(9 days)
The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. This device is not intended for mammography applications.
The new tilt table will support performing procedures like CO2 studies. Venography.
The new tilt table is offered as an option for Innova 4100, in place of the existing Omega V table, which is part of the Innova 4100 system already cleared under K023178.
The provided text describes a 510(k) summary for the GE Medical Systems Innova 4100 Digital Fluoroscopic Imaging System with an optional Tilt Table. It focuses on establishing substantial equivalence to a predicate device based on product characteristics and safety information, rather than performance against specific acceptance criteria derived from a clinical or technical study for the new tilt table option itself.
Therefore, many of the requested elements regarding acceptance criteria, device performance, and study details are not present in this document. The submission is primarily a declaration of equivalence based on design and safety standards.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission for K033244 is a 510(k) for a modification (new tilt table option) to an already cleared device (Innova 4100). The basis for clearance is substantial equivalence to a predicate device (Siemens Axiom Artis, K021021), not a performance study against specific acceptance criteria for the tilt table's diagnostic performance. The document states:
"The GE Medical System's Innova 4100, with a new Tilt table option for patient positioning, for diagnostic fluoroscopic imaging is substantially equivalent to Siemens Axiom Artis (K021021). This opinion is based on the information contained in the comparison table (Attachment 3), and the product data sheets (Attachment 4 & 5)."
This implies a comparison of specifications and features, not a clinical performance study with predefined acceptance criteria for the new option.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. As no such performance study is described, there is no test set, sample size, or data provenance.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided. As no such performance study is described, there's no ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not provided. As no such performance study is described, there's no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance. This device is a digital fluoroscopic imaging system, not an AI-powered diagnostic tool.
6. If a Standalone Performance Study Was Done
This information is not provided. No standalone performance study (algorithm only) is described, as the submission focuses on hardware equivalence and safety for a new option.
7. The Type of Ground Truth Used
This information is not provided. No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as there's no performance study described for the new tilt table option.
8. The Sample Size for the Training Set
This information is not provided. This document does not describe any machine learning or AI component requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. This document does not describe any machine learning or AI component for which ground truth would be established for a training set.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.