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The NORMA 10 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the NORMA 10 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*. When interpreted by trained physicians, these images provide information that can be useful in determining a diagnosis.

• Anatomical regions: extremities and selected sections of the . head.
• H-1 Nuclei excited: .
• Diagnostic uses: T1, T2, T2* and density weighted . imaging.

The NORMA 10 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The NORMA 10 is a fixed system. ODIN Technologies Ltd., has developed an open MRI system based on an innovatively designed permanent magnet of 0.12 Tesla. The system is compact, displaceable, inexpensive and widely open. The magnetic probe consists of two lateral permanent-magnet poles that can be adjusted laterally and longitudinally, mounted on a C-arm gantry. The anatomic region to be scanned is positioned between the poles. Except for the anatomic region been scanned, the patient is positioned outside of the gantry, thus enhancing patient comfort and reducing the possibility of a claustrophobic reaction.

Here's an analysis of the provided text, extracting the acceptance criteria and study information related to the device.

Acceptance Criteria and Device Performance

The provided document describes the NORMA 10, a Magnetic Resonance Diagnostic Device. The acceptance criteria are broadly defined by compliance with NEMA standards and FDA guidance for MRDDs. The "reported device performance" is a general statement that the device meets these performance specifications.

• Specific Absorption Rate (SAR): Below levels of significant risk as described in FDA Guidance for the Submission Of Premarket Notification for Magnetic Resonance Diagnostic Device, dated November 14, 1998.
• Time-Varying Gradient Fields (dB/dt): Below levels of significant risk as described in FDA Guidance for the Submission Of Premarket Notification for Magnetic Resonance Diagnostic Device, dated November 14, 1998. | The results obtained from the safety tests including acoustic noise, Specific Absorption Rate (SAR) and Time-Varying Gradient Fields (dB/dt) were found to be below the levels of significant risk as described in the FDA Guidance. |
  | Performance | - Signal-to-Noise Ratio (SNR): Meets performance specifications claimed.
• Geometric Distortion: Meets performance specifications claimed.
• Image Uniformity: Meets performance specifications claimed.
• Slice Thickness: Meets performance specifications claimed.
• Characterization of Special Purpose Coils: Meets performance specifications claimed.
• Spatial Resolution: Meets performance specifications claimed. | The performance results obtained including Signal-to-Noise Ratio (SNR), Geometric Distortion, Image Uniformity, Slice Thickness, Characterization of Special Purpose Coils and spatial resolution meets the performance specifications claimed. |

Study Details

Based on the provided text, the study conducted for the NORMA 10 was a technical performance and safety validation study, not a clinical diagnostic efficacy study in the modern sense of AI-powered devices.

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

   • Sample Size: Not explicitly stated as a number of patients or images. The text states: "The scans were performed on normal anatomy including extremities and selected sections of the head." This implies a small, internal test set primarily focused on technical parameters rather than a large clinical cohort.
   • Data Provenance: The scans were performed "at the Odin premises" in Israel. The data is prospective in the sense that it was generated specifically for this testing, but it's not a prospective clinical trial.

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

   • This information is not provided. Given the nature of the testing (technical performance and safety), "ground truth" would likely be established through physical measurements and engineering specifications, not expert diagnostic interpretation of clinical cases. The device is intended to be "interpreted by trained physicians", but the testing described does not involve such interpretation for performance validation.

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

   • Not applicable/Not provided. The testing described focuses on objective measurements against engineering specifications and regulatory safety limits.

4. 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, a multi-reader, multi-case comparative effectiveness study was not performed. This document predates widespread AI in medical imaging and focuses on the fundamental safety and technical performance of an MRI hardware system.

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

   • No, this is not an AI algorithm. This device is a Magnetic Resonance Imaging (MRI) machine itself. The "testing of the system" refers to the performance of the hardware.

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

   • The "ground truth" for the technical performance aspects (SNR, geometric distortion, image uniformity, slice thickness, spatial resolution) would be based on physical phantom measurements and engineering specifications.
   • For safety aspects (acoustic noise, SAR, dB/dt), the "ground truth" is regulatory limits defined in FDA guidance documents.

7. The sample size for the training set:

   • Not applicable/Not provided. This is an MRI hardware device, not a machine learning model that requires a training set.

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

   • Not applicable/Not provided, as there is no training set for this type of device.

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