Search Results

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.

Model Wu-vwx-yz, where u = R or T; v=P or M; w=1 to 3; x= 1 to 6; y= 0 to 2; z=1 to 3, the ZeroWire wireless device is designed as a wireless transmitter and receiver pair which allows delivery of a video signal over a radio frequency link to video destination such as Radiance and Endo Vue devices. The device can operate on up to 9 channels.

This submission (K131115) is for a firmware modification to the existing ZeroWire Duo Wireless HD Video Transfer System (predicate device K100195), increasing the number of available channels from 3 to 9. The document states that clinical data is not needed for this type of wireless device according to 510(k) submission guidance. However, the submission does include test results in a clinical environment to demonstrate substantial equivalence to the predicate device.

Given this context, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" will be interpreted based on the provided information, which focuses on demonstrating equivalence rather than establishing new performance criteria for a novel device. The "acceptance criteria" here would be the successful demonstration of performance, safety, and effectiveness equivalent to the predicate device, as claimed in the conclusion.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size for the "test results in clinical environment." It simply states that such results were provided.
• Data Provenance: The document does not specify the country of origin. It does state that the test results were collected in a "clinical environment," implying a prospective or retrospective observational study or testing directly within a clinical setting. Given the context of showing equivalence for a firmware update, a prospective testing phase in a clinical environment is more likely.

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

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: This information is not provided in the document.

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method for the test set.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device for a firmware update to a wireless video transfer system, not on assessing human reader performance.

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

• The device is a "wireless video transfer system." Its performance is inherently about the quality and reliability of video transmission, not an AI algorithm performing a diagnostic task. The "test results in clinical environment" would assess the device's ability to transmit video without degradation or interference, which is a standalone performance assessment of the device's hardware and firmware. Therefore, implicitly, yes, a standalone performance assessment of the wireless video transfer capabilities was done.

7. The Type of Ground Truth Used

• For a wireless video transfer system, the "ground truth" would likely involve objective measures of video quality, signal integrity, latency, and reliability of the wireless link, assessed against a "gold standard" or expected performance during endoscopic and general surgical procedures. While not explicitly defined as "ground truth" in the diagnostic sense, the clinical environment test results would have compared the device's video output/performance against a known good reference or accepted clinical standard. It is not expert consensus, pathology, or outcomes data in the typical sense; rather, it relates to the technical fidelity of video transmission during surgical procedures.

8. The Sample Size for the Training Set

• The document is about a firmware modification for an existing device. It does not mention any machine learning or AI components that would require a "training set" in the traditional sense of AI algorithm development. Therefore, the concept of a training set sample size is not applicable here.

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

• As a training set is not applicable, this information is not provided.

Ask a specific question about this device