(102 days)
The Vital Pak is an expansion of the currently marketed General Anesthesia System (GAS). It is, like the GAS, a customizable, convenience packaged group of sterile and non-sterile disposable devices. The devices are used during the setup and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure. The Vital Pak is designed to conveniently package together those devices, chosen by each institution, that are legally marketed, and typically and repeatedly used by the anesthesia clinicians.
The Vital Pak is an expansion of the currently marketed General Anesthesia System (GAS). It is, like the GAS, a customizable, convenience packaged group of sterile and non-sterile disposable devices. The devices are used during the setup and performance of anesthesia procedures (e.g., general anesthesia, cardiac anesthetic procedures, etc.) and may, depending on the institutions protocol, be used during the transport to and recovery from the same anesthetic procedure. The Vital Pak is designed to conveniently package together those devices, chosen by each institution, that are legally marketed, and typically and repeatedly used by the anesthesia clinicians.
The provided text is a 510(k) Summary for a medical device called "Vital Pak". This document describes the device, its intended use, and its claim of substantial equivalence to previously cleared devices.
Crucially, this document is for a "convenience packed group of sterile and non-sterile disposable devices" used during anesthesia procedures. It is not an AI/ML-driven device or a device that performs diagnostic or prognostic functions based on complex algorithms. Therefore, the questions related to acceptance criteria for AI models, study design (test sets, ground truth, experts, MRMC studies), training sets, etc., are not applicable to the Vital Pak device.
The "device performance" in this context refers to the safety and efficacy of the kit based on the safety and efficacy of its individual, legally marketed components, and the claim that packaging them together does not alter their intended use or performance.
Therefore, I cannot populate the requested table and answer the study-related questions as they pertain to AI/ML or complex algorithms, which are not relevant to the Vital Pak described in this 510(k) summary.
Here's why the questions are not applicable:
- No new performance claims or algorithmic outputs: The Vital Pak is a collection of existing, cleared devices. It doesn't generate new data, interpretations, or diagnoses that would require performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.
- No "study" in the AI/ML sense: The "proof" for the Vital Pak's safety and effectiveness lies in the fact that its individual components are already cleared and that assembly into a kit doesn't introduce new risks or modify functionality. There wouldn't be a study involving test sets, ground truth, or expert readers as you would expect for an AI diagnostic tool.
- No "acceptance criteria" for algorithmic performance: The acceptance criteria for this type of device would revolve around sterility, packaging integrity, shelf life, and the appropriate selection of already-cleared components – not diagnostic accuracy.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).