Philips Radiology Smart Assistant is intended to provide patient positioning feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a software which informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is not intended for diagnostic purposes. It is not intended to be used as the basis for repeating an image.

Device Description

Philips Radiology Smart Assistant is a software package intended to be used by qualified healthcare professionals. The software is used with general purpose computing hardware for the processing, display of images, and patient positioning feedback within a clinical environment. Philips Radiology Smart Assistant software supports receiving and displaying images from X-ray systems.

The system supports receiving, sending, storing, acceptance and displaying of medical images received from the following modality types via DICOM: DX as well as hospital/radiology information systems.

Philips Radiology Smart Assistant includes a post-processing patient positioning feedback function for posterior-anterior (PA) chest X-ray images. The patient positioning assessment is intended to provide a qualified healthcare professional with timely feedback on the quality of acquired X-ray images that do not suffice the positioning quality standards of clinical guidelines. The quality check comprises an assessment of the following parameters:

Collimation
Patient Rotation
Patient Inhalation State

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Philips Radiology Smart Assistant, based on the provided text:

Acceptance Criteria and Device Performance

The document states that the Philips Radiology Smart Assistant provides "patient positioning feedback using validated 2D X-Ray systems" and "informs Healthcare Professionals regarding patient positioning quality in accordance with clinical guidelines." The quality check specifically assesses:

Collimation
Patient Rotation
Patient Inhalation State

However, the provided text does not contain a specific table of acceptance criteria with numerical targets or the reported device performance for these criteria. It generally states that the device "met the acceptance criteria" in the clinical performance study, but the criteria themselves are not quantified.

Table of Acceptance Criteria and Reported Device Performance (Based on available information):

Acceptance Criteria Category	Specific Criteria (as inferred)	Reported Device Performance
Patient Positioning Feedback	Accurate assessment of Collimation	"supports the performance of the Philips Radiology Smart Assistant in identification of patient positioning quality issues."
	Accurate assessment of Patient Rotation	"supports the performance of the Philips Radiology Smart Assistant in identification of patient positioning quality issues."
	Accurate assessment of Patient Inhalation State	"supports the performance of the Philips Radiology Smart Assistant in identification of patient positioning quality issues."
Overall Performance	Safe and effective for specified intended use	"The clinical performance study demonstrates that the Philips Radiology Smart Assistant is safe and effective for the specified intended use."

Study Details:

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in terms of a specific number. The document mentions "previously acquired posteroanterior (PA) chest X-ray images."
Data Provenance: Not explicitly stated. The images were "previously acquired," but the country of origin and whether it was retrospective or prospective are not mentioned. Given they are "previously acquired," it's highly likely to be retrospective.

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

Number of Experts: Not explicitly stated. The document mentions "the positioning quality assessment of clinicians." It does not specify how many clinicians.
Qualifications of Experts: Not explicitly stated beyond "clinicians." The qualifications (e.g., radiologist with X years of experience) are not provided.

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

Adjudication Method: Not explicitly stated. The document refers to "the positioning quality assessment of clinicians," but it does not detail any consensus or adjudication process (e.g., 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

MRMC Study: No, an MRMC comparative effectiveness study was not specifically described in the provided text. The study compared the algorithm's assessment to "clinicians using standard diagnostic metrics," which suggests a comparison of the AI's output against human assessment, but not a study of human readers with vs. without AI assistance.
Effect Size: Not applicable, as an MRMC comparative effectiveness study was not detailed.

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

Standalone Performance: Yes, a standalone performance study was conducted. The "algorithm's assessment as to whether or not an image met quality criteria for aspects of patient positioning quality was compared to the positioning quality assessment of clinicians." This indicates the algorithm's decisions were evaluated independently against a human-defined ground truth.

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

Type of Ground Truth: Expert assessment/consensus. The ground truth was established by "the positioning quality assessment of clinicians using standard diagnostic metrics."

8. The sample size for the training set:

Sample Size for Training Set: Not mentioned in the provided text. The document refers only to the clinical performance study on "previously acquired posteroanterior (PA) chest X-ray images."

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

Ground Truth Establishment for Training Set: Not mentioned in the provided text. The document focuses on the validation study and does not describe the training process or how its ground truth was established.

Summary

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December 13, 2021

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Philips Medical Systems DMC GmbH % Connie Pascual Sr. Regulatory Affairs Specialist Roentgenstrasse 24-26 Hamburg, Hamburg 22335 GERMANY

Re: K212186

Trade/Device Name: Philips Radiology Smart Assistant Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, JAA Dated: November 12, 2021 Received: November 15, 2021

Dear Connie Pascual:

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 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

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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 medical devices and radiation-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,

, for

Thalia T. Mills, Ph.D. Director 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) K212186

Device Name Philips Radiology Smart Assistant

Indications for Use (Describe)

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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7. 510(k) Summary

510(k) Summary of Safety and Effectiveness

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

Date Prepared:	November 12, 2021
Manufacturer:	Philips Medical Systems DMC GmbHRoentgenstrasse 24-2622335 HamburgGERMANYEstablishment Registration Number: 3003768251
Primary Contact Person:	Connie PascualRegulatory Affairs ManagerPhone: +1 (978) 659-2440E-mail: connie.pascual@philips.com
Secondary Contact Person:	Ann LebarPhone: +1 (414) 217-6244E-mail: ann.lebar@philips.com
Device Name:	Philips Radiology Smart Assistant
Classification:
Classification Name:	System, X-Ray, Stationary
Classification Regulation:	21 CFR 892.1680
Classification Panel:	Radiology
Device Class:	Class II
Product code:	KPR, JAA
Trade Name/Device Name:	Philips Radiology Smart Assistant
Primary Predicate Device:
Manufacturer:	Philips Medical Systems DMC GmbH
510(k) Clearance:	K210692
Classification Regulation:	21 CFR Part 892.1680
Classification Name:	System, X-Ray, Stationary
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	KPR
Trade Name/Device Name:	DigitalDiagnost

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Reference Device:	Philips Healthcare Informatics, Inc.
510(k) Clearance:	K182926
Classification Regulation:	21 CFR 892.2050
Classification Name:	System, Image Processing, Radiological
Classification Panel:	Radiology
Device Class:	Class II
Product Code:	LLZ
Trade Name/Device Name:	IntelliSpace Radiology

Device description:
Philips Radiology Smart Assistant is a software package intended to be used by
qualified healthcare professionals. The software is used with general purpose
computing hardware for the processing, display of images, and patient positioning
feedback within a clinical environment. Philips Radiology Smart Assistant software
supports receiving and displaying images from X-ray systems.

The system supports receiving, sending, storing, acceptance and displaying of
medical images received from the following modality types via DICOM: DX as well
as hospital/radiology information systems.

Philips Radiology Smart Assistant includes a post-processing patient positioning
feedback function for posterior-anterior (PA) chest X-ray images. The patient
positioning assessment is intended to provide a qualified healthcare professional
with timely feedback on the quality of acquired X-ray images that do not suffice the
positioning quality standards of clinical guidelines. The quality check comprises an
assessment of the following parameters:

Collimation
Patient Rotation
Patient Inhalation State

Indications for
Use:
Philips Radiology Smart Assistant is intended to provide patient positioning
feedback using validated 2D X-Ray systems. Philips Radiology Smart Assistant is a
software which informs Healthcare Professionals regarding patient positioning
quality in accordance with clinical guidelines. Philips Radiology Smart Assistant is
not intended for diagnostic purposes. It is not intended to be used as the basis for
repeating an image.

Fundamental
Scientific
Technology:
The proposed device, Philips Radiology Smart Assistant, is a software accessory to
currently marketed parent predicate device, DigitalDiagnost (K210692). This
software is used with general purposed computing hardware for the processing and
display of images throughout a clinical environment by healthcare professionals.
The Philips Radiology Smart Assistant provides post-processing patient positioning
feedback for PA chest X-ray images.

At a high level the Philips Radiology Smart Assistant and the parent predicate
device (K210692) are based on the following equivalent elements:

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Similar Intended Use
Prescription Only
Compatibility with standard radiological images
Processes and displays digital radiographic images

The following technological differences exist between the proposed and parent predicate device:

Anatomy of interest is PA chest images only
Patient Positioning Feedback feature
. Not intended to be used on pediatric population

Summary of technological characteristics:

The presented technological differences are considered low risk, providing additional features such as the Patient Positioning Feedback for the purposes of training and education for healthcare professionals. This new functionality has been verified and validated, and does not raise new questions on safety and/or effectiveness. This new features has not changed the intended use and operational principles of the parent predicate device. Therefore, Philips Radiology Smart Assistant is substantially equivalent to the currently marketed parent predicate device, DigitalDiagnost (K210692).

Non-clinical performance testing has been performed on the Philips Radiology Smart Summary of Assistant and demonstrates compliance with the following international and FDA-Non-Clinical recognized consensus standards and FDA guidance document: Performance Data:

' EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
I IEC 82304-1:2016 Health Software – General requirements for product safety
트 IEC 62366-1:2015 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

Non-Clinical verification and or validation tests have been performed with regards to the intended use, the technical characteristics claims, the requirement specifications and the risk management results.

Non-Clinical verification and or validation test results demonstrate that the Philips Radiology Smart Assistant:

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.

Therefore, the Philips Radiology Smart Assistant is substantially equivalent to the primary currently marketed and predicate device, DigitalDiagnost (K210692) in terms of safety and effectiveness.

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Summary of The Philips Radiology Smart Assistant did require a clinical study based upon the following attributes: Clinical Data:

Main Feature Patient Positioning Feedback ●
. Indications for use

Clinical performance testing was conducted on previously acquired posteroanterior (PA) chest X-ray images in order to demonstrate the performance of the Philips Radiology Smart Assistant in providing patient positing feedback. The algorithm's assessment as to whether or not an image met quality criteria for aspects of patient positioning quality was compared to the positioning quality assessment of clinicians using standard diagnostic metrics. The results of the clinical performance study support the performance of the Philips Radiology Smart Assistant in identification of patient positioning quality issues. The clinical performance study demonstrates that the Philips Radiology Smart Assistant is safe and effective for the specified intended use.

The Philips Radiology Smart Assistant is a software accessary that is substantially Substantial equivalent to its predicate parent device, DigitalDiagnost (K210692), in terms of Equivalence similar intended use and different technological characteristics that do not raise Conclusion: different questions of safety and effectiveness. A clinical performance study was performed to demonstrate the performance of the patient positioning feedback algorithm. Substantial equivalence was demonstrated with non-clinical performance (verification and validation) tests, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC 82304, IEC 62366 and EN ISO 14971. The results of these tests demonstrate that Philips Radiology Smart Assistant met the acceptance criteria and is adequate for the specified intended use.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.