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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.

The Alphenix, INFX-8000H/B, V8.0, is 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.

This document describes the Alphenix, INFX-8000H/B, V8.0, an X-ray system. The information provided heavily emphasizes device changes and regulatory compliance, but does not contain the specific details required to answer your questions about acceptance criteria performance and the study that proves the device meets them.

This is a 510(k) Premarket Notification Summary, which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device. It highlights modifications to an existing device (Alphenix, INFX-8000H, V3.52 to V8.0) rather than a de novo submission of a novel device requiring a full clinical trial for performance validation against specific acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document states "Testing included conformity testing to IEC standards and phantom testing was conducted to verify image metrics related to improvements in image quality" and "This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system." However, it does not provide specific acceptance values or detailed performance metrics.
• Sample size used for the test set and the data provenance: The document mentions "phantom testing" but no details on the number of phantoms or the nature of the data. It explicitly states "Clinical images were deemed not necessary for the aforementioned improvements via design control and risk management activities." This implies no human patient data was used for testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as clinical images were not used.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document states "Clinical images were deemed not necessary," which indicates an MRMC study was not performed.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an X-ray system, not an AI algorithm for diagnosis. Performance is measured by image quality and system functionality, not diagnostic accuracy of an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, if any, for phantom testing would be based on known phantom characteristics, not clinical ground truth methods.
• The sample size for the training set: Not applicable. This is a medical imaging hardware system with associated control software, not a machine learning model that requires a training set.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on regulatory compliance, engineering changes, and demonstrating that the updated X-ray system maintains the safety and effectiveness of its predicate device, primarily through bench and phantom testing against engineering specifications and industry standards. It does not contain information about studies designed to prove device performance against specific clinical acceptance criteria using human data, as would be expected for a novel diagnostic AI algorithm.

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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.

The Alphenix, INFX-8000F/B, V8.0, is a single or dual plane 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 (either one or two) 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 text is a 510(k) summary for the Alphenix, INFX-8000F/B, V8.0, an X-ray system. It describes changes made to a previously cleared device. However, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI-powered medical device's performance evaluation.

Specifically, the document states:

• "This submission contains test data that demonstrates that the system modifications result in performance that is equal to or better than the predicate system."
• "Testing of the modified system was conducted in accordance with the applicable standards published by the International Electromechanical Commission (IEC) for Medical Devices and XR Systems."
• "Risk analysis and verification/validation testing, conducted through bench testing, are included in this submission which demonstrates that the requirements for the modifications made to the system have been met."
• "Additionally, Image Quality metrics utilizing phantom image evaluations were employed in bench testing which demonstrates that the requirements for the modifications made to the system have been met."
• "Software Documentation for a Moderate Level of Concern... is also included as part of this submission. Software modules were subject to verification and/or validation testing to ensure that they were properly integrated into the existing software platform."

The summary lacks the specific details required for the requested table and study information, particularly concerning numerical performance metrics, sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, which are typical for AI/ML device performance claims. The changes described are primarily related to hardware components, system software versions (for "improved usability"), and workflow enhancements for the X-ray system itself, not the performance of a new AI-driven diagnostic algorithm.

Therefore, I cannot generate the requested table and detailed study description based solely on the provided text. The document refers to "test data," "risk analysis," "verification/validation testing," and "Image Quality metrics utilizing phantom image evaluations," but it does not specify the quantitative acceptance criteria or the numerical results of these tests in a way that aligns with the questions asked (e.g., sensitivity, specificity, or reader improvement with AI assistance).

If this document were for an AI/ML device making diagnostic claims, the level of detail regarding performance testing would be much higher, including specific metrics and study designs that involve human readers or ground truth derived from expert consensus/pathology.

The questions you've asked are highly relevant for the regulatory review of AI/ML-driven medical devices. However, this specific 510(k) summary (K182415) seems to be for an imaging system with software/hardware updates, not necessarily an AI-powered diagnostic algorithm that would require the in-depth clinical performance validation often associated with AI.

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