The XRoad 4343 F 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 4343 F MED is a lightweight, cassette-sized, flat panel X-ray detector for digital radiography. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure. The outside dimensions of the detector are 460 mm × 15 mm, which fits into a standard X-ray cassette Bucky. The active area is 430 mm × 430mm at a pixel pitch of 100um. The detector can be integrated into a fixed room X-ray system to enable digital radiography.

AI/ML Overview

The PerkinElmer XRpad 4343 F MED Flat Panel Detector is a digital radiography device. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding reported performance for the XRpad 4343 F MED. Instead, it relies on demonstrating equivalence to a predicate device (XRpad 4336 MED, K140551) through comparable non-clinical performance values and the applicability of the predicate's clinical data.

However, key comparative performance characteristics are presented:

Characteristic	Acceptance Criteria (Predicate Device K140551)	Reported Device Performance (XRpad 4343 F MED)
Intended Use /	Same as predicate	Same
Indications for Use
Customer Applications	Single energy, single shot RAD in 100 µm	Same
Panel	Single substrate amorphous silicon active TFT/diode array	Same
Scintillator	Direct deposition CsI:T1	Same
Pixel pitch	100 µm	Same
Limiting resolution	5 lp/mm	Same
Binning capable	2 × 2 binning for 200 µm	Same
Housing material	Aluminum with carbon-fiber	Same
X-ray synchronization interface	Dedicated trigger in/out signal lines or Automatic Exposure Detection	Same
Software	Windows OS	Same
DQE (Detective Quantum Efficiency)	Comparable to predicate device	Comparable to predicate device
MTF (Modulation Transfer Function)	Comparable to predicate device	Comparable to predicate device

Differences noted for the proposed device (not framed as acceptance criteria but as distinguishing features from the predicate):

Pixel matrix: 3556 × 4320 pixels (Predicate) vs. 4318 × 4320 pixels (Proposed)
Active area: 355 mm × 430 mm (Predicate) vs. 430 mm × 430 mm (Proposed)
External dimensions: 384 mm × 460 mm × 15 mm (Predicate) vs. 460 mm × 460 mm × 15 mm (Proposed)
Weight: Approximately 4 kg (Predicate) vs. Approximately 5 kg (Proposed)
Communication interface: Gb Ethernet or 802.11n WiFi (Predicate) vs. Gb Ethernet, No wireless capability (Proposed)
Power: External power supply or battery (Predicate) vs. External power supply (Proposed)
Battery capacity: 53Wh (Predicate) vs. No battery option (Proposed)

The foundational acceptance criterion is "Substantial Equivalence" to the predicate device, demonstrated by showing that the proposed device has comparable performance and operational standards, produces images of equivalent diagnostic quality, and that potential hazards have been studied and controlled.

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

The document states that a new clinical study was not required for the XRpad 4343 F MED device.
Instead, the predicate device, XRpad 4336 MED, was cleared using clinical data derived from testing to support K122495 (XRD 1622 AP3 MED).
The document implies that the "clinical study data submitted in K122495" served as the basis for the clinical evaluation, but it does not provide details on the sample size or data provenance (e.g., country of origin, retrospective/prospective nature) for K122495. It only states that this data was deemed "applicable" to the XRpad 4336 MED and, through non-clinical testing, also applicable to the XRpad 4343 F MED.

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

The document does not provide information on the number of experts or their qualifications, as it refers to a prior 510(k) submission (K122495) for clinical data.

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

The document does not provide information on the adjudication method, as it refers to a prior 510(k) submission (K122495) for clinical data.

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:

No MRMC comparative effectiveness study was done or reported in this 510(k) summary for the XRpad 4343 F MED, nor does it involve AI assistance. This device is a flat panel x-ray detector, not an AI-powered diagnostic tool. The document relies on demonstrating non-inferiority/equivalence to a predicate physical device.

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

This question is not applicable as the XRpad 4343 F MED is a hardware device (flat panel detector) for capturing radiographic images, not a standalone algorithm.

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

The document does not explicitly state the type of ground truth used for the clinical data referenced from K122495.
However, given the nature of radiographic imaging devices, it is highly probable that the ground truth for the clinical data in K122495 would have been established through expert radiological interpretation and potentially confirmed by pathology or clinical outcomes, but this is not confirmed in the provided text.

8. The sample size for the training set:

The document does not mention any training set for the XRpad 4343 F MED, as it is a hardware device and not an algorithm requiring a training set in the AI/machine learning sense.

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

This question is not applicable as no training set (in the context of algorithms) is mentioned or used for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures facing to the right. The figures are connected and appear to be in motion.

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

October 23, 2014

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

Re: K142698

Trade/Device Name: XRpad 4343F MED Flat Panel Detector Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 22, 2014 Received: September 23, 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

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

510(k) Number (if known)

K142698

Device Name

XRpad 4343 F 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)

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510(k) Summary XRpad 4343 F MED Flat Panel Detector

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: K142698

October 15, 2014

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 XRpad 4343 F MED 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 Detector
	510(k) Clearance: K140551; August 1, 2014Product Code: MQBClassification Name: Stationary X-ray SystemClassification Regulation: 21 CFR 892.1680

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Device Description:

The outside dimensions of the detector are 460 mm × 15 mm, which fits into a standard X-ray cassette Bucky. The active area is 430 mm × 430mm at a pixel pitch of 100um.

The detector can be integrated into a fixed room X-ray system to enable digital radiography. The following accessories are available for the XRpad 4343 F MED:

XRpad IPU (Interface Power Unit) ●
XRpad LPT Detector Cable 3 m / 10 ft. ●
AC Cable IEC 60320 C13 DE ●
AC Cable IEC 60320 C13 US ●
Trigger Cable 5 m / 16.5 ft. ●
Trigger Cable 20 m / 65.5 ft.
XRD GigE Interface Cable 7.6 m / 25 ft. ●
XRD GigE Interface Cable 15.25 m / 50 ft. ●
XRD GigE Interface Cable 30.5 m / 100 ft.

The XRpad 4343 F 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.

Indications For Use:

The XRpad 4343 F MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-rav 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

Characteristics	ModelPerkinElmerXRpad 4336 MED (K140551)	Proposed ModelPerkinElmerXRpad4343 F MED
Intended Use /Indications forUse	The XRpad 4336 MED when used with aradiographic imaging system, is indicatedfor use in generating radiographic imagesof human anatomy for diagnostic X-rayprocedures, wherever conventional screen-film (SF), digital radiography (DR), orcomputed radiography (CR) systems maybe used. It is not intended formammographic use.	Same
CustomerApplications	Single energy, single shot RAD in 100 µm	Same
Panel	Single substrate amorphous silicon activeTFT/diode array	Same
Scintillator	Direct deposition CsI:T1	Same
Pixel matrix	3556 × 4320 pixels	4318 × 4320 pixels
Pixel pitch	100 µm	Same
Limitingresolution	5 lp/mm	Same
Binningcapable	2 × 2 binning for 200 µm	Same
Active area	355 mm × 430 mm	430 mm × 430 mm
Externaldimensions(w×l×h)	384 mm × 460 mm × 15 mm	460 mm × 460 mm × 15 mm
Weight	Approximately 4 kg	Approximately 5 kg
Housingmaterial	Aluminum with carbon-fiber	Same
Communicationinterface	Gb Ethernet or 802.11n WiFi	Gb EthernetNo wireless capability
WiFi band	5.1-5.3 GHz	None
X-raysynchronizationinterface	Dedicated trigger in/out signal lines orAutomatic Exposure Detection	Same
Power	External power supply or battery	External power supply
Batterycapacity	53Wh	No battery option
Connector	For fixed installation	Same
Software	Windows OS	Same

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Summary of Studies:

The proposed new device and the XRpad predicate device utilize similar technology and materials, are similar in design and construction, and have the same intended use. The construction and physical characteristics of the PerkinElmer XRpad 4343 F MED compared to the predicate PerkinElmer XRpad 4336 MED are similar. The difference is related to the increase in dimensions and does not impact image quality.

The PerkinElmer XRpad 4343 F MED flat panel detector has successfully completed internal non-clinical testing, complies with standards and regulations such as UL and IEC. A new clinical study was not required for the XRpad 4343 MED device. The predicate device, XRpad 4336 MED, was cleared using clinical data derived from testing to support K122495 (XRD 1622 AP3 MED) and applicable to the predicate device. The XRpad 4343 MED device differences do not invalidate the applicability of the clinical study data submitted in K122495. Through non-clinical testing, we have demonstrated the clinical data collected with the (XRD 1622 AP3 MED) in K122495 is also applicable to the XRpad 4343 MED device as it was applicable for the XRpad 4336 MED device.

Summary of Design Control and Risk Management:

The XRpad 4343 F MED flat panel X-ray detector is a modification of the XRpad 4336 MED (K140551). The 43 cm × 43 cm XRpad 4343 F MED, as compared to the 43 cm × 36 cm XRpad 4336 MED, is larger in one dimension, is heavier, and does not have a battery, or wireless capability.

The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.

Summary of Non-Clinical Data:

To demonstrate the equivalence of the PerkinElmer XRpad 4343 F MED to the predicate device, PerkinElmer has performed internal non-clinical testing and demonstrated compliance with accepted standards and regulations such as UL and IEC following the non-clinical considerations outlined in the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, August, 1999. The non-clinical testing was conducted and demonstrated the main physical values of the XRpad 4343 F MED such as DQE and MTF are comparable to the predicate device. The non-clinical performance testing conducted and resulting data demonstrate substantial equivalence.

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Substantial Equivalency:

The proposed device and predicate device (XRpad 4336 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 Xray procedures, wherever conventional screen-film (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:

Similar to the predicate device, the XRpad 4343 F MED has comparable performance and operational standards. Potential hazards have been studied and controlled by a Risk Management Plan. The non-clinical software verification and validation test results demonstrate that the PerkinElmer XRpad 4343 F MED complies with international and FDA recognized consensus standards and meets the acceptance criteria and is adequate for its intended use.

Based on the information supplied in this 510(k) PerkinElmer concludes, the XRpad 4343 F MED is substantially equivalent to the currently marketed device. XRpad 4336 MED (K140551) in terms of safety and effectiveness.

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.