(90 days)
Anatomical region : Extremities Nuclei excited Diagnostic uses : 2D imaging, 3D imaging
Model Name : Ortho 8000 Isotope : Proton Imaging Model Characteristics Magnet Permanent 0.17 Tesla Static Field strength +/-20ppm over 16cm DSV Homogeneity RF Coil Types - Leg coil l Transmit/receive coil for knee/foot/ankle/leg/elbow 15 cm Diameter x 8 cm Length - 2. Arm Coil Transmit/receive coil for hand/wrist/forearm 10 cm Diameter x 6 cm Length - 3 18 cm Loop Coil Transmit/receive coil for general purpose use - 4 12 cm Loop Transmit/receive coil for general purpose use Data Acquisition Modes Phase and frequency encoding to sample k-space 2D Multiple Slice 2D Multiple Slice, Multiple Echo 3D Multiple Slice Pulse Sequences Spin echo Gradient (Field) echo Inversion recovery Dynamic imaging These sequences can provide T1 weighted, T2 weighted, T2* weighted images Reconstruction Techniques 2D Fourier Transform 3D Fourier Transform Type of Installation Fixed Site Slice Selection Methods Selective excitation in the presence of a field gradient Phase encoding for 3D Display Matrix 256 x 256 1 - 4 Simultaneous Images Acquisition Matrix 64 - 256 in steps of 1 for the phase encoding direction 256 in the frequency encoding direction Image Acquisition Time 2D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps 3D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps x Number of Slice Encoding Steps Image Pre and Post Processing Magnitude Value Pixel Value Horizontal/Vertical Line Profiles Spatial Filtering - Hamming Filter in Frequency and Phase Directions Number of Slices, Range and Increment 2D - 1-16 in steps of 1 3D - 16 slice only Slice Orientation Transverse (Axial) Sagittal Coronal Oblique 3 Orthogonal Plane Scouts Interslice Spacing, minimum, maximum and increment 0 mm, 10mm, Increment 1 mm
This analysis is based on the provided FDA 510K Summary for the INNER VISION MRI Ortho 8000 device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily outlines specifications rather than explicit "acceptance criteria" in the sense of predefined thresholds for clinical utility. However, the "Imaging Performance" section (Section 3.C) provides detailed technical specifications for the device that implicitly serve as acceptance criteria for its functional performance. The device's performance is then reported against these specifications in Section 7. "CONCLUSIONS FROM TESTING."
| Performance Metric | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Signal-to-Noise Ratio (SNR) | ||
| Leg Coil | SNR > 20:1 (Transverse, Sagittal, Coronal, Oblique) | "The signal to noise ratio values were consistently above the target specification values for each of the coils with the parameters measured above." (Section 7) |
| Arm Coil | SNR > 40:1 (Transverse, Sagittal, Coronal) | "The signal to noise ratio values were consistently above the target specification values for each of the coils with the parameters measured above." (Section 7) |
| 18 cm Loop Coil | SNR > 30:1 (Transverse, Sagittal, Coronal) | "The signal to noise ratio values were consistently above the target specification values for each of the coils with the parameters measured above." (Section 7) |
| 12 cm Loop Coil | SNR > 30:1 (Transverse, Sagittal*, Coronal) | "The signal to noise ratio values were consistently above the target specification values for each of the coils with the parameters measured above." (Section 7) |
| Uniformity | ||
| All Coils | Non-Uniformity < +/-20% (Transverse, Sagittal, Coronal) | "Non-uniformity was < +/- 20% for all coil and sequence combinations tested." (Section 7) |
| Geometric Distortion | Geometric Distortion < +/- 5% (Transverse, Sagittal, Coronal) | "Geometric distortion was < +/- 5% for all coil and sequence combinations tested." (Section 7) |
| Slice Profile (Arm coil) | >80% of material within Full Width Half Maximum. | No direct quantitative report comparing to the >80% specification is provided in Section 7, but it generally implies compliance. "The measurement methods used are based on calibration using a well characterised physical object and provide direct evidence of the performance characteristics of the scanner." (Section 7) |
| Slice Thickness (Arm coil) | 2-10 mm in 1mm increments (Transverse, Sagittal, Coronal) | "Slice thickness, spacing and gap were all within the quoted specifications using the frequency encoding method." (Section 7) |
| Slice Spacing (Arm coil) | 0-10 mm in 1mm increments (Transverse, Sagittal, Coronal) | "Slice thickness, spacing and gap were all within the quoted specifications using the frequency encoding method." (Section 7) |
| Spatial Resolution (Leg Coil) | Maximum theoretical pixel resolution = 0.31 mm; 1 mm test rods resolved in all 4 quadrants | "1 mm test rods resolved in all 4 quadrants Transverse, Sagittal. Coronal." (Section 3.C.e) - This implies the device met this specifically stated resolution for the Leg Coil. The conclusion states, "the InnerVision MRI extremity scanner meets the performance specifications claimed." (Section 7) |
Study Details
The provided document describes a technical performance verification study rather than a clinical trial directly assessing diagnostic accuracy or human reader performance.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): The document does not specify a "sample size" in terms of clinical cases or individual patients. Instead, the testing was performed using a phantom. The phantom used is described as a "well characterised physical object" (Section 7) and described in more detail in Section 3.C as a "Specification Volume 75mm length x 75 mm diameter Cylinder," with details on "1mm test rods resolved in all 4 quadrants."
- Data Provenance: The technical and imaging performance tests were conducted at Middlesex Hospital, London, England. The study period was February - July 1996.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: This information is not provided.
- Qualifications of Experts: This information is not provided.
- Note: Given it's a technical performance study using a phantom, the "ground truth" is typically established by physical measurements of the phantom and known engineering principles, not via expert consensus on clinical images.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/Not described. The ground truth for technical performance metrics (SNR, uniformity, distortion, slice thickness) on a phantom is based on the known properties of the phantom and direct physical measurements, not on a human adjudication process for diagnostic interpretations.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes the technical performance and safety of an MRI device itself, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this study is of an MRI scanner, not an AI algorithm. Therefore, "standalone (algorithm only)" is not applicable.
7. The type of ground truth used:
- The ground truth for the technical performance tests was established by physical properties of a well-characterized phantom and direct physical measurements (Section 7).
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. This document describes the performance evaluation of an MRI system, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, the establishment of ground truth for a training set is not relevant to this document.
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INNER VISION MRI
Specialized MRI Systems for Medicine. Industry and Research
NOV 12 1996
FDA 510K Summary
Submitter's Name : Dr Martyn Paley
Postal Address : PO Box 8232, London, W5 3WY
+44 0802 791352 (Tel) Telephone Number : +44 1535 635066 (Fax)
( 1)
Contact Person : Dr Martyn Paley
Date Summary Prepared : 18th July 1996
INNERVISION MRI Ltd., PO Box 8232, London W5 3WY Directors : Martyn Paley BSc PhD CPhys FInstP, John McGinley BA DPhil MInstP
IMRI/510KSUM/1/1/001
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1. DEVICE NAME: Magnetic Resonance Diagnostic Device
Trade/Proprietary Name: Ortho 8000
2. EQUIVALENT DEVICE : Esaote Biomedica ArtoScan
3. DEVICE DESCRIPTION
A. Device Characteristics
Model Name : Ortho 8000
Isotope : Proton Imaging
Model Characteristics
Magnet Permanent
0.17 Tesla Static Field strength +/-20ppm over 16cm DSV Homogeneity
RF Coil Types
- Leg coil l Transmit/receive coil for knee/foot/ankle/leg/elbow 15 cm Diameter x 8 cm Length
-
- Arm Coil Transmit/receive coil for hand/wrist/forearm 10 cm Diameter x 6 cm Length
- 3 18 cm Loop Coil Transmit/receive coil for general purpose use
- 4 12 cm Loop Transmit/receive coil for general purpose use
Data Acquisition Modes
Phase and frequency encoding to sample k-space 2D Multiple Slice 2D Multiple Slice, Multiple Echo 3D Multiple Slice
Pulse Sequences
Spin echo Gradient (Field) echo Inversion recovery Dynamic imaging These sequences can provide T1 weighted, T2 weighted, T2* weighted images
Reconstruction Techniques
2D Fourier Transform
IMRI/510KSUM/1/1/001
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3D Fourier Transform
Type of Installation
Fixed Site
Slice Selection Methods
Selective excitation in the presence of a field gradient Phase encoding for 3D
Display Matrix
256 x 256 1 - 4 Simultaneous Images
Acquisition Matrix
64 - 256 in steps of 1 for the phase encoding direction 256 in the frequency encoding direction
Image Acquisition Time
2D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps 3D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps x Number of Slice Encoding Steps
Image Pre and Post Processing
Magnitude Value Pixel Value Horizontal/Vertical Line Profiles Spatial Filtering - Hamming Filter in Frequency and Phase Directions
Number of Slices, Range and Increment
2D - 1-16 in steps of 1 3D - 16 slice only
Slice Orientation
Transverse (Axial) Sagittal Coronal Oblique 3 Orthogonal Plane Scouts
Interslice Spacing, minimum, maximum and increment
0 mm, 10mm, Increment 1 mm
B Safety Parameters
| Static Field Strength | 0.17 Tesla |
|---|---|
| Rate of change of magnetic field, maximum | < 6 Tesla/Second |
| Radiofrequency Power Deposition, maximum | < 0.4 W/Kg |
IMRI/510KSUM/1/1/00 I
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、
:
| C. Imaging Performance | |
|---|---|
| Specification Volume | |
| 75mm length x 75 mm diameter Cylinder | |
| a. Signal to Noise Ratio (SNR) | |
| 1 | Leg Coil |
| SNR > 20:1 Transverse, Sagittal, Coronal, Oblique | |
| 2 | Arm Coil |
| SNR > 40:1 Transverse, Sagittal, Coronal | |
| 3 | 18 cm Loop Coil |
| 4 | 12 cm Loop Coil |
| SNR > 30:1 Transverse, Sagittal, Coronal | |
| b. Uniformity | |
| 1 | Leg Coil |
| Non-Uniformity <+/-20% Transverse, Sagittal, Coronal | |
| 2 | Arm Coil |
| Non-Uniformity < +/-20% Transverse, Sagittal, Coronal | |
| 3 | 18 cm Loop Coil |
| Non-Uniformity < +/-20% Transverse, Sagittal, Coronal | |
| 4 | 12 cm Loop Coil |
| Non-Uniformity < +/-20% Transverse, Sagittal*, Coronal | |
| c. Geometric Distortion | |
| Geometric Distortion < +/- 5% Transverse, Sagittal, Coronal | |
| d.1 Slice Profile | |
| Arm coil | |
| >80% of material within Full Width Half Maximum. See detailed plots. Transverse, Sagittal, Coronal | |
| d.2 Slice Thickness | |
| Arm coil |
IMRI/510KSUM/1/1/001
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2-10 mm in 1mm increments - Transverse, Sagittal, Coronal
d.3 Slice Spacing
Arm coil
0 - 10 mm in 1mm increments - Transverse, Sagittal, Coronal
Simultaneous Slices
16 maximum
e Spatial Resolution
Leg Coil
Maximum theoretical pixel resolution = 80/256 mm = 0.31 mm
I mm test rods resolved in all 4 quadrants Transverse, Sagittal. Coronal.
Note : Performance parameters measured using the phantom and techniques described in Section 8B below.
4. INTENDED USE
Anatomical region : Extremities Nuclei excited Diagnostic uses : 2D imaging, 3D imaging
5 TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE
See Appendix A
6. CLINICAL DATA
Testing of the system was performed at the Middlesex Hospital, London, England during the period February - July 1996. Clinical scans performed included investigation of Du Puytrens contracture of the hand localisation of the calcaneus for steroid injections and scans of the normal anatomy of the toes, feet, ankles, lower leg, knee and upper thigh, fingers, hand, wrist, forearm. elbow and upper arm.
7. CONCLUSIONS FROM TESTING
The measurement methods used are based on calibration using a well characterised physical object and provide direct evidence of the performance characteristics of the scanner.
The signal to noise ratio values were consistently above the target specification values for each of the coils with the parameters measured above.
Non-uniformity was < +/- 20% for all coil and sequence combinations tested.
Geometric distortion was < +/- 5% for all coil and sequence combinations tested.
Slice thickness, spacing and gap were all within the quoted specifications using the frequency encoding method. This method relies on accurate calibration of the Field of View using MR imaging. The size of the test object is very accurately known and the measurement method provides a scale with 256 pixels. It is believed that this method gives more reliable results than the slice ramp technique which was also used to confirm the measurements. This is because the method has a much higher signal to noise ratio.
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In conclusion, the InnerVision MRI extremity scanner meets the performance specifications claimed.
8. OTHER INFORMATION REQUIRED BY FDA
ﺘﻴﺒ :
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Appendix A
Equivalency Information
This information has been obtained from a recent report by FCRI.
:
IMRI/FDANICHE/1/1/001
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| Model | Esatote/Lunar Artoscan | Innervision/Vision Ortho 8000 |
|---|---|---|
| Clinical application | Extremities | Extremities |
| Magnet type | Permanent | Permanent |
| Field Strength | 0.18T | 0.17T |
| 5 Gauss Fringe Field m | 0.6/0.28 | 0.3/0.3 |
| Shimming | Passive | Passive/Active |
| Gradient Subsystem mT/m Risetime to 10mT/m msec | 10/0.5 | 15/0.5 |
| Computer System | PC DX2, 66 | 2 x PC Pentium 100 MHz |
| Memory Size (MB) | 32 | 16+16 |
| Array Processor | DSP 25 Mflops | DSP Dalanco Spry Model 500 |
| Storage Media | MOD | MOD, Tape |
| No. Images Stored | 5,000 | 5,000 |
| Imaging Modes | ||
| Single | Yes | Yes |
| MultiSlice | Yes | Yes |
| Volume Study | Yes | Optional |
| Other | 3 Plane Scout View | 3 Plane Scout View |
| Reconstruction time | ||
| Single Slice (sec) | 1.5 | 5 |
| Multi Slice (sec) | 1.5 | 5 |
| Volume Study | 1.5 | 20/slice average |
| Cardiac Gating | NA | NA |
| Respiratory Gating | NA | NA |
| Angiography | NA | NA |
| Spectroscopy | NA | NA |
| Pulse Sequences | SE, Multiple SE, GE, IR, STIR, 3D, TSE, TME. HSE | SE, Multiple SE, GE, IR, STIR 3D |
| Repetition Time (msec) | 50-5000SE, 40-5000 GE, 260-5000 IR, 100-4000 STIR | 50-5000SE, 35-5000 GE, 100-5000 IR |
| Echo Time (msec) | 18-120 SE, 12-34 GE, 18-34 IR, 12-120 TSE | 20-100 SE, 5 GE, 20 IR |
| Inversion Time (msec) | 50-800 | 25-999 |
| Slice Thickness mm | 2-10 0.5 incr 2D, 0.8 - 10 0.1 incr 3D | 2 - 10 1 incr 2D, 1-10 1 incr 3D |
| FOV mm | 100 - 200 | 80 - 200 |
| Displayed FOV | 110 max Increments of 10 | 200 max increments of 1 |
| FOV offsets | NA | NA |
| Scan Orientations | Transverse, coronal, sagittal, oblique, compound oblique | Transverse, coronal, sagittal oblique |
| Measuring Matrix | 128x128 to 256x256 2D 128x128x8 to 256x256x128 3D | 64x256 to 256x256 2D 64x256x16 to 256x256x16 3D Incr 1 in phase |
| Display Matrıx | 254x238, 510x478 | 256x256, 512x512 |
| Pixel Intensity | 0-4095 | 0-255 |
| Spatial Resolution | 0.4 mm | 0.5 |
| Coils | Knee 2 Sizes, Extremity | Arm Coil, Leg Coil, 12 cm Loop, 18 cm Loop |
| Bore Diameter W x H cm | 16 × 33.6 | 20 x 75 |
| Bore Features | Self centring mechanism, internal RF shield, Leg-locking device | Self centring mechanism |
| Cooling System | Not required | Air Conditioning Control +/- 1C |
| Cryogens | NA | NA |
| Magnet Weight | 1000 | 500 |
| HxWxD cm | 120x73x52 | 118x51x52 |
| Dicom 3.0 | Optional | From 3rd Party |
| Power Requirements | ||
| Line Voltage | 110 | 110/240 |
| KVA | 1.3 | <3 |
| AC BTU | 4500 | <10,000 |
| Siting Requirement ft2 | <100 | <100 |
| RF shielding | Integral | Modular screened room |
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.