(92 days)
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.
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.
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.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.