(15 days)
As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.
The Philips XD-S is a workstation (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data, and to generate, process and handle digital X-ray images. As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography. The complete X-ray system would further include other subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software.
The provided text is a 510(k) summary for the Philips XD-S Direct Radiography Workstation/Package. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria based on clinical performance metrics (e.g., sensitivity, specificity, accuracy).
The "Performance Standards" section refers to compliance with federal X-Ray performance standards, electrical safety standards, electromagnetic compatibility standards, and DICOM. These are regulatory and technical standards, not clinical performance acceptance criteria in the sense of a medical diagnostic device.
Therefore, I cannot populate the table or answer most of your specific questions related to clinical performance studies, as this information is not present in the provided document.
Here's what can be extracted based on your request, along with explanations for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance (if stated) |
|---|---|---|
| Clinical Performance (e.g., Accuracy, Sensitivity, Specificity) | Not specified in the document. | Not specified in the document. |
| Federal X-Ray Performance Standards | CFR 1020.30, .31 | Complies |
| Electrical Safety Standards | UL 60950-1, IEC 60950-1, UL 60601-1, IEC 60601-1 | Complies |
| Electromagnetic Compatibility Standards | IEC-601-1-2, CISPR-11 | Complies |
| Digital Imaging Communication Standard | ACR/NEMA DICOM | Complies |
| Software Level of Concern | MINOR (according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May/11/2005) | MINOR |
| Product Risk Management | Executed according to ISO 14971 | All risks reduced to an acceptable level |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Provided: The document does not describe a clinical performance test set, its sample size, or the provenance of any data used for such a test. The evaluation here is based on substantial equivalence and compliance with technical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Information Not Provided: As no clinical performance study or test set is described, there is no mention of experts or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Provided: No test set is described.
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
- Information Not Provided: This device is a digital image acquisition workstation, not an AI-powered diagnostic assist tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Provided: This device is a workstation for acquiring, processing, storing, and displaying images. It does not contain an autonomous algorithm whose standalone performance would typically be evaluated in this context. Its "standalone version" refers to its integration level with other X-ray system components, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information Not Provided: No clinical performance study requiring ground truth is described.
8. The sample size for the training set
- Information Not Provided: This document does not describe a machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Information Not Provided: Not applicable, as no training set is described.
Summary of Device Evaluation in the 510(k) Summary:
The Philips XD-S Direct Radiography Workstation/Package obtained clearance through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices (Philips Digital Diagnost and Philips Computed Radiography). The evaluation also focused on:
- Compliance with federal X-ray performance standards and various international electrical safety and electromagnetic compatibility standards.
- Adherence to the DICOM standard for digital imaging communication.
- The use of mature technology and software deemed to have a MINOR level of concern.
- Implementation of product risk management according to ISO 14971, with all risks reduced to an acceptable level.
The 510(k) process for this type of device (a digital image acquisition workstation) at the time (2007) typically focused on safety, fundamental performance, and equivalence to existing devices, rather than detailed clinical performance metrics like sensitivity and specificity derived from a dedicated clinical study against a defined ground truth.
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510(k) Summary of Safety and Effectiveness
JAN -5 2007
In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems North America Company herewith submits a Summary of Safety and Effectiveness.
| MANUFACTURER: | Philips Medical Systems DMC GmBHRoentgenstrasse 24Hamburg, Germany D-22335 |
|---|---|
| Establishment Registration No.: | 3003768251 |
| SUBMITTER: | Philips Medical Systems22100 Bothell Everett HighwayBothell, WA 98021-8431 |
| Establishment Registration No.:Contact: | 1217116Lynn Harmer425-487-7312 |
| DATE PREPARED: | 11 November 2006 |
| CLASSIFICATION NAME: | System, image processing, radiological, Class I(LLZ)Solid State X-Ray Imager (Plat Panel/DigitalImager), Class II (MQB) |
| COMMON/USUAL NAME: | Digital image acquisition workstation |
| TRADE/PROPRIETARY NAME: | PHILIPS XD-S Direct RadiographyWorkstation/Package |
PERFORMANCE STANDARDS:
This device complies with the federal X-Ray performance standards (CFR I 020.30, .31) as well as with relevant national and international standards for Electrical Safety (UL 60950-1, IEC 60950-1, UL 60601-1, IEC 60601-1) as well as international standards for Electromagnetic Compatibility (IEC-601-1-2, CISPR-11) and the ACR/NEMA DICOM digital imaging communication standard.
SYSTEM DESCRIPTION:
The Philips XD-S is a workstation (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data, and to generate, process and handle digital X-ray images.
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As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.
The complete X-ray system would further include other subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc.
There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software.
Available options are:
- touch-screen monitor .
- . image stitching
- . PCR image plate reader connection
- second flat detector .
- . X-ray generator user interface integration
- direct printer connection .
INTENDED USE:
As part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialists areas like intensive care, trauma, or pediatric work, excluding mammography
EQUIVALENCE INFORMATION:
The PHILIPS XD-S Direct Radiography Workstation/Package is considered substantially equivalent to the Philips Digital Diagnost, which received FDA marketing on November 25, 1998, under the name Philips Bucky Vision in 510(k) Number K982795.
In relation to the image plate reader connection, the PHILIPS XD-S is substantially equivalent to the Philips Computed Radiography, which received FDA marketing on December 18, 1996, under 510(k) Number K964124.
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SAFETY INFORMATION:
The Philips XD-S Direct Radiography Workstation/Package uses mature technology. It is designed to be in compliance with National and International safety standards well as the DICOM communication standard.
lmage data are not compressed for storage and the applied image processing is fully reversible.
The software used in the Wokstation is equivalent to the software used in the predicate devices. The Level of Software concern is MINOR as determined according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May/11/2005.
A product risk mangement is cxecuted according to ISO 14971 and all risks are reduced to an acceptable level by implementation and verification of appropriate measures.
Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence,
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Philips Medical Systems North America Company % Mr. Marc M. Mouser Program Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
JAN - 5 2007
Re: K063781
Trade/Device Name: PHILIPS XD-S Direct Radiography Workstation/Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2006 Received: December 21, 2006
Dear Mr. Mouser:
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 udicec 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 adulterstion.
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.
Image /page/3/Picture/9 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line beneath the word "Centennial".
Protecting and Promoting Public Health
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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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Kuc 378i
Indications for Use
Kor 3781 510(k) Number (if known):
Device Name: PHILIPS XD-S Direct Radiography Workstation/Package
Indications For Use:
As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off Division of Reproductive, Abdo and Radiological Devices 510(k) Number __
§ 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).