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The AS-10 is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices. The device is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

The AS-10 is a solid state x-ray imager. It intercepts x-ray photons and the scintillator of the AS-10 emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value.

The subject of this Special 510(k) submission is a change to the AS-10 to make the PowerBox (PB-09), Power Supply Cable, and Optical Cable optional components. This change will allow for the use of any power source and non-Canon cables, given they meet the provided specifications. In addition, changes have been made to the firmware in the AS-10 detector unit and PowerBox to implement bug fixes and functional improvements. Together, these changes make up the AS-10.

The provided document describes a Special 510(k) submission for the Canon AS-10 device, detailing changes made to its optional components and firmware. The focus of this submission is to demonstrate substantial equivalence to its predicate device (Canon AS-10 / CXDI-401RF, K171194), rather than a de novo performance study. Therefore, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or a study design involving expert readers, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness.

Instead, the submission focuses on affirming that the modifications did not negatively impact the device's conformance with existing performance and safety standards.

Here's a breakdown of the information that is and is not available based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or reported performance metrics against such criteria. The "Performance" section focuses on demonstrating continued conformance with regulatory standards after modifications.

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

Not applicable. This is a Special 510(k) submission for modifications, not a new device requiring a clinical performance study with a test set. The changes involved making PowerBox, Power Supply Cable, and Optical Cable optional components, and updating firmware for bug fixes and functional improvements.

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

Not applicable, as no clinical test set requiring ground truth establishment is described.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication 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 MRMC study is mentioned. The AS-10 is an imaging device (Solid State X-Ray Imager), not an AI-driven interpretive tool for physicians.

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

Not applicable. The AS-10 is the imaging hardware itself, not an algorithm.

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

Not applicable, as no clinical performance study requiring ground truth is described.

8. The sample size for the training set

Not applicable. This document describes a hardware and firmware modification, not a machine learning model that would require a training set.

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

Not applicable, as no training set for a machine learning model is described.

Summary of Device Modifications and Performance Activities (as per document):

The submission for the Canon AS-10 is a Special 510(k), indicating minor modifications to an already cleared device (predicate K171194).

The modifications are:

• Making the PowerBox (PB-09), Power Supply Cable, and Optical Cable optional components. This allows for the use of any power source and non-Canon cables that meet provided specifications.
• Updating firmware in the AS-10 detector unit and PowerBox to implement bug fixes and functional improvements.

How Performance was Addressed in this Submission:

The document states:

• "The fundamental scientific technology of the AS-10 has not been modified."
• "The detector unit of the AS-10 has not been modified..."
• "Evaluation of the changes to the AS-10 confirmed that the changes did not impact AS-10 conformance with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-2, 60601-1-3, 60601-1-6, 62366, 60601-2-54, 60825-1, and 62304." (Note: IEC 62220-1 is also listed elsewhere but not explicitly linked to the conformance statement here).
• "These verification/validation activities successfully demonstrated that the device continues to meet the standards for the areas impacted by the device modifications to the predicate device and raises no new questions regarding either safety or effectiveness when compared to the predicate device."

Therefore, the "acceptance criteria" in this context are adherence to established international and U.S. performance/safety standards for medical electrical equipment and X-ray systems, and the "study" involves verification and validation (V&V) activities to confirm that the modifications did not degrade this conformance. This is a common approach for Special 510(k) submissions where the changes are limited and do not introduce new risks or alter the fundamental operating principles of the device.

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The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.

The AS-10 / CXDI-401RF is a solid state x-ray imager. It intercepts x-ray photons and the scintillator of the AS-10 / CXDI-401RF emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value.

The provided text describes a 510(k) premarket notification for a medical device, the AS-10 / CXDI-401RF, an x-ray imager. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a detailed clinical study with acceptance metrics for a diagnostic device.

Therefore, the requested information cannot be fully extracted as it pertains to a diagnostic AI/CADe device, which this submission does not explicitly detail. This submission focuses on the safety and effectiveness of new imaging hardware (a flat panel detector) and its comparability to existing technology.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its equivalence.

Here's an attempt to answer based on the provided text, recognizing the limitations of the document's content for your specific questions:

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

The document does not explicitly state "acceptance criteria" in the context of a diagnostic performance study with specific metrics (like sensitivity, specificity, or AUC) as one might find for an AI/CADe device. Instead, it compares the technical specifications and non-clinical performance of the AS-10 / CXDI-401RF to its predicate devices. The "performance" is implicitly demonstrated by showing that the new device's technical parameters are comparable to or improved upon the predicates and that it is safe and effective.

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 "non-clinical image comparisons involving flat panel display static and dynamic images taken with the new device and the predicate device CXDI-50RF." However, it does not specify a "sample size" in terms of number of patients or specific images, nor does it provide details on data provenance (country, retrospective/prospective). The testing focused on technical performance rather than clinical data sets.

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. The non-clinical tests described focus on technical image quality and system performance rather than a diagnostic evaluation requiring expert readers to establish ground truth.

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

Not applicable, as no expert human readers or adjudication process for diagnostic interpretations are 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 applicable. This submission is for new imaging hardware, not an AI/CADe device designed to assist human readers.

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

Not applicable. This is not an algorithm.

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

For the "non-clinical image comparisons," the "ground truth" would likely be objective measurements of image quality (e.g., DQE, MTF, noise characteristics) comparing the new device's output to the predicate device's output, rather than a clinical ground truth established by medical experts or pathology.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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