(28 days)
STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD).
When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis.
STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR).
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client's existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user's current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs.
The provided document is a 510(k) premarket notification for SpinTech, Inc.'s "STAGE" device. It outlines the device description, indications for use, comparison to a predicate device, and a summary of non-clinical testing. However, it explicitly states that clinical testing was not necessary to demonstrate substantial equivalence, and therefore, does not contain information about a study proving the device meets specific acceptance criteria based on human reader performance, expert-established ground truth, or MRMC studies.
Here's a breakdown of the information available based on your request, highlighting the missing elements:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested (e.g., sensitivity, specificity, AUC values).
It states: "All predefined acceptance criteria for the performance testing were met. The results from the performance testing executed on STAGE produced results consistently according to its intended use." This is a general statement that the device passed internal testing, but no specific metrics are quantified or presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as there was no clinical testing. The non-clinical testing focused on software verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there was no clinical testing involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there was no clinical testing (and thus no test set adjudicated by experts).
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as explicitly stated, "Clinical testing was not necessary to demonstrate substantial equivalence of STAGE to the predicate device." Therefore, no effect size of human reader improvement with or without AI assistance is reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states: "STAGE was tested in accordance with SpinTech's verification and validation procedures," and "All predefined acceptance criteria for the performance testing were met." This implies standalone testing of the algorithm's performance against internal acceptance criteria (e.g., accuracy of calculations, image generation quality). However, specific metrics (like quantitative measures of accuracy, precision for the generated images or maps) for this standalone performance are not detailed. The focus is on the device generating outputs according to its intended methodology and not on diagnostic accuracy in a clinical context without human interpretation. The device is a "post-processing software medical device intended for use in the visualization of the brain" and "When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis." This indicates it's designed to be used with human interpretation, not as a standalone diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" would likely be based on established computational models, mathematical correctness of transformations, or comparison to reference data generated by known methods, rather than clinical ground truth like pathology or expert consensus. Specific details on the type of ground truth used for the verification and validation are not provided.
8. The sample size for the training set
This information is not provided. The document describes the device as a software that analyzes input data to generate various images and maps. While some methodologies might involve "fitting" (e.g., lease squares fitting), it's not explicitly stated if a machine learning model requiring a distinct "training set" was utilized in a conventional sense for the image generation process, beyond the CROWN filtering algorithm being "intended to improve specific STAGE outputs." The document details the methodologies as unchanged from the predicate, and focuses on the generation of images/maps based on specific signal processing and mathematical transformations, rather than a machine learning model that would require a large training dataset for learning.
9. How the ground truth for the training set was established
This information is not provided, as details about a distinct training set for a machine learning model are absent.
In summary, this 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical software verification and validation, without the need for clinical studies involving human observers or detailed performance metrics against clinical ground truth.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 28, 2022
SpinTech, Inc. % Rana Hachem Management Representative / Business Operations Manager 30200 Telegraph Road Suite 140 BINGHAM FARMS MI 48025
Re: K223079
Trade/Device Name: Stage Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LLZ Dated: September 28, 2022 Received: September 30, 2022
Dear Rana Hachem:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name STAGE
Indications for Use (Describe)
STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced Tl weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD).
When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis.
STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR).
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for SpinTech MRI. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in a sans-serif font. Below the company name is the tagline "from image to insight" in a smaller font size.
K223079
510(k) Summary
| Date Prepared: | September 28, 2022 |
|---|---|
| Submitter: | SpinTech, Inc.30200 Telegraph Road, Suite 140Bingham Farms, MI 48025 |
| Contact: | Rana El HachemManagement Representative / Business Operations ManagerSpinTech, Inc.(248) 712-6789rana@ spintechmri.com |
| Proprietary Name: | STAGE |
| Common Name: | System, Imaging Processing, Radiological |
| Classification Name: | Magnetic resonance diagnostic device |
| Regulation Number: | 21 CFR Section 892.1000 |
| Classification Code: | LNH / LLZ |
| Review Panel: | Radiology |
| SubstantiallyEquivalent Devices: | K210843 - SpinTech, Inc. STAGE |
Device Description:
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client's existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user's current DICOM viewing software. STAGE has been modified from the predicate to include
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Image /page/4/Picture/0 description: The image is the logo for SpinTech MRI. The logo consists of a blue atom-like graphic on the left, followed by the words "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font, also in blue. The logo is clean and modern, with a focus on the company's name and its mission.
CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
| STAGEQuantitativeOutput | Output Methodology | Technical CharacteristicsComparison |
|---|---|---|
| T1 MapImage: T1 Map | STAGE uses a least squares fitting overvariable flip angles to quantify T1.Expected Contrast: WM, GM, CSFcontrast will appear similar to aconventional T2W scan.Comparable Conventional ScanContrast: T1W (inverted) | Methodology Unchanged |
| R2* MapImage: R2* MapCROWNenabled R2*Map | STAGE uses a least squares fitting overvariable echo times to quantify $R2*/T2*$ .The optional CROWN filter is compatiblewith R2* Map.Expected Contrast: Veins and midbrainGM structures and cortical GM shouldbe bright relative to surrounding tissues.Diamagnetic tissue (major WM tracts,calcifications) should also appear bright.Comparable Conventional ScanContrast: SWI /SWAN (inverted) | Methodology UnchangedCROWN functionality available foralternate R2* Map output. |
| T2* MapImage: T2* Map | STAGE calculates T2* by simply takingthe inverse from the quantified R2*result.The optional CROWN filter is compatiblewith T2*Map. | Methodology UnchangedCROWN functionality available foralternate T2* Map output. |
| CROWNenabled T2*MapImage: Brain scan*differentpatient scans | GM structures and cortical GM shouldbe dark relative to surrounding tissues.Diamagnetic tissue (major WM tracts,calcifications) should also appear dark.Comparable Conventional ScanContrast: SWI/SWAN | |
| PD MapImage: Brain scan | PD maps are quantified from the samevariable flip angle calculation as T1maps, using the intercept rather than theslope of the least squares fit.The optional CROWN filter is compatiblewith PD Map. | Methodology UnchangedCROWN functionality available foralternate PD Map output. |
| CROWNenabled PDMapImage: Brain scan | Expected Contrast: WM, GM, CSFcontrast will appear similar to aconventional T2W scan. However veinsand midbrain GM structures and corticalGM should be slightly darker relative tosurrounding tissues.Comparable Conventional ScanContrast: PDW | |
| Susceptibilityweighted imagemapping(SWIM)Image: Brain scanSWIM | The SWIM output, also known as QSMin the field, has been widely used andtested in research. The STAGE versionuses a weighted average iterative TKD(Threshold-based K-space Domain)approach. The phase data from eachecho is unwrapped and then thebackground fields are removed. As afirst pass, the inverse dipole kernel (thefundamental kernel used to reconstructSWIM images) is defined using athreshold of 0.1 to estimate the ill-posedvalues. The veins are then thresholdedout of this first pass result and theirgeometry is used to improve theestimation ill-posed values. This processis iterated 4 times to get a SWIM resultfor each echo. Last a weighted average | Methodology Unchanged |
| echoes to the final SWIM output.Expected Contrast: Veins and midbrain GM structures and cortical GM should be bright relative to surrounding tissues. Diamagnetic tissue (major WM tracts, calcifications) should appear dark.Comparable Conventional Scan Contrast: SWI /SWAN (inverted) | ||
| STAGEQualitativeOutput | ||
| T1 WeightedEnhanced(T1WE)Image: T1WE brain scanCROWNenabled T1WeightedEnhanced(T1WE)Image: CROWN enabled T1WE brain scan*differentpatient scans | To create enhanced T1W data, STAGE subtracts the PDW input data with negative WM/GM contrast from the T1W input data with positive WM/GM contrast. This is not a synthetic image calculated from the quantitative maps.The optional CROWN filter is compatible with T1WE.Expected Contrast: This output should appear like a conventional T1 weighted anatomical scan.Comparable Conventional Scan: MPRAGE | Methodology UnchangedCROWN functionality available for alternate T1WE output. |
| Susceptibilityweightedimaging (SWI) | The SWI from STAGE uses the same general process: high-pass filtering the phase data, creating a mask, and applying it to the magnitude data.The optional CROWN filter is compatible with SWI. | Methodology UnchangedCROWN functionality available for alternate SWI output. |
| Image: SWICROWNenabledSusceptibilityweightedimaging (SWI)Simulated SWI*differentpatient scans | Expected Contrast: Veins and midbrainstructures should appear dark relative tosurrounding tissues. Diamagnetic tissue(major WM tracts, calcifications) shouldalso appear dark.Comparable Conventional Scan: SWI/SWAN | |
| TrueSusceptibilityweightedimaging (tSWI)tSWI | True SWI works the same way exceptusing iSWIM data to create a mask,helping eliminate the geometrydependence of the phase data.The optional CROWN filter is compatiblewith tSWI.Expected Contrast: Veins and midbrainstructures should appear dark relative tosurrounding tissues. Diamagnetic tissue(major WM tracts, calcifications) shouldalso appear dark.Comparable Conventional ScanContrast: SWI /SWAN | Methodology UnchangedCROWN functionality available foralternate tSWI output. |
| Image: CROWNenabled TrueSusceptibilityweightedimaging (tSWI)Simulated tSWI | ||
| *differentpatient scans | ||
| Pseudo SWIM(pSWIM)Image: pSWIM | Pseudo-susceptibility map (pSWIM) iscreated from an intensity projection ofthe filtered phase data. The results arenot quantitative but provide similarcontrast to SWIM.Expected Contrast: Veins and midbrainGM structures and cortical GM shouldbe bright relative to surrounding tissues.Comparable Conventional ScanContrast: SWI /SWAN MIP (inverted) | Methodology Unchanged |
| ModifiedpSWIM(mpSWIM)Image: mpSWIM | Modified pseudo-susceptibility map(mpSWIM) are created from an intensityprojection of the filtered phase data. Theresults are not quantitative but providesimilar contrast to SWIM.Expected Contrast: Veins and midbrainGM structures and cortical GM shouldbe bright relative to surrounding tissues.Highly diamagnetic tissue (calcifications)should appear dark.Comparable Conventional ScanContrast: SWI /SWAN MIP (inverted) | Methodology Unchanged |
| Magneticresonanceangiography(MRA)Image: MRA | The STAGE MRA output uses amaximum intensity projection of the T1Winput data to exploit the time of flighteffect of the arterial blood.Expected Contrast: Arterial blood flowinginto the imaging slab should be bright.Other tissues should show little to nocontrast.Comparable Conventional ScanContrast: TOF MRA | Methodology Unchanged |
| SimulatedSynthetic dualinversionrecovery (DIR) | Any simulated data (e.g., DIR) arecreated through a forward simulationprocess using the T1 and PD maps asinput.The optional CROWN filter is compatible | Methodology Unchanged |
| Image: Brain scan | with simulated DIR.Expected Contrast: For the three DIRoutputs, either GM, WM, or CSF alonewill be bright and the rest will be dark.Comparable Conventional ScanContrast: Dual Inversion Recovery | |
| Simulated T1WImage: Brain scan | Any simulated data are created througha forward simulation process using theT1 and PD maps as input.Expected Contrast: For the three DIRoutputs, either GM, WM, or CSF alonewill be bright and the rest will be dark.Comparable Conventional ScanContrast: Dual Inversion Recovery | Methodology UnchangedCROWN functionality available foralternate simulated T1W output. |
| Simulated PDWImage: Brain scan | Any simulated data are created througha forward simulation process using theT1 and PD maps as input.Expected Contrast: For the three DIRoutputs, either GM, WM, or CSF alonewill be bright and the rest will be dark.Comparable Conventional ScanContrast: Dual Inversion Recovery | Methodology UnchangedCROWN functionality available foralternate simulated PDW output. |
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Image /page/5/Picture/0 description: The image shows the logo for SpinTech MRI. The logo consists of a blue circular graphic with three orbiting lines on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font size and also in blue.
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Image /page/6/Picture/0 description: The image shows the logo for SpinTech MRI. The logo features a stylized atom symbol on the left, followed by the text "SpinTechMRI" in a blue sans-serif font. Below the company name is the tagline "from image to insight" in a smaller font size.
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Image /page/7/Picture/0 description: The image is the logo for SpinTech MRI. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font size.
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Image /page/8/Picture/0 description: The image shows the SpinTech MRI logo. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font.
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Image /page/9/Picture/0 description: The image is the logo for SpinTech MRI. The logo features a stylized atom graphic to the left of the company name. The text "SpinTech" is in a dark blue, and "MRI" is in a lighter blue. Below the company name is the tagline "from image to insight" in a smaller font.
Indications for Use:
STAGE is a post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced TI weighted images, susceptibility weighted imaging (SWI) images, susceptibility weighted image map (SWIM) images, pseudo-SWIM (pSWIM) images, modified pSWIM (mpSWIM) images, true SWI (tSWI) images, MR angiography (MRA) images, simulated dual-inversion recovery (DIR) images, and maps of TI, R2*, and proton density (PD).
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Image /page/10/Picture/0 description: The image is a logo for SpinTech MRI. The logo features a blue atom-like graphic on the left, followed by the text "SpinTechMRI" in blue. Below the text, there is a tagline that reads "from image to insight" in a smaller font size.
When interpreted by a trained physician, STAGE images may provide information useful in determining diagnosis.
STAGE is indicated for brain imaging only and should always be used in combination with at least one other conventional MR acquisition ( e.g., T2 FLAIR).
Comparison of Technological Characteristics:
The STAGE fundamental technological characteristics are similar to those of the predicate device as noted in the following table.
| Characteristic | Predicate DeviceSTAGE (v. 1.1)SpinTech, Inc.(K210843) | Proposed DeviceSTAGE (v 2.0 incl. CROWN)SpinTech, Inc.(TBD) | SimilaritiesandDifferences |
|---|---|---|---|
| Classification | Class II | Class II | Identical |
| Regulation | 21 CFR 892.1000 | 21 CFR 892.1000 | Identical |
| RegulationName | Magnetic resonance diagnosticdevice | Magnetic resonance diagnosticdevice | Identical |
| Product Code | LNHLLZ | LNHLLZ | Identical |
| Prescription | Rx only | Rx only | Identical |
| Indications forUse | STAGE is a post-processingsoftware medical deviceintended for use in thevisualization of the brain.STAGE analyzes input datafrom MR imaging systems.STAGE utilizes magnitude andphase data acquired withspecific parameters to generateenhanced Tl weighted images,susceptibility weighted imaging(SWI) images, susceptibilityweighted image map (SWIM)images, pseudo-SWIM(pSWIM) images, modifiedpSWIM (mpSWIM) images, trueSWI (tSWI) images, MRangiography (MRA) images,simulated dual-inversionrecovery (DIR) images, andmaps of TI, R2*, and protondensity (PD).When interpreted by a trainedphysician, STAGE images mayprovide information useful indetermining diagnosis. | STAGE is a post-processingsoftware medical deviceintended for use in thevisualization of the brain.STAGE analyzes input datafrom MR imaging systems.STAGE utilizes magnitude andphase data acquired withspecific parameters to generateenhanced Tl weighted images,susceptibility weighted imaging(SWI) images, susceptibilityweighted image map (SWIM)images, pseudo-SWIM(pSWIM) images, modifiedpSWIM (mpSWIM) images, trueSWI (tSWI) images, MRangiography (MRA) images,simulated dual-inversionrecovery (DIR) images, andmaps of TI, R2*, and protondensity (PD).When interpreted by a trainedphysician, STAGE images mayprovide information useful indetermining diagnosis. | Identical |
| STAGE is indicated for brain | STAGE is indicated for brain | ||
| imaging only and should alwaysbe used in combination with atleast one other conventionalMR acquisition ( e.g., T2FLAIR). | imaging only and should alwaysbe used in combination with atleast one other conventionalMR acquisition ( e.g., T2FLAIR). | ||
| Intended Users | Qualified Radiologist | Qualified Radiologist | Identical |
| Type of ImagingScans | MRI | MRI | Identical |
| TargetOrgan/System | MR Brain | MR Brain | Identical |
| LoadingMultiple Studies | Yes | Yes | Identical |
| TechnologicalFeatures | Supports 1.5T ImagesSupports 3.0T ImagesFiltered Phase MapsIntensity ProjectionAutomatic High-Pass FilteringB1 CorrectionN/A | Supports 1.5T ImagesSupports 3.0T ImagesFiltered Phase MapsIntensity ProjectionAutomatic High-Pass FilteringB1 CorrectionCROWN | Identical |
| Output Map | Enhanced T1 weighted images | T1 weighted images | Similar |
| T1 weighted imageswith white noise reduced viaCROWN | |||
| SWI | SWI | Similar | |
| SWI with white noise reducedvia CROWN | |||
| SWIM | SWIM | Identical | |
| pSWIM | pSWIM | Identical | |
| mpSWIM | mpSWIM | Identical | |
| tSWI (SWI algorithm) | tSWI | Similar | |
| tSWI with white noise reducedvia CROWN | |||
| MRA (intensity projection) | MRA | Identical | |
| Simulated data (DIR, T1W,PDW) | DIRT1WPDW | Similar | |
| DIR, T1W, and PDW with whitenoise reduced via CROWN | |||
| T1 map | T1 map | Identical | |
| R2* map (T2=1R2*) | R2* map | Similar | |
| R2* map with white noisereduced via CROWN | |||
| PD map | PD map | Similar | |
| PD map with white noise | |||
| reduced via CROWN | |||
| Pulse Sequence | 3D Spoiled GRE (w/ phase data) | 3D Spoiled GRE (w/ phase data) | Identical |
| Hardware | CPU – i7-6700TE 2.4Ghz (minimum)RAM – 16 GB (minimum) | STAGE 2.0 is a Software Only device.Hardware provided by the client must meet the following minimum requirements:CPU – 6 cores 2.1GHz (minimum), 8+ cores 2.6GHz (recommended)RAM – 16GB (minimum)Disk Space – 128GB (minimum) | Difference |
| Operating System | Windows 10 | Windows 10 | Identical |
| Sterility | N/A | N/A – Software only device | Similar |
| Biocompatibility | N/A | N/A – Software only device | Similar |
| Electrical Safety | UL ANSI/AAMI ES 60601-1: 2012 (v3.1) (STAGE Module) | N/A – Software only device | Difference |
| Thermal Safety | N/A | N/A | Identical |
| Energy Used/Delivered | N/A | N/A | Identical |
| Chemical Safety | N/A | N/A | Identical |
| Radiation Safety | N/A | N/A | Identical |
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Image /page/11/Picture/0 description: The image shows the SpinTech MRI logo. The logo features a stylized atom graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font.
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Image /page/12/Picture/0 description: The image is the logo for SpinTech MRI. The logo consists of a blue atom-like graphic on the left, followed by the words "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font, also in blue. The logo is clean and modern, with a focus on the company's name and its mission.
Non-Clinical Testing Summary:
The following design control, risk management and quality assurance methodologies were utilized to develop STAGE:
- . Risk Analysis
- Requirements Review .
- Design Reviews .
- Testing on Unit Level (Verification) .
- . Integration Testing (System Verification)
- Performance Testing (V&V) .
- Safety Testing (V&V) .
- Simulated Use Testing (Validation) .
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Image /page/13/Picture/0 description: The image is the logo for SpinTech MRI. The logo features a blue atom-like graphic on the left, followed by the text "SpinTechMRI" in blue. Below the company name is the tagline "from image to insight" in a smaller font, also in blue. The logo is clean and professional, conveying a sense of innovation and expertise in the field of medical imaging.
Software documentation for Moderate Level of Concern software per the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005, was established and maintained for STAGE. STAGE was tested in accordance with SpinTech's verification and validation procedures.
All predefined acceptance criteria for the performance testing were met. The results from the performance testing executed on STAGE produced results consistently according to its intended use.
Clinical Testing Summary:
Clinical testing was not necessary to demonstrate substantial equivalence of STAGE to the predicate device.
Conclusions Drawn from Non-Clinical Tests:
The subject device and the predicate devices are substantially equivalent, with respect to intended use, instructions for use, design features, technological characteristics, performance criteria, and safety and effectiveness. The subject device is substantially equivalent to the predicate device, K210843.
Conclusion:
The non-clinical software testing performed on STAGE demonstrates that STAGE performs according to its intended use. SpinTech, Inc. considers STAGE (subject device) to be substantially equivalent to the legally marketed predicate device, K210843.
§ 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.