The XRpad2 3025 HWC-M, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammonfions .

Device Description

standard X-ray cassette Bucky

topad IPU-2 (Interface and Power Un
KRpad LPT2 Detector Cable
XRpad Protective Insert 307
OV Cable IEC 60320 C13
........ Cable IEC 60320 CLS
frigger Cable 5 m/16.5
ger Cable 20 m/65
GigE Interface Cable 15.25 m/ Interface Cable 7.6 m/2
E Interface Cable 30.5 m/100

AI/ML Overview

The provided text is a 510(k) premarket notification for the PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector. It seeks to prove substantial equivalence to a predicate device (PerkinElmer XRpad 4336 MED, K140551) rather than demonstrating that the device meets specific acceptance criteria through a clinical study with a test set of human images.

Therefore, many of the requested elements regarding acceptance criteria, study design, and ground truth establishment for a clinical performance study on human images are not explicitly present or applicable in this document because the submission focuses on non-clinical performance and technical equivalence for an X-ray detector, not an AI/CADe device that interprets images. This document describes the device itself and its technical performance, not its diagnostic accuracy in a clinical setting with human readers.

However, I can extract information related to the technical performance of the device, which serves as the "acceptance criteria" and "proof" in the context of this 510(k) submission.

Summary of Device Acceptance Criteria and Performance (Based on Technical Equivalence):

This submission is a 510(k) for an X-ray flat panel detector, not an AI or CADe device. The "acceptance criteria" here are based on demonstrating that the new device's technical specifications and performance are substantially equivalent to a previously cleared predicate device, ensuring it performs as intended for generating radiographic images.

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic (Acceptance Criteria - implicitly comparable to predicate)	Predicate Device (XRpad 4336 MED, K140551)	Proposed Device (XRpad2 3025 HWC-M)	Fulfilled? (Based on "Same" or acceptable differences)
Intended Use / Indications for Use	Generating radiographic images of human anatomy for diagnostic X-ray procedures. Not for mammographic use.	Same	Yes
Scintillator	Direct deposition CsI:Tl	Same	Yes
Pixel pitch	100 µm	Same	Yes
Limiting resolution	5 lp/mm	Same	Yes
Binning capable	2x2 binning for 200 µm	Same	Yes
Communication interface	Gb Ethernet or 802.11n WiFi	Same	Yes
WiFi band	5.1-5.3 GHz	5.1-5.9 GHz	Yes (Wider band acceptable)
X-ray synchronization interface	Dedicated trigger in/out signal lines or Automatic Exposure Detection	Same	Yes
Power	External power supply or battery	Same	Yes
Software library	Windows OS	Windows and Linux OS	Yes (Expanded OS support acceptable)
Key Physical Differences (Not direct "acceptance criteria" but noted)
Pixel matrix	3556 x 4320 pixels	2508 x 3004 pixels	Different (Smaller size, noted as "decrease in dimensions")
Data transmit area	355 mm x 432 mm	250 mm x 300 mm	Different (Smaller size, noted as "decrease in dimensions")
External dimensions (w x l x h)	384 mm x 460 mm x 15 mm	282 mm x 332 mm x 15.5 mm	Different (Smaller size)
Weight	3.8 kg	1.8 kg	Different (Lighter)
Housing material	Aluminum with carbon-fiber	Same	Yes
Finish	Matte carbon-fiber front with white silk-screen active area markers	Same	Yes

Note: The document states "The modifications are related to the decrease in dimensions and does not impact image quality." This implies that while the dimensions are different, the critical image quality parameters, which are the 'acceptance criteria' for this type of device, are maintained.

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

This is a non-clinical performance study. The "test set" consists of the device itself undergoing various physical and electrical performance tests.
The document explicitly states: "PerkinElmer has performed internal non-clinical testing to demonstrate the safety and effectiveness of the XRpad2 3025 HWC-M Flat Panel Detector."
There is no mention of a sample size of human images or data provenance (country of origin, retrospective/prospective) because this submission is about the technical performance of the X-ray detector hardware, not its diagnostic performance on patient images assessed by humans or AI.

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 applicable. This submission relies on engineering and physics measurements to establish the performance of the X-ray detector, not diagnostic interpretations by medical experts. The ground truth for this device's performance would be derived from quantitative measurements like DQE, MTF, resolution, etc., performed in a lab setting.
The document mentions "BE and MTF are comparable to the predicate device. The non-clinics [sic] findings show that the detector complies with standards and regulations." This refers to objective physical measurements.

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

Not applicable. There is no human image interpretation in this submission, so no adjudication of expert opinions is required.

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 applicable. This is an X-ray detector, not an AI or CADe device. No MRMC study was performed or is relevant for this type of 510(k) submission.

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

Not applicable. This is an X-ray detector, not an algorithm, so "standalone performance" in the context of AI is not relevant. Its "standalone performance" is its technical image acquisition capabilities.

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

The ground truth for this device's "performance" is based on quantitative physical measurements (e.g., Modulation Transfer Function (MTF) to assess spatial resolution, Detective Quantum Efficiency (DQE) to assess dose efficiency, electrical and mechanical tests) according to recognized industry standards (e.g., IEC standards, as implied by "complies with standards and regulations").
The document specifically mentions "BE and MTF are comparable to the predicate device." BE likely refers to "Beam Energy" or some other physical characteristic.

8. The sample size for the training set:

Not applicable. This is a hardware device. It does not use a "training set" in the machine learning sense. Its design and validation are based on engineering principles and physical testing.

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

Not applicable. As above, no training set for machine learning is involved.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized graphic of what appears to be a human figure.

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

September 1, 2016

PerkinElmer, Inc. % Ms. Dawn M. Spooner Associate Director, Regulatory Affairs 940 Winter Street WALTHAM MA 02451

Re: K161942

Trade/Device Name: XRpad2 3025 HWC-M Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 14, 2016 Received: July 15, 2016

Dear Ms. Spooner:

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 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 (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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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/Resourcesfor You/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.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K161942

Device Name

XRpad2 3025 HWC-M Flat Panel Detector

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart 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)

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:

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"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."

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olsand

əsinə aid bərində aid bir və qarşına qalındığı var. Azərbaycan filmlərinin siyahıya əlin qırmızı viri

The assigned 510(k) number is: X161942

910Z 'SI Isnany

Submitted By:	PerkinElmer Medical Imaging2175 Mission College Blvd.Santa Clara, CA 95054U.S.A.
Contact Person:	Dawn SpoonerAssociate Director, Regulatory AffairsTel. 781-663-6071Fax. 781-663-5969
Device Name:	PerkinElmer XRpad2 3025 HWC-M Flat Panel Detector
Classification:	Product Code: MQBClassification Name: Stationary X-ray SystemClassification Regulation: 21 CFR 892.1680
Predicate Device:	PerkinElmer XRpad 4336 MED Flat Panel Detector510(k) Clearance: K140551; August 1, 2014Product Code: MQBClassification Name: Stationary X-ray SystemClassification Regulation: 21 CFR 892.1680

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evice Description

standard X-ray cassette Bucky ﻳﻮﻧﻴﻮ ﻟﻮﻃﻨﻴﻦ ﺍﻟﺴﻴﺎﺳﻲ ﻟﻠﻤﺮﺍﺗﺐ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺍﺿﻊ ﺍﻟﻤﺘﺎﺣﺔ ﺍﻟﻤﺘﺎﺣﺔ ﺍﻟﻌﺎﻡ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻌﺎﺩﻟﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺣﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺎﺑﻌﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻘﺎﺩ ﺍﻟﻤﺘﺤﺪﺓ in sug doily .unu c.cl x mm 0.282 × um 0.282 × um 0.282 × mm winioni

Xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
topad IPU-2 (Interface and Power Un
KRpad LPT2 Detector Cable
XRpad Protective Insert 307
OV Cable IEC 60320 C13
........ Cable IEC 60320 CLS
frigger Cable 5 m/16.5
ger Cable 20 m/65
GigE Interface Cable 15.25 m/ Interface Cable 7.6 m/2
E Interface Cable 30.5 m/100

Indications For Use

əsn ondare o (ЯП) үүдбэлэгийн төрий (ЧЗ) шүү-пээлэг төлөлтөлтөг тэлэгээгүй хэлийн хэлийн хэлийн хэлийн and and

{5}------------------------------------------------

Comparison Chart

Characteristics
Intended Use /Indications forUse	The XRpad 4336 MED when usedwith a radiographic imaging system, isindicated for use in generatingradiographic images of humananatomy for diagnostic X-rayprocedures, wherever conventionalscreen-film (SF), digital radiography(DR), or computed radiography (CR)systems may be used. It is not intendedfor mammographic use.	Same
Model	PerkinElmerXRpad 4336 MED(K140551)	Proposed ModelPerkinElmerXRpad2 3025 HWC-M
Panel
Scintillator	Direct deposition CsI:Tl	Same
Pixel pitch	$100 \mu m$	Same
Pixel matrix	3556 × 4320 pixels	2508 × 3004
Limitingresolution	5 lp/mm	Same
Binningcapable	2 x 2 binning for 200 $\mu m$	Same
Data transmitarea	355 mm x 432 mm	250 mm x 300 mm
Externaldimensions(w x l x h)	384 mm x 460 mm × 15 mm	282 mm x 332 mm × 15.5 mm
Weight	3.8 kg	1.8 kg
Housingmaterial	Aluminum with carbon-fiber	Same
Finish	Matte carbon-fiber front with whitesilk-screen active area markers	Same
Communicationinterface	Gb Ethernet or 802.11n WiFi	Same
WiFi band	5.1-5.3 GHz	5.1-5.9 GHz
X-raysynchronizationinterface	Dedicated trigger in/out signal lines orAutomatic Exposure Detection	Same
Power	External power supply or battery	Same
Softwarelibrary	Windows OS	Windows and Linux OS

{6}------------------------------------------------

Summary of Studies

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vs w . ອີກາ່າວະ 1821 ເມກາວເປັນ ລາວ. internal no-climical testing, complies with standards and regulations such as U duros Allufessans san rollosted to MCC MH OMH ST0C Thed Ax and Huiyan and A x (CEM ESA SSAI CAX) add this the states and leasters now a osh are and and and and of aldesting the (CEM ESA CC91 CAX) SCAZZTX Trodums As a 6 MED device.

many of Design Control and Risk Managemen

not impact image quality MED (X 140551). The modifications are related to the decrease in dimensions and sque 2025 HWC-M flat panel X-ray detector is modification of the Reppe

A min and and and a more a fit de descreative de server many and be by Free cessfully mitigated and accepted is modification were reviewed and implemented as part of product desi suditiones suobrezed bue system befinant in tall boblyono tusursesss The specific risk control supprective measures to mitigate th

Summary of Non-Clinical Data

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{7}------------------------------------------------

Substantist Equiivalency

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Conclusion.

its intended use. supeps si bur single sousides sus states the sprepatis and is and is a a pure

in fəsiləsindən filmlərinə aid olunan filmlərinin filmlərində vasitəsinə aid (123041) CIN əsinə aid bir və bulunun məqli (xi)01 ç sidir ui bərldqus qortanından ən bir mənələrini əsasən

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.