As a part of a radiographic system, the Philips Eleva Workspot with SkyPlate Detectors is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyPlate Detectors is suitable for all routine radiography exams. including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

Device Description

The Philips Eleva Workspot with SkyPlate Detectors is a workstation (computer, keyboard, display, mouse), introducing the new flat solid state X-ray detectors "SkyPlate". It is used by the operator to generate, process and handle digital X-ray images. There are two different product configurations of the Philips Eleva Workspot with SkyFlow Detectors: Philips ProGrade, and Philips Eleva Workspot for DigitalDiagnost. The Philips ProGrade is used as a retrofit upgrade for the Philips BuckyDiagnost (K945278), whereas the Philips Eleva Workspot for DigitalDiagnost integrates a new generation of wireless portable x-ray detectors (SkyPlate) to replace the x-ray detector WPD FD-W17 (K090625) within the Philips DigitalDiagnost radiography system.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the Philips Eleva Workspot with SkyPlate Detectors, focusing on demonstrating substantial equivalence to predicate devices. While it mentions that a study was conducted, it lacks specific details on the acceptance criteria and the study design parameters you've requested.

Here's what I can extract and what's missing:

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

Acceptance Criteria: The document mentions that "the non-clinical performance data demonstrate substantial equivalence" and that "the results of these tests demonstrate that Philips Eleva Workspot with SkyPlate Detectors the acceptance criteria and are adequate for this intended use." However, it does not explicitly list the quantitative acceptance criteria. It mentions that main physical values like DQE and MTF are "basically equal or better than the predicate device."
Reported Device Performance:
- MTF: Ranging from 61% to 14% (predicate 60% to 15%)
- DQE: Ranging from 66% to 24% (predicate 66% to 22%)
- In both cases, the device's performance is stated as "equal or better" than the predicate.

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

Sample Size (Test Set): Not specified in the provided text.
Data Provenance: Not specified, but the study was a "single-blinded concurrence study." Given the manufacturer is German, it's possible at least part of the data is from Germany or other European countries, but this is not confirmed. The document only mentions the study was conducted "according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices."

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

Not specified. The document states it was a "concurrence study" but does not detail the number or qualifications of experts.

4. Adjudication method for the test set:

Not specified. The study is referred to as a "single-blinded concurrence study," which implies some form of comparison or agreement, but the specific adjudication method (e.g., 2+1, 3+1) is not provided.

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

The document describes a "single-blinded concurrence study" comparing the new x-ray detectors to a predicate device. This is a direct comparison of imaging capabilities, not an MRMC study assessing the improvement of human readers with AI assistance. The device itself is an X-ray detector and workstation, not an AI-driven interpretive tool. Therefore, an effect size of human improvement with AI is not relevant or reported here.

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

The study described is a "concurrence study" to confirm "images of equivalent diagnostic capability." This implies comparing the diagnostic utility of images produced by the new device against the predicate, which inherently involves human interpretation. It is not an algorithm-only standalone performance evaluation in the context of an AI device.

7. The type of ground truth used:

The study aimed to confirm "images of equivalent diagnostic capability." This suggests the ground truth was based on diagnostic interpretations, likely clinical diagnoses made by experts from the images, but the exact nature (e.g., expert consensus, pathology, outcomes data) is not explicitly stated.

8. The sample size for the training set:

Not applicable. This device is an X-ray detector and workstation, not an AI model that requires a training set. The "study" refers to a comparison of image quality and diagnostic capability for regulatory purposes.

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

Not applicable, as there is no training set for an AI model.

In summary, the provided document focuses on demonstrating the substantial equivalence of the Philips Eleva Workspot with SkyPlate Detectors to existing predicate devices based on non-clinical performance data (like DQE and MTF) and a clinical "concurrence study" to confirm equivalent diagnostic capability. It does not provide the detailed study design, sample sizes, expert qualifications, or adjudication methods typically required for the more in-depth analyses you are requesting, especially concerning AI device evaluation.

Summary

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Image /page/0/Picture/0 description: The image shows a document with the text "JUL 2 5 2014" and "K 141736 Page 1 of 4" written on it. The word "PHILIPS" is also visible in large, bold letters. The document appears to be a page from a larger set of documents, possibly related to a patent or legal filing, given the date and reference number.

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.

Manufacturer:

Philips Medical Systems DMC GmbH Roentgenstrasse 24-26 22335 Hamburg GERMANY Establishment registration number: 3003768251

Contact Person:

Gerold Schwarz Q&R Segment Lead Radiography/Fluoroscopy Phone: +49 40 5078-1116 Fax: +49 40 5078-2022 E-mail: gerold.schwarz@philips.com.

Device Name:

Philips Eleva Workspot with SkyPlate Detectors

Classification:

(Primary) Product code (Primary) Classification Name: (Primary) Classification Regulation: (Secondary) Product code: (Secondary) Classification Name: (Secondary) Classification Regulation: Classification Panel: Device Class:

Predicate Device: . Trade Name:

(Primary predicate device) Manufacturer:

510(k) Clearance: Product codes Classification Names:

Classification Regulations: Trade Name: (Secondary predicate device) Manufacturer:

510(k) Clearance: Product code

MQB Stationary x-ray system

21CFR 892.1680

LLZ Picture archiving and communications system 21 CFR 892.2050

Radiology Class II

Philips Eleva Workspot

Philips Medical Systems DMC GmbH K140771; April 25, 2014 MQB, LLZ Stationary x-ray system. Picture archiving and communications system 21CFR 892.1680, 21 CFR 892.2050 Wireless Portable Detector FD-W17

Philips Medical Systems DMC GmbH K090625, March 24, 2009 MQB

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Image /page/1/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is horizontally oriented and centered in the image. The font is simple and clear, making the word easily readable.

Classification Name: Classification Regulation:

Device description:

Stationary x-ray system 21CFR 892.1680

The Indication for Use of the Philips Eleva Workspot with SkyFlow Detectors is identical to that of the currently marketed and predicate device, Philips Eleva Workspot, (cleared in K140771, April 25, 2014), and is as follows:

As a part of a radiographic system, the Philips Eleva Workspot with Sky-Flow Detectors is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyPlate Detectors is suitable for all routine radiography exams. including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

The Philips Eleva Worksnot with SkvFlow Detectors employs the same basic construction and fundamental scientific technology as provided with the currently marketed and primary predicate device, Philips Eleva Workspot (cleared in K140771, April 25, 2014), with regards to the functionality of the following: image receptor type, image processor, automatic image processing, manual image processing, advanced image processing, image export (interfaces), and the use of standard monitors. The new SkyPlate detectors employ the same basic construction and fundamental scientific technology as provided with the currently marketed and secondary predicate device Wireless Portable Detector FD-W17 (cleared in K090625, March 24, 2009).

Based on the information provided above, the Philips Eleva Workspot with SkyFlow Detectors is considered substantially equivalent to the currently marketed and predicate device, Philips Eleva Workspot, in terms of fundamental scientific technology.

The non-clinical performance testing constrains that the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or better than the predicate device ranging from 61% to 14% for MTF (predicate 60% to 15%) and from 66% to 24% for DQE (predicate 66% to 22%).

The non-clinical performance data demonstrate substantial equivalence. They include (but are not limited to):

Indications for Use:

Fundamental Scientific Technology:

Summary of Non-Clinical Performance Data:

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PHILIPS

A Detective Quantum Efficiency (DQE)
公 Modulation Transfer Function (MTF)
Aliasing A
A Output signal level
A Lag. Memory Effects and Ghost Images
人 Allowable types and quantity of defects
Change in detection sensitivity
A Latent image decay characteristic
A Recovery time for radiographic devices
Dose requirements and reciprocity changes
A Stability of device characteristics
A Uniformity of device characteristics
Reuse rate for radiographic devices A
小 Test pattern image tests

The Philips Eleva Workspot with SkyFlow Detectors complies with the following international and FDA-recognized consensus standards:

. IEC 62304 Medical device software – Software life cycle processes
AAMI/ANSI IEC 62366 Application of usability engineering to medi-● cal devices
ISO 14971 Application of risk management to medical devices .
ANSI/AAMI ES60601-1 Medical Electrical Equipment -- Part 1: . General Requirements For Basic Safety And Essential Performance
. IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
. IEC 60601-1-3 Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment
. IEC 60601-2-54 Medical Electrical Equipment - Part 2-54: Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment For Radiography And Radioscopy
. IEC 62220-1 ME equipment - Part 1-2: Determination of the detective quantum efficiency
· � NEMA PS 3.1 - 3.20 Digital Imaging And Communications In Medicinc (DICOM) Set
. ISO 10993-1 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process

Non-clinical software verification and validation tests have been performed with regards to the intended use, technical claims, requirements specifications and risk management results.

The non-clinical software verification and validation test results demonstrate that the Philips Eleva Workspot with SkyFlow Detectors complies with international and FDA-recognized consensus standards and meets the acceptance criteria and is adequate for its intended use. Therefore, the

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PHILIP

Philips Eleva Workspot with SkyPlate Detectors is substantially equivalent to the currently marketed device, Philips Eleva Workspor (K140771; 25 April 2014) combined with Philips Wireless Detector FD-W17 (K090625; 24 March 2009) in terms of safety and effectiveness.

Summary of Clinical Data:

A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors SkyPlate provide images of equivalent diagnostic capability to the predicate device, the Philips WPD FD-W17, and its results demonstrate substantial equivalence.

Substantial Equiva-The Philips Eleva Workspot with SkyPlate Detectors is substantially lence Conclusion: equivalent to the currently marketed and predicate device (Philips Eleva Workspot K140771 using the Philips Wireless Detector FD-W17, K090625) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, 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 62304, IEC 62366, ISO 14971, ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, IEC 62220-1, and NEMA PS 3.1 - 3.20.

The results of these tests demonstrate that Philips Eleva Workspot with SkyPlate Detectors the acceptance criteria and are adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, software validation, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

July 25, 2014

Philips Medical Systems DMC Gmbl I % Mr. Gerold Schwarz Q&R Segment Lead Radiography/Fluoroscopy Roentgenstrasse 24-26 Hamburg, 22335 GERMANY

K141736 Re: Trade/Device Name: Philips ProGrade; Philips Eleva Workspot for DigitalDiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB, LLZ Dated: June 24, 2014 Received: June 27, 2014

Dear Mr. Schwarz;

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 mislcading.

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 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.

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Page 2-Mr. Schwarz

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 yours.

Smh.7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

tions for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141736

Device Name

Philips Eleva Workspot with SkyPloate Detectors

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subparl D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.7)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of Information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Public Bung Scrivices (301) 443-4740 EFF

Philips Eleva Workspot with SkyPlate Detectors Premarket Notification - Bundled Special 510(k) - Pagc 28 of 141 -

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.