The Integris 3D-RA release 4.2 is intended to assist the physicians when analyzing 2-Dimensional, DSA X-ray images by creating 3-Dimensional views from sets of 2-Dimensional images created during rotational angiographic runs.

Device Description

The Integris 3D-RA release 4.2 device allows the user to obtain a three dimensional impression of vasculature with a single contrast injection. This 3D impression is acquired by rotating the C-arm isocentrically around the region of interest. Exposures are made as the arteries in the region of interest are being filled. The set of 2-Dimensional images form the rotational angiographic examination and is transferred via DICOM connection to the 3D-RA workstation. A 3-Dimensional image is constructed from the delivered image information resulting in an object which can be viewed from almost any angle.

AI/ML Overview

The provided text is a 510(k) summary for the Philips Integris 3D-RA, release 4.2. This document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness compliance based on existing standards. It does not contain information about studies proving the device meets specific acceptance criteria based on performance metrics.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Here's what I can extract from the provided text regarding general safety and effectiveness:

General Safety and Effectiveness Criteria (Compliance-based, not performance-based):

Acceptance Criteria (Compliance)	Reported Device Performance (Compliance)
Compliance with federal performance standards for radiological health (21 CFR, Title 21, subchapter J – Radiological Health, parts 1020.10 and 1040.10).	"The device and its labeling will comply with the applicable requirements of the federal performance standards (Code of Federal Regulations, Title 21, subchapter J – Radiological Health, parts 1020.10 and 1040.10)."
Compliance with ACR/NEMA DICOM digital imaging communication standard.	"Additionally the Integris 3D-RA release 4.2 complies with the ACR/NEMA DICOM digital imaging communication standard."
Compliance with Underwriters Laboratories Standard for Safety UL 60950.	"The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety UL 60950. All required documents and reports have been or will be supplied to the appropriate oversight agency to establish compliance with the applicable requirements."
Device does not introduce new indications for use.	"The Philips 3D-RA, release 4.2 does not introduce new indications for use..."
Device does not result in any new potential hazard.	"...nor does the use of the device result in any new potential hazard."
Substantial equivalence to the predicate device (Integris 3D-RA release 1, FDA ref. K983877).	"The Integris 3D-RA release 4.2 device is substantially equivalent to the Integris 3D-RA release 1 (FDA ref. K983877)." and "Philips Medical Systems considers the Philips 3D-RA release 4.2 substantially equivalent with the predicate device." This was affirmed by the FDA's letter stating, "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...".

Regarding the specific questions you asked, this document provides no information on the following:

Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device's indication for use is "to assist physicians", implying a human-in-the-loop scenario, but no performance study is described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

This 510(k) summary is a declaration of compliance with regulatory standards and substantial equivalence, not a detailed report of a device performance study with specific acceptance criteria beyond regulatory compliance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in bold, black letters against a white background. The font is sans-serif and appears to be a standard, blocky typeface. The letters are evenly spaced and fill most of the frame, creating a clear and easily readable logo or brand name.

Philips Medical Systems North America

Koyo254

510(k) SUMMARY

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

Company Name:Address:	Philips Medical Systems North America Company22100 Bothell Everett HighwayP.O.Box 3003Bothell, WA 98041-3003, USA
Registration No.:	1217116
Contact Person:Telephone No.:	Lynn Harmer(425) 487-7312
Date prepared:	22 January 2003
Device (Trade) Name:	Integris 3D-RA, release 4.2
Regulation Name:	Picture archiving and communications system
Regulation Number:	21 CFR 892.2050
Regulatory Class:	II
Product Code:	90 LLZ

Predicate Device:

The Integris 3D-RA release 4.2 device is substantially equivalent to the Integris 3D-RA release 1 (FDA ref. K983877.)

Device Description:

Indications for Use:

The Integris 3D-RA release 4.2 device is intended to assist physicians when analyzing 2-Dimensional, DSA X-ray images by creating 3-Dimensional views from sets of 2-Dimensional images created during rotational angiographic runs.

Image /page/0/Picture/13 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a shield-shaped emblem. The emblem contains a stylized representation of waves and stars. The waves are depicted as three horizontal lines, and there are two four-pointed stars, one above and one below the waves.

100 Bothell Everett Highway othell. Washington 98021 425 487-7000

{1}------------------------------------------------

General Safety and Effectiveness:

The device and its labeling will comply with the applicable requirements of the federal performance standards (Code of Federal Regulations, Title 21, subchapter J – Radiological Health, parts 1020.10 and 1040.10). Additionally the Integris 3D-RA release 4.2 complies with the ACR/NEMA DICOM digital imaging communication standard.

The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety UL 60950. All required documents and reports have been or will be supplied to the appropriate oversight agency to establish compliance with the applicable requirements.

Conclusion:

The Philips 3D-RA, release 4.2 does not introduce new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Philips 3D-RA release 4.2 substantially equivalent with the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2004

Philips Medical Systems North America Company % Mr. John So Senior Project Engineer/Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K040254 Trade/Device Name: Philips Integris 3D-RA, release 4.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: February 3, 2004 Received: February 4, 2004

Dear Mr. So:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brygdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

Page 2

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known) :

K040254

Philips Integris 3D-RA release 4.2 Device Name :

Indications For Use :

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) ાવ

Over-The-Counter Use

Daniel A. Glenn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

(Optional Format 1-2-96)

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).