The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging, Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. IMR images will be used by a trained medical professional for diagnosis of clinical conditions in patients, including pediatrics and adults, who have been prescribed a CT scan as part of their clinical care

Device Description

The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging. Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. The IMR Software Application will reside on any Philips CT System that meets minimum software platform and hardware requirements. IMR enables the user to apply iterative reconstruction techniques to reconstruct raw CT data to generate diagnostic CT images. The use of IMR to reconstruct images may be done prospectively or retrospectively.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Philips IMR Software Application, based on the provided text:

1. Acceptance Criteria and Device Performance

IMR Image Quality Parameter	Reported Device Performance (Lower Limit)	Reported Device Performance (Upper Limit)
Dose Reduction (with simultaneous improved image quality)	60% lower radiation dose with 43% improvement in low contrast detectability and 83% less image noise.	80% lower radiation dose with 80% improvement in low contrast detectability and 70% less image noise.
High-Contrast Spatial Resolution Improvement	1.2x improvement	1.7x improvement
Low-Contrast Detectability Improvement	2.5x improvement	3.6x improvement
Noise Reduction	Up to 90% image noise reduction	N/A (single value given)

2. Sample Size and Data Provenance

Test Set (Clinical Image Evaluation): 110 clinical image raw data sets.
Data Provenance: Not explicitly stated (e.g., country of origin). The text refers to "clinical image raw data sets," implying retrospective data.

3. Number of Experts and Qualifications for Ground Truth (Clinical Image Evaluation)

Number of Experts: A panel of eight physicians.
Qualifications: Not explicitly stated beyond "physicians."

4. Adjudication Method (Clinical Image Evaluation)

The text states: "Resulting data confirmed that the IMR software application provides diagnostic quality images and in majority of the cases, the physicians preferred the IMR images to standard (filter back projection) reconstruction." This suggests a comparative evaluation by the panel, likely involving subjective preference between FBP and IMR images, but a formal adjudication method like "2+1" or "3+1" is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: Yes, a "human observer study" was conducted for low contrast detectability (LCD), and a clinical image evaluation involving "a panel of eight physicians."
Effect Size of human readers' improvement with AI vs. without AI assistance:
- Low Contrast Detectability (4-AFC Detection human observer study): The resulting data "confirmed the improved LCD using the IMR application," with an improvement range of 43% - 80% relative to filtered backprojection, as demonstrated through phantom-based tests.
- Clinical Image Evaluation: Physicians "preferred the IMR images to standard (filter back projection) reconstruction in the majority of the cases." No specific quantitative improvement (effect size) for human readers is given for this study beyond preference.

6. Standalone Performance (Algorithm Only)

Was it done?: Yes, objective image quality testing was conducted using phantoms to determine noise, CT number uniformity, and high-contrast spatial resolution. The CT scan data was reconstructed by the IMR software application and compared to filtered backprojection. These are standalone performance metrics of the algorithm.

7. Type of Ground Truth Used

Phantom-based tests: For noise, CT number uniformity, high-contrast spatial resolution, and low contrast detectability, phantom-based measurements were used as the ground truth, following methodologies like IEC 61223-3-5 and a 4-AFC detection human observer study with a low-contrast pin phantom.
Clinical Image Evaluation: For the clinical image evaluation, the ground truth was based on the diagnosed quality and preferences of a panel of eight physicians, comparing IMR to standard (FBP) reconstructions. This is a form of expert consensus/subjective evaluation.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size used for training the IMR software application. The studies described are primarily for performance testing and validation.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how ground truth was established for a training set, as it focuses on performance testing rather than development or training methodologies.

Summary

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510(k) Summarv

Philips IMR Software Application

The summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter:
  Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143

Contact:

Christine Anderson Regulatory Affairs Specialist Tel.: (440) 483-7732 Fax: (440) 483-4918

Date of Summary: November 16, 2012

1. Device Name and Classification
  Philips IMR Software Application

Device Classification:

Device Name:

Computed Tomography X-Ray System. The FDA has classified the Computed Tomography X-Ray System and its accessories as Class II in 21 CFR 892.1750 (Product Code: 90 JAK)

3. Predicate Device Information

The Philips IMR Software Application is comparable in type and substantial equivalence to the legally marketed devices currently in commercial distribution, namely:

a. Philips IRT Software Application - K113483

b. Philips Brilliance Volume CT System K060937

4. Device Description

JUN 7 2013

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IMR Software Application will reside on any Philips CT System that meets minimum software platform and hardware requirements. IMR enables the user to apply iterative reconstruction techniques to reconstruct raw CT data to generate diagnostic CT images. The use of IMR to reconstruct images may be done prospectively or retrospectively.

1. Indications for Use
  The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered backprojection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging. Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. IMR images will be used by a trained medical professional for diagnosis of clinical conditions in patients, including pediatrics and adults, who have been prescribed a CT scan as part of their clinical care.
1. Comparison to Predicate
  In the opinion of Philips, the IMR Software Application is of a comparable type and substantially equivalent to the Philips Brilliance Volume CT System and the IRT Software Application, the legally marketed devices described in section 3 above. IRT reconstructs images from raw data based on iterative processing using the raw and image data. IMR is identical to IRT except for additional use cases and additional claims for image quality, as measured on a phantom, and dose reduction claims, as evaluated via a human observer study. Therefore, IMR expands on the capabilities of IRT.

Predicate 510(k) Number Brilliance Volume K060937 Philips IRT Software K113483 Application

Cleared June 5, 2006 September 26, 2012

1. Safetv
  The Philips IMR software application is manufactured in accordance with the Quality System Requlation (QSR) 21 CFR 820 and to International Standards ISO 13485:2003. Potential hazards are identified in a hazard analysis and controlled in the following manner:

Software: Safety is assured by the company procedures that conform to accepted practices, including the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Instructions for Use are provided with the software application for the safe and effective operation of the application by the user.

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8. Performance Testing Summary

Non-clinical Testing

Obiective image quality testing was conducted using phantoms and following the methodology in IEC 61223-3-5, Evaluation and routine testing in medical departments - Parts 3-5: Acceptance test - Imaging performance of computed tomography x-ray equipment for determining noise, CT number uniformity and high contrast spatial resolution. The CT scan data was reconstructed both with filtered backproiection and the IMR software application for comparison. Additionally, a Four Alternative Force Choice (4-AFC) Detection human observer study was conducted with a four Low Contrast pin phantom for evaluating low contrast detectability (LCD). In this study, a cohort of human subjects was required to identify a low contrast pin in a panel of four images. In order to characterize the statistical nature of the detection of a low contrast object in an image with noise, the test was repeated multiple times for each test subject, and multiple test subjects were used. The resulting data confirmed the improved LCD using the IMR application.

IMR may simultaneously enable 60% - 80% lower radiation dose; and 43% -80% low-contrast detectability improvement; and 70% - 83% less image noise, relative to filtered backprojection, as demonstrated through phantom-based tests. Low-contrast detectability was assessed using a reference abdomen protocol, based on a 4-AFC phantom test.

IMR may alternatively enable 1.2x - 1.7x high-contrast spatial-resolution improvement; or 2.5x - 3.6x low-contrast detectability improvement; or up to.90% image noise reduction, relative to filtered backprojection, as demonstrated through phantom-based tests. Lower image noise assessed using a Reference Chest Protocol; Improved high-contrast spatial resolution using Reference Abdomen and Thorax Protocols: Improved low-contrast detectability using a Reference Abdomen Protocol. All metrics tested on phantoms.

Clinical Image Evaluation

A total of 110 clinical image raw data sets were reconstructed with filtered backprojection and then with the IMR software application to compare image quality. The FBP and IMR images were evaluated image quality by a panel of eight physicians. Resulting data confirmed that the IMR software application provides diagnostic quality images and in majority of the cases, the physicians preferred the IMR images to standard (filter back projection) reconstruction.

Conclusion

IMR may simultaneously enable:

· 60% 80% lower radiation dose; and
· 43% 80% low-contrast detectability improvement; and
· 70% 83% less image noise.

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relative to filtered backprojection, as demonstrated through phantom-based tests (1).

IMR may alternatively enable:

· 1.2x 1.7x high-contrast spatial-resolution improvement(1): or
· 2.5x 3.6x low-contrast detectability improvement 13; or
· Up to 90% image noise reduction(4),

relative to filtered backprojection, as demonstrated through phantom-based tests.

Note : In clinical practice, the use of IMR may reduce CT patient dose depending on the clinical task, patient size, anatomical location, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task.

IMR Image QualityParameter	Results	Test Conditions
Dose Reduction:60%-80% lowerdose withsimultaneousimproved imagequality [1]	60% lower radiationdose with a 43 %improvement in lowcontrast detectabilityand 83% less imagenoise	Lower (60%) limit as specified by:IMR settings:• Reference Protocol1: Abdomen• CTDIvol: 4 mGy• Slice thickness: 0.8/0.4mm• Clinical indication: Sharp• Level: L3As compared to:FBP settings• Reference Protocol: Abdomen• CTDIvol: 10mGy,• Slice thickness: 0.8/0.4 mm,• Standard filter: CAs tested on the MITA CT IQPhantom manufactured by PhantomLaboratories, model CCTI83 and lowcontrast detectability testing usinghuman observers.

The table below represents the test conditions used to achieve the above performance parameters

4 Reference protocols refer to the standard factory reference protocols provided on the CT scanner

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80% lower radiationdose with a 80%improvement in lowcontrast detectabilityand 70% less imagenoise.	Upper limit (80%) as specified byIMR settings:• Reference protocol: Abdomen• CTDIvol: 2mGy• Slice thickness: 0.8/0.4mm• Clinical indication: Smooth• Level: L3As compared to:FBP settings• Reference Protocol: Abdomen• CTDIvol: 10mGy• Slice thickness: 0.8/0.4 mm,• Standard filter: B
	As tested on the MITA CT IQPhantom manufactured by PhantomLaboratories, model CCT183 and lowcontrast detectability testing usinghuman observers.

and the same of the same

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PHILIPS

Philips Medical Systems (Cleveland) Inc.

High-contrastspatial resolutionimprovement [2]	1.2x – 1.7x high-contrast spatial-resolution improvement	High-contrast spatial resolution (x-y)and image noise.Lower limit as specified by:IMR settings Reference Protocol: Abdomen CTDIvol: 4mGy Slice thickness: 1.0/0.5 mm Clinical Indication: Sharp Level: L3. As compared to:FBP Settings Reference Protocol: Abdomen CTDIvol: 4mGy Slice thickness: 1.0/0.5 mm, Standard filter: B Upper limit as specified by:IMR settings Reference Protocol: Thorax/HighRes Helical Protocol CTDIvol: 20mGy Slice thickness: 1.0/0.5 mm Matrix: 512 matrix Clinical Indication: Sharp Level: L3 As compared to:FBP Settings Reference Protocol: Abdomen CTDIvol: 20mGy Slice thickness: 1.0/0.5 mm, Standard filter: B Tested on the CatPhan 600
Low-contrastdetectabilityimprovement [3]	2.5x – 3.6x low-contrastdetectabilityimprovement	Lower limit as specified by:IMR Settings:• Reference Protocol: Abdomen• CTDIvol: 10 mGy• Slice thickness: 0.8/0.4 mm,• Clinical Indication: Sharp• Level: L3As compared to:FBP Settings• Reference Protocol: Abdomen• CTDIvol: 10mGy• Slice thickness: 0.8/0.4 mm,• Standard filter: CUpper limit as specified by:IMR Settings:• Reference Protocol: Abdomen• CTDIvol: 4 mGy• Slice thickness: 0.8/0.4 mm,• Clinical Indication: Smooth• Level: L3As compared to:FBP Settings• Reference Protocol: Abdomen• CTDIvol: 4mGy• Slice thickness: 0.8/0.4 mm,Standard filter: BAs tested on the MITA CT IQPhantom manufactured by PhantomLaboratories, model CCT183 and lowcontrast detectability testing usinghuman observers
Noise reduction [4]	90% image noisereduction	IMR Settings:• Reference Protocol: Chest• CTDIvol: 20 mGy• Slice thickness: 0.8/0.4 mm,• Clinical Indication: Smooth• Level: L3As compared to:FBP Settings:• Reference Protocol: Chest• CTDIvol: 20mGy• Slice thickness: 0.67/0.34 mm,• Standard filter: BTested on the CatPhan 600 withcylindrical body ring

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PHILIPS

Philips Medical Systems (Cleveland) Inc.

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Based on the above considerations, it is Philips' opinion that the results of the verification and validation testing and the results of the risk analysis demonstrates safety and effectiveness of the Philips IMR Software Application and that it is substantially equivalent to the predicate devices documented above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 7, 2013

Philips Medical System (Cleveland) Inc. % Ms. Christine Anderson Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143

Re: K123576

Trade/Device Name: IMR Software Application Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 31, 2013 Received: June 04, 2013

Dear Ms. Anderson:

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 vour 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

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Page 2 - Ms. Anderson

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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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Indications for Use

510(k) Number (if known):

K123576

Device Name:

IMR Software Application

Indications for Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE-DO-NOT-WRIFE-BELOW-THIS-LINE-EON-ANOTHER-PAGE-IF-NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K123576 510(k)

Page 1 of 1

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.