(49 days)
The intended use of the proposed GE Imatron e-Speed EBT Scanner System remains unchanged from the intended uses of prior predicate Imatron devices and other scanners. The e-Speed is designed -- as are all predicate devices -- to produce cross sectional images of the entire human anatomy.
Specifically, the e-Speed is intended:
- to permit radiologic visualization of the heart, blood vessels, or lymphatic system, during or after injection of a contrast medium;
- to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;
- to permit the data from certain three dimensional images to also be presented in time-sequenced or cine fashion;
- to permit the data from three dimensional images to be viewed from a point of view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways;
- to be used for clinical situations requiring determination of specific quantitative information, such as the determination of calcium or other materials in bone, tumors, or organs;
- to be used by the physician as an aid in the diagnosis of lung pathology;
- for real-time motion studies, vascular and tissue blood flow analysis, and full three-dimensional volume imaging.
The e-Speed will make use of previously cleared workstation software products and software applications.
Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.
The e-Speed EBT Scanner System ("e-Speed") is composed of a Gantry/Front End Assembly, Rear Electrical/Mechanical Assembly with Electron Source, Patient Table, Operator Console, Computer, HV Power Supply and Power Conditioning and Distribution System, water chiller, and associated accessories.
Materials: Materials and construction are equivalent to the C150XP EBT Scanner System (K001550) and are compliant with UL2601-1, IEC 60601-1, and 21CFR Subchapter J.
Design: The system is designed to be an angiographic X-ray system, and a whole body CT scanner utilizing electron beam technology, a modernized beam control system and redesigned x-ray data acquisition system, a higher power HV supply, an operator console, and the capability to scan at 0.050 sec as the primary mode of operation.
The provided document is a 510(k) summary for the GE Imatron e-Speed Electron Beam Tomography (EBT) Scanner System, not a study report detailing acceptance criteria and performance metrics in the way a clinical trial or algorithm validation study would.
This document focuses on establishing substantial equivalence to predicate devices. Therefore, it does not contain the specific information requested regarding acceptance criteria, study methodologies, and performance metrics typically associated with establishing a device's efficacy against defined criteria.
Here's a breakdown of why the requested information cannot be fully provided from this document:
- No specific acceptance criteria: The document asserts that the e-Speed EBT Scanner System performs "as well as or better than devices currently on the market" and is "substantially equivalent" to predicate devices. It discusses design, material composition, energy source, and radiation characteristics, and compliance with safety standards (UL2601-1, IEC 60601-1, 21CFR 1020.30, 1020.31, 1020.33, 21CFR Subchapter J), but it does not list quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for specific medical conditions).
- No detailed study: The document refers to "System verification and validation to ensure performance to specifications" and "Adherence to industry and international standards." However, it does not present a detailed study with methods, sample sizes, ground truth establishment, or performance results in the manner requested for an AI/device performance study.
Given the nature of this 510(k) submission, the requested table and information about specific study parameters are not present. The document focuses on regulatory compliance and substantial equivalence, not detailed performance validation against specific diagnostic criteria.
Response based on the provided document:
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Safety Standards Compliance UL2601-1 Compliant IEC 60601-1 Compliant 21CFR 1020.30 Compliant 21CFR 1020.31 Compliant 21CFR 1020.33 Compliant 21CFR Subchapter J Compliant Performance Equivalence Performance relative to currently marketed devices Performs "as well as or better than" devices currently on the market. Considered "substantially equivalent" to other marketed devices with the same indications for use and meeting similar standards. Risk Management Identified and controlled by system verification/validation and adherence to standards. Adverse effects on health controlled Identified and controlled by system verification/validation and adherence to standards. Design/Material/Energy/Radiation Characteristics Substantially equivalent to predicate angiographic and whole body X-ray computed tomography systems Substantially equivalent to currently marketed angiographic and whole body X-ray computed tomography systems. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This information is not provided in the 510(k) summary. The document does not describe a specific clinical test set or its provenance for diagnostic performance evaluation, as it's a submission for substantial equivalence based on engineering and safety standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This information is not provided. No specific test set requiring expert ground truth establishment for diagnostic performance is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. No specific test set or adjudication method is described.
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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:
- No MRMC or AI assistance study is mentioned. This device is a CT scanner, not an AI-powered diagnostic algorithm designed to assist human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a medical imaging scanner (CT system), not an algorithm. Therefore, "standalone algorithm performance" is not applicable in the context requested. The document asserts the overall system's performance is "as good as or better than" predicate devices.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided. The document focuses on engineering specifications, safety compliance, and functional equivalence, not on diagnostic accuracy validated against specific ground truth types.
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The sample size for the training set:
- This information is not provided. This document does not pertain to the training of a machine learning algorithm.
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How the ground truth for the training set was established:
- This information is not provided. This document does not pertain to the training of a machine learning algorithm.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.