(83 days)
The Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional cardiac angiography and optionally, rotational cardiac angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional cardiac angiography procedures.
The Digital Fluoroscopic Imaging System is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodide scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition equipment then to network (in using DICOM) for applications such as postprocessing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an angiographic monoplane positioner, a table, an X-RAY system and a digital detector.
The Innova 2000 S system is identical to the Innova 2000 system but without the optional features.
The provided document is a 510(k) summary for the GE Medical Systems Innova 2000 and Innova 2000S. It does not contain acceptance criteria or a detailed study proving the device meets specific performance criteria in the way typically expected for novel diagnostic algorithms or AI-driven devices.
Instead, this submission is centered on demonstrating substantial equivalence to previously cleared predicate devices. The "Summary of Studies" explicitly states:
- "Not applicable as the digital technology (SSXD, i.e., flat panel detectors) has already been clinically compared in the submission of LCV+ Version 2 (K993037) with the image intensified technology system LC introduced in 1989 (cleared under K890348) and found substantially equivalent."
This indicates that the performance of the core technology (flat panel detectors for fluoroscopic imaging) was established in a prior submission (K993037) by comparing it to an older image intensifier technology. For the current submission (K022322), the manufacturer is asserting that the Innova 2000 and Innova 2000S, utilizing the same digital technology, are substantially equivalent to the LCV+ Version 2.
Therefore, many of the requested details about acceptance criteria and a specific study proving the device meets them cannot be extracted from this document, as this type of study was not the primary focus of this specific 510(k) given its reliance on substantial equivalence to prior art.
However, I can address the points based on the information available and what is explicitly stated as not applicable:
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A table of acceptance criteria and the reported device performance
- Not provided in this document. The submission relies on substantial equivalence to predicate devices, rather than presenting new performance data against specific acceptance criteria for this particular device.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided in this document. The "Summary of Studies" states "Not applicable," referring to a prior submission (K993037) for the clinical comparison. Details about the test set for that prior comparison are not included here.
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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)
- Not provided in this document. See point 2.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in this document. See point 2.
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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 study described for this submission. The device (Innova 2000/2000S) is a hardware imaging system, not an AI-driven image analysis tool intended to assist human readers as described in this context. The comparison mentioned is between different imaging technologies (digital flat panel vs. image intensifier).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an imaging system, not an algorithm, in the context of standalone performance studies for AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided in this document. See point 2. The prior clinical comparison (K993037) would have likely used clinical diagnostic equivalence by expert radiologists as the ground truth.
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The sample size for the training set
- Not applicable/Not provided. This device is an imaging system, and there's no mention of a "training set" in the context of machine learning model development within this submission.
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How the ground truth for the training set was established
- Not applicable/Not provided. See point 8.
§ 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.