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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.

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.

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.

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