The Philips Multislice CT Systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment supports, components and accessories. The scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.

The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society.

*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Description

There are no functional, performance, feature, or design changes required for the qualified CT systems onto which the LDCT LCS Option is applied. Because none of the CTs will require hardware or software modifications, the Philips Low Dose CT Lung Cancer Screening option and the currently marketed and predicate Philips Multislice CT System for qualified CT systems in the installed base consists of:

A set of up to three reference LDCT LCS protocols: standard reconstruction, standard reconstruction with iDose 4, and with IMR iterative reconstruction (where applicable), for each qualified CT System on a per CT platform basis;
Detailed instructions on how to create the protocols on the corresponding CT System; and
A dedicated Instructions for Use for LDCT LCS that covers all qualified systems.

AI/ML Overview

This document is a 510(k) premarket notification for the Philips Multislice CT System with Low Dose CT Lung Cancer Screening. It primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a standalone study proving the device meats specific acceptance criteria in a clinical setting with human readers.

However, based on the provided text, I can infer the acceptance criteria relate to maintaining image quality parameters for Low Dose CT Lung Cancer Screening (LDCT LCS) that are equivalent to or better than standard CT performance, especially given the reduced radiation dose. The "study" proving this largely relies on non-clinical bench testing and references to external clinical literature and trials.

Here's a breakdown of the information you requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study with patients. Instead, it focuses on demonstrating that the LDCT LCS option does not degrade image quality compared to existing CT systems and that existing clinical evidence supports the efficacy of LDCT LCS itself.

Here's a table based on the image quality parameters evaluated in non-clinical testing and the reported outcome of that testing:

Acceptance Criteria (Inferred from Image Quality Parameters Evaluated)	Reported Device Performance (Non-Clinical Bench Testing Outcomes)
Spatial Resolution (MTF): Ability to visualize fine anatomical details, preserved at lower dose.	"MTF is a measure of the high contrast spatial resolution performance of the system. Nodules in the lung are high contrast objects and therefore, MTF should be preserved at lower dose conditions." "Demontrates that the image quality metrics including MTF... are substantially equivalent among different family of scanners (Brilliance 16, Brilliance Big Bore, Brilliance 64/Ingenuity, Brilliance iCT and IQon)."
Contrast Resolution (CNR): Ability to differentiate tissues with subtle differences in attenuation, sufficient for nodule detection.	"Sufficient Contrast-to-Noise is needed to detect solid and non-solid nodules in the lung. This parameter accounts for the contrast between an object and the background. This could also be a parameter that could influence nodule detectability." "The CNR scans were completed using the LDCT LCS scan protocols for all scanners in the comparison." "The results of non-clinical bench testing demonstrate that the image quality metrics including... Contrast to Noise Ratio are substantially equivalent among different family of scanners." "The contrast of the lung nodules it high relative to this increased noise, demonstrated by the CNR results (section 18) and NLST study."
Image Noise (Standard Deviation): Acceptable background noise levels at reduced dose, not compromising nodule detectability/sizing.	"As dose is reduced, background noise in the image increases. If this noise becomes too large, nodule detectability and sizing measurement may be compromised." "The results of non-clinical bench testing demonstrate that the image quality metrics including... Image noise... are substantially equivalent among different family of scanners." "Noise goes up by the square root of the mAs. The contrast of the lung nodules it high relative to this increased noise, demonstrated by the CNR results (section 18) and NLST study."
Noise Power Spectrum (NPS): Acceptable noise texture, not influencing nodule detection capabilities.	"Similar to the noise, changes in texture of the noise may have an influence on the nodule detection capabilities." "The NPS scans were completed using the LDCT LCS scan protocol." "The results of non-clinical bench testing also demonstrate the image quality parameters for iDose4 and IMR reconstructions are equivalent to, or better than standard FBP reconstruction."
Slice Thickness: Accurate slice thickness for clear edges and boundaries of nodules.	"The ability to produce slice thicknesses (FWHM of the slice sensitivity profile) that are close to the nominal slice thickness is important in defining clear edges and boundaries of the nodule." "The results of non-clinical bench testing demonstrate that the image quality metrics including... Slice Thickness... are substantially equivalent among different family of scanners."
CT Number Uniformity: Sufficient uniformity in the lung for robust nodule detectability.	"In a low dose scanning protocols such as with lung cancer screening, maintaining sufficient CT number uniformity throughout the lung and its various structures is important for more robust detectability of the nodules." "The results of non-clinical bench testing demonstrate that the image quality metrics including... CT number linearity, CT number accuracy... are substantially equivalent among different family of scanners."
CT Number Linearity: Measured CT number in a nodule not significantly affected by low dose scanning.	"In a low dose scanning protocols such as with lung cancer screening, the CT number measured in a nodule may be affected and therefore measuring CT number linearity is important." "The results of non-clinical bench testing demonstrate that the image quality metrics including... CT number linearity... are substantially equivalent among different family of scanners."
Image Artifacts: No new or increased artifacts obscuring anatomical details or mimicking pathology.	(Implicit in overall image quality assessment, not explicitly detailed as a separate quantified metric but mentioned as an important image quality parameter). "Image artifacts can obscure anatomical details and mimic pathology."
Geometric Distortion: Accuracy of measurements and image correlation with other modalities.	(Implicit in overall image quality assessment, not explicitly detailed as a separate quantified metric but mentioned as an important image quality parameter). "Geometric distortion can affect the accuracy of measurements and the ability to correlate images with other modalities."

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

Test Set Sample Size: Not applicable in the context of a clinical patient test set for this specific submission. The "test set" for demonstrating substantial equivalence related to image quality was composed of various CT scanner models and reconstruction algorithms.
Data Provenance: The primary data used to support the efficacy of LDCT LCS itself comes from externally referenced clinical literature, specifically the National Lung Screening Trial (NLST) (N Engl J Med 2011; 365:395-409) and the International Early Lung Cancer Action Program (I-ELCAP), along with "subsequent literature." These were large-scale prospective clinical trials, likely conducted across multiple centers, including within the US (NLST).

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

Number of Experts: Not applicable for this specific submission's non-clinical testing. The non-clinical image quality phantom measurements do not involve expert interpretation for ground truth.
Qualifications of Experts: For the external clinical trials (NLST, I-ELCAP) referenced, radiologists and other medical professionals were involved in establishing diagnoses and outcomes, but their specific numbers and qualifications are not detailed in this 510(k) document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable for this specific submission's non-clinical testing. No human adjudication was performed for the image quality metrics tested.

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

MRMC Comparative Effectiveness Study: No, a multi-reader, multi-case comparative effectiveness study with human readers (with vs. without AI assistance) was not conducted or presented in this 510(k) submission. This submission is for the CT system itself with a low-dose protocol option, not for an AI-powered CAD (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) device. The device does not incorporate AI for interpretation.

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

Standalone Performance Study: No, a standalone algorithm-only performance study was not conducted or presented in this 510(k) submission. The device is a CT scanner, not an independent algorithm for diagnosis or detection.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth:
- For the image quality bench testing: Ground truth was established by the physical phantoms used for measurements (e.g., wire phantom for MTF, ramp/disk phantom for slice thickness, water/density phantoms for CT numbers).
- For the clinical efficacy of LDCT LCS (referenced externally): The ground truth for the NLST and I-ELCAP studies would have included pathology reports (for confirmed cancers), clinical follow-up/outcomes data (for stable or resolving nodules), and potentially expert consensus reviews of indeterminate findings.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This submission describes a CT scanner with a new protocol, not a machine learning algorithm that requires a training set. The reconstruction algorithms (iDose4, IMR) themselves would have been developed using various data, but details are not provided here.

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

Ground Truth for Training Set: Not applicable, as this is not an AI/ML device requiring a training set with ground truth established through labeled data in the context of this submission.

Summary

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

April 8, 2016

Philips Medical Systems (Cleveland), Inc. % Michael Chilbert, Ph.D., P.E. Quality & Regulatory Engineer 595 Miner Road CLEVELAND OH 44143

Re: K153444

Trade/Device Name: Philips Multislice CT System with Low Dose CT Lung Cancer Screening Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 9, 2016 Received: March 10, 2016

Dear Dr. Chilbert:

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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)

K153444

Device Name Philips Multislice CT System with Low Dose CT Lung Cancer Screening

Indications for Use (Describe)

The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society.

*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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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IPS a

510(k) Summary of Safety and Effectivness

[As required by 21 CFR 807.92(c)]

Applicant's Name:Address:	Philips Medical Systems (Cleveland), Inc.595 Miner RoadCleveland, OH 44143USA
Contact Person:Title:Address:	Michael Chilbert, Ph.D., P.E.Quality & Regulatory Engineer595 Miner RoadCleveland, OH 44143USA
Telephone number:Fax number:E-mail:	+1 440 483-3284+1 440 483-4918Michael.chilbert@philips.com
510(k) SummaryDate of Preparation:	24-November-2015
Device Trade Name:	Philips Multislice CT System with Low Dose CT Lung CancerScreening
Common or Usual Name:	Computed Tomography X-ray system
ClassificationName:Regulation:Class:Product Code:Panel:	Computed Tomography X-ray system21 CFR 892.1750IIJAKRadiology
Primary Predicate device	K033326 - Philips Plus CT Scanner

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Indications for Use	The indications for use of the currently marketed Philips Multislice CT Systems is the same as the proposed Philips Multislice CT Systems with Low Dose CT Lung Cancer Screening, provided below, except for the addition of lung screening indication noted in bold italic print :The Philips Multislice CT Systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer.The screening must be performed within the established inclusion criteria of programs/ protocols that have been approved and published by either a governmental body or professional medical society. - Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Device Description:	Philips Low Dose CT Lung Cancer Screening option can be used with Philips whole body multi-slice CT X-Ray Systems installed in a healthcare facility (clinic / hospital). These systems provide a continuously rotating X-ray tube and detector array with multi- slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. Reconstruction algorithms available are standard reconstruction (filtered back projection), iDose 4 and IMR iterative reconstruction. These systems also include signal analysis and display equipment, patient and equipment supports, components and accessories.There are no functional, performance, feature, or design changes required for the qualified CT systems onto which the LDCT LCS Option is applied. Because none of the CTs will require hardware or software modifications, the Philips Low Dose CT Lung Cancer Screening option and the currently marketed and predicate Philips Multislice CT System for qualified CT systems in the installed base consists of: A set of up to three reference LDCT LCS protocols: standard reconstruction, standard reconstruction with iDose4, and with IMR iterative reconstruction (where applicable), for each qualified CT System on a per CT platform basis; Detailed instructions on how to create the protocols on the corresponding CT System; and

Indications for Use

The indications for use of the currently marketed Philips Multislice CT Systems is the same as the proposed Philips Multislice CT Systems with Low Dose CT Lung Cancer Screening, provided below, except for the addition of lung screening indication noted in bold italic print :The Philips Multislice CT Systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer.The screening must be performed within the established inclusion criteria of programs/ protocols that have been approved and published by either a governmental body or professional medical society. - Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Description:

Philips Low Dose CT Lung Cancer Screening option can be used with Philips whole body multi-slice CT X-Ray Systems installed in a healthcare facility (clinic / hospital). These systems provide a continuously rotating X-ray tube and detector array with multi- slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. Reconstruction algorithms available are standard reconstruction (filtered back projection), iDose 4 and IMR iterative reconstruction. These systems also include signal analysis and display equipment, patient and equipment supports, components and accessories.There are no functional, performance, feature, or design changes required for the qualified CT systems onto which the LDCT LCS Option is applied. Because none of the CTs will require hardware or software modifications, the Philips Low Dose CT Lung Cancer Screening option and the currently marketed and predicate Philips Multislice CT System for qualified CT systems in the installed base consists of: A set of up to three reference LDCT LCS protocols: standard reconstruction, standard reconstruction with iDose4, and with IMR iterative reconstruction (where applicable), for each qualified CT System on a per CT platform basis; Detailed instructions on how to create the protocols on the corresponding CT System; and

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A dedicated Instructions for Use for LDCT LCS that covers ● all qualified systems.
This submission is a bundled 510(k) based on the primary predicate K033326, adding a new Indication for Use to Philips multislice CT systems.

iCT Family(K060937)	IQon(K133674)	Brilliance 64/Ingenuity Family(K033326)	Brilliance 16 Family(K012009)	Big Bore Family(K033357)
Brilliance iCT SP	IQon Spectral CT	Brilliance CT 40-channel	Brilliance 16-sliceconfiguration	Brilliance CT BigBore
Brilliance iCT		Brilliance CT 64-channel	Brilliance 16 Power	Brilliance CT BigBore Radiology
iCT TVI		Brilliance CT 64-channel w/ Essencetechnology	Ingenuity Flex	Brilliance CT BigBore Oncology
iCT Elite		Ingenuity Core	GEMINI 16Power PET/CT	GEMINI TF BigBore PET/CT
		Ingenuity Core128	GEMINI TF 16-slice
		Ingenuity CT	TruFlight SelectPET/CT
		Ingenuity Elite	GEMINI TFReady PET/CT
		Ingenuity TF PET/CT(64 & 128)	GEMINI LXL PET/CT
		Vereos (64 & 128)
		GEMINI TF 64-slice

Intended Use:

Philips Low Dose CT Lung Cancer Screening option used in Philips Multislice CT Systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

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Substantial Equivalence:

The following review is performed for the Philips Multislice CT System with Low Dose CT Lung Cancer Screening 510(k) submission using the FDA Guidance for Industry on General/Specific Intended Use. Evaluation is provided for the guidance sections given below in support of substantial equivalence. The given level of specificity information and responses to the decision-making criteria show that the new Indication for Use (IFU) of Low Dose CT Lung Cancer Screening falls within the general intended use of the predicate devices. The procedures used for diagnostic imaging or screening are the same; scanning parameters may differ. This is demonstrated with lung nodule application (K023785), available on all the predicate systems. This application may be utilized in both diagnostic and screening evaluations. For the purpose of LDCT LCS, a target population is defined in NLST and I-ELCAP and these studies provide a considerable body of knowledge.

The level of specificity is defined as: a qualitative ranking of the proposed indications for use of a medical device. Levels of specificity for diagnostic and therapeutic devices in order of increasing specificity from general to specific can be categorized as follows:

Levels of Specificity for diagnostic medical devices:

Identification or measurement of a physical parameter or biochemical parameter
Identification of a new or specific target population (e.g., a certain age range) or anatomical location
Identification of the clinical use of the measurement (e.g., diagnosis, screening)
Identification of or implication of an effect on the clinical outcome

The level of specificity fits well within item 3, as this submission is adding an Indication for Use for Low Dose CT Lung Cancer screening. Level 2 specificity is applicable since LDCT LCS also identifies a new target population, based on the NLST trial. (N Engl J Med 2011; 365:395-409)

Decision-Making Criteria

The criteria that follow are provided as guidance on the Agency's decision-making process for determining substantial equivalence or non-equivalence for general/specific uses. ... These criteria should be evaluated in connection with the Levels of Specificity described earlier in this document.

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Risk- Does a specific use introduce new risks not normally associated with the general use of the device?

There are no functional, performance, feature, or design changes required for the Qualified CT system onto which this option is applied. The imaging tasks for using low dose CT for Lung Cancer Screening as opposed to the use of CT when nodules are suspected are identical. No new technology is needed. The risk profile of the CT scanners do not change, as the design and capabilities of these systems remain the same. Risk associated with screening the target population versus the benefit of screening is described in NLST and I-ELCAP. (N Engl J Med 2011; 365:395-409)

Public Health Impact- Does a specific use impact public health to a significantly greater degree than the general use of the device? ...

The risks associated with a LDCT LCS program/protocol identified by the USPSTF are: false-negative and false-positive results; incidental findings; over-diagnosis; and radiation exposure. Philips has analyzed the Risk Management Matrix (RMM) of the Qualified CT systems and determined these risks are fundamentally the same as those associated with the use of CT when there is a suspicion that a nodule may be present. Any residual risk is the same as with general imaging and is therefore acceptable.

Knowledge base- Is there a body of evidence available to the agency regarding a proposed specific use that reflects existing understanding by the medical community that the more specific use is a subset of the general use, rather than a new intended use? That evidence can be derived from such sources as the medical literature and practice guidelines.

There has been much analysis in the literature about the risk vs. benefits of LDCT LCS for high risk populations using an established inclusion criterial and a LCS program protocol. The benefits have been demonstrated to outweigh the risks provided the screening is performed according to established inclusion criteria (e.g. for high risk populations) and in accordance with an established LDCT LCS program protocol. The published literature, clinical trials, and governmental review as well as multiple medical professional society endorsements have now come to the conclusion that

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LDCT LCS performed under the above identified criteria is both safe and effective and provides a public health benefit to the high risk groups identified in the inclusion criteria.

Endpoints- To what degree can the performance or clinical endpoints (e.g., ability to ablate tissue; prevention of STDs) used to evaluate the general use be applied to the specific use?

The specific use (lung cancer screening for LDCT) does not impact public health to a significantly greater degree than the general use of LDCTs. The current use of CT provides significant public health benefit. Use for LDCT LCS only serves to increase the public health benefits. Large clinical trials such as NLST and I-ELCAP (N Engl J Med 2011; 365:395-409) demonstrate that there is a significant public health benefit for using LDCT LCS for the identified high risk populations using an established LCS program protocol.

Constraining the LDCT LCS indication for use to the populations outlined by the NLST and I-ELCAP clinical trials ensures a positive public health impact because screening is limited to the high risk groups medically and scientifically identified, with no impact on the general population.

Philips believes that there is more than sufficient scientific and medical evidence in the published literature and coverage decisions of the safety and effectiveness of LDCT LCS when performed with a pre-defined high risk group, according to a predefined screening program that includes dose targets.

Tool or treatment?- To what degree is the device used by the physician intended to perform a task as opposed to "being" the treatment …?

The performance of the CT scanners is not changed; the modes of operation to accomplish low dose CT lung cancer screening are available on all Philips CT systems included in the submission.

Adjunctive therapy- To what degree does another product not routinely needed for the general use need to be used in conjunction with the device to achieve the specific use safely and effectively?

There are no adjunctive products required for lung cancer screening of the target population.

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7. Design changes- To what extent does a modification to a medical device to facilitate the specific use render it less applicable to the other aspects of the general use?	There are no design changes to Philips CT systems to perform lung cancer screening of the target population. The qualified CT systems that include the lung cancer screening option continue to comply with the applicable US and international safety and performance standards such as Code of Federal Regulations Title 21, Subchapter J – Radiological Health, NEMA, DICOM, and IEC standards. The device is designed and manufactured under the Quality System Regulations of 21CFR 820.
	The design, intended use and technology provided with the proposed Philips Multislice CT System with Low Dose CT Lung Cancer Screening are identical to the currently marketed and predicate Philips Multislice CT System, and therefore are considered substantially equivalent
Summary of Non-Clinical Testing:	Non-clinical performance testing has been completed on Philips Multislice CT Systems and demonstrates substantial equivalence in the performance of the proposed Philips Multislice CT System with Low Dose CT Lung Cancer Screening. The currently marketed and predicate Philips Multislice CT Systems maintain compliance with the FDA performance and recognized consensus, as indicated in their original 510(k) submissions. Demonstration of substantial equivalence for the currently marketed and predicate Philips Multislice CT System was done by a comparison of IQ metrics from Philips published specifications.
	The results of non-clinical bench testing demonstrate that the image quality metrics including MTF, Image noise, CT number linearity, CT number accuracy, Slice Thickness, Contrast to Noise Ratio are substantially equivalent among different family of scanners (Brilliance 16, Brilliance Big Bore, Brilliance 64/Ingenuity, Brilliance iCT and IQon). The results of bench testing also demonstrate the image quality parameters for iDose4 and IMR reconstructions are equivalent to, or better than standard FBP reconstruction. The Noise Power Spectrum (NPS) curves were plotted for Standard FBP reconstruction, iDose4 and IMR.

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Image Quality Parameter	Rationale for Inclusion in Substantial Equivalence
Spatial Resolution	Spatial resolution is a key image quality parameter that affects the ability to visualize fine anatomical details.
Contrast Resolution	Contrast resolution is a key image quality parameter that affects the ability to differentiate tissues with subtle differences in attenuation.
Image Artifacts	Image artifacts can obscure anatomical details and mimic pathology.
Image Uniformity	Image uniformity affects the ability to accurately assess the relative attenuation of tissues across the image.
Geometric Distortion	Geometric distortion can affect the accuracy of measurements and the ability to correlate images with other modalities.
Table 2: Image Quality Parameters and Inclusion Rationale for Substantial Equivalence
Image QualityParameter	Reason for inclusion
ModulationTransferFunction(MTF)	MTF is a measure of the high contrast spatial resolution performance of thesystem. Nodules in the lung are high contrast objects and therefore, MTFshould be preserved at lower dose conditions.MTF is traditionally made at high contrast levels, of a wire or bar phantom.These high contrast measurements are not affected by noise. Certainly thenoise levels of low dose lung cancer screening.
Slice Thickness	The ability to produce slice thicknesses (FWHM of the slice sensitivityprofile) that are close to the nominal slice thickness is important in definingclear edges and boundaries of the nodule.Slice Thickness is also measured with a high density ramp or disk phantom.Like MTF these are not affected by noise levels used in LDCT LCS.
CT numberuniformity	In a low dose scanning protocols such as with lung cancer screening,maintaining sufficient CT number uniformity throughout the lung and itsvarious structures is important for more robust detectability of the nodules.Uniformity is needed to maintain CT number separation between structures.Uniformity is degraded by beam hardening. Beam hardening corrections arenot degraded by noise. Added noise from low dose scanning makes beamhardening errors harder to see because they are buried in the noise.
CT numberlinearity	In a low dose scanning protocols such as with lung cancer screening, the CTnumber measured in a nodule may be affected and therefore measuring CTnumber linearity is important.Linearity is not affected by low dose scanning. The net effect is similar toUniformity.
Image noise(standarddeviation)	As dose is reduced, background noise in the image increases. If this noisebecomes too large, nodule detectability and sizing measurement may becompromised.Noise goes up by the square root of the mAs. The contrast of the lungnodules it high relative to this increased noise, demonstrated by the CNRresults (section 18) and NLST study.
Noise PowerSpectrum (NPS)	Similar to the noise, changes in texture of the noise may have an influenceon the nodule detection capabilities.The NPS scans were completed using the LDCT LCS scan protocol.
Contrast toNoise (CNR)	Sufficient Contrast-to-Noise is needed to detect solid and non-solid nodulesin the lung. This parameter accounts for the contrast between an object andthe background. This could also be a parameter that could influence noduledetectability.The CNR scans were completed using the LDCT LCS scan protocols for allscanners in the comparison.

Since Philips does not have formal, published system level specifications for NPS and CNR, these metrics were evaluated specifically for demonstration of substantial equivalence.

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Summary of ClinicalTesting:	Philips believes that there is sufficient evidence in the publishedliterature and coverage decisions of the safety and effectiveness ofLow Dose CT Lung Cancer Screening when performed on a pre-defined high risk group, according to a pre-defined screeningprogram that includes dose targets. Reference publications, clinicaltrials, medical professional society guides and recommendations,and governmental body review and recommendations form theclinical evidence that establishes the requisite safety andeffectiveness.
Conclusion:	Philips believes that the proposed Philips Multislice CT Systemwith Low Dose CT Lung Cancer Screening is similar to scanningapplications that are incorporated in the currently marketedand predicate Philips Multislice CT System`. There are nosignificant differences that may raise new issues of safety oreffectiveness. Bench tests have been performed todemonstrate that the proposed Philips Multislice CT Systemwith Low Dose CT Lung Cancer Screening is as safe andeffective as the applications that are incorporated in thecurrently marketed and predicate Philips Multislice CT System,without raising any new safety and/or effectiveness concerns.

Summary of ClinicalTesting:

Philips believes that there is sufficient evidence in the publishedliterature and coverage decisions of the safety and effectiveness ofLow Dose CT Lung Cancer Screening when performed on a pre-defined high risk group, according to a pre-defined screeningprogram that includes dose targets. Reference publications, clinicaltrials, medical professional society guides and recommendations,and governmental body review and recommendations form theclinical evidence that establishes the requisite safety andeffectiveness.

Conclusion:

Philips believes that the proposed Philips Multislice CT Systemwith Low Dose CT Lung Cancer Screening is similar to scanningapplications that are incorporated in the currently marketedand predicate Philips Multislice CT System`. There are nosignificant differences that may raise new issues of safety oreffectiveness. Bench tests have been performed todemonstrate that the proposed Philips Multislice CT Systemwith Low Dose CT Lung Cancer Screening is as safe andeffective as the applications that are incorporated in thecurrently marketed and predicate Philips Multislice CT System,without raising any new safety and/or effectiveness concerns.

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.