(87 days)
The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiography procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional angiography procedures. This device is not intended for mammography applications.
The Innova 3100 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 post-processing, printing, viewing and archiving. The Innova 3100 consists of an angiographic monoplane positioner, a table, an X-RAY system and a digital detector. The SuperFast Gantry (InnovaTrace) includes capacitive sensor technology and optimized collision avoidance software that permits an increase of pivot and C-arm speed of up to 20°/sec.
The provided document for the GE Innova 3100 Digital Fluoroscopic Imaging System is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a novel algorithm.
Therefore, the requested information, particularly regarding specific acceptance criteria, a standalone study with defined performance thresholds, and details on ground truth establishment and expert adjudication for a new AI-based device, is not present in this document.
Instead, the document states:
- "Summary of Studies: Not applicable as Innova 3100 is considered substantially equivalent to Innova 4100 in terms of image quality and diagnostic capabilities."
This indicates that extensive new clinical performance studies to establish specific acceptance criteria for a novel device, as might be done for an AI algorithm, were not conducted or deemed necessary for this 510(k) clearance due to direct comparison and equivalence to existing, already cleared devices.
However, I can extract information related to the device and its comparison to predicates.
Here's a breakdown of what can be inferred or is directly stated, with explicit mention of what is not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable thresholds for a novel device's performance. The "acceptance criteria" here is met by demonstrating substantial equivalence to predicate devices.
- Reported Device Performance: The primary "performance" reported is its equivalence to the predicate in "image quality and diagnostic capabilities." No specific metrics (e.g., sensitivity, specificity, AUC) are provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable/Not provided. No separate "test set" from a performance study is mentioned because the submission relies on substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable/Not provided. Ground truth establishment for a test set is not mentioned as part of this equivalence submission.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. This is not an AI device, and no MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is an imaging system, not an AI algorithm.
7. The Type of Ground Truth Used:
- Not applicable/Not provided. For substantial equivalence, the "ground truth" is that the predicate device is safe and effective.
8. The Sample Size for the Training Set:
- Not applicable/Not provided. This is an imaging system, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not provided.
Summary based on the provided document:
The GE Innova 3100 Digital Fluoroscopic Imaging System sought 510(k) clearance by demonstrating substantial equivalence to previously cleared predicate devices:
- Innova 4100 (K023178) for the overall system and image quality/diagnostic capabilities.
- Innova 2000/Innova 2000S (K022322) for the SuperFast Gantry (InnovaTrace) with capacitive sensor feature.
The rationale provided for not needing new clinical performance studies (which would typically define acceptance criteria and collect performance data) is: "Not applicable as Innova 3100 is considered substantially equivalent to Innova 4100 in terms of image quality and diagnostic capabilities."
The acceptance criteria are therefore implicitly met by:
- The device being designed for the same intended use (fluoroscopic images for vascular/rotational angiography, replacing image intensifier technology).
- The device having similar technological characteristics (amorphous silicon detector with cesium iodide scintillator).
- The manufacturer's conclusion that the system provides fluoroscopic images "equivalent to the diagnostic capabilities of the predicate images."
- Control of potential hazards through a risk management process, including hazard identification, risk evaluation, and a Software Development and Validation Process.
The FDA's clearance letter confirms their review and determination that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market.
§ 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.