The Stryker Vision Elect WHDTV (VE WHDTV) is intended for video display during surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The VE WHDTV is a non-sterile reusable device not intended for use in the sterile field. The VE WHDTV is intended for use by qualified physicians having complete knowledge of these surgical procedures.

Device Description

The Vision Elect WHDTV (VE WHDTV) is a high-definition, widescreen LCD surgical display with a maximum resolution of WUXGA (1920 × 1200 at 60 Hz). The VE WHDTV supports various video inputs, including digital RGB, analog RGB, serial digital interface (SDI), component video (YPbPr/RGB), S-video, and C-video.

The VE WHDTV features an optional optical module accessory, which allows it to receive a high-definition video signal over fiber optic cables. It also features an optional wireless transmitter, which allows it to receive a high-definition video signal over a radio-frequency link.

AI/ML Overview

The provided 510(k) summary for the Stryker Vision Elect WHDTV focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software function. This document describes a traditional medical device (a display monitor) and its accessories, not an AI or algorithm-driven system.

Therefore, most of the requested information regarding acceptance criteria, study design parameters (sample size, data provenance, ground truth, adjudication, MRMC studies, standalone performance), and training set details are not applicable or available in this document.

Here's an analysis based on the provided text, highlighting what is present and what is missing based on your request:

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

Acceptance Criteria: The document implies acceptance criteria based on established electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and radio frequency device (47 CFR Part 15) requirements. However, specific performance thresholds (e.g., minimum brightness, contrast ratio, color accuracy, latency) are not explicitly stated in a tabular or descriptive format.
Reported Device Performance: The document states the device has a "maximum resolution of WUXGA (1920 × 1200 at 60 Hz)" and supports various video inputs. This is a technical specification, not a performance metric against specific acceptance criteria.
Missing from Document: Specific, measurable performance acceptance criteria (e.g., "display must achieve a contrast ratio of X:1" or "latency must be less than Y milliseconds") are not provided. There are no performance results presented in the context of meeting such criteria.

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

Not Applicable/Not Provided: This device is a display monitor. Evaluation for substantial equivalence typically involves engineering testing against standards and functional verification, not clinical studies with "test sets" of data or patients in the sense an AI algorithm would be evaluated. Therefore, no sample size, data provenance, or study type (retrospective/prospective) for a test set is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Provided: As this is a hardware display device, the concept of "ground truth" established by medical experts for a test set is not relevant to its regulatory submission for substantial equivalence.

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

Not Applicable/Not Provided: No adjudication method is mentioned as there is no test set or expert evaluation of medical 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

Not Applicable/Not Provided: MRMC studies are used for evaluating diagnostic performance, often with AI. This device is a display, not a diagnostic tool or AI assistance system.

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

Not Applicable/Not Provided: This device is a display, not an algorithm.

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

Not Applicable/Not Provided: The concept of "ground truth" in this context is irrelevant to the submission for a display monitor.

8. The sample size for the training set

Not Applicable/Not Provided: As this is a hardware device and not an AI/ML algorithm, there is no "training set."

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

Not Applicable/Not Provided: No training set exists for this device.

Summary of what the document does provide:

Device description: A high-definition, widescreen LCD surgical display with specific resolution and input capabilities.
Intended Use: Video display during various surgical procedures (arthroscopy, laparoscopy, thorascopy, endoscopy, general surgery) by qualified physicians. It is a non-sterile, reusable device.
Predicate Device: Stryker Vision Elect HDTV (non-510(k) cleared, Class I device).
Basis for Equivalence: Same intended use, technological differences (wireless and optical module optional additions, WHDTV vs. HDTV) do not raise new questions of safety and efficacy compared to the predicate.
Compliance with Standards: The device and its accessories will meet electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and radio frequency (47 CFR Part 15) requirements. These standards act as the "acceptance criteria" for basic safety and performance, but specific quantitative pass/fail values are not listed.

Summary

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stryker

Endoscopy

510(k) SUMMARY

Device Sponsor:

OCT - 2 2008

Sponsor andManufacturer:	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138FDA Registration # 2936485
CorrespondenceRegarding this 510(k):	Monica BarrettSr. Regulatory Affairs RepresentativeStryker Endoscopy5900 Optical CourtSan Jose, CAt: 408-754-2078f: 408-754-2521monica.barrett@stryker.com

Device Name:

Proprietary Name:	Stryker Vision Elect WHDTV
Common and Usual Name:	television, monitor, screen, display, flat panel, flat screen
Classification Name:	General & Plastic Surgery Devices PanelSurgical camera and accessoriesClass I, 21 CFR 878.4160Product Code FWF

Predicate Device:

The VE WHDTV is substantially equivalent in terms of safety and efficacy to currently available viewing systems on the market including the Stryker Vision Elect HDTV.

Device Description:

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Endoscopy

The VE WHDTV and its accessories will meet the necessary electrical safety (IEC 60601-1), EMC (IEC 60601-1-2) and radio frequency device (47 CFR part 15) requirements.

Intended Use:

Predicate Device:

The Stryker Vision Elect WHDTV is substantially equivalent in terms of safety and efficacy to the currently marketed devices including the Stryker Vision Elect HDTV.

Name: Stryker Vision Elect HDTV Manufacturer: Stryker Endoscopy 510(k) #: N/A, Class I, 21 CFR 878.4160 Surgical camera and accessories

Substantial Equivalence:

When compared to the predicated device listed above, the Stryker VE WHDTV has the same intended use and the technological differences do not raise new questions of safety and efficacy. Therefore, the Stryker VE WHDTV is substantially equivalent to the predicate marketed device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Endoscopy % Ms. Monica Barrett Senior Regulatory Affairs Representative 5900 Optical Court San Jose, California 95138

OCT - 2 2008

Re: K081995

Trade/Device Name: Stryker Vision Elect Wireless High Definition Television (Stryker VE WHDTV)

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories. Regulatory Class: II Product Code: GCJ Dated: Scptember 11, 2008 Received: September 11, 2008

Dear Ms. Barrett:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. Monica Barrett

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,

Sincerely vours.

Mark N. Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Device Name: Stryker Vision Elect Wireless High Definition Television (Stryker VE WHDTV).

<081995 510(k) Number if known:

Contraindications:

There are no contraindications for this product.

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 Device Evaluation (ODE)

Mark Millerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K081995

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.