The Sony PVM-2551MD OLED Monitor is intended to provide color video displays of images from surgical camera systems. The PVM-2551MD is a widescreen, highdefinition monitor for real-time use during minimally invasive surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery.

Device Description

The Sony PVM-2551MD OLED Monitor is a color video monitor and is intended primarily for use in a medical environment for displaying images captured during minimally invasive and general surgical procedures. The monitor features a 24.5inch widescreen OLED panel and Sony's TRIMASTER™ technology, which has been developed to provide accurate color reproduction, precision imaging, and quality picture consistency. The monitor employs full high-definition (HD) performance with 1920 x 1080 pixels, an aspect ratio of 16:9, and a pixel efficiency of 99.99%. OLED (an acronym for Organic Light-Emitting Diode) is a flat-panel screen technology that represents an advance in display technology. It is an emissive technology that generates light from each pixel. The process that is the basis of OLED is electroluminescence. In the Sony PVM-2551MD OLED Monitor, the OLED panel makes use of an organic material, which emits light when an electric current is applied. Being self-emitting, the strength of luminescence can be controlled by the amount of electric current. This results in quick motion picture response, high contrast and wide dynamic range, and rich color reproduction. In addition to digital signals, the Sony PVM-2551MD OLED Monitor accepts analog signals and converts them to digital signals. The Sony PVM-2551MD OLED Monitor is designed with the flexibility to support a variety of formats as standard and also has two built-in option slots to select, expand, and change input/output signals.

AI/ML Overview

Please note that the provided 510(k) summary for the Sony PVM-2551MD OLED Monitor does not describe a study involving AI or machine learning for medical diagnosis or classification. Therefore, I am unable to provide information on topics such as AI effectiveness, expert ground truth adjudication for AI, or training/test set details for AI.

The document describes a medical monitor, which is a display device, not an AI-powered diagnostic tool. The "Performance Testing" section is very brief and focuses on compliance with recognized standards for electromagnetic compatibility and electrical safety, which are typical for hardware devices.

Here's the information based on the provided document, with an emphasis on what is present and what is explicitly not present:

Acceptance Criteria and Device Performance Study for Sony PVM-2551MD OLED Monitor

This document describes the 510(k) submission for the Sony PVM-2551MD OLED Monitor, a color video monitor intended for displaying images captured during surgical procedures. The performance testing described focuses on the device's compliance with safety and electromagnetic compatibility standards, rather than diagnostic accuracy or an AI algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Stated)	Reported Device Performance
Electrical Safety	Compliance with recognized electrical safety standards.	"demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety."
Electromagnetic Compatibility (EMC)	Compliance with recognized EMC standards.	"demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety."
Image Display Functionality	Ability to provide color video displays of images from surgical camera systems, with features like accurate color reproduction, precision imaging, quality picture consistency, high-definition (1920x1080), 16:9 aspect ratio, 99.99% pixel efficiency, quick motion picture response, high contrast, wide dynamic range, rich color reproduction. (These are performance claims, not explicitly defined acceptance criteria in the context of a "study" here, but rather characteristics of the product.)	The device incorporates a 24.5-inch widescreen OLED panel and TRIMASTER™ technology to achieve these characteristics. It accepts analog and digital signals.
Equivalence to Predicate	Substantial equivalence to the Stryker Vision Elect WHDTV (K081995) in overall purpose and function, with differences not affecting safety or effectiveness.	The submission concludes substantial equivalence based on similarities in overall purpose and function.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. This document describes performance testing for a hardware display device, not an AI or diagnostic algorithm that would typically use a "test set" of patient data. The testing mentioned refers to engineering compliance tests.
Data Provenance: Not applicable. No patient data or medical images were used for performance evaluation in the context of a "test set" as understood for AI devices. The testing relates to the device's physical and electronic characteristics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth, in the context of medical image interpretation for an AI device, is not relevant to the evaluation of a display monitor.

4. Adjudication Method for the Test Set

Not applicable. No "test set" of medical cases requiring expert adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention an MRMC study. The device is a display monitor, and the study described is not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No. This device is a display monitor, not a standalone algorithm.

7. Type of Ground Truth Used

Not applicable. Ground truth for diagnostic accuracy is irrelevant for evaluating a medical display monitor's compliance with safety and EMC standards.

8. Sample Size for the Training Set

Not applicable. There is no AI or machine learning algorithm described, and thus no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI or machine learning algorithm described, and thus no training set or ground truth establishment relevant to AI.

Summary

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510(k) Summary for Sony PVM-2551MD OLED Monitor (per 21 CFR 807.92)

JUN 2 8 2012

1. APPLICANT / SPONSOR

Sony Electronics Inc. Sony Medical Systems Division 1 Sony Drive Park Ridge, NJ 07656

Contact Person: Ms. Aleta Moeller 201-358-4182 Telephone:

June 8, 2012 Date Prepared:

2. DEVICE NAME

Sony PVM-2551MD OLED Monitor Proprietary Name: Common/Usual Name: Monitor Endoscope and Accessories Classification Name:

3. PREDICATE DEVICE

· Stryker Vision Elect WHDTV, Stryker Endoscopy, K081995

4. DEVICE DESCRIPTION

OLED (an acronym for Organic Light-Emitting Diode) is a flat-panel screen technology that represents an advance in display technology. It is an emissive technology that generates light from each pixel. The process that is the basis of OLED is electroluminescence. In the Sony PVM-2551MD OLED Monitor, the OLED panel makes use of an organic material, which emits light when an electric Being self-emitting, the strength of luminescence can be current is applied.

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Ki20611

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controlled by the amount of electric current. This results in quick motion picture response, high contrast and wide dynamic range, and rich color reproduction.

In addition to digital signals, the Sony PVM-2551MD OLED Monitor accepts analog signals and converts them to digital signals.

The Sony PVM-2551MD OLED Monitor is designed with the flexibility to support a variety of formats as standard and also has two built-in option slots to select, expand, and change input/output signals.

5. INTENDED USE

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Sony PVM-2551MD OLED Monitor has the same overall purpose and function as the predicate device cited above. Both of the systems are intended to provide color video displays of images from surgical camera systems.

7. PERFORMANCE TESTING

Testing of the Sony PVM-2551MD OLED Monitor demonstrated that the device is in compliance with applicable requirements of recognized standards for electromagnetic compatibility and electrical safety.

8. CONCLUSION

Based on the similarities in overall purpose and function, the Sony PVM-2551MD OLED Monitor has demonstrated substantial equivalence to the cited predicate device and any differences do not affect the safety or effectiveness of the device.

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Image /page/2/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the people in the United States.

Public Health Service

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

JUN 2 8 2012

Sony Electronics, Incorporated % Aptiv Solutions Ms. Cynthia Sinclair Principal Consultant, Regulatory Services, Aptiv Solutions 49 Plain Street North Attleboro, Massachusetts 02760

Re: K120611

Trade/Device Name: Sony PVM-2551MD OLED Monitor Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, FET Dated: June 08, 2012 Received: June 11, 2012

Dear Ms. Sinclair:

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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Cynthia Sinclair

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

urs,

Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K12.0611

Indications for Use

510(k) Number (if known): K120611

Sony PVM-2551MD OLED Monitor Device Name:

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Osher for mxm

Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120611

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.