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.

Device Description

AI/ML Overview

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.

Summary

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K955417

- 8 1996 ATTACHMENT 2

510(k) Summary

MAID

VITAL PAK

Prepared February 29, 1996

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and Sec. 801.92(c).

Submitter's Name and Address:

Vital Signs, Inc. 20 Campus Road Totowa, NJ 07512

Contact Person:

Ms. Whitney Torning Telephone: (201) 790-1330, Extension 392 Fax: (201) 790-7585

1. Name of Device:
  Classification Name: Common Name: Proprietary Name:

Accessory to Monitor, Cardiac Output, Thermal Anesthesia Kit Vital Pak

1. Classification:
  C.F.R. Section: Panel: Product Code: Device Class:

21 CFR 870.1435 Cardiovascular 74KFN Class II

ડ. Performance Standards:
No performance standard(s) applicable to this device have been promulgated under Section 514 of the Food, Drug and Cosmetic Act.
ર. Device Description and Indicated Use:
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.

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Substantial Equivalence:

The Vital Pak is an expansion of the General Anesthesia System (GAS). The GAS was described in the 510(k) K945455 and received FDA clearance on December 23, 1994. Since, the addition of legally marketed devices to the GAS does not either change the intended use of the kit, nor does it affect the safety or efficacy of the kit, the Vital Pak is substantially equivalent to the GAS.

The Vital Pak is "convenience packaging" of devices legally marketed and commercially available. The packaging of this convenience kit does not alter the intended use of any of its individual devices. The Vital Pak is as safe and effective as the devices included. Therefore, the Vital Pak is also substantially equivalent to the devices included in it.

[END OF SUMMARY]

Regulation Number and Section

§ 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).