The XRpad 4336 MED, 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 mammographic use.

Device Description

The XRpad 4336 MED is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator. The XRpad 4336 MED detector has an active area of 43.2cm x 35.5cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi. The detector can be integrated into a fixed room X-ray system to enable digital radiography. The XRpad 4336 MED detector is designed to work with any X-ray system (consisting of an X-ray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc are designed to support the necessary compatibility.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as typically found in a clinical performance study. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics.

However, based on the available information, here's what can be inferred and what is explicitly stated:

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

The document states that the device successfully completed "internal nonclinical testing" and "complies with standards and regulations such as UL and IEC." It also mentions that the proposed device and predicate device "have been shown to produce images of equivalent diagnostic quality."

Acceptance Criteria (Inferred from regulatory compliance and substantial equivalence claim):
- Compliance with UL and IEC standards (general safety and performance).
- Produce images of equivalent diagnostic quality to the predicate device.
- Meet applicable detector parameters such as dynamic range, exposure time range, energy range, image size, resolution, and detective quantum efficiency (implied as supporting compatibility).
Reported Device Performance:
- Successfully completed internal nonclinical testing.
- Complies with UL and IEC standards.
- Produces images of equivalent diagnostic quality to the predicate device.
- (Specific numerical performance metrics for acceptance criteria like DQE, resolution, etc., are not provided in this summary.)

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

The document explicitly states: "No clinical studies were conducted in support of the XRpad 4336 MED as agreed upon during Pre-Submission discussions with the Agency for the predicate device (K122495). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence."

Therefore, there is no test set, sample size, or data provenance from a clinical study to report. The evaluation was based on nonclinical testing and comparison to engineering specifications and performance of the predicate device.

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

Since no clinical studies were conducted and no test set with human-interpreted ground truth was used for a direct performance claim, this information is not applicable and not provided.

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

Not applicable, as no clinical test set was used.

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. The device is a flat panel X-ray detector, not an AI-powered diagnostic tool. No MRMC study was performed, and no AI assistance is mentioned.

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

Not applicable, as the device is hardware (an X-ray detector) and not an algorithm.

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

For the nonclinical testing mentioned, the "ground truth" would be engineering specifications and measurements against established physical standards and benchmarks, rather than clinical ground truth like pathology or expert consensus. The primary "ground truth" for showing equivalence was the performance data and specifications of the predicate device (XRD 1622 AP3 MED X-ray system).

8. The sample size for the training set:

Not applicable, as this is hardware, not an algorithm requiring a training set.

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

Not applicable.

Summary

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Image /page/0/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 three human profiles facing to the right, with flowing lines representing hair or movement.

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

August 1, 2014

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

Re: K140551

Trade/Device Name: Perkinelmer. XRpad 4336 MED Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 05, 2014 Received: May 06, 2014

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.

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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Indications for Use

510(k) Number (if known)

K140551

Device Name

XRpad 4336 MED

Indications for Use (Describe)

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

2 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)

FDA

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510k Summary

This summary of 510(k) safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510 (k) number is K140551

August 1, 2014

Submitted by:	PerkinElmer Medical Imaging2175 Mission College Blvd.Santa Clara, CA 95054
Contact Person:Primary:	Dawn SpoonerTel. 781-663-6071Fax. 781-663-5969
Trade Name:	PerkinElmer XRpad 4336 MED Flat Panel Detector
Common Name:Regulation:	Stationary X-ray system (21 CFR 892.1680)
Classification Name:	Stationary X-ray system
Classification:	90 Radiology
Product Code:	(MQB)
Predicate device:	XRD 1622 AP3 MED X-ray system (Flat Panel Detector insystem) [K122495]

Device Description:

The XRpad 4336 MED is a flat panel X-ray detector consisting of an amorphous silicon panel with a directly deposited CsI:Tl scintillator.

The XRpad 4336 MED detector has an active area of 43.2cm x 35.5cm at a pixel pitch of 100μm. Data and control communication is accomplished via a Gigabit Ethernet interface or 802.11n WiFi.

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The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the XRpad 4336 MED

XRpad™ LBP (Lithium Battery Pack) ●
XRpadTM LBC (Lithium Battery Charger) ●
XRpad™ IPU (Interface Power Unit) ●
XRpad™ LPT Detector Cable, 3m/100ft ●
. XRpad™ Protective Insert
. XRpad™ 4336 Connector Cover Set
Trigger cable (in lengths of 5 m or 20 m) ●
GigE interface cable (in lengths of 7.6 m. 15.25 m. or 30.5 m) .

The XRpad 4336 MED detector is designed to work with any X-ray system (consisting of an X-ray source, generator, collimator, and positioner) intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures. Applicable detector parameters, such as dynamic range, exposure time range, energy range, image size, resolution, detective quantum efficiency, etc are designed to support the necessary compatibility.

Intended Use:

The XRpad 4336 MED. 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 mammographic use.

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Comparison Chart:

Comparison of the XRpad 4336 MED device with its predicate.

Characteristics	Proposed devicePerkinElmer XRpad4336 MED	Predicate device(K122495)PerkinElmer XRD1622 AP3 MED
Intended Use / Indicationsfor Use	The XRpad 4336 MED, when used with aradiographic imaging system, is indicated for usein generating radiographic images of humananatomy for diagnostic X-ray procedures,wherever conventional screen-film (SF), digitalradiography (DR), or computed radiography (CR)systems may be used. It is not intended formammographic use.	Same
Panel	Single substrate amorphous silicon activeTFT/diode array	Same
Scintillator	Direct deposition CsI:Tl	Same
Pixel matrix	3556 × 4320 pixels	2048 × 2048 pixels
Pixel pitch	100 μm	200 μm
Active area	355 mm × 432 mm	409 mm × 409 mm
External dimensions(w×l×h)	384 mm × 460 mm × 15 mm	500 mm × 560 mm ×22 mm
Weight	Approximately 4 kg	Approximately 9 kg
Housing material	Aluminum with carbon-fiber	Aluminum
Communication interface	Gb Ethernet or 802.11n WiFi	Gb Ethernet
Power	External power supply or battery	External powersupply

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Summary of Studies:

The PerkinElmer XRpad 4336 MED flat panel detector has successfully completed internal nonclinical testing, complies with standards and regulations such as UL and IEC. No clinical studies were conducted in support of the XRpad 4336 MED as agreed upon during PreSubmission discussions with the Agency for the predicate device (K122495). The conduct of a clinical concurrence study was deemed unnecessary to demonstrate substantial equivalence.

Substantial Equivalency:

The proposed device and predicate device (XRD 1622 AP3 MED flat panel detector) both utilize similar technology and materials, are similar in design and construction, and have been shown to produce images of equivalent diagnostic quality. Both devices are intended for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screenfilm (SF), digital radiography (DR), or computed radiography (CR) systems may be used. The devices are not intended for mammographic use. Both devices produce digital images which can be transmitted to imaging software of the X-ray unit.

Conclusion:

The PerkinElmer XRpad 4336 MED is substantially equivalent to the PerkinElmer XRD 1622 AP3 MED (K122495) flat panel detector predicate device.

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.