(14 days)
The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications.
The Digital Fluoroscopic Imaging System is designed to perform fluoroscopic x-ray examinations. The detector is comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital image can be sent through a Fiber Channel link to an acquisition system then to network (in using DICOM) for applications such as post-processing, printing, viewing and archiving. Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-RAY system and a digital detector.
The provided text is a 510(k) summary for the GE Healthcare Digital Fluoroscopic Imaging System-Innova 2100-IQ. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study with quantified results.
Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, training set details) is not available in this document.
Here's what can be extracted and what is explicitly stated as not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the Innova 2100-IQ. The primary focus is on establishing substantial equivalence to previously cleared devices (Innova 3100, Innova 2000/2000S, LCV+ Version 2) based on similar technology, intended use, and complying with equivalent standards.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The document states that clinical data references from previous products (LCV+ Version 2 and Innova 4100/3100) are being used for comparison. No new study with a dedicated test set for the Innova 2100-IQ to prove specific performance metrics is described.
- Data Provenance: The document refers to "clinical data have been submitted for first digital products in the family introduced by GE Medical Systems-Europe ie LCV+ Version 2 for cardiology diagnostic and interventional procedures, and in Innova 4100 for vascular angiography diagnostic and interventional procedures." This indicates that the data would be retrospective from prior studies on older, related GE devices, likely originating from Europe as mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new test set or ground truth establishment process is described for the Innova 2100-IQ in this summary. The substantial equivalence argument relies on the performance of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No new test set or adjudication process is described in this summary.
5. 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:
Not applicable. This device is a digital fluoroscopic imaging system, not an AI-assisted diagnostic tool. No MRMC study is mentioned, nor is any AI component.
6. 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, and its performance is inherently linked to human operation and interpretation. The performance evaluation discussed concerns its equivalence to existing imaging systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As no specific new study to establish performance for the Innova 2100-IQ is detailed, the concept of "ground truth" for this device's performance demonstration is based on the established diagnostic capabilities and image quality of its predicate devices, which were determined through their own clinical evaluations (likely involving expert interpretation of images relative to diagnostic outcomes, though not specified here).
8. The sample size for the training set:
Not applicable. The Innova 2100-IQ is a hardware and software imaging system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI/ML algorithm.
Summary of the Study (as described in the document):
The document effectively states that no new clinical study was conducted specifically for the Innova 2100-IQ to demonstrate performance against new acceptance criteria. Instead, the argument for safety and effectiveness, and thus meeting an implicit "acceptance criterion" of being safe and effective for its intended use, is based on substantial equivalence to previously cleared predicate devices:
- Predicate Devices: Innova 3100 (K031637), Innova 2000/Innova 2000S (K022322), and LCV+ Version 2 (K993037).
- Rationale for No New Study: "References in term of clinical data have been submitted for first digital products in the family introduced by GE Medical Systems-Europe ie LCV+ Version 2 for cardiology diagnostic and interventional procedures, and in Innova 4100 for vascular angiography diagnostic and interventional procedures. As Innova 2100-IQ is considered substantially equivalent to Innova 3100 (predicated by Innova 4100), and LCV+ Version 2 in terms of image quality and diagnostic capabilities, it is not applicable."
This indicates that due to the substantial equivalence to existing devices with proven "image quality and diagnostic capabilities," a separate, new clinical study demonstrating specific performance metrics for the Innova 2100-IQ was deemed unnecessary. The "proof" is the established safety and effectiveness of the predicates.
§ 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.