Search Results

The Vita Flex CR System is intended for digital radiography using a phosphor storage screen for standard radiographic diagnostic images. The LL is indicated for Long Length Imaging examinations of long areas of anatomy such as the leg and spine.

The Vita Flex CR System with LLI is a Computer Radiography (CR) acquisition scanner, which includes mechanical and software interface to the LLI cassette. The device is constructed from a Man Machine Interface panel, a CR scanner and infrastructure, which enables connection to external applications, i.e. to import command messages, to export images and provide status messages. The LLI is a CR cassette, which is used for Long Length Imaging X Ray examinations of long areas of anatomy.

The Vita Flex CR system with LLI accepts an x-ray cassette with a screen. An X-ray cassette is a light-resistant container that protects the screen from exposure to daylight, and allows the passage of X-rays through the front cover on to the phosphor layer of the screen. When stroked by radiation the intensifying screen fluoresces emitting a light that creates the image.

Our Vita Flex CR system take a cassette as an input and it extracts an exposed screen and scans in the image off the screen. The image is stored on the computer system attached to the Vita Flex CR system. Once the scan is complete the screen data is erased and the screen is placed back inside the cassette to be used again by the customer.

When a cassette is properly inserted into the scanner, the scanner will lock the cassette in place. Once locked into place the cassette door can be opened to allow the scanner to feed the screen into the unit.

The operation of the scanning of the LLI cassette and screen will be done exactly as the predicate. Since the size of a long length imaging screen and cassette is large, the operation consists of 2 scans – scanning one half of the image, then turning the cassette around and scanning the second half of the image.

The document describes the regulatory submission for the Vita Flex CR System with LLI, a digital radiography system. The key argument for its clearance is its substantial equivalence to a previously cleared predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating this substantial equivalence through non-clinical testing, rather than a clinical trial with human subjects.

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the demonstration of equivalent or improved performance compared to the predicate device across various features and operational parameters. The reported device performance is presented as a comparison between the modified device (Vita Flex CR System with LLI) and the predicate device (Point of Care including LLI).

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

The document explicitly states: "Given the differences from the predicate device, clinical testing is not necessary for the subject device. Bench testing alone is sufficient to demonstrate substantial equivalence."

Therefore, there was no "test set" in the sense of a dataset of patient images. The evaluation was based on bench testing of the device's hardware and software components. The "sample size" would refer to the number of devices tested, or the number of tests performed on a device, not a patient image sample size. No specific numbers are provided for the quantity of bench tests or units tested, beyond the general statement that "Bench testing was performed."

Data Provenance: Not applicable as no clinical or image data was used for testing.

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

Not applicable. As no clinical testing or image-based test set was used, there was no need for expert radiologists to establish ground truth.

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

Not applicable. No image-based test set where adjudication would be relevant.

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

No. An MRMC study was not performed. The device is a digital radiography system, not an AI-powered diagnostic aid meant to assist human readers. The submission focuses on the safety and performance of the imaging equipment itself in comparison to its predicate.

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

No. This describes the performance of the imaging system and its included components, not a standalone algorithm.

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

Not applicable. The "ground truth" for this submission was the established performance and safety characteristics of the predicate device and relevant industry standards (IEC, etc.). The modified device was evaluated against these benchmarks using non-clinical (bench) testing.

8. The sample size for the training set

Not applicable. This device is a hardware system with integrated software, not a machine learning model that requires a "training set."

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

Not applicable. No training set was used.

Ask a specific question about this device