The C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Device Description

The C32SP+/C32S+ 3MP Color LCD Display is a display system for medical viewing, with high resolution 2048 x 1536, built-in brightness stabilization circuit 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 3MP Color LCD Display (C32SP+/C32S+) and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the manner of an AI/human performance study. The document states that "All of parameters comply with 21CFR1020.33 and related IEC standards" and that the differences "do not affect the safety and effectiveness (SE)." This suggests that acceptance criteria would be defined by adherence to these standards and the comparison tables to the predicate device.

Given the nature of the document as a 510(k) submission for an LCD display, it focuses on technical specifications and substantial equivalence rather than clinical performance or human-in-the-loop studies typically associated with AI-powered devices. No information is present regarding:

Sample sizes for test sets or training sets
Data provenance
Number or qualifications of experts
Adjudication methods
Multi-reader multi-case (MRMC) comparative effectiveness studies
Standalone algorithm performance
Type of ground truth used

Therefore, the requested information elements cannot be fully populated as they are not within the scope of this document.

However, based on the comparative tables provided, we can infer the acceptance criteria are alignment with the predicate device's specifications and compliance with relevant standards. The reported device performance is its technical specifications as listed.

Here's a breakdown based on the available information:

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

The acceptance criteria are implicitly defined by the parameters of the predicate device and relevant standards (21CFR1020.33, IEC 60601-1, IEC 60601-1-2). The reported device performance is its specifications, which are presented as comparable or superior to the predicate.

Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (C32SP+/C32S+)
Panel Size and Type: 21.3", TFT LCD display	21.3", TFT LCD display
Pixel Pitch: 0.2115 mm	0.2115 mm
Native Resolutions: 2048 x1536	2048 x1536
Brightness: 1700 cd/m² (or comparable)	1700 cd/m²
Contrast Ratio: 1300:1 (or comparable/better)	1400:1 (considered better)
Network Interface: USB(1 Up, 2 Downstream)	USB(1 Up, 2 Downstream)
Active Display Size: 433.2mm x324.9mm (or comparable)	433.152mm x324.864mm
Operating Temperature: 0°C ~ 40°C	0°C ~ 40°C
Transport/Storage Temperature: -20°C ~ 60°C	-20°C ~ 60°C
Operating Relative Humidity: 8% ~80% (non-condensing)	15%~85%
Transport/Storage Relative Humidity: 5% ~95%	10%~90%
Power Capacity: <40W (or comparable)	<80W
Input Voltage: 100~240v (or comparable)	DC12V/7.0A
Usability: Button operation, LED indicator	Button operation, LED indicator
Mode of operation: Continuous operation	Continuous operation
Biocompatibility: Not needed	Not needed
Sterilization: Not needed	Not needed
Electrical & Mechanical safety: Class I, Ordinary equipment, Complies with IEC 60601-1	Class I, Ordinary equipment, Complies with IEC 60601-1
EMC Evaluation: Complying with IEC 60601-1-2	Complying with IEC 60601-1-2

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

Sample size: Not applicable and not mentioned. The evaluation is based on technical specifications and comparison to a predicate device, not a diagnostic performance study with patient data.
Data provenance: Not applicable.

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

Not applicable. There is no mention of human experts establishing ground truth for a test set in this context. The "ground truth" for this device would be its conformity to engineering specifications and safety standards.

4. Adjudication method 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:

No. This device is an LCD display, not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.

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

Not applicable. This device does not have an algorithm in the sense of AI or image processing. Its performance is purely hardware-based.

7. The type of ground truth used:

The "ground truth" is adherence to established technical specifications, safety standards (e.g., 21CFR1020.33, IEC 60601-1, IEC 60601-1-2), and the technical characteristics of the legally marketed predicate device.

8. The sample size for the training set:

Not applicable. This document is not about an AI/machine learning device that requires 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 handwritten text on a white background. The text includes "K140103" on the top line, followed by "Page 1 of 6" on the second line. The bottom left corner has the text "510(k) Submission".

510(k) Summary

FEB 1 4 2014

[As required by 21 CFR 807.92]

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

December 24, 2013

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:	3MP Color 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: BARCO N.V., Nio Color 3MP LED has been cleared by FDA through 510(k) No.K131295 (Decision Date -May 29, 2013),

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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 C32SP+/C32S+ 3MP Color LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Panel	21.3", TFT monochrome LCD screen, antiglare
Brightness (typ.)	1700 cd/m²
CR (typ.)	1400:1
Viewing angle	R/L 176°, U/D 176° Typ. (CR > 10)
Pixel Pitch	0.2115mm
Native resolution	2048 x 1536
Display area	433.152mm(H) x 324.864mm(V)
Compatible video signals	640 x 480@60Hz(progressive)2048x1536@60Hz(progressive)
Horizontal resolution	2048 x 1536
Bandwidth	216MHz
Aspect ratio	4:3
Screen size	21.3" real diagonal
Power	DC12V/7.0A
Power consumption	Max. 80 W
Input signals	DVI-D, Display Port
Digital input	TMDS ( single )
Plug and play	VESA DDC 2B
Dimension	369.0mm (W) x 482.6mm (H) x 63.6mm (D) (without Stand )369.0 mm (W) x 626.6 mm (H) x 234.8mm (D) (with Stand )

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

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Weight	6.5kg (without Stand)9.5kg (with Stand)
Operatingtemperature andhumidity:	Temperature: 0°C ~ 40°CHumidity: 15%~85%
Storagetemperature andhumidity:	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 DeviceC32SP+/C32S+	Predicate DeviceNio Color 3MP LED
1	IntendedUse	The C32SP+/C32S+ 3MP ColorLCD Display is intended to beused in displaying and viewingdigital images (excluding digitalmammography) for review andanalysis by trained medicalpractitioners.	"Nio Color 3MP LED" isintended to be used as a tool indisplaying and viewing digitalimages (excluding digitalmammography) for review andanalysis by trained medicalpractitioners.

8.2 Comparison table

Table 2 General Comparison

ID	ComparisonItem	Proposed DeviceC32SP+/C32S+	Predicate DeviceNio Color 3MP LED
2	Performance
2.1	Panel Size and Type	21.3", TFT LCD display	21.3", TFT LCD display
2.2	Pixel Pitch	0.2115 mm	0.2115 mm
2.3	Available CabinetColors	Black	Black
2.4	Native Resolutions	2048 x1536	2048 x1536
2.5	Brightness	1700 cd/m2	1700 cd/m2
2.6	Contrast Ratio	1400:1	1300:1
2.7	Network Interface	USB(1 Up, 2 Downstream)	USB(1 Up, 2 Downstream)
2.8	Active Display Size	433.152mm x324.864mm	433.2mm x324.9mm
3	Physical Specifications
3.1	Dimensions(Wx Hx D)	369.0mm (W) x 482.6mm (H)	375mm x 488mm x 84mm(without Stand)
ID	Comparison Item	Proposed DeviceC32SP+/C32S+	Predicate DeviceNio Color 3MP LED
		x 63.6mm (D) (without Stand)	Portrait:375mm x 620~520mmx 235mm
		369.0 mm (W) x 626.6 mm (H)x 234.8mm (D) (with Stand)	Landscape:488mm x 563~463mmx 250mm(with Stand)
	Temperature
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	<40W
4.2	Input Voltage	DC12V/7.0A	100~240v
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't be 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 andthermal safety evaluation isconducted as per therequirements of the standard	The electrical, mechanicaland thermal safety evaluationis conducted as per therequirements of the standard
ID	ComparisonItem	Proposed DeviceC32SP+/C32S+	Predicate DeviceNio Color 3MP LED
		IEC 60601-1.	IEC 60601-1.
9	Electromagnetic Compatibility
9.1	EMC Evaluation	Complying withIEC 60601-1-2	Complying withIEC 60601-1-2

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3MP Color LCD Display

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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(excluding digital mammography) for review and analysis by trained medical practitioners. So the SE is not affected.

Review of ID 2 - Performance, except the item as below, it is the same, so the SE is not affected.

1. Contrast Ratio, The proposed device is 1400:1 and the predicate device is 1300:1, but the 1400:1 is better than 1300:1 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.

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

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K140103
Page 6 of 6
510(k) Submission

based on the information provided in this premarket notification, Shenzhen Beacon Display Technology Co., Ltd concludes that C32SP+/C32S+ 3MP Color 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 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 emblem featuring an abstract representation of an eagle or bird-like figure with three horizontal lines extending from its body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 14, 2014

Shenzhen Beacon Display Technology Co., Ltd. % Ms. Wu Oin Room 201, Incubator Building, CASTD High-tech South 1st Street Shenzhen, Guangdong 518057 CHINA

Re: K140103

Trade/Device Name: 3MP Grayscale LCD Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 26, 2013 Received: January 15, 2014

Dear Ms. Qin:

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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Page 2-Ms. Qin

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/Resourcesfor You/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/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 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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Imgur

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): K140103

Device Name: G32SP+/G32S+ 3MP Grayscale LCD Display

Indications for Use:

The G32SP+/G32S+ 3MP Grayscale LCD Display is intended to be used in displaying and viewing digital images (excluding 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)

fm.p.)

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

510(k) K140103

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).