StentBoost Live is intended to assist the physician during percutaneous coronary interventions.
StentBoost Live provides real-time enhanced visualization of stents.
StentBoost Live provides real-time enhanced visualization of stents in relation to coronary vessels.
StentBoost Live assists in the treatment of cardiovascular diseases by visualizing the placement and deployment of coronary stents.
StentBoost Live is suitable for use with the entire adult human population.
StentBoost Live is a software medical device and does not come in contact with a human subject.

Device Description

StentBoost Live is a software medical device intended to provide enhanced visualization of stents in coronary vessels in real-time. It supports the physician in placing and deploying stents.
The StentBoost Live is connected to a Philips interventional X-ray System and uses X-ray generated data as input.
StentBoost Live uses radiopaque balloon markers to provide real-time stent enhanced visualization by displaying a motion compensated average stent image.
StentBoost Live provides X-ray System integration with the Philips interventional X-ray System to allow automatic power on and off of StentBoost Live. In addition the user interactions can be controlled from the table-side of the X-ray System.
StentBoost Live provides the option for the physician to create DICOM compatible snapshots and movies of the enhanced image for reporting and archiving when connected to a picture archiving and communication system (PACS).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Philips StentBoost Live, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with numerical performance metrics against which the device was measured for a specific clinical task. Instead, it describes various verification and validation activities conducted to ensure the device performs as intended and is safe and effective. The device performance is generally stated in terms of its ability to meet documented requirements and user needs.

Acceptance Criteria Category (Derived)	StentBoost Live Performance (Reported in Document)
Software Life Cycle Compliance	Complies with IEC 62304
Usability Engineering Application	Complies with IEC 62366-1
Risk Management	Complies with ISO 14971
Labeling/Symbols	Complies with ISO 15223-1
DICOM Compatibility	Complies with NEMA PS 3.1 - 3.20 (2016)
General Verification Testing	Passed tests for system level requirements, risk control measures, privacy, security, reliability, performance, and interoperability.
Algorithm Verification (Marker Detection)	Demonstrated sufficient functioning for marker pair detection performance.
Algorithm Verification (Benchmark vs. Predicate)	Benchmarked against predicate device (StentBoost R4) to ensure sufficient functioning of algorithms. (Specific metrics not provided, but implies comparable or improved performance).
Usability Validation	Performed with representative intended users in a simulated environment; results support intended use, user needs, and claims.
Expert Opinion Validation	Performed in a simulated environment with certified interventional cardiologists; experts evaluated a wide range of previously acquired X-ray data. (Implies positive expert evaluation, specific metrics not given).
In-House Simulated Validation	Validation protocols addressing clinical user needs and device navigation workflow were executed and passed by experienced Clinical Marketing Specialists.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Algorithm Verification Testing: "previously acquired x-ray data" was used. The exact number of cases or images is not specified.
- Expert Opinion Validation: "Previously acquired x-ray data was used to allow the expert to evaluate a wide range of variance e.g. region to treat, detector format, patient, acquisition angles." The exact number of cases is not specified.
- Usability Validation: Conducted with "representative intended users" in a simulated environment. The number of users or sessions is not specified.
- In-house Simulated Validation: Validation protocols were performed. The number of cases or scenarios is not specified.
Data Provenance: The document states "previously acquired x-ray data" for algorithm and expert opinion validation. There is no information provided regarding the country of origin of this data or if it was retrospective or prospective. Given it was "previously acquired," it implies retrospective data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: "certified interventional cardiologists" were used for expert opinion validation. The specific number of cardiologists is not stated.
Qualifications of Experts: "certified interventional cardiologists." For in-house simulated validation, "experienced Clinical Marketing Specialists with clinical knowledge gained from work experience and hospital visits" were used, and stated to be "equivalent to the intended operator profiles." No years of experience are specified for either type of expert.
Ground Truth Establishment for Test Set: For algorithm verification, the ground truth for marker detection and benchmarking against the predicate was likely established through internal methods by Philips. For expert opinion validation, the experts themselves performed the evaluation of the device's visualization capabilities, effectively establishing a subjective "ground truth" on performance in a simulated clinical context.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the expert opinion or any other validation tests where multiple experts might have been involved. The "expert opinion validation" implies experts individually evaluated the device, but how disagreements or consensus was reached is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was reported. The evaluation seems to focus on the standalone performance and usability of StentBoost Live. The document states: "StentBoost Live did not require clinical trials to establish substantial equivalence to the currently marketed StentBoost R4."

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study in the form of "Algorithm verification testing" was done. This testing involved:

"determining marker pair detection performance"
"benchmark testing against the predicate device, StentBoost R4."

These tests evaluated the algorithms using "previously acquired x-ray data" to ensure their "sufficient functioning."

7. Type of Ground Truth Used

Algorithm Verification: The ground truth for marker pair detection was likely defined by Philips engineers based on expected or known marker locations in the "previously acquired x-ray data." For benchmarking, the predicate device's output served as a reference.
Expert Opinion Validation: The ground truth was established by the subjective evaluation and professional judgment of the "certified interventional cardiologists" regarding the "enhanced visualization of stents." This is a form of expert consensus/opinion in a simulated environment.
Usability and In-House Simulated Validation: The "ground truth" was defined by predefined user needs, clinical workflows, and safety mitigations, where successful execution against these criteria constituted validation.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the StentBoost Live algorithms. It is inferred that algorithms were trained, but details about the training data are not disclosed.

9. How Ground Truth for the Training Set Was Established

The document does not contain information on how the ground truth was established for any training set.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 7, 2017

Philips Medical Systems Nederland B.V. % Ms. Elaine Alan Regulatory Affairs Specialist Veenpluis 4-6 5684 PC Best THE NETHERLANDS

Re: K170144

Trade/Device Name: StentBoost Live Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, LLZ Dated: May 9, 2017 Received: May 10, 2017

Dear Ms. Alan:

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

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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.

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/ResourcesforYou/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,

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) K170144

Device Name

StentBoost Live

Indications for Use (Describe)

StentBoost Live is intended to assist the physician during percutaneous coronary interventions.

StentBoost Live provides real-time enhanced visualization of stents.

StentBoost Live provides real-time enhanced visualization of stents in relation to coronary vessels.

StentBoost Live assists in the treatment of cardiovascular diseases by visualizing the placement and deployment of coronary stents.

StentBoost Live is suitable for use with the entire adult human population.

StentBoost Live is a software medical device and does not come in contact with a human subject.

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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510(k) Summary

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

Date Prepared:	January 13, 2017
Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Primary ContactPerson:	Ms. Elaine AlanRegulatory Affairs SpecialistPhone: +1 858 764 1281E-mail: elaine.alan@philips.com
Secondary ContactPerson:	Ms. Liselotte Kornmann, PhDSenior Manager Regulatory AffairsPhone: +31 611621238E-mail: liselotte.kornmann@philips.com
Device:
Trade Name:	StentBoost Live
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Regulation:	21 CFR, Part 892.1650
Classification Panel:	Radiology
Device Class:	Class II
Primary Product Code:	OWB (Interventional Fluoroscopic X-Ray system)
Secondary Product Code:	LLZ (System, Image Processing, Radiological)
Predicate Device:
Trade Name:	StentBoost Rel. 4
Manufacturer:	Philips Medical Systems Nederland B.V.
510(k) Clearance:	K132305 (October 30, 2013)
Classification Name:	Image-intensified fluoroscopic x-ray system
Classification Regulation:	21 CFR, Part 892.1650
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	OWB, LLZ

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Device description:	StentBoost Live is a software medical device intended to provide enhancedvisualization of stents in coronary vessels in real-time. It supports the physicianin placing and deploying stents.The StentBoost Live is connected to a Philips interventional X-ray System anduses X-ray generated data as input.StentBoost Live uses radiopaque balloon markers to provide real-time stentenhanced visualization by displaying a motion compensated average stentimage.StentBoost Live provides X-ray System integration with the Philipsinterventional X-ray System to allow automatic power on and off of StentBoostLive. In addition the user interactions can be controlled from the table-side ofthe X-ray System.StentBoost Live provides the option for the physician to create DICOMcompatible snapshots and movies of the enhanced image for reporting and archiving when connected to a picture archiving and communication system (PACS).
Indications for Use:	StentBoost Live, provided as accessory to the Philips Interventional X-raysystem, has the following indications for use:StentBoost Live is intended to assist the physician during percutaneous coronaryinterventions.StentBoost Live provides real-time enhanced visualization of stents.StentBoost Live provides real-time enhanced visualization of stents in relation tocoronary vessels.StentBoost Live assists in the treatment of cardiovascular diseases by visualizingthe placement and deployment of coronary stents.StentBoost Live is suitable for use with the entire adult human population.StentBoost Live is a software medical device and does not come in contact witha human subject.
	The indications for use of StentBoost Live are similar to the currently marketedand predicate device StentBoost Rel. 4 except that:The use of StentBoost Live is restricted to cardiovascular proceduresinstead of both vascular and cardiovascular procedures. StentBoost Live provides real-time enhanced visualization of stents.
	However, the difference does not alter the intended use of the device nor doesit affect the safety and effectiveness of the device relative to the predicatedevice. Both devices have the same intended use: they are accessories to thecurrently marketed Philips Interventional X-ray system and both are X-rayinterventional applications which provide enhanced visualization of stents in relation to vessels and assist in the treatment of cardiovascular diseases through
Technologicalcharacteristics:	StentBoost Live employs comparable technology as implemented in thepredicate device StentBoost Rel. 4 :Both tools provide enhanced (i.e. motion-compensated average) stentvisualization of both a pre and post stent deployment created from markersfound in a 2D image sequence acquired on the interventional X-ray system Both tools provide full integration with the interventional X-ray system Both tools have Picture Archiving Communication System compatibility The technological differences between StentBoost Live and its predicate deviceStentBoost Rel. 4 are noted below: For StentBoost Rel. 4 the enhanced image is only available once theacquisition is completed where for StentBoost Live the enhanced imagevisualization of the placement and deployment of the stent in the examroom is in real-time. StentBoost Rel. 4 provides StentBoost Subtract mode of operation which isnot needed in StentBoost Live . StentBoost Rel. 4 provides StentBoost Vascular mode of operation which isnot supported in StentBoost Live . StentBoost Live provides improved workflow guidance. StentBoost Live is automatically switched on and off with the X-ray systemwhich is not available in the StentBoost Rel 4 . StentBoost Rel. 4 provides a manual measurement tool to measure thediameter of a deployed stent which is not available in the StentBoost Livesince providing post-deployment stent measurements is not essential forthe workflow. The measurement functionality is still available throughother software tools provided by the Philips Interventional X-ray system. StentBoost Live can only be controlled in the exam room where StentBoostRel. 4 can be controlled in both the exam and control room. Due to the real-time workflow of StentBoost Live , use outside of the exam room is notneeded. StentBoost Rel. 4 allows optional manual indication of the marker positionwhere StentBoost Live allows the user to indicate the marker search regionusing the collimation feature of the Philips interventional X-ray system. The differences between StentBoost Live and the predicate device StentBoostRel. 4 do not raise any new questions regarding safety or effectiveness.Based on the information provided above, StentBoost Live is consideredsubstantially equivalent to the primary currently marketed and predicate devicein terms of technological characteristics

visualization of the placement and deployment of coronary stents.

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Based on the information provided above, StentBoost Live is considered substantially equivalent to the predicate device StentBoost Rel. 4 in terms of Indications for Use.

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Summary of Non-Clinical Performance Data:

Non-clinical performance testing has been performed on StentBoost Live and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

IEC 62304 Medical device software - Software life cycle processes (Ed. 1.1, 2015-06).
. IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Ed. 1.0, 2015-02).
ISO 14971 Medical devices – Application of risk management to medical devices (Ed. 2.0, 2007).
. ISO15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Second Edition 2012-07-01).
NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (2016).
Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
. Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016 (document number 1757).

The following software verification and validation activities have been performed for StentBoost Live:

. General verification testing: software verification has been performed to cover the system level requirements of the System Requirements Specification as well as the identified risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements. These protocols address functional and non-functional aspects of StentBoost Live such as reliability, performance and interoperability.
Algorithm verification testing: Dedicated algorithm verification testing has been performed with previously acquired x-ray data to ensure sufficient functioning of the algorithms. Verification consisted of determining marker pair detection performance and benchmark testing against the predicate device, StentBoost R4.

General Validation Results

Non-clinical software validation testing provided evidence for the intended use, user needs and claims:

Usability validation: Was performed with representative intended users in a a) simulated environment.
b) Expert opinion Validation: The expert opinion validation was performed in a

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simulated environment with certified interventional cardiologists. Previously acquired x-ray data was used to allow the expert to evaluate a wide range of variance e.g. region to treat, detector format, patient, acquisition angles.

c) In-house simulated Validation: Validation protocols were created to address each clinical user need in the form of a device navigation workflow. Additional protocols were created to ensure that the Instructions for Use is written on the correct detail level as well as the verification of the effectiveness of the safety mitigations. The protocols were executed in a simulated clinical setting. The validation protocols have been performed by experienced Clinical Marketing Specialists with clinical knowledge gained from work experience and hospital visits. All test participants have experience in the relevant clinical area and therefore are considered equivalent to the intended operator profiles as defined in the Intended use.

Summary of Clinical	StentBoost Live did not require clinical trials to establish substantial equivalence
Performance Data:	to the currently marketed StentBoost R4. Substantial equivalence was
	demonstrated with the following attributes:

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

Verification and validation tests as described above were performed on the StentBoost Live according to the following FDA-recognized consensus standards and FDA guidance documents:

. IEC 62304 Medical device software – Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79,
IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0, 2015-02). FDA/CDRH recognition number 5-95,
. Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016 (document number 1757),
. Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Conclusion: The verification and validation test results of StentBoost Live, comprising of verification testing, usability validation, validation of the user needs and specific claims, and expert opinion validation are passed and support the safety and effectiveness of the product. It conforms to the intended use, the user needs and the claims and is therefore considered substantially equivalent to the currently marketed device StentBoost R4.

StentBoost Live is substantially equivalent to the predicate device StentBoost Substantial Rel. 4 in terms of indications for use, technological characteristics and safety and Equivalence

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Conclusion:

effectiveness.

Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that StentBoost Live complies with the requirements specified in the international and FDA-recognized consensus standards and is as safe and effective as its predicate device and does not raise any new safety and/or effectiveness questions.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.