 is indicated for use in generating radiographic Images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

CANON X-RAY DIGITAL CAMERA CXDI-11 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 procedures.

CANON X-RAY DIGITAL CAMERA CXDI-11 is used to directly capture and convert conventional projection X-ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations. CANON X-RAY DIGITAL CAMERA CXDI-11 differs from traditional X-ray systems in that instead of exposing a film for subsequent wet chemical processing to create a hardcopy image, a device is used to capture the image in electronic form. The digital data are then used to produce diagnostic hardcopy and reference-softcopy images.

Here's a breakdown of the acceptance criteria and the study details for the Canon X-Ray Digital Camera CXDI-11, based on the provided text:

Acceptance Criteria and Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a numerical or percentage format typically seen. Instead, the study's goal was to demonstrate that the image quality of the Canon Digital Radiography System (CXDI-11) was substantially equivalent to conventional x-ray film. This qualitative assessment of "substantial equivalence" is the de-facto acceptance criteria.

Additional Performance Metrics (not explicitly linked to "acceptance criteria" but included in comparison):

Study Details

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

   • Sample Size: Not explicitly stated as a number of cases or images. The document mentions "various inpatient cases."
   • Data Provenance: Not specified, but given the context of a 510(k) summary for a US market application, it's reasonable to infer that the data was likely from a US (or generally Western) clinical setting. It is a retrospective study as it involved evaluating "analog films... read twice."

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

   • Number of Experts: Not specified. The document states "Qualified readers evaluated both digital and analog films."
   • Qualifications of Experts: Not explicitly stated, beyond being "Qualified readers." Typically, for imaging studies, these would be radiologists, but their specific experience level is not provided.

3. Adjudication Method for the Test Set:

   • Not explicitly stated. The study involved "Qualified readers evaluated both digital and analog films." There's no mention of multiple readers reaching a consensus or any formal adjudication process beyond individual readers' assessments. The mention of readers reading analog films twice to assess consistency suggests individual reader scoring rather than a consensus approach for the primary equivalency comparison.

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:

   • No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance.
   • This study was a comparison between a new digital radiography system (CXDI-11) and a conventional film/screen system, not an AI-assisted interpretation study. The CXDI-11 device is a capture device, not an AI interpretation tool.

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

   • Yes, in essence, a comparison of the "standalone" performance of the imaging systems was done. The study's primary objective was to evaluate the image quality of films generated by the CXDI-11 compared to conventional film, as assessed by human readers. While human readers were involved in the assessment, the focus was on the inherent quality of the image produced by the device, not the reader's diagnostic performance with or without the device (beyond assessing image quality).

6. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

   • The "ground truth" for the comparison of image quality was based on expert subjective assessment by "qualified readers." They evaluated the images for "overall image quality, as well as for image quality with respect to specific anatomical areas." There's no mention of objective pathology or outcomes data being used to establish a 'true' diagnosis or lesion presence for the purpose of image quality assessment. The "ground truth" here is the perceived quality by experts.

7. The Sample Size for the Training Set:

   • Not applicable / Not mentioned. The CXDI-11 is an X-ray digital camera, a hardware device for capturing images. It's not an AI algorithm that learns from a training set of data. The document describes a clinical evaluation study for image quality, not the development or training of an AI model.

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

   • Not applicable / Not mentioned. As explained above, there is no AI algorithm training set for this device.

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