Philips Orthopaedic Applications is a suite of software applications designed to assist medical professionals such as orthopaedic surgeons, physicians and radiologists in planning and evaluating orthopaedic procedures using medical images.

The applications are intended to view and manipulate 2D and 3D medical images; to calibrate and make length, angle and area measurements on such images; to represent and manipulate surgical planning templates overlaid on such images; to plan and simulate the effect of treatments by transforming such images; and to print and store the results of these measurements and simulations.

Device Description

The Philips Orthopaedic Applications software runs on "off the shelt" standard PC components using a Microsoft Operating System. It can be used as stand-alone SW applications or as a Plug-in on advanced image processing workstations or review workstations (PACS).

These applications provide digital alternatives for the tools medical specialists are used to work with when using conventional images printed on film: callipers, pencil, transparent sheets, scissors and tape. The software tools transform these conventional tools for working with digital images on a computer display.

AI/ML Overview

The provided text is a 510(k) summary for the Philips Orthopaedic Applications, which is a software suite. This document focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, many of the requested details about a study evaluating the device's performance against acceptance criteria are not present in the provided text. The document primarily focuses on the device's description, intended use, and substantial equivalence to existing devices. It does not contain information about clinical trials, performance metrics, ground truth establishment, or sample sizes related to a performance study.

Based on the provided text, here's what can be extracted and what is missing:

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

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance is based on demonstrating substantial equivalence to predicate devices in terms of functionality and safety.
Reported Device Performance: Not reported in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity). The document states that the device "does not introduce new indications for use, nor does the use of the device result in any new potential hazard."

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

Not provided. The document does not describe a test set or any performance study data.

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)

Not provided. Ground truth establishment for a performance study is not discussed.

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

Not provided. Adjudication methods are not discussed as no performance study is detailed.

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

Not provided. The document does not mention an MRMC study or any AI assistance, as the device is a set of software tools for viewing, manipulating, and measuring medical images, and planning procedures. It's not described as an AI-driven diagnostic aid.

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

Not fully applicable in the context of this document. The device is described as software applications to assist medical professionals, implying a human-in-the-loop interaction rather than a standalone algorithmic diagnosis. No standalone performance study is detailed.

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

Not provided. As no performance study is detailed, the type of ground truth is not mentioned.

8. The sample size for the training set

Not provided. Training data for algorithms is not discussed. This product is described as software tools, not a machine learning model that requires a training set in the typical sense.

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

Not provided. Ground truth establishment for a training set is not discussed.

Summary of what the document focuses on instead:

The Philips Orthopaedic Applications 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices (Agfa IMPAX® OT3000 Orthopedic Workstation and Sectra Orthopedic Package). This means the FDA concluded that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The core argument for substantial equivalence is based on:

Device Description: The software runs on standard PC components and can be standalone or a plug-in.
Intended Use: To assist medical professionals in planning and evaluating orthopedic procedures using medical images through viewing, manipulation, calibration, measurement (length, angle, area), template overlay, and simulation.
Safety and Effectiveness: Complies with ACR/NEMA DICOM standard, and importantly, "does not introduce new indications for use, nor does the use of the device result in any new potential hazard."

Essentially, the "study that proves the device meets the acceptance criteria" in this context is the submission and FDA's review of the 510(k), where the acceptance criteria are alignment with the predicate devices and the proof is the demonstrated lack of new safety/effectiveness concerns or new indications for use compared to those predicates. No specific performance metrics or clinical study results are detailed in this summary.

Summary

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NOV - 2 2004

PHILIPS

Philips Medical Systems

K042867

510(k) Summary

Philips Orthopaedic Applications

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

General Information I

Company Name:	Philips Medical Systems North America Company
Address:	22100 Bothell Everett HighwayBothell Washington 98021-8431USA
Contact Person	Lynn T. Harmer
Telephone Number:	425-478-7312
Prepared (date):	September 24, 2004
Device Name:	Philips Orthopaedic Applications
Classification Name:	Image Processing System
Regulation number	892.2050
Classification:	Class: II
ProCode:	90 LLZ
Common/Usual Name:	Workstation
Predicate Devices:	Agfa Corporation: IMPAX® OT3000 Orthopedic WorkstationSectra Imtec AB: Sectra Orthopedic Package

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K042867

Information Supporting Substantial Equivalence Determination II

System Description:

Intended Use:

Philips Orthopaedic Applications is a suite of software applications designed to assist medical professionals such as Orthopaedic surgeons, physicians and radiologists in planning and evaluating Orthopaedic procedures using medical images.

The software packages are designed to run on standard PC hardware ("off the shelf" standard computer components) and are available as stand-alone applications or as plug-ins for specified advanced image processing workstations or review workstations (PACS).

General Safety and Effectiveness:

The Orthopaedic Applications complies with ACR/NEMA DICOM digital imaging communication standard.

Conclusion:

The Philips Orthopaedic Applications 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 Orthopaedic Applications to be substantially equivalent to the Agfa IMPAX® OT3000 Orthopedic Workstation (K040334) and the Sectra Orthopedic Package (K031590).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines extending from its head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2004

· Philips Medical Systems North America Company % Ms. Melissa J. DeGuia Associate Project Engineer/ Program Reviewer 'Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K042867

Trade/Device Name: Philips Orthopaedic Applications Regulation Number: 21 CFR 892.2050 . Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: October 15, 2004 Received: October 18, 2004

'Dear Ms. DeGuia:

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 reguirements for annual registration, listing 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 (Premarket Approval), 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.

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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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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. brogdon

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

Enclosure

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Indications for Use

8042867 Unknown_ 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Philips Orthopaedic Applications Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042867

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).