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The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging 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. Those devices are not intended for mammography applications.

Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications.

InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications.

The Innova 3D is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 2100''' (2100-IQ) aiready cleared under K050489), Innova 4100''' and Innova 3100'''.

The InnovaSpin is offered as an option for Innova 4100 (already cleared under K033244), Innova 3100 (already cleared under K031637), Innova 4100'0 and Innova 3100'9.

The Digital Fluoroscopic Imaging Systems Innova are 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 describes a 510(k) summary for GE Healthcare's Digital Fluoroscopic Imaging Systems (Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ) with optional Innova 3D or InnovaSpin. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a new device's accuracy or effectiveness.

Therefore, the document does not contain detailed acceptance criteria or a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

However, it does describe the basis for substantial equivalence, which serves as a form of "acceptance criteria" in a regulatory context, and the "study" (or rather, the data referenced) used to support this claim.

Here's a breakdown of the requested information based on the provided text, with explicit notes where the information is not present:

Acceptance Criteria and Device Performance Study for GE Innova Digital Fluoroscopic Imaging Systems

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • For Innova 3D option: Clinical data was "submitted in the Advantage 3D XR 510K (K954355)." The sample size for this prior submission is not specified in the provided document.
  • For InnovaSpin option: Clinical data was "submitted in the LCV+ Version 2 system 510K (K993037)." The sample size for this prior submission is not specified in the provided document.
  • For Innova 2000 "Fast Spin Rotational Angiography" option (previous clearance to establish equivalence for InnovaSpin): Cleared without clinical data "based on the fact that this mode of acquisition does not address different anatomies versus LCV+ Version 2 system (K993037)."
• Data Provenance: The document states "previously submitted clinical data are applicable for this submission." The original provenance (e.g., country of origin, retrospective/prospective) of these referenced clinical datasets (K954355 and K993037) is not specified in the provided text.

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

• This information is not provided in the document as no new clinical study analyzing expert performance or ground truth establishment is described for this specific 510(k) submission. The submission relies on prior clearances.

4. Adjudication method for the test set:

• This information is not provided in the document, as no new clinical study with expert adjudication is described.

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:

• A MRMC comparative effectiveness study is not mentioned or described in the document. The submission is focused on demonstrating substantial equivalence to existing devices and software options through technical comparison and referencing prior clinical data, not explicitly on AI assistance or reader improvement.

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

• A standalone algorithm performance study is not described in the document. The Innova 3D and InnovaSpin are described as "software options" that "assist the physician" or "permit fast spin rotational angiography," implying they are tools used by a human, rather than standalone diagnostic algorithms.

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

• The document references prior "clinical data" but does not specify the type of ground truth used in those original studies that supported the predicate devices.

8. The sample size for the training set:

• This information is not provided in the document. Since the submission relies on demonstrating substantial equivalence to already marketed devices and software, and not on developing a new AI algorithm from scratch, the concept of a "training set" in the context of machine learning is not discussed.

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

• This information is not provided in the document, as no training set is described for this submission.

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