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The Patient Administration Set is a radionuclide rebreathing system and an accessory intended solely for use with the Technegas® Generator. It is designed for use as a conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure.

The Patient Administration Sets (PAS) consist of a flexible plastic tubing with a distal plastic connector which can be affixed to a radionuclide generator, a T-section connector with (2) one way valves which permits inhalation of the generated radionuclide gas and subsequent absorption of expelled gas during exhalation via a semipermeable microparticle filer. A mouthpiece (choice of soft silicone or hard plastic) is affixed to the proximal end of T-section connector for patient breathing.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Patient Administration Set" (PAS). It primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device.

Therefore, the document does NOT contain the information needed to answer the questions about acceptance criteria and a study proving a device meets them in the context of an AI/ML-driven medical device performance study (e.g., diagnostic accuracy, human-AI collaboration).

The Patient Administration Set is described as a "radionuclide rebreathing system" and an accessory for a radionuclide generator used in lung ventilation imaging. The "modifications" mentioned are related to labeling, exhalation filter changes (new supplier, industry-standard composition), and packaging. The "Design Verification and Validation Testing" performed consists of laboratory tests to confirm dimensions, tolerances, biocompatibility, and structural integrity, ensuring compatibility with the Technegas™ generator. These are engineering design verification tests, not performance studies as typically understood for AI/ML devices.

Here's why the requested information cannot be extracted from the provided text:

• No AI/ML Component: The device described is a physical medical device (tubing, connectors, filter, mouthpiece) for administering a radionuclide. There is no mention of any artificial intelligence or machine learning component.
• Performance Metrics for AI/ML are Absent: Questions about sensitivity, specificity, AUC, human reader improvement with AI assistance, standalone algorithm performance, training/test set sample sizes, and ground truth establishment are relevant to AI/ML diagnostic or predictive tools, not to a physical radionuclide administration set.
• "Acceptance Criteria" in this context: The "acceptance criteria" for this device (the Patient Administration Set) would be related to its physical and functional integrity (e.g., no leaks, correct dimensions, proper flow, biocompatibility, filter efficiency) and compliance with regulatory standards. These are verified through the "Design Verification and Validation Testing" which are laboratory tests, not clinical performance studies comparing diagnostic accuracy or clinical outcomes.
• No "Study" as requested: The "study" mentioned ("Design Verification and Validation Testing") is a series of engineering tests, not a clinical trial or performance study involving human subjects or AI model evaluation.

In summary, the provided FDA document is a regulatory clearance for a physical medical device, not a performance study report for an AI/ML diagnostic or therapeutic device. Therefore, it does not contain the information required to answer your specific questions.

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