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These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skall, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.

The provided document is a 510(k) summary for the Sedecal Millennium Plus Digital Diagnostic X-Ray System. It states that the new device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study as requested.

The document primarily focuses on establishing substantial equivalence by comparing the new device's characteristics and intended use to those of its predicate devices (Sedecal Millennium Digital K042876 and Sedecal X Plus LP Plus K062335) and by stating that it passes bench and test laboratory evaluations to applicable standards (21 CFR 1020.30 and IEC 60601).

Therefore, I cannot provide the requested table and detailed information based on the content of this document. The document explicitly states:

"The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."
and
"After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Sedecal Inc that the Scdecal Millennium Plus Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."

This indicates that general safety and effectiveness testing was conducted, but the specific details of the acceptance criteria, study design, performance metrics, sample sizes, ground truth, or expert involvement are not disclosed in this 510(k) summary.

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These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

These digital diagnostic x-ray systems consist of a tubehead/collimator assembly mounted on a U-Arm, along with a generator, generator control, and an x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV, with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.

The provided 510(k) summary for the Sedecal X-Plus LP Plus Digital Diagnostic X-Ray System (K090238) does not contain the information requested regarding acceptance criteria and a specific study proving the device meets those criteria, as you would typically expect for performance data of AI/CADe devices.

This submission is for a traditional X-ray system, and the approval is based on substantial equivalence to predicate devices, rather than a performance study with defined acceptance criteria for diagnostic accuracy.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this type of device, the acceptance criteria are generally related to demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and effectiveness through comparison of technical characteristics and adherence to relevant performance standards.
• Reported Device Performance: The document states, "The results of bench and test laboratory indicates that the new device is as safe and effective as the 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):

• This information is not provided in the document. The approval is based on "bench and test laboratory" results and comparison of specifications, not a clinical test set with patient data for diagnostic accuracy assessment.

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

• This information is not applicable/provided. No clinical reader study or ground truth establishment relevant to diagnostic accuracy is described.

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

• This information is not applicable/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, an MRMC comparative effectiveness study was not done. This device is a digital X-ray system, not an AI or CADe device designed to assist human readers or provide diagnostic interpretations.

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

• No, a standalone performance study was not done. This is an imaging acquisition device, not an algorithm.

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

• Not applicable. The "ground truth" for this submission revolves around engineering performance verified by "bench and external laboratory testing to applicable standards" (e.g., 21 CFR 1020.30, IEC-60601) to demonstrate the device functions as intended and is safe. It's not about diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. This isn't an AI/machine learning device that requires a training set.

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

• Not applicable.

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CANON DIGITAL RADIOGRAPHY CXDI-50G 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-50G 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.

Here's an analysis of the provided text regarding the Canon CXDI-50G device, focusing on acceptance criteria and study details.

Based on the provided text, the Canon CXDI-50G is a digital radiography device intended to replace conventional film/screen radiographic systems. The submission is a 510(k) premarket notification to establish substantial equivalence to predicate devices (Canon CXDI-31 and CXDI-40G).

Critically, the provided document DOES NOT contain a study with specific acceptance criteria and performance metrics for the CXDI-50G itself, nor does it detail a standalone clinical performance study or a multi-reader multi-case (MRMC) comparative effectiveness study.

The submission primarily focuses on demonstrating substantial equivalence based on:

• Technical Specifications: Stating that the technical specifications, imaging principle, physical characteristics, and intended use are "the same as those of the CXDI-40G including pixel pitch," with modifications primarily in physical appearance, mechanical structure, and sensor size (from 43x43cm to 35x43cm).
• Software Changes: Highlighting that the control software V6.0 for CXDI-50G includes changes from V5.0 (used in CXDI-40G) to add control for the CXDI-50G sensor and some GUI changes.
• Design Control Activities: General reference to "results of our design control activities" to support equivalence.

Since there is no explicit performance study detailed for the CXDI-50G against defined acceptance criteria, I cannot fill in most of the requested information. However, I can infer what the "acceptance criteria" and "reported device performance" are being judged against: substantial equivalence to the predicate devices.

Summary of Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated in the provided text. The document relies on similarity to predicate devices rather than a new standalone test set.

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)

• Not applicable. No specific independent expert review for a test set is described. The assessment is based on the manufacturer's technical comparison to predicate devices, reviewed by the FDA.

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

• Not applicable. No specific adjudication method for a test set 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

• No, an MRMC comparative effectiveness study was not done or reported. This device primarily focuses on converting conventional X-ray images to digital, not on AI-assisted interpretation.

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

• No, a standalone performance study against specific clinical criteria was not explicitly detailed or reported in this document. The submission is for substantial equivalence to existing devices that are already cleared for standalone use in digital radiography.

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

• Not explicitly stated. The "ground truth" for the substantial equivalence claim is essentially the established performance and safety of the predicate devices (CXDI-31 and CXDI-40G).

8. The sample size for the training set

• Not applicable/Not stated. This document describes a hardware device (digital X-ray imager) and its controlling software, not a machine learning algorithm that would require a "training set" in the conventional sense.

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

• Not applicable/Not stated. See point 8.

In conclusion: The provided 510(k) submission for the Canon CXDI-50G is a declaration of substantial equivalence to previously cleared predicate devices (CXDI-31 and CXDI-40G). It does not present a de novo clinical study with specific acceptance criteria, a test set, expert review, or detailed performance metrics for the CXDI-50G as a new device. The "acceptance criteria" are implicitly met by demonstrating that the device is technically and functionally equivalent to already cleared devices, suggesting that its performance would be similar and thus acceptable.

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