The Philips Iterative Reconstruction Technique (IRT) Software Application is intended to reconstruct raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection reconstruction. Resulting IRT images are to be used to supplement conventional Filtered Back Projection images to aid the physician in diagnosis; they are not to be used as the sole basis for diagnosis.

Device Description

The Philips IRT Software Application is a software option used for the reduction of noise in an image. IRT iteratively reconstructs raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection (FBP) reconstruction. This feature will be used by radiologists as a supplementary method to reconstruct CT raw data, in addition to traditional FBP.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Philips Iterative Reconstruction Technique (IRT) Software Application:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Objective Image Quality	Noise levels less than or equal to images produced by standard Filtered Back Projection (FBP).	"IRT iteratively reconstructs raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection (FBP) reconstruction." and "Resulting data confirmed that the IRT application provides equivalent or better noise reduction." and "IRT affords a reduction in noise...with no degradation in high contrast spatial resolution, CT number accuracy, or CT number uniformity."
Low Contrast Detectability (LCD)	Improved LCD compared to FBP.	"The resulting data confirmed the improved LCD using the IRT application." and "...an improvement in LCD..."
High Contrast Spatial Resolution	No degradation compared to FBP.	"...no degradation in high contrast spatial resolution..."
CT Number Accuracy	No degradation compared to FBP.	"...no degradation in...CT number accuracy..."
CT Number Uniformity	No degradation compared to FBP.	"...no degradation in...CT number uniformity."

Study Information

The provided text describes both non-clinical and clinical image data testing.

2. Sample size used for the test set and the data provenance:

Non-clinical testing (Objective Image Quality):
- Test Set Description: Phantom raw CT scan data.
- Sample Size: Not explicitly stated, but implies multiple phantom scans were reconstructed for comparison.
- Data Provenance: Not specified, but generally phantom data is created in a controlled lab/testing environment.
Non-clinical testing (Low Contrast Detectability - LCD):
- Test Set Description: Images used for an observer study with a low contrast test object.
- Sample Size: "The test was repeated multiple times for each test subject, and multiple test subjects were used." (Specific numbers not given).
- Data Provenance: Not specified, but likely generated in a controlled testing environment.
Clinical testing (Noise Reduction):
- Test Set Description: Clinical image raw data sets.
- Sample Size: Not explicitly stated.
- Data Provenance: Not specified, but implied to be retrospective as it refers to existing "clinical image raw data sets."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the Low Contrast Detectability (LCD) observer study: "a cohort of human subjects was required to identify a low contrast test object..."
- Number of experts: Not specified beyond "multiple test subjects."
- Qualifications of experts: Not explicitly stated. It only mentions "human subjects," not necessarily radiologists or experts in image perception.
For Objective Image Quality and Clinical Noise Reduction where ground truth is based on physical measurements or direct comparison, no external experts are mentioned for establishing ground truth.

4. Adjudication method for the test set:

Objective Image Quality and Clinical Noise Reduction: No explicit human adjudication method is described for these. The comparison seems to be based on direct measurement (noise, CT number uniformity, high contrast spatial resolution) or visual comparison of noise levels by Philips.
Low Contrast Detectability (LCD): The "observer study" served as the evaluation method, where human subjects (not explicitly "adjudicators" in the sense of resolving conflicting interpretations, but rather participants identifying objects) made determinations. No specific adjudication protocol (like 2+1 or 3+1) is mentioned for resolving differences among these subjects, as the data was likely used to characterize the statistical nature of detection.

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:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the document in the typical sense of measuring reader performance with and without AI assistance for diagnosis.
An observer study was conducted for Low Contrast Detectability (LCD), which involves multiple human subjects. However, its stated purpose was to confirm improved LCD using IRT, not to quantify diagnostic improvement of human readers with IRT versus without it as an assistive tool to be compared against a human-only baseline. The IRT images are intended to "supplement conventional Filtered Back Projection images to aid the physician in diagnosis," suggesting an assistive role, but the study described doesn't measure this specific comparative effectiveness for diagnostic improvement.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, standalone performance was a primary focus.
- The "Objective image quality testing" using phantoms evaluated the algorithm's performance (noise, CT number uniformity, high contrast spatial resolution) directly by comparing IRT reconstructions to FBP reconstructions.
- The "Clinical image raw data sets" were also used to compare noise reduction between IRT and FBP.
- The IRT software application is described as an "iterative reconstruction technique" which processes raw data independently to produce images.

7. The type of ground truth used:

Objective Image Quality (Phantoms): Ground truth was established by the known physical properties and measurements from the phantoms, adhering to methodologies like IEC 61223-3-5. This is a form of physical/definitive measurement ground truth.
Low Contrast Detectability (LCD): Ground truth was the verifiable presence or absence of the low contrast test object within the images. This is a form of definitive presence/absence ground truth.
Clinical Noise Reduction: Ground truth for noise reduction was based on direct comparison of noise levels between IRT and FBP reconstructions of the same raw clinical data. This relies on comparative measurement ground truth against an established baseline (FBP).

8. The sample size for the training set:

The document does not provide any information about the training set size or how the algorithm was trained. This 510(k) summary focuses on the verification and validation (testing) of the final product.

9. How the ground truth for the training set was established:

As the document does not mention a training set, it does not provide information on how its ground truth was established.

Summary

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SEP 2 6 2012

Philips Medical Systems (Cleveland) Inc.

510(k) Summary

Philips Iterative Reconstruction Technique (IRT) 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 21, 2011

1. Device Name and Classification
  Philips IRT Software Application Device Name:

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

1. Predicate Device Information
  The Philips IRT Software Application is comparable in type and substantial equivalence to the legally marketed devices currently in commercial distribution, namely:
a. Philips Brilliance Volume CT System K060937
1. Device Description

The Philips IRT Software Application is a software option used for the reduction

² Iterative Reconstruction Technique (IRT) is the current working descriptive name for the reconstruction process. During development the term iMR, a preliminary engineering name, was also used. Documentation in this 510(k) may use either the term Iterative Reconstruction Technique (IRT) or iMR. Both terms refer to the same process.

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Philips Medical Systems (Cleveland) Inc.

of noise in an image. IRT iteratively reconstructs raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection (FBP) reconstruction. This feature will be used by radiologists as a supplementary method to reconstruct CT raw data, in addition to traditional FBP.

1. Indications for Use
  The Philips IRT Software Application is intended to iteratively reconstruct raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection reconstruction. Resulting IRT images are to be used to supplement conventional Filtered Back Projection images to aid the physician in diagnosis; they are not to be used as the sole basis for diagnosis.
1. Comparison to Predicate
  In the opinion of Philips IRT Software Application is of a comparable type and substantially equivalent to the Philips Brilliance Volume CT System, the legally marketed device described in paragraph 3 above. IRT uses similar operating principles for the reconstruction of raw data from a CT scanner into viewable images. Most of the image reconstruction steps are identical to the FBP reconstruction except that IRT contains an iterative step in the preprocessing chain that reduces the noise and during the image post processing chain where there is an additional function that reduces pixel noise in the images while keeping the structures intact.

Predicate	510(k) Number	Cleared
Brilliance Volume	K060937	June 5, 2006

1. Safetv
  The Philips IRT 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.

1. Performance Testing Summary
  Non-clinical testing was conducted with the IRT Software Application in the following manner:

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Philips Medical Systems (Cleveland) Inc.

Objective 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. Raw CT scan data using phantoms were reconstructed both with filtered backprojection and the IRT software application for comparison. Additionally, low contrast detectability (LCD) was evaluated via an observer study. In this study, a cohort of human subjects was required to identify a low contrast test object 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 IRT application.

Clinical image raw data sets were reconstructed with filtered backprojection and then with the IRT software application to compare noise reduction. Resulting data confirmed that the IRT application provides equivalent or better noise reduction.

In summary, the verification test evidence indicates that, under the conditions evaluated. IRT affords a reduction in noise and an improvement in LCD, with no degradation in high contrast spatial resolution, CT number accuracy, or CT number uniformity. Therefore, the IRT application provides equivalent or better noise reduction as compared to the filtered backprojection used in the Brilliance Volume CT.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES "

Public Health Service

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

SEP 26 2012

Ms. Christine Anderson Regulatory Affairs Specialist Philips Medical System (Cleveland) Inc. 595 Miner Road CLEVELAND OH 44183

Re: K113483

Trade/Device Name: Philips Iterative Reconstruction Technique Software Application Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 22, 2012 Received: August 23, 2012

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to maket the devices indication we nave reviewed your Section >10(k) promained is substantially equivalent (for the indications felerenced above and nave uctchillion the are as a see concess marketed in interstate for use stated in the enclosure) to regarly manatiment date of the Medical Device American Fred. Fred Drug commerce prior to May 26, 1976, the encordance with the provisions of the Federation (AMA) devices that have been reclassified in accession of a premarket approval application (PMA). and Cosment Act (Act) that do not require apple of a 12 general controls provisions of the Act. The Act. The Act. The Act. The You may, dierelove, market mo device, cauje requirements for annual registration, listing of general controls provisions of the fiel lieve and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such a title 21 If your device is classified (Scc above) into one it (Special in the found in Title 21, and in Title 21, and in Title 21, additional controls. Existing major regulations arouning your control.
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further Code of Peachar Four device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a substainle of the requirements of the Act .
that FDA has made a determination that your device complies with other requirements of that FDA has illiade a determination and your correct by other Federal agencies. You must of any Pederal Statures and regulations and udinated to: registration and listing (21
comply with all the Act's requirements, including, but not answering (scopying of comply with all the Act 3 requirements, incrueilig, on actively of the reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice modical device reated adverse ovelity systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality device as described in your Section 510(k) premarket with anow you to begin marketing your intial equivalence of your device to a legally marketed noticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Parts 801 and If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 under the MDA regulation (27 Of RT art 000), posses and .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 Tou may other belief general mornlations on Jon's Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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PHILIPS

Philips Medical Systems (Cleveland) Inc.

510(k) Number (if known): K K K13483

Page 1 of 1

Philips Iterative Reconstruction Technique Software Application Device Name:

Indications for Use:

The Philips Iterative Reconstruction Technique (IRT) Software Application is intended to reconstruct raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection levels less than or oqual to integration is a migration of the supplement conventional rosoner astion. I toballang mages to aid the physician in diagnosis; they are not to be used as the sole basis for diagnosis.

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

Over-the-Counter Use (Part 21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER LINE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
ORYD
K113483

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.