(133 days)
No
The document describes standard CT reconstruction algorithms (filtered back projection, iDose 4, IMR) and focuses on image quality metrics and clinical evidence from published literature and trials, not AI/ML model performance.
No
The device is intended for diagnostic imaging and screening for early detection of lung nodules, not for treating or rehabilitating a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The scanners are intended to be used for diagnostic imaging".
No
The device is described as an "option" for existing Philips Multislice CT Systems, which are hardware devices. While the option itself might primarily consist of software protocols and instructions, it is inextricably linked to and dependent on the physical CT scanner hardware for its function. The description explicitly states it is used "with Philips whole body multi-slice CT X-Ray Systems."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Philips Multislice CT Systems are imaging devices that use X-rays to create cross-sectional images of the body. They do not perform tests on biological samples.
- Intended Use: The intended use is for diagnostic imaging and low dose CT lung cancer screening, which involves acquiring images of the lungs for visual interpretation by a healthcare professional.
- Device Description: The description focuses on the hardware (X-ray tube, detector array), image reconstruction algorithms, and software protocols for acquiring and processing image data. There is no mention of handling or analyzing biological samples.
The device is a medical imaging system used for diagnosis and screening based on anatomical visualization, not on the analysis of biological specimens.
N/A
Intended Use / Indications for Use
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.
Product codes
JAK
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 A dedicated Instructions for Use for LDCT LCS that covers all qualified systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray
Anatomical Site
Body, Lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility (clinic / hospital)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Philips believes that there is sufficient evidence in the published literature and coverage decisions of the safety and effectiveness of Low Dose CT Lung Cancer Screening when performed on a pre-defined high risk group, according to a pre-defined screening program that includes dose targets. Reference publications, clinical trials, medical professional society guides and recommendations, and governmental body review and recommendations form the clinical evidence that establishes the requisite safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Image Quality Parameters: Spatial Resolution, Contrast Resolution, Image Artifacts, Image Uniformity, Geometric Distortion, Modulation Transfer Function (MTF), Slice Thickness, CT number uniformity, CT number linearity, Image noise (standard deviation), Noise Power Spectrum (NPS), Contrast to Noise (CNR).
Predicate Device(s)
Reference Device(s)
K060937, K133674, K012009, K033357
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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.
1
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
2
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 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.
| 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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3
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 Road
Cleveland, OH 44143
USA |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person:
Title:
Address: | Michael Chilbert, Ph.D., P.E.
Quality & Regulatory Engineer
595 Miner Road
Cleveland, OH 44143
USA |
| Telephone number:
Fax number:
E-mail: | +1 440 483-3284
+1 440 483-4918
Michael.chilbert@philips.com |
| 510(k) Summary
Date of Preparation: | 24-November-2015 |
| Device Trade Name: | Philips Multislice CT System with Low Dose CT Lung Cancer
Screening |
| Common or Usual Name: | Computed Tomography X-ray system |
| Classification
Name:
Regulation:
Class:
Product Code:
Panel: | Computed Tomography X-ray system
21 CFR 892.1750
II
JAK
Radiology |
| Primary Predicate device | K033326 - Philips Plus CT Scanner |
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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a blue color. The background is white, which makes the word stand out.
| 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 |
- 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. |
5
- 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-slice
configuration | Brilliance CT Big
Bore |
| Brilliance iCT | | Brilliance CT 64-
channel | Brilliance 16 Power | Brilliance CT Big
Bore Radiology |
| iCT TVI | | Brilliance CT 64-
channel w/ Essence
technology | Ingenuity Flex | Brilliance CT Big
Bore Oncology |
| iCT Elite | | Ingenuity Core | GEMINI 16
Power PET/CT | GEMINI TF Big
Bore PET/CT |
| | | Ingenuity Core128 | GEMINI TF 16-slice | |
| | | Ingenuity CT | TruFlight Select
PET/CT | |
| | | Ingenuity Elite | GEMINI TF
Ready 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
8
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.
9
| 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 Quality | |
| Parameter | Reason for inclusion |
| Modulation | |
| Transfer | |
| Function | |
| (MTF) | 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. | |
| MTF is traditionally made at high contrast levels, of a wire or bar phantom. | |
| These high contrast measurements are not affected by noise. Certainly the | |
| noise levels of low dose lung cancer screening. | |
| Slice Thickness | 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. | |
| 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 number | |
| uniformity | 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. | |
| Uniformity is needed to maintain CT number separation between structures. | |
| Uniformity is degraded by beam hardening. Beam hardening corrections are | |
| not degraded by noise. Added noise from low dose scanning makes beam | |
| hardening errors harder to see because they are buried in the noise. | |
| CT number | |
| linearity | 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. | |
| Linearity is not affected by low dose scanning. The net effect is similar to | |
| Uniformity. | |
| Image noise | |
| (standard | |
| deviation) | As dose is reduced, background noise in the image increases. If this noise |
| becomes too large, nodule detectability and sizing measurement may be | |
| compromised. | |
| 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) | 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. | |
| Contrast to | |
| Noise (CNR) | 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. |
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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Image /page/11/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out.
| Summary of Clinical
Testing: | Philips believes that there is sufficient evidence in the published
literature and coverage decisions of the safety and effectiveness of
Low Dose CT Lung Cancer Screening when performed on a pre-
defined high risk group, according to a pre-defined screening
program that includes dose targets. Reference publications, clinical
trials, medical professional society guides and recommendations,
and governmental body review and recommendations form the
clinical evidence that establishes the requisite safety and
effectiveness. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Philips believes that the proposed Philips Multislice CT System
with Low Dose CT Lung Cancer Screening is similar to scanning
applications that are incorporated in the currently marketed
and predicate Philips Multislice CT System`. There are no
significant differences that may raise new issues of safety or
effectiveness. Bench tests have been performed to
demonstrate that the proposed Philips Multislice CT System
with Low Dose CT Lung Cancer Screening is as safe and
effective as the applications that are incorporated in the
currently marketed and predicate Philips Multislice CT System,
without raising any new safety and/or effectiveness concerns. |