IntelliSpace Radiology Software (client) is a software package intended to be used by trained professionals, including but not limited to Radiologists, physicians, administrators and medical technicians.

The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment.

IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.

Mammography images may only be interpreted using display monitors approved for digital mammography.

Device Description

The subject device IntelliSpace Radiology product described in this section is a modification of the previously cleared IntelliSpace PACS 4.x software device (K111804). Changes made or being implemented are described in Section 12 'Substantial Equivalence Discussion'.

IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicians, administrators and medical technicians.

The software is used with general purpose computing hardware for the presentation, processing. measurement and distribution of images and associated data throughout a clinical environment.

IntelliSpace Radiology software supports receiving, sending, printing, and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, and OP as well as hospital/radiology information systems.

AI/ML Overview

This document, K182926, is a 510(k) summary for the Philips IntelliSpace Radiology, cleared on December 6, 2018. It is a Picture Archiving and Communications System (PACS) software.

Here's an analysis of the provided information regarding acceptance criteria and the study:

Key Takeaways from the Document:

No Clinical Studies Performed or Required: The document explicitly states: "The subject of this premarket submission, IntelliSpace Radiology did not require clinical studies to support equivalence." and "The non-clinical performance tests provided in this 510(k) premarket notification demonstrated that the subject device IntelliSpace Radiology is as safe and effective as its predicate device IntelliSpace PACS 4.x (K111804) without raising any new safety and/or effectiveness concerns." This means the evaluation was based entirely on non-clinical performance and a comparison to a predicate device.
Focus on Verification and Validation (V&V): The primary evidence for meeting acceptance criteria comes from V&V testing. The document states: "Verification and Validation (V&V) activities were performed for proposed IntelliSpace Radiology system and demonstrated that the predetermined acceptance criteria were successfully met."
Acceptance Criteria: The acceptance criteria are implicitly defined by compliance with several international and FDA-recognized consensus standards and an FDA guidance document, alongside Philips' own internal verification and validation processes and risk management. The general statement is that the device "meets the acceptance criteria and is adequate for its intended use."

Given the above, direct answers to some of your specific questions are not available because the device's clearance was based on non-clinical performance testing and substantial equivalence to a predicate device, not a clinical performance study with human readers or AI algorithms in the way you've framed some of the questions.

Here's the information extracted from the document in response to your prompts, along with explanations where direct answers are not applicable due to the nature of a 510(k) summary for a PACS system:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Standards/Guidance)	Reported Device Performance
Compliance with ISO 14971 (Risk Management)	All risks sufficiently mitigated, no new risks introduced, overall residual risks acceptable.
Compliance with IEC 62304 (Medical Device Software Lifecycle)	Software verification and validation tests conducted.
Compliance with IEC 62366-1 (Usability Engineering)	Software verification and validation tests conducted.
Compliance with NEMA-PS 3.1-PS 3.20 (DICOM Standards)	Supports DICOM studies receiving, sending, printing, and displaying from various modality types.
Compliance with FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices	Software for this device considered "moderate" level of concern. Verification and validation performed as recommended by this guidance.
Meeting Requirement Specifications / Intended Use	"IntelliSpace Radiology was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, technological characteristics claims, requirement specifications and the risk management results." The test results "demonstrate that IntelliSpace Radiology... meets the acceptance criteria and is adequate for its intended use."
Functional Equivalence to Predicate Device (IntelliSpace PACS 4.x - K111804) for listed features (Table 5-1 pages 6-7)	The device "is substantially equivalent to the currently marketed predicate device IntelliSpace PACS 4.x (K111804) in terms of indications for use, design features, fundamental scientific technology, and safety and/or effectiveness." Specific feature comparisons are in Table 5-1.
Safety and Effectiveness Equivalence to Predicate Device	"IntelliSpace Radiology is substantially equivalent... in terms of safety and effectiveness."

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

This information is not provided in the 510(k) summary. Given that this was a non-clinical V&V study for a PACS system, there isn't typically a "test set" in the sense of clinical images from patients with specific conditions. The testing would involve simulated data, synthetic data, and real (but de-identified) clinical images to verify functionalities, data integrity, display accuracy, and adherence to standards like DICOM. The provenance (country, retrospective/prospective) is not relevant for this type of non-clinical software validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. Since this was a non-clinical software verification and validation, there was no "ground truth" derived from expert clinical reads in the context of diagnostic accuracy. The ground truth would be conformance to specifications, software requirements, and industry standards.

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

This information is not applicable/provided. No clinical adjudication method was used given the non-clinical nature of the study.

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

No MRMC study was done. The document explicitly states: "The subject of this premarket submission, IntelliSpace Radiology did not require clinical studies to support equivalence." This device is a PACS system, not an AI-assisted diagnostic tool designed to directly improve reader performance in the diagnostic task itself. Its role is to present, process, measure, and distribute images.

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

This information is not applicable/provided in the context of an "algorithm only" performance study. The device is a PACS system, which is a foundational software infrastructure for image management, not a standalone diagnostic algorithm providing a finding. Its "performance" is about its ability to correctly handle and display images and data, which was evaluated through non-clinical V&V.

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

The "ground truth" for this device's validation was conformance to its own technical specifications, software requirements, and adherence to recognized industry standards (e.g., DICOM). It was not based on clinical ground truth (like pathology or expert consensus on disease presence) because it's a PACS system that manages imaging data, not an AI algorithm making diagnostic inferences.

8. The sample size for the training set

This information is not applicable/provided. The IntelliSpace Radiology is a PACS system, a software package for image management, not an AI/Machine Learning model that requires a "training set" of data to learn from.

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

This information is not applicable/provided for the same reason as point 8.

Summary

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Philips Healthcare Informatics, Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street. Nw BUFFALO, MN 55313

December 6, 2018

Re: K182926

Trade/Device Name: IntelliSpace Radiology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 27, 2018 Received: November 28, 2018

Dear Mark Job:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

Robert A. 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) K182926

Device Name IntelliSpace Radiology

Indications for Use (Describe)

The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment.

Mammography images may only be interpreted using display monitors approved for digital mammography.

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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Philips Healthcare Informatics, Inc.

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5 510(K) SUMMARY

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510(k) Summary

IntelliSpace Radiology

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

Date Prepared: September 5, 2018

I. Submitter's name and address

Manufacturer:	Philips Healthcare Informatics, Inc.4430 Rosewood Drive, Suite 200Pleasanton, CA 94588USAEstablishment Registration Number: 2954704
Contact Person:	Elfriede PaganSr. Manager, Regulatory AffairsPhone: (321) 339-9144E-mail: phiiregulatory@philips.com

II. Device information

Subject Device:

IntelliSpace Radiology Device Name: Common/Usual Name: Radiology Image and Information Management System Classification: Classification name: Picture Archiving and Communications System Device class: Class II Classification regulation: 21 CFR 892.2050 Classification panel: Radiology Product Code: LLZ

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III. Predicate device information

Predicate Device:

Trade name:	IntelliSpace PACS 4.x
Manufacturer:	Philips Healthcare Informatics, Inc.
510(k) clearance:	K111804
Classification name:	Picture Archiving and Communications System
Device class:	Class II
Classification regulation:	21 CFR 892.2050
Classification panel:	Radiology
Product code:	LLZ

IV. Device Description

IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicians, administrators and medical technicians.

The software is used with general purpose computing hardware for the presentation, processing. measurement and distribution of images and associated data throughout a clinical environment.

V. Indications for Use

The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment.

Mammography images may only be interpreted using display monitors approved for digital mammography.

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Comparison of Technological Characteristics with the Predicate Device VI.

The subject device IntelliSpace Radiology (ISR) product described in this section is a modification of the previously cleared IntelliSpace PACS 4.x software device (K111804). The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment by healthcare professionals.

IntelliSpace Radiology product uses the standard principles of operation typically seen in PACS systems such as database and image management systems, image processing tools, and standard measurement tools. Both the subject device and the predicate device provide Diagnostic Review Solution for radiology and other areas where images are utilized, such as Visible Light. ISR is utilizing client-server technology, communication and interoperability with hospital systems, such as radiology workflow providers and image archives.

A comparison matrix below (please see Table 5-1 below) provides a comparison which outlines a high-level overview of the differences and similarities between IntelliSpace Radiology and the predicate device, IntelliSpace PACS 4.x (K111804).

#	Specification / Feature	IntelliSpaceRadiology(subject device)	PredicateIntelliSpacePACS 4.x(K111804)
1.	Software Image and Information managementsystem	Yes	Yes
2.	Hardware Platform requirements	Yes	Yes
System Configuration
3.	Windows Operating System	Yes	Yes
4.	TCP-IP Network Protocol	Yes	Yes
5.	Supports High Resolution Diagnostic Monitors	Yes	Yes
6.	Storage capabilities	Not supported	Yes
7.	Multiple monitor support	Yes	Yes
Communication and Interoperability with other image management systems
8.	Supports DICOM studies received from differentmodalities types	Yes -CT, MR, NM, US,XA, PET, CR, DX,DR, RF, RT, MG,SC, VL, and OP	Yes-CT, MR, NM, US,XA, PET, DX, DR,RF, RT, MG, SC,VL
9.	Support for IHE Profiles for Key Image Notes (KIN)and Digital Breast Tomosynthesis (DBT)	Yes	No
Operating Platform requirements
10.	Client-server technology	Yes	Yes
11.	Thin client installer	Yes	Yes
12.	Multiple concurrent user support	Yes	Yes
Interfaces with other Image management systems
#	Specification / Feature	IntelliSpaceRadiology(subject device)	PredicateIntelliSpacePACS 4.x(K111804)
13.	Supported Data and Multi Modalities	Supportsreceiving,sending, printing,storing anddisplaying studiesreceived from thefollowing modalitytypes via DICOM:CT, MR, NM, US,XA, PET, CR, DX,DR, RF, RT, MG,SC, VL, and OPas well ashospital/Radiologyinformationsystems.	Supportsreceiving,sending, printing,storing anddisplaying studiesreceived from thefollowing modalitytypes via DICOM:CT, MR, NM, US,XA, PET, DX, DR,RF, RT, MG, SC,VL as well ashospital/Radiologyinformationsystems.
14.	Federation	Yes	Yes
15.	Vendor Neutral Archive for Client	Yes	Yes
	Patient-Exam Worklist Browser
16.	Patient Exam Query Tool	Yes	Yes
17.	Patient Exam Worklist Filters	Yes	Yes
	Image Display/Formatting/Navigation
18.	Multiple Monitor layout option	Yes	Yes
19.	Scales image to window	Yes	Yes
20.	Next/Previous Image/ Series/ Page Options	Yes	Yes
21.	Cine Toolset	Yes	Yes
22.	Image/Series Linking	Yes	Yes
23.	Image Rotate/Flip	Yes	Yes
24.	Image Zoom/Pan	Yes	Yes
25.	Scout lines Tool	Yes	Yes
26.	Image Stacking	Yes	Yes
27.	Hanging Protocols	Yes	Yes
28.	Grayscale Softcopy Presentation State (GSPS)	Yes	Yes
29.	Tomosynthesis Slice Indicator	Yes	No
30.	Bidirectional Tomo Localizer	Yes	No
31.	Tomo Slab View	Yes	No
32.	Tomo Localizer Mode	Yes	No
	Measurement and Annotations
33.	Measurement Tools	Yes	Yes
34.	Linear Measurements (Ruler)	Yes	Yes
35.	Angle	Yes	Yes
36.	Cobb Measurement	Yes	Yes
37.	ROI Circle	Yes	Yes
38.	ROI Freehand	Yes	Yes
#	Specification / Feature	IntelliSpaceRadiology(subject device)	PredicateIntelliSpacePACS 4.x(K111804)
40.	Point Value	Yes	Yes
41.	Calibrating Images	Yes	Yes
42.	Angle Line Ratio	Yes	No
43.	Ultrasound Measurements	Yes	Yes
44.	Annotation Tools	Yes	Yes
	Results
45.	View/Print Diagnostic Reports from RIS	Yes	Yes
	Printing/Export/Save Images...
46.	Printing images to Paper	Yes	Yes
47.	Printing images to Film	Yes	Yes
48.	Save images as BMP, JPEG, TIF files	Yes	Yes
49.	Export of Patient-Exams	Yes	Yes
	General Usage
50.	Designed for diagnostic review of images insideand outside of Radiology	Yes	Yes
	Clinical Tools
51.	Remote Reading Tools / Teleradiology	Yes	Yes
52.	Image Filters	Yes	Yes
53.	Variable Slice Thickness for CT (Slab Reading)	Yes	Yes
54.	Exam Notes	Yes	Yes
55.	Key Image Series	Yes	Yes
56.	Patient Merging	Yes	Yes
57.	Standard Mammography	Yes	Yes
58.	Advanced Mammography Module	Yes	No
	Management Tools
59.	Patient Management	Yes	Yes
60.	Exam Management	Yes	Yes
61.	Exception Study	Yes	Yes
62.	User Security Access Management	Yes	Yes
63.	Dictionary Management	Yes	Yes
64.	Auditing Tools	Yes	Yes
65.	Billing	Yes	Yes
66.	Easy Client Installer	Yes	Yes
67.	Data Migration	Yes	Yes
68.	Workflow Layer	Yes	Yes
69.	System Monitoring	Yes	Yes
	Third Party Application Support
70.	PowerScribe	Yes	Yes
71.	Cardiology Enterprise Viewer	Yes	Yes
72.	Application Programming Interface	Yes	Yes
73.	Universal Data Manager	Yes	No
74.	IntelliSpace PACS Anywhere	Yes	No

Table 5-1 Technological characteristics comparison

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The subject device, IntelliSpace Radiology, has implemented features designated to bring the product up to date with current technologies and customer requests. Presented technological differences are considered low risk, providing further support to clinicians in visualization. These functionalities were verified and validated, and do not raise new questions on safety and/or effectiveness. These features have not changed the intended use and operational principles of the device. Therefore, IntelliSpace Radiology is substantially equivalent to the currently marketed predicate device IntelliSpace PACS 4.x (K111804) in terms of technological characteristics.

VII. Performance Data

Section 16 'Software' provides a summary of the technical documentation, which includes nonclinical verification and validation tests. These tests are performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results, and according to the following International and FDA-recognized consensus standards and FDA guidance document.

The following performance data was provided in support of the substantial equivalence determination.

Summary of Non-clinical testing

No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on IntelliSpace Radiology product and demonstrates compliance with the following International and FDArecognized consensus standards and FDA guidance document:

ISO 14971 Medical devices – Application of risk management to medical devices
. IEC 62304 Medical device software - Software life cycle processes
I IEC 62366-1 Medical devices – Part 1: Application of usability engineering to medical devices
트 NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
I Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could resultlead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to a minor injury to the patient or operator.

IntelliSpace Radiology was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, technological characteristics claims, requirement specifications and the risk management results.

The test results in this 510(k) premarket notification demonstrate that IntelliSpace Radiology:

. complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
meets the acceptance criteria and is adequate for its intended use.

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Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable.

Therefore, IntelliSpace Radiology is substantially equivalent to the currently marketed predicate device IntelliSpace PACS 4.x (K111804) in terms of safety and effectiveness.

Summary of Clinical Testing

The subject of this premarket submission, IntelliSpace Radiology did not require clinical studies to support equivalence.

VIII. Substantial Equivalence Conclusion

IntelliSpace Radiology is substantially equivalent to the currently marketed predicate device IntelliSpace PACS 4.x (K111804) in terms of indications for use, design features, fundamental scientific technology, and safety and/or effectiveness.

Additionally, substantial equivalence was demonstrated with non-clinical performance testing. Verification and Validation (V&V) activities were performed for proposed IntelliSpace Radiology system and demonstrated that the predetermined acceptance criteria were successfully met. The non-clinical performance tests provided in this 510(k) premarket notification demonstrated that the subject device IntelliSpace Radiology is as safe and effective as its predicate device IntelliSpace PACS 4.x (K111804) without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).