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This device is a digital radiography/fluoroscopy system use in a diagnostic interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

This device in an x-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm, which is equipped with an x-ray tube, beam limiter and x-ray receptor, x-ray controller, computers with system and processing software, and a patient radiographic table.

The provided document describes a 510(k) premarket notification for a modified medical device, the INFX-8000V with Wireless Footswitch. The submission is a "Special 510(k)", which typically implies minor modifications to a previously cleared device that do not raise new questions of safety or effectiveness. As such, the study conducted is primarily for verification testing to ensure the modification (addition of a wireless footswitch) does not negatively impact the device's performance compared to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list a table of acceptance criteria with specific numerical targets. Instead, it states that the performance of the modified device is "equal to or better than the predicate device." This is a common approach for Special 510(k) submissions where the focus is on maintaining equivalence rather than achieving new performance benchmarks.

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

The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing described is "verification testing," which for a modification like a wireless footswitch, would likely involve engineering tests, functional tests, and EMC/wireless compatibility tests rather than clinical studies with patient data.

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

This information is not provided in the document. Given the nature of the modification (a wireless footswitch for an X-ray system), the "ground truth" would likely relate to the functionality and safety of the footswitch (e.g., signal integrity, latency, safety interlocks) rather than diagnostic accuracy requiring expert image interpretation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. This type of method (e.g., 2+1, 3+1) is typically associated with studies involving human interpretation of medical images where disagreements among experts need to be resolved to establish a definitive ground truth. Such a process is not applicable to the verification testing of a wireless footswitch's functionality.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies compare the diagnostic performance of human readers, often with and without AI assistance, across a set of cases. This type of study is not relevant to the modification of adding a wireless footswitch to an X-ray system.

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

A standalone performance study was not done in the context of an AI algorithm. The device in question is an X-ray system with a wireless footswitch, not an AI diagnostic algorithm. The "standalone" performance here would refer to the functional performance of the footswitch itself (e.g., responsiveness, signal range, battery life), which would be part of the verification testing. However, the document doesn't detail these specific tests.

7. The Type of Ground Truth Used

For the purpose of verifying the wireless footswitch modification, the "ground truth" would likely be based on:

• Engineering specifications and standards: Confirming the footswitch meets its design requirements.
• Functional performance metrics: Demonstrating reliable operation, accurate signal transmission, and appropriate response times.
• Safety standards conformance: Ensuring electrical safety, electromagnetic compatibility, and risk mitigation related to wireless communication.

The document does not explicitly state the "type of ground truth" using these terms but implies conformance to standards and verification through risk management.

8. The Sample Size for the Training Set

This concept is not applicable to this submission. "Training set" refers to data used to train machine learning models. The device being modified is an X-ray system, and there is no indication that any AI or machine learning component was introduced or significantly altered that would require a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no mention of a training set or AI model development in this submission.

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This device is intended to perform interventional studies of the head, body, heart and lower extremities in an angiographic situation. This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

This device in an x-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm , that is equipped with an x-ray tube, beam limiter and x-ray receptor, x-ray controller, computers with system and processing software, and a patient radiographic table.

Here's an analysis of the provided text regarding the Toshiba INFX-8000V with 3D Roadmapping, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness for a modification to an existing device (adding CT image import for 3D Roadmapping). It is not a detailed study report or clinical trial. Therefore, much of the requested information (like specific acceptance criteria, detailed performance metrics, sample sizes, and expert qualifications for a full "study") is not present in this type of document. The 510(k) submission relies on the concept of substantial equivalence to a predicate device, meaning it is considered as safe and effective as the existing, legally marketed device.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance metrics in the format of a table. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (INFX-8000V, K101868) and ensuring the new functionality (CT image import for 3D Roadmapping) does not compromise safety or effectiveness.

The reported device performance is implicitly that the device is as safe and effective as the predicate device, with the added benefit of using existing CT datasets.

Study Information (Based on Available Text)

Given the nature of a 510(k) for a modification, a full-fledged "study" as one might expect for a novel device is not described. The document focuses on demonstrating that the modification does not alter the fundamental safety or effectiveness of the predicate device.

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

   • Sample Size: Not specified. The document states that the modification "allows the clinician to perform the same task as the cleared configuration without having to make additional x-ray exposures" by using "existing data sets from CT." This implies no new clinical test sets were generated specifically for this 510(k) modification to evaluate the 3D Roadmapping functionality itself, as it is leveraging existing image data (CT) and applying an already cleared functionality. The core functionality was presumably evaluated in the predicate device's clearance.
   • Data Provenance: Not specified. The "existing data sets from CT" would originate from standard clinical CT scans, but their specific origin (country, retrospective/prospective) is not detailed.

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

   • Not applicable/Not specified. A formal "ground truth" establishment process for a specific test set, with expert numbers and qualifications, is not detailed in this 510(k) summary for this modification. The assessment is more about the technical integration and consistency with the predicate device.

3. Adjudication Method for the Test Set:

   • Not applicable/Not specified. No adjudication method is described as there isn't a specific "test set" in the traditional sense for evaluating the modified 3D Roadmapping performance.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is not mentioned or described. The submission focuses on substantial equivalence based on technical changes and existing clinical practices.

5. Standalone Performance Study (Algorithm Only):

   • No. This is a modification to an integrated x-ray system, not a standalone AI algorithm. The 3D Roadmapping itself is an existing feature of the device.

6. Type of Ground Truth Used:

   • Not applicable/Not specified for this modification. For the core 3D Roadmapping functionality, the "ground truth" would implicitly be the clinical utility and anatomical accuracy as perceived by medical professionals in actual procedures, which was established for the predicate device. This modification simply changes the source of the 3D data from device-acquired 3D-DSA to imported CT images.

7. Sample Size for the Training Set:

   • Not applicable/Not specified. This is a modification that integrates existing CT data for an existing function, not a new AI algorithm requiring a training set. The software likely implements established image processing techniques rather than a machine learning model that needs "training" in the typical sense.

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

   • Not applicable/Not specified for the reasons above.

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