The Precise Image is a reconstruction software application for a Computed Tomography X-Ray System intended to produce images of the head and 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. Precise Image has been evaluated and available on preselected reference protocols for adult subjects. Precise Image is not indicated for use in pediatric subjects.

The CT system with Precise Image is indicated for head, whole body and vascular X-ray Computed Tomography applications. These scanners are intended to be used for diagnostic imaging.

Precise Image uses an Artificial Intelligence powered reconstruction that is designed for low radiation dose, provides lower noise, and improves low contrast detectability.

Device Description

The proposed Precise Image is a reconstruction software application that may be used on a Philips whole-body computed tomography (CT) X-Ray System. Precise Image is a robust reconstruction software application, utilizing technological advancements in Artificial Intelligence and a Convolutional Neural Networks (CNN), When used, Precise Image generates CT images that provides an image appearance similar to traditional FBP images while reducing dose and improving image quality.

The implemented algorithm includes 5 user-adjustable settings to match the Radiologist's preference for dose reduction and image quality.

The proposed Precise Image reconstruction has been trained on and may be used on the currently marketed predicate device Philips Incisive CT System (K180015).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Philips Precise Image device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Low Contrast Resolution (20 cm Catphan phantom)	5 mm @ 0.3% @ 5.5 mGy CTDIvol (Improved, better low contrast resolution at lower dose levels compared to predicate's 4 mm @ 0.3% @ 22 mGy CTDIvol)
Noise Reduction and Low Contrast Detectability	Achieving up to 85% lower noise at 80% lower dose and 60% better low contrast detectability (Improved compared to standard mode, which is the baseline for the claim)
Noise Power Spectrum (NPS) Shift	Where noise is reduced by at least 50%, the system shall shift the noise power spectrum of images by no more than 6% as compared to the same data reconstructed without Precise Image. (Will not shift NPS more than 6%)
Application	Head, Body, and Vascular (Matches predicate's Head, Body, Vascular, and Cardiac applications in relevant scan types)
Scan Regime	Continuous Rotation (Identical to predicate)
Scan Field of View	Up to 500 mm (Identical to predicate)
Minimum Scan Time	0.35 sec for 360° rotation (Identical to predicate)
Noise in Standard Mode (21.6 cm water-equivalent)	0.27% at 27 mGY (Identical to predicate)
Compliance with Standards and Guidance	Maintains compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-44, IEC 62304, ISO 10993-1, ISO 14971, Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Discussion Paper.
Image Quality (Clinical Evaluation)	All images were evaluated to have good image quality by certified radiologists.
Diagnostic Confidence, Sharpness, Noise Level, Image Texture, and Artifacts	Evaluated on a five-point Likert scale, demonstrating substantial equivalence to the predicate.

Study Details

Sample Size for Test Set and Data Provenance:
- Sample Size: 55 image set pairs.
- Data Provenance: The document states "Sample clinical images are provided with this submission," implying these are real clinical images. No specific country of origin is mentioned, nor is it explicitly stated if the data is retrospective or prospective. However, given they are "clinical images" and used for evaluation, it's highly likely they are retrospective images from existing clinical practice.
Number of Experts and Qualifications:
- Number of Experts: 6 board-certified radiologists.
- Qualifications: "board certified radiologists." No specific years of experience or subspecialty are provided.
Adjudication Method for the Test Set:
- The document implies individual evaluations by each of the 6 radiologists on a Likert scale for various image attributes. It does not mention any explicit adjudication method (like 2+1 or 3+1 consensus) for the ground truth of the test set itself. The radiologists assessed "Diagnostic Confidence. Sharpness, Noise level. Image texture and Artifacts." The study compares the proposed device images against predicate device images, with the radiologists providing their individual assessment on these attributes.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? Yes, a comparative image evaluation study was performed by 6 board-certified radiologists on 55 image set pairs.
- Effect size of human readers improvement with AI vs without AI assistance: The document states that the evaluation was to "evaluate Diagnostic Confidence. Sharpness, Noise level. Image texture and Artifacts on a five point Likert scale" demonstrating "substantial equivalence to the currently marketed predicate device Philips Incisive CT (K180015)." It highlights improvements in low contrast resolution, noise reduction, and low contrast detectability of the device itself compared to the predicate/standard mode, but does not quantify human reader improvement (e.g., AUC, sensitivity, specificity) with AI assistance versus without it. The evaluation focused on image quality and characteristics, not diagnostic accuracy changes for the human reader.
Standalone (Algorithm Only) Performance Study:
- Yes, the performance characteristics like "Low Contrast Resolution," "Noise Reduction and Low Contrast Detectability," and "Noise Power Spectrum" are measurements of the algorithm's output (the reconstructed image) and are done in a standalone manner without human intervention influencing these specific metrics. The clinical image evaluation by radiologists also assesses the output of the algorithm relative to the predicate.
Type of Ground Truth Used:
- For the quantitative technical specifications (e.g., low contrast resolution, noise, NPS), the ground truth is based on phantom measurements (e.g., "20 cm Catphan phantom," "21.6 cm water-equivalent").
- For the clinical image evaluation, the "ground truth" for comparison is the predicate device's images (Incisive CT and Brilliance iCT), with radiologists evaluating the attributes of the Precise Image compared to these established images. There is no mention of a separate, definitive, clinical ground truth (e.g., pathology, clinical outcomes) for the diagnosis from these images. The radiologists are evaluating image quality characteristics and comparing them.
Sample Size for the Training Set:
- Not explicitly stated in the provided text. The document mentions, "The proposed Precise Image reconstruction has been trained on and may be used on the currently marketed predicate device Philips Incisive CT System (K180015)." However, it doesn't give a specific number of images or cases used for training.
How the Ground Truth for the Training Set was Established:
- Not explicitly stated in the provided text. It mentions the device "has been trained on" the predicate device's data, implying that the established high-quality images from the predicate device likely served as a reference or ground truth for the AI training process to guide the AI in producing similar or improved image characteristics. However, the specific method of ground truth establishment for training data is not detailed.

Summary

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January 14, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Philips Medical Systems Nederland, B.V. % Michael Chilbert Regulatory Affairs Engineer Veenpluis 4-6 Best Noord-Brabant, 5684 PC NETHERLANDS

Re: K210760

Trade/Device Name: Precise Image Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: December 10, 2021 Received: December 13, 2021

Dear Mr. Michael 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210760

Device Name Precise Image

Indications for Use (Describe)

The CT system with Precise Image is indicated for head, whole body and vascular X-ray Computed Tomography applications. These scanners are intended to be used for diagnostic imaging.

Precise Image uses an Artificial Intelligence powered reconstruction that is designed for low radiation dose, provides lower noise, and improves low contrast detectability.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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SECTION 5 510(K) SUMMARY

HA300-006-05 Revision: 01 Status: Approved Page: 1 of 5

CT/AMI

SECTION 5 510(K) SUMMARY

510(k) Summary for K210760

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared:Manufacturer:	January 13, 2022Philips Medical Systems Nederland B.V.Veenpluis 6,5684 PC BESTThe NetherlandsEstablishment Registration Number: 3015777306
Primary ContactPerson:	Michael Chilbert, Ph.D., P.E.Regulatory Affairs EngineerPhone: 440-869-4576E-mail: Michael.chilbert@philips.com
SecondaryContact Person:	Douglas KentzDirector of Regulatory AffairsPhone: (262) 389-7369E-mail: douglas.kentz@philips.com
Device:	Trade Name:	Precise Image
	Common name:	Computed Tomography x-Ray System
	Classification Name:	Computed Tomography x-Ray System
	Classification Regulation:	21CFR 892.1750
	Classification Panel:	Radiology
	Device Class:	II
	Primary Product Code:	JAK
	Secondary Product Code:	Not Applicable
PredicateDevice:	Trade Name:	Incisive CT
	Manufacturer:	Philips Healthcare (Suzhou) Co., Ltd.
	510(k) Clearance:	K180015
	Classification Name:	Computed Tomography X-Ray System
	Classification Regulation:	21CFR §892.1750
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	JAK
ReferenceDevice:	Trade Name:	Brilliance iCT
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) Clearance:	K162838
	Classification Name:	Computed Tomography X-Ray System
	Classification Regulation:	21CFR §892.1750
	Classification Panel:	Radiology
	Device Class:	Class II
	Product Code:	JAK

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PHILIPSBG Diagnostic Imaging	SECTION 5510(K) SUMMARY	HA300-006-05Revision: 01Status: ApprovedPage: 2 of 5
DeviceDescription:	The proposed Precise Image is a reconstruction software application that may be usedon a Philips whole-body computed tomography (CT) X-Ray System. Precise Image is arobust reconstruction software application, utilizing technological advancements inArtificial Intelligence and a Convolutional Neural Networks (CNN), When used, PreciseImage generates CT images that provides an image appearance similar to traditionalFBP images while reducing dose and improving image quality.The implemented algorithm includes 5 user-adjustable settings to match the Radiologist'spreference for dose reduction and image quality.
	The proposed Precise Image reconstruction has been trained on and may be used on thecurrently marketed predicate device Philips Incisive CT System (K180015).
Indications forUse / IntendedUse:	The Precise Image is a reconstruction software application for a Computed TomographyX-Ray System intended to produce images of the head and body by computerreconstruction of x-ray transmission data taken at different angles and planes. Thesedevices may include signal analysis and display equipment, patient and equipmentsupports, components and accessories. Precise Image has been evaluated and availableon preselected reference protocols for adult subjects. Precise Image is not indicated foruse in pediatric subjects.
	The CT system with Precise Image is indicated for head, whole body and vascular X-rayComputed Tomography applications. These scanners are intended to be used fordiagnostic imaging.
	Precise Image uses an Artificial Intelligence powered reconstruction algorithm that isdesigned for low radiation dose, provides low noise, and improves low contrastdetectability.
TechnologicalCharacteristics	The proposed Precise Image reconstruction software application, has the samefundamental design characteristics and are based on comparable technologies found inthe currently marketed predicate device Philips Incisive CT (K180015)
	This 510(k) submission addresses the following:
	Precise Image is an Artificial Intelligence powered reconstruction algorithm that isdesigned for low radiation dose, provides low noise, and improves low contrastdetectability as compared to iDose, as well as improve image appearance thatmore closely resembles Filtered Back Projection (FBP) at higher doses.The currently marketed predicate Philips Incisive CT (K180015) is being used fordiagnostic imaging in radiology, interventional radiology and cardiology and inoncology as part of treatment preparation and radiation therapy planning. Thefundamental scientific technology and design of the proposed Precise Imagereconstruction software application is equivalent to the currently marketedpredicate device Philips Incisive CT (K180015).

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PHILIPS BG Diagnostic Imaging

SECTION 5 510(K) SUMMARY

HA300-006-05 Revision: 01 Status: Approved Page: 3 of 5

CT/AMI

Technological Characteristics ComparisonDesign and Fundamental Scientific Technology
Device	Predicate Device:Incisive CT System(K180015)	Proposed Device:Precise Image softwareapplication	Conclusion
Application	Head, Body, Vascularand Cardiac	Head, Body and Vascular	Proposed device has scantypes found in thepredicate,
Scan Regime	Continuous Rotation	Continuous Rotation	Scan data used forreconstruction - Identical,
Scan Field ofView	Up to 500 mm	Up to 500 mm	Identical
Scan modes	SurviewAxial-after-AxialDynamic ScanHelical Scan	Axial-after-AxialHelical Scan	Proposed device has scantypes found in thepredicate
Low ContrastResolution (20 cmCatphanphantom)	4 mm @ 0.3% @ 22 mGyCTDIvol	5 mm @ 0.3% @ 5.5mGy CTDIvol	Improved, better lowcontrast resolution at lowerdose levels.
Minimum ScanTime	0.35 sec for 360° rotation	0.35 sec for 360° rotation	Identical
Noise in StandardMode (asmeasured on21.6 cm water-equivalent)	0.27% at 27 mGY	0.27% at 27 mGY	Identical
Noise Reductionand Low ContrastDetectability	N/A - Standard mode(baseline for claim)	achieving up to 85% lowernoise at 80% lower doseand 60% better lowcontrast detectability	Improved, better noisereduction and low contrastdetectability
Noise PowerSpectrum	N/A - Standard mode(baseline for claim)	Where noise is reducedby at least 50%, thesystem shall shift thenoise power spectrum ofimages by no more than6% as compared to thesame data reconstructedwithout Precise Image	Will not shift NPS morethan 6%
Application	Head, Body, Vascularand Cardiac	Head, Body and Vascular	Proposed device has scantypes found in thepredicate.
Scan Regime	Continuous Rotation	Continuous Rotation	Scan data used forreconstruction - Identical.

Based on the information provided above, the proposed Precise Image reconstruction software application for Philips CT Systems is considered substantially equivalent to the currently marketed predicate device Philips Incisive CT (K180015), in terms of fundamental scientific technology.

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CT/AMI

SECTION 5 510(K) SUMMARY

Summary ofNon-ClinicalPerformanceData:	Non-clinical performance testing has been performed on the proposed Precise Imagereconstruction software application for CT Systems.Philips CT Systems, comply with the following International and FDA recognizedconsensus standards and FDA guidance document(s).IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012(or IEC 60601-1: 2012 reprint) (FDA Recognition Number: 19-4) IEC 60601-1-2:2014: (FDA Recognition Number :19-8) IEC 60601-1-3:2008+A1:2013 (FDA Recognition Number: 12-269) IEC 60601-1-6:2010 +A1: 2013 (FDA Recognition Number: 5-89) IEC 60601-2-44:2009/AMD2:2016 (FDA Recognition Number: 12-302) IEC 62304:2006 + A1: 2015 (FDA Recognition Number: 13-79) ISO 10993-1:2009/Cor.1:2010 (FDA Recognition Number: 2-220) ISO 14971 2nd Edition. (FDA Recognition Number: 5-40)
	Device Specific Guidance Document:Guidance for Industry and FDA Staff – Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices" (issued May 11, 2005) International and FDA-recognized consensus IEC 62304 "Medical device software- Software life cycle processes" (Edition 1.1, 2006). FDA/CDRH recognitionnumber 13-79. Proposed Regulatory Framework for Modifications to ArtificialIntelligence/Machine Learning (AI/ML)-Based Software as a Medical Device(SaMD) Discussion Paper. (April 2, 2019)
	Design Verification planning and testing was conducted at the sub-system and at thesystem level. The sub-systems are tested against the sub-system requirementsspecifications (SSRS) and the system level verification is conducted against the systemrequirement specifications (SRS). System and sub-system verification activitiesdemonstrate the system or sub-systems meet the established system and sub-systemlevel design input requirements. System and sub-system level requirements may beverified by manual test, automated test, inspection/analysis, or any combination of thethree. Design verification also includes Image Quality verification and risk analysis/riskmitigation testing.
	The traceability between the requirements, the hazard mitigations and the test protocolsare described in the Traceability Matrix. The Traceability Matrix also shows the overall testresults per requirement and per hazard mitigation. The summary and conclusion ofresults are provided in the System Verification Test Report.
	Non-Clinical design validation testing covered the intended use and commercial claimsValidation testing included clinical image evaluation and workflow validation.
	All these tests were used to support substantial equivalence of the proposed PreciseImage reconstruction software application and demonstrate that the proposed PreciseImage reconstruction software application for CT Systems.

ç Maintains compliance with the aforementioned international and FDA-recognized consensus standards and/or FDA device specific guidance document, and;
. Meets the acceptance criteria and is adequate for its intended use.

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SECTION 5 510(K) SUMMARY

Therefore, the proposed Precise Image reconstruction software application for Philips CT Systems is considered substantially equivalent to the currently marketed predicate device Philips Incisive CT (K180015) in terms of safety and effectiveness.

Summary of Clinical Performance Data:

The proposed Precise Image reconstruction software application for CT Systems did not require any external clinical study. A comparative image evaluation study was performed on 55 image set pairs from Precise Image and the predicate Incisive CT and Brilliance iCT by 6 board certified radiologists to evaluate Diagnostic Confidence. Sharpness, Noise level. lmage texture and Artifacts on a five point Likert scale. The substantial equivalence to the currently marketed predicate device Philips Incisive CT (K180015) was demonstrated with the following attributes:

Indication for use; .
Technological characteristics; ●
Non-clinical and clinical performance testing; and .
. Safety and effectiveness.

Sample clinical images are provided with this submission, which were reviewed and evaluated by certified radiologists. All images were evaluated to have good image quality.

Substantial The proposed Precise Image reconstruction software application for Philips CT Systems is substantially equivalent to the currently marketed predicate device Philips Incisive CT Equivalence (K180015) in terms of design. features and fundamental scientific technology. The Precise Conclusion: Image reconstruction software application for Philips CT Systems does not introduce any new risk nor impact safety and effectiveness.

Additionally, substantial equivalence was demonstrated by non-clinical and clinical (verification and validation) performance tests provided in this 510(k) premarket notification. These tests demonstrate that the proposed Precise Image reconstruction software application for CT Systems complies with the requirements specified by Philips Medical Systems Nederland B.V. and the international and FDA-recognized consensus standards and is as safe and effective as its currently marketed predicate device Philips Incisive CT (K180015) without raising any new safety and/or effectiveness concerns.

CT/AMI

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.