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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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