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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.

February 23, 2018

SpinTech, Inc. % Kay Fuller, RAC Regulatory Affairs Consultant 30200 Telegraph Road, Suite 140 BINGHAM FARMS MI 48025

Re: K173224

Trade/Device Name: SPIN-SWI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LLZ Dated: January 12, 2018 Received: January 17, 2018

Dear Ms. Fuller:

We have reviewed vour 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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D.'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173224

Device Name SPIN-SWI

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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15. 510(k) SUMMARY

SpinTech, Inc.

SPIN-SWI Application Software

February 14, 2018

The following summary is provided pursuant to Section 513 (I) (3) (A) of the Federal Food Drug and Cosmetic Act:

1. GENERAL INFORMATION

Submitter Information:	SpinTech, Inc.30200 Telegraph RoadSuite 140Bingham Farms, MI 48025
Contact Information:	Kay Fuller, RACPrincipal Regulatory & Clinical Research ConsultantMedical Device Regulatory Solutions, LLC734-846-7852
2. DEVICE INFORMATION
Device Name:	SPIN-SWI application software
Proprietary Name:	SPIN-SWI
Common Name:	System, Imaging Processing, Radiological
Classification Name:	Magnetic resonance diagnostic device
Classification Code:	LNH, LLZ
Regulation Number:	21 CFR § 892.1000

3. PREDICATE DEVICE

The SpinTech, Inc. SPIN-SWI application device is substantially equivalent to the predicate device, Philips' SWIp application device, cleared for US commercialization via K131241 on 8/30/2013.

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4. DEVICE DESCRIPTION

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.

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5. INDICATIONS FOR USE

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The SPIN-SWI application's fundamental technological characteristics are similar to those of the predicate device as described in this submission, and in noted in the following table.

Feature Comparison Criteria	Subject DeviceSPIN-SWI K173224	Predicate DeviceK131241	SubjectDevice SEto K131241?
21 CFR Reg #, Product Code &	21 CFR §892.1000	21 CFR §892.1000	Yes
Classification	LNH, LLZClass II	LNHClass II
Requlation Name	Magnetic resonance diagnostic device	Magnetic resonance diagnostic device	Yes
Prescription Device - Rx Only	Yes	Yes	Yes
Indications for Use	The SpinTech, Inc. SPIN-SWI application isintended for use in the post-acquisition imageenhancement of MRI acquired 3D gradient-echoimages of the brain. When used in combination withother clinical information, the SPIN-SWI applicationmay aid the qualified radiologist with diagnosis byproviding enhanced visualization of structurescontaining venous blood such as cerebral venousvasculature.	SWIp is a software option intended for use on Achieva and Ingenia1.5T & 3.0T MR Systems. It's indicated for magnetic resonanceimaging of the Brain. SWIp is a technique using phase information toenhance contrast between tissues presenting susceptibilitydifferences, such as deoxygenated blood or some mineral deposits(e.g. calcium deposits). Due to this contrast enhancement, SWIpimages are sensitive for structures containing venous blood such ascerebral venous vascularture. When used in combination with otherclinical information, SWIp may help the expert radiologist in thediagnosis of various neurological pathologies	Yes
Intended Users	Qualified Radiologist and Technologist	Qualified Radiologist and Technologist	Yes
Type of Imaging Scans	MRI	MRI	Yes
Target Organ/System	MR Brain	MR Brain	Yes
Loading Multiple Studies	Yes	Yes	Yes
Technological Features	Supports 1.5T ImagesSupports 3.0T Images(Siemens MRI Systems Only)	Yes1.5T &3.0T(Achieva & Ingenia Only)	Yes
	Filtered Phase Maps	Yes	Yes
	Minimum Intensity Projection	No	No
	Automatic High-Pass Filtering	Yes	Yes
Sterility	N/A	N/A	N/A
Biocompatibility	N/A	N/A	N/A
Electrical Safety	N/A	N/A	N/A
Thermal Safety	N/A	N/A	N/A
Energy Used/Delivered	N/A	N/A	N/A
Chemical Safety	N/A	N/A	N/A
Radiation Safety	N/A	N/A	N/A

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7. NON-CLINICAL TESTING SUMMARY

The following design control, risk management and quality assurance methodologies were utilized to develop the SPIN-SWI application:

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)

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, is also included in this premarket notification submission. The SpinTech SPIN-SWI application was tested in accordance with SpinTech's verification and validation procedures.

predefined acceptance criteria for the engineering All performance testing were met for all test cases across different imaging parameters, field strength and different subjects. The results from the pre-clinical testing performed on the SPIN-SWI application, demonstrate that the SPIN-SWI application produces results consistently according to its intended use.

8. CLINICAL TESTING SUMMARY

The subject device of this premarket notification, SPIN-SWI application, did not require clinical studies to support substantial equivalence to the predicate device.

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.

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9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

The subject device and the predicate device are substantially equivalent, with respect to intended use, instructions for use, design features, technological characteristics, manufacturing methods, performance criteria, special controls, and safety and effectiveness. The subject device is substantially equivalent to the predicate device (K131241) noted herein.

10. CONCLUSION

The non-clinical and clinical testing contained herein demonstrates the SPIN-SWI application performs according to its intended use. SpinTech, Inc. considers the SPIN-SWI application software (subject device) to be substantially equivalent to the legally marketed predicate device (K131241) noted herein, and is safe and effective for its labeled intended use.

Regulation Number and Section

§ 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.