SWIp is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems. It's indicated for magnetic resonance imaging of the Brain. SWIp is a technique using phase information to enhance contrast between tissues presenting susceptibility differences, such as deoxygenated blood or some mineral deposits (e.g. calcium deposits). Due to this contrast enhancement, SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature. When used in combination with other clinical information, SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.

Device Description

SWIp (Susceptibility Weighted Imaging with Phase enhancement) exploits the susceptibility differences between tissues. It is based on a 3D FFE acquisition, multiecho compatible, generating high resolution magnitude and phase images.

Phase images are unwrapped to create Susceptibility Weighted Phase (SW-P) images highlighting phase changes due to local susceptibility differences. The magnitude images and SW-P information are combined to generate Susceptibility Weighted Magnitude (SW-M) images with enhanced susceptibility contrast. SW-M images show de-oxygenated blood, such as veins, as hypo-intense signals.

The feature requires:

Specific parameter settings for the 3D FFE sequence, within cleared parameter limits, to acquire the MR signals
A new calculation function to generate SW-M and SW-P images. This function uses a set of MR images as input that is generated in a cleared manner from the acquired MR signals.
The new images need to be stored and displayed with the appropriate labels (SW-M and SW-P), applying the facilities provided by the cleared platform.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SWIp device, formatted to answer your specific questions.

Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA. It often summarizes validation and verification activities rather than providing detailed clinical study protocols and results. As such, some of the information you've requested regarding specific clinical trial methodologies (like MRMC study effect size, concrete acceptance criteria tables with performance metrics) is not explicitly present in this type of document. The summary focuses on demonstrating substantial equivalence to predicate devices based on non-clinical and clinical tests confirming safety and intended use.

Based on the available information:

Acceptance Criteria and Device Performance

A table of acceptance criteria and the reported device performance

The document does not present a formal table of quantitative acceptance criteria and corresponding reported device performance metrics in the way one might see in a detailed clinical trial report for an AI/CAD product. Instead, it refers to successful completion of non-clinical and clinical tests, with conclusions drawn about the device's acceptable performance for its intended use.

Implicit Acceptance Criteria and Reported Performance:

Criteria Category	Implicit Acceptance Criteria	Reported Device Performance
Non-Clinical Performance	Device functions as designed without crashes, hang-ups, or workflow issues.	"All the tests performed for SWIp were successful. While using SWIp, the system didn't crash or hang-up. Workflow was smooth and no problems occurred." (DHF176222 Verification Test Report)
Clinical Performance	Device meets all clinical user needs on specified MR systems (Achieva and Ingenia 1.5T and 3.0T systems) and helps expert radiologists in diagnosis. SWIp images sensitive for structures containing venous blood, enhancing contrast for susceptibility differences.	"The clinical validation of SWIp has completed successfully. All clinical user needs are passed for Achieva and Ingenia. 1.5T and 3T systems." (DHF176223 Validation Test Report). "SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature."
Safety & Effectiveness	Device is safe, effective, and performs as well as or better than legally marketed predicate devices; does not introduce new indications or hazards.	"The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use." "The SWIp software does not introduce new indications for use, nor does the use of the device result in any new potential hazard."
Parameter Compliance	Specific parameter settings for 3D FFE sequence are within cleared parameter limits.	"Specific parameter settings for the 3D FFE acquisition, multiecho compatible, generating high resolution magnitude and phase images... within cleared parameter limits, to acquire the MR signals."
Image Generation/Display	New calculation function generates SW-M and SW-P images accurately; images are stored and displayed with appropriate labels.	"A new calculation function to generate SW-M and SW-P images... The new images need to be stored and displayed with the appropriate labels (SW-M and SW-P), applying the facilities provided by the cleared platform."

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size (number of patients/scans) used for the clinical validation test set (DHF176223 Validation Test Report). It also does not specify the country of origin of the data or whether the data was retrospective or prospective. It generally refers to "clinical user needs are tested as part of the validation."
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)

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical validation. It mentions that SWIp "may help the expert radiologist in the diagnosis of various neurological pathologies," implying radiologists are the target users, but provides no details on how their expertise was leveraged for ground truth in the study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for establishing ground truth for the test set.
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 MRMC comparative effectiveness study is described in this 510(k) summary. The device, SWIp, is a new image acquisition and processing technique (Susceptibility Weighted Imaging with Phase enhancement) that generates new image types (SW-M and SW-P images), not an AI/CAD system assisting human readers directly. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply in the context of this specific device's described function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

SWIp is described as a "new calculation function to generate SW-M and SW-P images" based on acquired MR signals, which are then "stored and displayed." This function is inherent to the MR system's reconstruction capabilities. The validation focuses on the successful generation and utility of these images for clinical interpretation. In essence, the "algorithm only" performance is evaluated by whether the resulting images are correct, interpretable, and serve their intended purpose for the expert radiologist. The document confirms the "new calculation function" generates the new output images and that these images "are sensitive for structures containing venous blood."
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The specific type of ground truth used is not detailed. The language "may help the expert radiologist in the diagnosis of various neurological pathologies" suggests that ground truth would ultimately be related to established clinical diagnoses, likely confirmed by expert radiologist interpretation (possibly consensus, but not explicitly stated) and potentially in conjunction with other clinical information, as SWIp "is used in combination with other clinical information." Pathology or outcomes data are not mentioned as direct ground truth sources for the image validation itself.
The sample size for the training set

The document does not mention a training set, as SWIp appears to be a deterministic image reconstruction algorithm rather than a machine learning model that requires a distinct training phase.
How the ground truth for the training set was established

Not applicable, as a training set for machine learning is not mentioned for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the text "K131241 Page 1 of 4" in a handwritten font. The text is smaller than the word "PHILIPS" and is located in the upper right corner of the image.

Philips Medical Systems Nederland B.V.

510(k) Summary

SWIp

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information21 CFR 807.92 (a)(1), (2)
Company Name:	Philips Medical Systems Nederland B.V.
Address:	Veenpluis 4-65684 PC BestThe Netherlands	AUG 30 2013
Registration No.:	3003768277
Contact Person:	Susan QuickTel: (440)-483-2291Fax: (440)-483-4918E-mail: susan.quick@philips.com
Prepared (date):	2013 April 29
Trade Name of Device:	SWIp
Classification:	Class II
Regulatory Section:	Magnetic Resonance Diagnostic Device.892.1000
Product Code:	90LNH

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K13124/
Page 2 of 4

21 CFR 807.92(a)(3):Legally marketed predicate device to which substantial equivalence is claimed:

1. Predicate Device:	ACHIEVA R4 1.5T and ACHIEVA R4 3.OT (aka Ingenia)
Manufacturer:	Philips Healthcare
Predicate Device k#:	K110151
2. Predicate Device:	Discovery MR450
Manufacturer:	GE Healthcare
Predicate Device k#:	K083147
3. Predicate Device:	MAGNETOM Trio a Tim System
Manufacturer:	Siemens Medical Solutions
Predicate Device k#:	K050200

21 CFR 807.92(a)(4): Description of the device that is the subject of this premarket notification :

Summary of functions of the device and its major components

The feature requires:

Specific parameter settings for the 3D FFE sequence, within cleared parameter . limits, to acquire the MR signals
A new calculation function to generate SW-M and SW-P images. This function uses . a set of MR images as input that is generated in a cleared manner from the acquired MR signals.
· The new images need to be stored and displayed with the appropriate labels (SW-M and SW-P), applying the facilities provided by the cleared platform.

21 CFR 807.92(a)(5); Intended Use

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combination with other clinical information. SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.

21 CFR 807.92(a)(6): Technological Characteristics:

The main functional units in the software are:

Methods (acquisition of MR signals by means of MR pulse sequences)
Reconstruction (transforming the MR signals to images)
Patient Administration {storing of the images in the database and providing access}
Viewing (display of images)

The technical impact of the feature SWIp comprises:

Methods: modify an existing sequence to acquire the data required for SWIp, within the cleared limits provided by the basic MR system.
Reconstruction: add a new calculation function that generates the new output images SW-M and SW-P.
Patient Administration and Viewing: enable storage and display of the new output images with appropriate labels (SW-M and SW-P).

No off-the-shelf software is used for the feature SWIp. The off-the-shelf software used in the basic MR system for the Ingenia and Achieva 1.5T and 3.0T MR systems machine is cleared by K110151.

SWIn is not designed to be connected to an external network.

Hardware platform description

SWIp does not require any change of the hardware platform. The main extension introduced by SWIp, the new reconstruction algorithm, runs on the Reconstructor computer.

Computer characteristics:

Manufacturer: HP; Model: Z400 or Z420; Processor clock: 3.6 GHz; RAM: 16-. 32 GB RAM: Processors: 1-2 x quad core
Operating system: Windows 7, 64 bits .

The SWIp algorithm does not add specific requirements to the Ingenia and Achieva 1.5T and 3.0T. MR systems machine as cleared by K110151.

Workflow

The only new element for the operator of the SWIp-feature in this clinical routine workflow is:

1. Protocol selection: The operator selects an ExamCard with SWIp protocols
1. Planscan phase: Optionally the operator may want to change the predefined selection of output image-types

All other steps are not changed. The generated image types can be viewed, postprocessed, printed and archived as any other image type.

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K131241
d or Page 4 of 4

21 CFR 807.92(b)(1): Brief discussion of nonclinical tests submitted, referenced o relied on in this premarket notification:

The non-clinical tests that are included in the submission are as follows

· DHF176222 Verification Test Report
The conclusion from testing the device is:

All the tests performed for SWIp were successful. While using SWIp, the system didn't crash or hang-up. Workflow was smooth and no problems occurred.

21 CFR 807.92(b)(2): Brief discussion of clinical tests submitted, referenced or relied on in this premarket notification:

The clinical user needs are tested as part of the validation.

DHF176223 Validation Test Report .
The conclusion from testing the device is:

The clinical validation of SWIp has completed successfully. All clinical user needs are passed for Achieva and Ingenia. 1.5T and 3T systems.

21 CFR 807.92(b)(3): The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section:

The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use.

The SWip software does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers SWIp to be substantially equivalent to the above mentioned predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of the HHS symbol, which is a stylized representation of a human form, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that resemble a person with outstretched arms. The text is in all caps and is relatively small compared to the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 30, 2013

Philips Medical Systems Nederland B.V. % Ms Susan Quick Regulatory Affairs Specialist Philips Medical Systems (Cleveland) Inc. 595 Miner Road CLEVELAND OH 44143

Re: K131241

Trade/Device Name: SWIp Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 30, 2013 Received: July 31, 2013

Dear Ms. Quick:

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. 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 (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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Page 2-Ms. Quick

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

Michael D. O'Hara

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indication for use

510(k) Number (if known):

SWIp Software option for ACHIEVA 1.5T and 3.0T, INGENIA 1.5T and Device Name: 3.0T MR Systems

Indication For Use:

SWIp is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems. It's indicated for magnetic resonance imaging of the Brain. SWIp is a technique using phase information to enhance contrast between tissues presentibility differences, such as deoxygenated blood or some mineral deposits (e.g. calcium deposits). Due to this contrast enhancement, SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature. When used in combination with other clinical information, SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.

Prescription Use メ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED]

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Michael D. O'Hara.

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) K131241

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.