Genie P&R is designed to display and process data acquired by nuclear medicine cameras for review by physicians. Genie P&R can retrieve data from nuclear imaging systems and archive the data.

Device Description

Genie P&R is a computer workstation used for the retrieval, archival, processing, analysis and management of nuclear medicine images (data). It consists of a UNIX based workstation (high resolution color monitor, keyboard, mouse, CD ROM), ethernet network connection and system software. Optional optical disk archive and laser filming/color hardcopy are available.

AI/ML Overview

This document describes a legacy device, the GE Medical Systems Genie Processing and Review Workstation, cleared in 1997. As such, the information provided is typical of the regulatory submissions from that era and does not contain the detailed study information (e.g., acceptance criteria, detailed performance metrics, ground truth establishment, sample sizes, MRMC studies) that are now standard for AI/ML-based devices. The submission primarily focuses on substantial equivalence to a predicate device rather than comprehensive performance studies with predefined acceptance criteria.

Therefore, many of the requested data points are not explicitly available or described in the provided text.

Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of quantitative performance metrics for the device itself. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing its functionalities to those of the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Same Intended Use	Genie P&R has the same intended use as the predicate device.
No New Safety Concerns	No new safety concerns are raised by the design of Genie P&R.
No New Effectiveness Concerns	No new effectiveness concerns are raised by the design of Genie P&R.
Functionality Match	Genie P&R can retrieve, archive, process, analyze, and manage nuclear medicine images, similar to the predicate device.

Study Information (Based on Provided Text)

Sample size used for the test set and the data provenance: Not specified. The document states "Summary Of Studies" but then only describes the device's capabilities without detailing any specific performance studies with test sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: An MRMC comparative effectiveness study was not conducted or reported. This type of study is typically for evaluating the impact of AI on human reader performance, which is not relevant for this device which functions as a processing and review workstation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a 'Processing And Review Workstation', implying human-in-the-loop for image review. No standalone algorithm-only performance is described as the device's purpose is to facilitate human review.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified.
The sample size for the training set: Not applicable/not specified. This device is described as a workstation for processing and review, not an AI/ML algorithm that would typically require a training set in the modern sense.
How the ground truth for the training set was established: Not applicable/not specified.

Summary

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GE Medical Systems

JAN - 9 1997

General Flectric Company P.O Box 414, Milwaukee. WI 53201

K964012

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) sammary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 (h).

Identification Of Submitter

JAN - 7 1997

Submitter:

Telephone: Fax: Date Of Preparation: Larry A. Kroger, Ph.D GE Medical Systems 3000 N. Grandview Blvd., W-709 Waukesha. WI 53188 (414) 544-3894 (414) 544-3863 September 30, 1996

Identification Of The Product

Device Proprietary Name:	GENIE Processing And Review Workstation (Genie P&R).
Common Name:	Nuclear Medicine Image Workstation
Classification Name:	Nuclear Tomography System, 892.1310
Establishment Reg. Number:	2126677
Manufacturing Location:	GE Medical Systems
	3000 N. Grandview Blvd.
	Waukesha, WI 53188

Marketed Devices

Predicate Device:	System	Manufacturer	510(k) #
	Starcam 4000	GE Medical Systems	K904174

Device Description

Indications For Use

Genie P&R is designed to display and process data acquired by nuclear medicine cameras for review by physicians. Genie P&R can retrieve data from nuclear imaging systems and archive the data.

Image /page/0/Picture/19 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.

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Summary Of Safety And Effectiveness Genie Page 2

Comparison With Predicate Device

Genie P&R and the predicate device can retrieve, archive and process nuclear medicine images. A comparison of the features indicates that Genie P&R has the same intended use as the predicate device. No new safety or effectiveness concerns are raised by the design of Genie P&R.

Summary Of Studies

Genie P&R can retrieve, archive, process, analyze and manage nuclear medicine images.

Conclusions

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In the opinion of GE Medical Systems. Genie P&R is substantially equivalent to the Starcam 4000 (image processing system only) manufactured by GE Medical Systems (510(k) # K904174). Genie P&R has the same intended use as the predicate device. No new safety or effectiveness concerns are raised by the design of Genie P&R.

Regulation Number and Section

N/A