Search Results

This device is intended to be used for generating fluoroscopic images of human anatomy for the diagnostic, surgical and interventional angiography and cardiology procedures of circulatory vascular system.

Not Found

The provided documents are a 510(k) submission and the FDA's acknowledgement letter for the Shimadzu GE OEC Altitude Angiographic X-ray System. These documents confirm the device's classification, intended use, and substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML-based device.

The GE OEC Altitude is an Angiographic X-ray System, a hardware medical device used for generating fluoroscopic images. The 510(k) refers to its physical components (MH-100 and DAR-2400-15B/30B from the predicate device Shimadzu Angiosigma NEO) and its functionality as an imaging system, not an AI/ML diagnostic or assistive tool.

Therefore, I cannot provide the requested information because the provided input does not describe an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML. The 510(k) process for this type of device typically focuses on technical specifications, safety, and performance characteristics like radiation dose, image quality (spatial resolution, contrast), and mechanical integrity, rather than diagnostic accuracy metrics produced by an AI.

Ask a specific question about this device

GE OEC Altitude is a Fluoroscopic Imaging System designed to provide fluoroscopic images of the patient during diagnostic, surgical and interventional angiography and cardiology procedures.

GE OEC Altitude is an image intensified fluoroscopic fixed C-arm system. It consists of a C-arm that supports a high-voltage generator, x-ray controls, image intensifier and flat panel display monitors. The system consists of a Ceiling suspended C-arm support (MH-200S), digital substraction system (DAR-9000) and a High Voltage generator (UD150B-40). It is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient, and supports image processing and recording devices. This system can be used in conjunction with a mobile or fixed surgical table.

The provided text describes a 510(k) summary for the GE OEC Altitude, a fluoroscopic imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria directly met by the device's algorithmic performance.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria for algorithmic performance or specific metrics for the GE OEC Altitude itself. Instead, it aims to prove substantial equivalence to a predicate device based on regulatory and safety standards.

The "reported device performance" is implicitly that the device performs comparably to the predicate and meets relevant safety and performance standards.

2. Sample Size Used for the Test Set and Data Provenance:

No information is provided about a specific test set for evaluating the GE OEC Altitude's image quality or diagnostic performance against a ground truth. The summary mentions evaluation to "appropriate performance standards" and "IEC 60601-1 International Medical Equipment Safety standard, IEC 60601-2-28 Particular Requirements of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis and IEC 60601-2-32 Particular Requirements of Associated Equipment for X-Ray Equipment for Safety." These are safety and general performance standards, not diagnostic efficacy studies with patient data.

Therefore, there is no information on:

• Sample size for a test set.
• Data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to the provided document. The submission does not describe a study involving expert-established ground truth for image interpretation or diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC comparative effectiveness study is not mentioned or described. The GE OEC Altitude is a fluoroscopic imaging system, not an AI-powered diagnostic tool. The document focuses on the hardware and its general imaging capabilities, establishing equivalence to another fluoroscopic system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No standalone algorithmic performance study is mentioned or described, as this device is not an AI algorithm.

7. The Type of Ground Truth Used:

No specific ground truth (expert consensus, pathology, outcomes data) is mentioned because the document does not describe a study evaluating the diagnostic accuracy of the GE OEC Altitude's images against such truths. The "ground truth" for the submission is regulatory compliance and functional equivalence to the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The GE OEC Altitude is a hardware imaging system, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no training set described.

Summary of the Study Mentioned in the Document:

The "Summary of Studies" section indicates that the GE OEC Altitude was evaluated for compliance with various performance and safety standards, specifically:

• IEC 60601-1 International Medical Equipment Safety standard
• IEC 60601-2-28 Particular Requirements of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis
• IEC 60601-2-32 Particular Requirements of Associated Equipment for X-Ray Equipment for Safety

The core of the submission is to demonstrate that the GE OEC Altitude is substantially equivalent to the predicate device, the AngioSpeed VC (consisting of MH-200S (K943545) and DAR-2400-15B/30B (K955395)). The conclusion states that "Usage of GE OEC Altitude does not result in any new potential hazards," implying that it meets the safety and performance profile established by the predicate device and the relevant standards. The "study" here is a regulatory comparison and compliance assessment, not a clinical trial or AI performance evaluation.

Ask a specific question about this device