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When used with a fluoroscope, the EBI® TargetCath™ Fluoro-Guided Steerable Catheter System can be used in the lumbar and sacral spine for delivery of drugs approved for epidural indications. The System may also be used for the purpose of assisting in the diagnosis and treatment of disease utilizing a caudal approach via the sacral hiatus.

The EBI® TargetCath™ Fluoro-Guided Steerable Catheter System consists of several components and different accessories for delivery of approved epidural drugs. This system includes a disposable catheter, and various accessories.

This document is a 510(k) summary for a medical device called the EBI® TargetCath™ Fluoro-Guided Steerable Catheter System. It describes the device and claims substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

Here's why and what's missing:

• Device Type: This is a catheter system, a physical medical device, not a diagnostic or AI-driven system that would typically have performance metrics like sensitivity, specificity, or image quality as acceptance criteria.
• 510(k) Focus: A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by comparing design, materials, intended use, and generally accepted performance standards (e.g., mechanical testing for a catheter) rather than presenting detailed clinical trial results or AI performance metrics.
• Content of the Document: The document explicitly states: "Also, mechanical testing demonstrates that the device meets its functional requirements." This indicates that the device's "performance" was likely assessed through engineering and bench testing, not a clinical study with patients and experts, and certainly not an AI-based study.

Therefore, I cannot provide the requested information. The document explicitly states:

• No acceptance criteria linked to diagnostic or AI performance are provided.
• No "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy, clinical outcomes, or AI performance is described. The "study" mentioned is "mechanical testing," which confirms functional requirements, not the parameters you've asked about (sensitivity, specificity, expert ground truth, sample sizes for AI training/testing).
• No information on AI performance, human reader improvement with AI, or standalone algorithm performance is available. This catheter is a physical device, not an AI system.

In summary, none of the specific information requested in the prompt regarding acceptance criteria, device performance metrics (like sensitivity/specificity), sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC/standalone AI studies is present in the provided text, as it describes a conventional medical device, not a diagnostic or AI-powered system.

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