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The use of the SDC4K Information Management System with Device and Voice Control Package is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control Package or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The SDC4K Information Management System with Device and Voice Control Package is a network compatible hardware platform that carries out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.

The SDC4K Information Management System with Device and Voice Control Package consists of the following components:

• 1. SDC4K Console which includes:
  • a) Class I Medical Device Data System (MDDS) functionality
  • b) Optional Device Control feature
  • c) Optional Voice Control feature
• 2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
• 3. Voice Control Package (software activation USB dongle and a wireless headset and base station)
• 4. Connected OR Spoke (Class I MDDS)

The SDC4K console carries out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as a standalone device. When upgraded with the Device Control and/or Voice Control package, the SDC4K Console extends its functionality to control compatible devices from its touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices. In addition, the SDC4K Information Management System with Device and Voice Control Package also provides compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the SDC4K is connected to the Spoke, Device Control can be extended to compatible devices connected to the Spoke.

The provided FDA 510(k) summary for the SDC4K Information Management System with Device and Voice Control Package outlines its performance data through various tests. However, it does not include a detailed table of acceptance criteria and reported device performance for specific functional metrics, nor does it describe a study design that would prove the device meets such criteria in terms of accuracy or clinical effectiveness.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Connected OR Hub with Device and Voice Control, K212055) by verifying compliance with recognized standards.

Here's an attempt to answer your questions based only on the provided text, highlighting what is included and what is explicitly not included:

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

The document provides a table of tests conducted and their outcomes, indicating "Pass" for each. These are related to safety, EMC, software validation, usability, and bench performance based on specifications and intended use. Specific quantitative performance metrics (e.g., accuracy, latency, success rate for voice control commands) against defined acceptance criteria are not provided.

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

The document does not specify sample sizes for any test sets mentioned (e.g., for usability or bench performance). It also does not mention data provenance, as the tests are primarily engineering and compliance-based rather than involving patient data or clinical studies. The document explicitly states: "the subject device does not require clinical studies to support the determination of substantial equivalence."

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

This information is not provided in the document. The tests described are largely against technical standards and internal specifications, rather than requiring expert consensus on a "ground truth" derived from clinical data.

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

Adjudication methods are not described, as the type of studies conducted (compliance and engineering tests) typically do not involve such processes.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned and is not applicable to this device, as it is an information management and control system, not an AI-assisted diagnostic or interpretative tool. The document states "the subject device does not require clinical studies to support the determination of substantial equivalence."

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

The device itself (SDC4K Information Management System with Device and Voice Control Package) includes human interaction (remote control, voice control, GUI). Therefore, a "standalone algorithm only" performance without human-in-the-loop is not directly relevant or described. The performance bench tests would assess the functionality of the system components and their integration, but not in a purely algorithmic, non-interactive context.

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

The concept of "ground truth" as typically understood in the context of diagnostic or AI performance evaluation (e.g., against pathology reports or clinical outcomes) is not applicable to the type of testing described. The "ground truth" in this context would be the successful execution of device commands, adherence to electrical safety, EMC, software, and usability standards, and meeting internal device input specifications.

8. The sample size for the training set

This information is not applicable and not provided. The device is an information management and control system, not a machine learning or AI algorithm that relies on a "training set" for its core function (beyond potentially voice recognition models, which are likely integrated commercial solutions and their training data is not discussed here).

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

This information is not applicable and not provided for the reasons stated in point 8.

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The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.

The ZeroWire® wireless device is a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to a video display such as Radiance and EndoVue LCD surgical monitors.

The provided text is a 510(k) summary for the NDSsi ZeroWire Duo Wireless HD Video Transfer System. It states that "Clinical data is not needed for this type of wireless device 510(k) submission." Therefore, it does not include a study proving the device meets specific acceptance criteria based on clinical performance metrics such as sensitivity, specificity, accuracy, or reader performance.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Stryker Vision Elect Wireless High Definition Television / K081995) through non-clinical tests and surgical-setting tests. The "acceptance criteria" can be inferred from the claims of equivalence and the characteristics described for the device, rather than explicit numerical performance targets.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical performance metrics (like sensitivity, specificity, or accuracy) are not provided, the "acceptance criteria" here relate to the functional and safety equivalence to the predicate device, and the "reported device performance" is a statement of that equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "surgical-setting test results" but does not detail the number of cases, participants, or specific parameters of these tests.
• Data Provenance: Not explicitly stated. The document describes "surgical-setting test results" but does not specify the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) summary focused on substantial equivalence through non-clinical and "surgical-setting tests" (likely functional testing in a surgical environment), it's improbable to be large-scale clinical trial data.

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

• This information is not provided as the submission states, "Clinical data is not needed for this type of wireless device 510(k) submission." Therefore, there's no mention of experts establishing ground truth in the context of diagnostic accuracy or similar clinical outcomes. The "ground truth" for the non-clinical and surgical-setting tests would likely be objective measurements of video signal quality, latency, interference resistance, and adherence to technical standards.

4. Adjudication Method for the Test Set

• This information is not provided for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical data is not needed for this type of wireless device 510(k) submission." The comparison is primarily technical and functional equivalence to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The device is a hardware system (transmitter and receiver for video transfer), not an algorithm that produces interpretations or diagnoses. Therefore, the concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not applicable to this device. The "standalone" performance here would refer to its ability to transmit video signals effectively, which is covered by the non-clinical and surgical-setting tests.

7. The Type of Ground Truth Used

• As clinical data for diagnostic purposes was not required, the "ground truth" used would be based on technical specifications, objective measurements, and compliance with established standards (e.g., video resolution, latency measurements, signal strength, interference levels, adherence to EN 60601-1, EN 60601-1-2, and FCC Part 15).

8. The Sample Size for the Training Set

• This device is a hardware system; it does not involve a "training set" in the context of machine learning or AI algorithms. The system's design and engineering are based on established electronics and wireless communication principles.

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

• As there is no training set for an AI/ML algorithm, this question is not applicable.

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