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The SpinTech, Inc. SPIN-SWI application is intended for use in the post-acquisition image enhancement of MRI acquired 3D gradient-echo images of the brain. When used in combination with other clinical information, the SPIN-SWI application may aid the qualified radiologist with diagnosis by providing enhanced visualization of structures containing venous blood such as cerebral venous vasculature.

The SPIN-SWI device includes a post-processing algorithm that enhances the contrast of tissues with different susceptibilities from 3D gradient-echo MRI images. The susceptibility of a biological tissue relates to the concentration of iron within it. which can be present in the form of deoxyhemoglobin, ferritin, hemosiderin, or other molecules. An MRI scan results in both magnitude and phase images. While magnitude is most commonly used clinically, the phase information can also be useful as it relates directly to the magnetic field. When tissues or objects of differing magnetic susceptibility are present, they perturb the field around them. This effect can be seen directly from phase images. While this perturbation already leads to signal loss in magnitude images, thus creating contrast, the phase information can still be used to enhance this contrast for local susceptibility changes. Enhancing this contrast allows us to visualize structures containing venous blood such as cerebral venous vasculature that may have not been visible prior to enhancement. Some technical challenges of SWI include eliminating the effects of unwanted background fields and choosing parameters to create optimal contrast. SPIN-SWI software works in conjunction with an FDA cleared third-party DICOM viewer as an image postprocessing solution in a PC workstation. The DICOM viewer (ORIS Visual) was FDA cleared on 4/29/2010 via K100335 and is used to transmit DICOM data and display the input and output images, the SPIN-SWI software application performs the SWI post-processing on 3D GRE input images to reconstruct the SWI output images.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

Disclaimer: The provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than exhaustive clinical study details for novel technologies. Therefore, some information requested, particularly regarding detailed clinical study performance, may not be explicitly present or extensively elaborated upon.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a specific table of quantitative acceptance criteria and corresponding reported device performance for a clinical outcome study. Instead, it states that "All predefined acceptance criteria for the engineering All performance testing were met for all test cases across different imaging parameters, field strength and different subjects" (page 6). This refers to internal verification and validation of the software's technical performance.

Similarly, for clinical validation, it states: "All predefined acceptance criteria for clinical validation testing, including clinical user needs testing, as a part of the SPIN-SWI performance validation testing efforts were met across all test cases. The results of the clinical validation related testing on the SPIN-SWI application demonstrates performed acceptable image quality and that all clinical user needs are met." (page 6).

This indicates qualitative acceptance regarding image quality and user needs, but not specific quantitative metrics like sensitivity, specificity, or improvement in diagnostic accuracy. The primary goal of this submission is to show substantial equivalence to a predicate device based on similar technological characteristics and performance, rather than a quantifiable improvement over existing methods or fulfilling specific performance thresholds in a clinical trial.

In summary, there is no discrete table of acceptance criteria and performance data as you might expect from a full clinical trial report. The acceptance criteria are broadly described as meeting "all performance testing" and "all clinical user needs."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of number of cases or patients. The document refers to testing "across different imaging parameters, field strength and different subjects" (for non-clinical testing) and "all test cases" for clinical validation.
• Data Provenance: Not specified. It's not mentioned if the data was retrospective or prospective, nor the country of origin. Given the focus on substantial equivalence, it's likely pre-existing or simulated data was used for much of the non-clinical testing, and possibly a limited set of clinical cases for validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: The device's intended user is a "qualified radiologist" (page 2, 5). The "clinical user needs testing" suggests involvement of such experts, but their number, specific qualifications (e.g., years of experience, subspecialty), or their role in establishing ground truth are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the lack of detail on specific expert involvement and ground truth establishment (other than "clinical user needs testing"), no adjudication method (e.g., 2+1, 3+1) is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, a traditional MRMC comparative effectiveness study was not performed or detailed. The summary explicitly states: "The subject device of this premarket notification, SPIN-SWI application, did not require clinical studies to support substantial equivalence to the predicate device" (page 6).
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? Yes, to some extent, as implied by the "Non-Clinical Testing Summary." The device is a "post-processing algorithm that enhances the contrast... When used in combination with other clinical information, the SPIN-SWI application may aid the qualified radiologist with diagnosis..." (page 4, 5).
  • The "non-clinical testing" and "performance testing (V&V)" seem to refer to the algorithm's output quality independently of human interpretation, focusing on whether it "produces results consistently according to its intended use" (page 6). However, specific metrics for standalone performance (e.g., sensitivity/specificity for detecting specific pathologies) are not provided, as its role is enhancement rather than direct diagnosis.

7. Type of Ground Truth Used for the Test Set

• Type of Ground Truth: Not explicitly stated. The "clinical validation testing" and "clinical user needs testing" suggest that the ground truth was based on the judgment of qualified radiologists regarding "acceptable image quality" and whether the enhanced visualization was beneficial. It's not specified if this involved pathology, outcomes data, or a strict expert consensus process for specific findings.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified. As a post-processing algorithm for image enhancement, it might rely on established imaging principles and signal processing, potentially requiring less "training" data in the machine learning sense compared to a deep learning diagnostic algorithm. Even if machine learning was involved, the training set size is not disclosed.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Established: Not specified. Similar to the test set, if training data were used, the method for establishing their ground truth is not detailed.

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