The G52SP+/G52S+ 5MP Grayscale LCD Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

Device Description

The G52SP+/G52S+ 5MP Grayscale LCD display is a display system for medical viewing, with high resolution 2560 x 2048, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.

AI/ML Overview

The provided document is a 510(k) summary for a medical display, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a device or algorithm is not present in this document.

This document describes a medical display (G52SP+/G52S+ 5MP Grayscale LCD Display) and argues for its substantial equivalence to a predicate device (Barcoview, Nio 5MP-21") based on technical specifications and intended use. It is a regulatory submission for market clearance, not a performance study.

However, I can extract the following information that is somewhat relevant to the request:

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

The document doesn't present "acceptance criteria" in the typical sense of a performance study with quantitative thresholds for diagnostic accuracy. Instead, it compares the proposed device's specifications to those of a predicate device to argue for "substantial equivalence." The "performance" refers to technical specifications rather than clinical performance.

Comparison Item (ID)	Proposed Device (G52SP+/G52S+) Performance	Predicate Device (Nio 5MP-21) Performance	Discussion of Difference & Substantial Equivalence Claim
Intended Use	Displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.	Displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.	Same; SE not affected.
Panel Size and Type	21.3", TFT LCD display	21.3", TFT LCD display	Same; SE not affected.
Pixel Pitch	0.165 mm	0.165 mm	Same; SE not affected.
Native Resolutions	2560×2048	2560×2048	Same; SE not affected.
Brightness	1200 cd/m²	700 cd/m²	Proposed device brightness is higher, stated as "better than" the predicate, thus SE not affected.
Contrast Ratio	1200:1	800:1	Proposed device contrast ratio is higher, stated as "better than" the predicate, thus SE not affected.
Network Interface	USB(1 Up, 2 Downstream)	USB(1 Up, 2 Downstream)	Same; SE not affected.
Active Display Size	422mm x338mm(HxV)	422mm x338mm(HxV)	Same; SE not affected.
Dimensions	Varied (e.g., 398.5mm (W) x 483.0mm (H) x 70.8mm (D) without Stand)	Varied (e.g., 382mm x 488mm x 114mm without Stand)	Comparable; SE not affected.
Operating Temperature	0°C ~ 40°C	0°C ~ 40°C	Same; SE not affected.
Transport/Storage Temperature	-20°C ~ 60°C	-20°C ~ 60°C	Same; SE not affected.
Operating Relative Humidity	15% ~85%	8% ~80%(non-condensing)	Comparable; SE not affected.
Transport/Storage Relative Humidity	10% ~90%	5% ~95%	Comparable; SE not affected.
Power Capacity	<80W	95W	Both comply with IEC 60601-1 and IEC 60601-1-2; SE not affected.
Input Voltage	DC12V/5.0A	100~250v	Both comply with IEC 60601-1 and IEC 60601-1-2; SE not affected.
Usability	Button operation, LED indicator	Button operation, LED indicator	Same; SE not affected.
Mode of operation	Continuous operation	Continuous operation	Same; SE not affected.
Biocompatibility Evaluation	Device does not contact patients; evaluation not needed.	Device does not contact patients; evaluation not needed.	Same; SE not affected.
Sterilization	Not needed.	Not needed.	Same; SE not affected.
Electrical, Mechanical, Thermal Safety	Evaluated per IEC 60601-1.	Evaluated per IEC 60601-1.	Same; SE not affected.
EMC Evaluation	Complying with IEC 60601-1-2.	Complying with IEC 60601-1-2.	Same; SE not affected.

Missing Information:

2. Sample sized used for the test set and the data provenance: Not applicable, as this is a device specification comparison, not a clinical or performance study involving a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 document does not describe a study involving human readers or AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is the documented specifications of the predicate device for comparison.
8. The sample size for the training set: Not applicable. This is not an AI/algorithm device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm device.

Summary

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Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads "K132610". Below that, the text reads "Page 1 of 1". At the bottom, the text reads "510(k) Submission".

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR807.92 (a) (1)]

December 24, 2012

2. Submitter's Information [21 CFR807.92 (a) (1)]

Name of Sponsor:	Shenzhen Beacon Display Technology Co., Ltd
Address:	Room 201, Incubator Building, CASTD, High-tech South 1ststreet, Nanshan District, Shenzhen 518057, China
Contact Name:	Wu Qin
Telephone No.:	+86 755 26995355
Fax No.:	+86 755 26995755
Email Address:	wuqin@beacon-display.cn

3. Trade Name, Common Name, Classification [21 CFR807.92 (a)

(2)]

Trade Name:	5MP Grayscale LCD Display
Common Name:	Display system, medical image workstation, and others
Classification:	892.2050 system, image processing, radiological
Product code:	LLZ
Classification Panel:	Radiology
Device Class:	II

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

The identified predicates within this submission are as follows:

Barcoview, Nio 5MP-21" has been cleared by FDA through 510(k) No.K062621 (Decision Date -Mar 19, 2007),

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5. Description of the Device [21 CFR 807.92(a) (4)]

6. Intended Use [21 CFR 807.92(a)(5)]

The G52SP+/G52S+ 5MP Grayscale LCD Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

Panel	21.3", TFT monochrome LCD screen, antigalre
Brightness (typ.)	1200 cd/m²
CR (typ.)	1200:1
Viewing angle	R/L 170°, U/D 170° Typ. (CR > 20)
Pixel Pitch	0.165 mm
Native resolution	2560 x 2048
Display area	422.4mm(H)x337.92mm (V)
Compatible video	640 x 480@60Hz(progressive)
signals	2560 x 2048@50Hz(progressive)
Horizontal resolution	2560 x 2048
Bandwidth	<300MHz
Aspect ratio	5:4
Screen size	21.3" real diagonal
Power	DC12V/5.0A
Power consumption	Max. 80 W
Input signals	DVI-D, Display Port
Digital input	TMDS (single)
Plug and play	VESA DDC 2B
Dimension	398.5mm (W) x 483.0mm (H) x 70.8mm (D) (without Stand)
	398.5 mm (W) x 629.6 mm (H) x 234.8mm (D) (with Stand)

7. Technological Characteristics [21 CFR 807.92(a)(6)]

510(k) Summary

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Weight	7.5kg (without Stand)11.2kg (with Stand)
Operating temperature and humidity:	Temperature: 0°C ~ 40°CHumidity: 15%~85%
Storage temperature and humidity:	Temperature: -20°C ~ 60°CHumidity: 10%~90%

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

8.1 Intended uses:

Table 1 Intended Use Comparison

ID	ComparisonItem	Proposed DeviceG52SP+/G52S+	Predicate DeviceNio 5MP-21
1	IntendedUse	The G52SP+/G52S+5MP Grayscale LCDDisplay is intended to beused in displaying andviewing digital images,including digitalmammography, forreview and analysis bytrained medicalpractitioners.	"The Nio 5MP-21" is intended to beused in displaying and viewing digitalimages, including digitalmammography, for review andanalysis by trained medicalpractitioners. The Nio 5MP- 21",containing the display MDNG-5121CB, the software NioWatch and thegraphic board BarcoMed Nio, will bemarketed as separate device.

8.2 Comparison table

Table 2 General Comparison

ID	ComparisonItem	Proposed DeviceG52SP+/G52S+	Predicate DeviceNio 5MP-21
2	Performance
2.1	Panel Size and Type	21.3", TFT LCD display	21.3", TFT LCD display
2.2	Pixel Pitch	0.165 mm	0.165 mm
2.3	Available CabinetColors	Black	Black
2.4	Native Resolutions	2560×2048	2560×2048
2.5	Brightness	1200 cd/m2	700 cd/m2
2.6	Contrast Ratio	1200:1	800:1
2.7	Network Interface	USB(1 Up, 2 Downstream)	USB(1 Up, 2 Downstream)
2.8	Active Display Size	422mm x338mm(HxV)	422mm x338mm(HxV)
	ComparisonItem	Proposed DeviceG52SP+/G52S+	Predicate DeviceNio 5MP-21
ID
3	Physical Specifications
3.1	Dimensions(Wx Hx D)	398.5mm (W) x 483.0mm (H)x 70.8mm (D) (without Stand)398.5 mm (W) x 629.6 mm (H)x 234.8mm (D) (with Stand)	382mm x 488mm x 114mm(without Stand)Portrait:408mm x 489~~549mmx 250mmLandscape:492mm x 531~~591mmx 250mm(with Stand)






3.2	Operating	0°C ~ 40°C	0°C ~ 40°C
3.3	Transport/ Storage	-20°C ~ 60°C	-20°C ~ 60°C
Relative humidity
3.4	Operating	15% ~85%	8% ~80%(non-condensing)
3.5	Transport/ Storage	10% ~90%	5% ~95%
4	Power Supply
4.1	PowerCapacity	<80W	95W
4.2	Input Voltage	DC12V/5.0A	100~250v
5	Human factors (operation characteristic)
5.1	Usability	Button operation,LED indicator	Button operation,LED indicator
5.2	Mode of operation	Continuous operation	Continuous operation
6	Biocompatibility
6.1	Evaluation	The proposed device does notcontain any components.thatcome into direct or indirectcontact with patients, so theevaluation doesn'tbe needed.	The proposed device doesnot contain any componentsthat come into direct orindirect contact with patients,so the evaluation doesn't beneeded.
7	Sterility
7.1	Sterilization	The proposed device does notneed sterilization.	The proposed device doesnot need sterilization.
8	Electrical & Mechanical safety& Thermal safety
8.1	Type of protectionagainst electricshock	Class I	Class I
8.2	Degree of protectionagainst harmfulingress of liquid	Ordinary equipment.	Ordinary equipment.
8.3	Evaluation	The electrical, mechanical and	The electrical, mechanical and
ID	ComparisonItem	Proposed DeviceG52SP+/G52S+	Predicate DeviceNio 5MP-21
		thermal safety evaluation isconducted as per therequirements of the standardIEC 60601-1.	and thermal safety evaluationis conducted as per therequirements of the standardIEC 60601-1.
9	Electromagnetic Compatibility
9.1	EMC Evaluation	Complying withIEC 60601-1-2	Complying withIEC 60601-1-2

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. '

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8.4 Discussion of Differences:

It is reasonable that there are some differences between our new system and its predicate. All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE).

Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. So the SE is not affected.

Review of ID 2 - Performance, except two items as below, both are the same, so the SE is not affected.

1. Brightness. The proposed device is 1200 cd/m² and the predicate device is 700 cd/m², but the 1200 cd/m² is better than 700 cd/m² in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.
1. Contrast Ratio, The proposed device is 1200:1 and the predicate device is 800:1, but the 1200:1 is better than 800:1 in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

Review of ID 3 - Physical Specifications, Dimensions and Relative humidity are comparable, so the SE is not affected

Review of ID 4 - Power Supply, both of them comply with IEC 60601-1 and IEC 60601-1-2. Therefore, they can be considered Substantially Equivalent in safety and effectiveness. So the SE is not affected.

Review of ID 5 - Human factors, both are the same, so the SE is not affected.

Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected.

Review of ID 7 - Sterility, both are the same, so the SE is not affected.

510(k) Summary

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Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected.

Review of ID 9 - EMC, both are the same, so the SE is not affected.

9. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenzhen Beacon Display Technology Co., Ltd concludes that G52SP+/G52S+ 5MP Grayscale LCD display is substantially equivalent to predicate devices with regard to safety and effectiveness.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drun Administration 10903 New Hampshire Avenue Document Control Center - WOGG-GOOD Silver Spring, MD 20993-0002

September 4, 2013

Shenzhen Beacon Display Technology Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, I.I.C. 1394 25th Street NW BUFFALO MN 55313

Re: K132610

Trade/Device Name: G52SP+/G52S+ 5MP Grayscale LCD Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: Ll.Z. Dated: August 19, 2013 Received: August 20, 2013

Dear Mr. Job:

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 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

lf 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 of medical device-related adverse events) (21 CFR 803): good manufacturing practive requirements as set

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Page 2-Mr. Job

forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default,htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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): K132610

Device Name: G52SP+/G52S+ 5MP Grayscale LCD Display

Indications for Use:

The G52SP+/G52S+ 5MP Grayscale LCD Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Smh.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K132610

Page 1 of 1

Regulation Number and Section

§ 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).