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The Innova 31310 (3131-IQ) and 21219 (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotation: h angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures.

They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

The Digital Fluoroscopic Imaging Systems are designed to perform biplane fluoroscopic x-ray examinations. The detectors are comprised of amorphous silicon with a cesium iodine scintillator. The resulting digital images can be sent through a Fiber Channel link to an acquisition system then to network (using DICOM) for applications such as post-processing, printing, viewing and archiving. The Digital Fluoroscopic Imaging System consists of a biplane positioner, a vascular table, an X-ray system, two X-ray generators/sources and two digital detectors.

The provided text describes a 510(k) summary for the GE Healthcare Innova 3131-IQ and Innova 2121-IQ Digital Fluoroscopic Imaging Systems. However, it explicitly states that clinical data was not necessary for these devices due to their substantial equivalence to previously cleared devices in terms of image quality and diagnostic capabilities. Therefore, a study proving device performance against acceptance criteria in the typical sense (e.g., measuring accuracy, sensitivity, specificity) was not performed or provided in this submission.

The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone performance study with acceptance criteria.

Here's a breakdown of the requested information based on the provided text, noting where information is explicitly stated as not applicable or not provided:

Acceptance Criteria and Device Performance Study

As stated in the document: "As Innova 31310 and 21210 are considered by Innova 4100 and LCV+ Version 2 in terms of image quality and diagnostic capabilities, reference to clinical data is not necessary (see attachment F for detailed justifications)". This means a specific performance study with acceptance criteria for the Innova 3131-IQ and 2121-IQ was not provided in this 510(k) submission.

Therefore, the table below will reflect this. The "Reported Device Performance" column cannot be filled with direct performance metrics from a study on these specific devices.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria listed are inferred from the claims of substantial equivalence and safety standards mentioned. Specific quantitative performance metrics (e.g., sensitivity, specificity, resolution) for the Innova 3131-IQ and 2121-IQ were not provided as part of a standalone study in this document.

Specific Study Information:

2. Sample size used for the test set and the data provenance:

   • Not applicable / Not provided. No specific test set or clinical study data was presented for these devices as substantial equivalence was claimed based on predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not provided. No specific test set requiring ground truth establishment was presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable / Not provided. No specific test set requiring adjudication was presented.

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 / Not provided. This device is a fluoroscopic imaging system, not an AI-assisted diagnostic tool for readers. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, implicitly. The device itself is a standalone imaging system. However, the performance evaluation was not a standalone test against specific clinical metrics but rather a claim of equivalence to existing devices. The document states: "As Innova 31310 and 21210 are considered by Innova 4100 and LCV+ Version 2 in terms of image quality and diagnostic capabilities, reference to clinical data is not necessary". This implies that the performance is assumed to be equivalent to the standalone performance of the predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable / Not provided. No direct ground truth was established for a new study on these devices. The "ground truth" for proving effectiveness relies on the established performance and safety of the predicate devices.

8. The sample size for the training set:

   • Not applicable / Not provided. This is an imaging hardware system, not an AI/algorithm-based diagnostic requiring a training set in the conventional sense.

9. How the ground truth for the training set was established:

   • Not applicable / Not provided. As above, this is not an AI/algorithm-based diagnostic device requiring a training set with ground truth.

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