Search Results

The InfiMed i?™ Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i-TM Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed is TM Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed i2m Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

The InfiMed if TM Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i " Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platform.

The modified InfiMed i TM Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R, Trixell Pixium RF4343. Varian PaxScan 4343CB), computer, monitor, and the digital imaging system.

The provided text describes a 510(k) submission for the Varian Medical Systems Nexus DRF Digital X-ray Imaging System (with PaxScan 4343CB). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in terms of diagnostic accuracy or impact on human readers.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Validation was completed in accordance with the Validation Protocols included with this submission" and that "Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria." However, the specific acceptance criteria and quantitative results of these validation protocols are not provided in the summary. The acceptance criteria above are implied from the statements about "substantial equivalence."

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

The document does not provide details about a specific "test set" in the context of a clinical performance study with human readers or diagnostic accuracy. It mentions "Clinical Data submitted is consistent with FDA guidance document 'Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices'." This suggests that any clinical data submitted would be in line with general requirements for imaging devices, but specific details about a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) are not included in this summary.

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. The submission focuses on demonstrating technical equivalence and safety/effectiveness relative to a predicate, not on a new clinical study involving expert interpretation for ground truth establishment.

4. Adjudication method for the test set

This information is not provided in the document.

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

There is no indication that an MRMC comparative effectiveness study was done, especially one involving "AI assistance." The device is described as a "Digital X-ray Imaging System," and the "Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques." This refers to standard image processing, not necessarily AI in the modern sense, and no comparative effectiveness study results are given.

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

There is no indication that a standalone algorithm performance study was conducted or reported in this summary. The device is an imaging system, not a diagnostic AI algorithm in itself.

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

The document does not specify the type of ground truth used for any clinical performance evaluation. Given the nature of a 510(k) for an imaging system upgrade (adding a new receptor), the clinical data likely involves demonstrating image quality and diagnostic utility in comparison to the predicate, rather than establishing new ground truth for specific pathologies.

8. The sample size for the training set

This information is not provided in the document. The device is an imaging system, and while it has image processing algorithms, the concept of a "training set" in the context of modern machine learning algorithms used for diagnostic purposes is not explicitly discussed or applicable here.

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

This information is not provided in the document, and the concept of a training set ground truth is not applicable given the details provided.

In summary:

This 510(k) summary is primarily focused on demonstrating substantial equivalence of a modified digital X-ray imaging system to an existing predicate device, largely based on technological characteristics and the claim of equivalent or better image quality. It does not contain the detailed clinical study information (sample sizes, expert qualifications, ground truth methods, MRMC studies, or AI performance metrics) that would be expected for a submission involving a novel diagnostic AI algorithm or a device requiring new clinical performance claims beyond equivalence to a predicate. The "clinical data" referenced is likely related to general image quality and functional performance as per the FDA guidance for solid-state X-ray imaging devices, rather than a specific study comparing diagnostic accuracy.

Ask a specific question about this device