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THE NORTECH GAS WARMING UNIT IS INDICATED FOR WARMING GAS (95-1069F / 35-41℃) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.

The CO2 Gas Warming Unit is designed to be used in conjunction with an insufflator to provide continuous non-adiustable heating of gas to a laparoscopic instrument. The CO2 Gas Warming Unit is comprised of a control unit and heat exchanger(available as disposable or re-usable) and power cords.

This document describes the Nortech CO2 Gas Warming Unit, which is a medical device designed to warm CO2 gas used during laparoscopic procedures. The provided content is a summary of safety and effectiveness, an FDA clearance letter, and the indications for use. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a predicate device rather than undergoing a de novo approval process based on novel safety and effectiveness studies.

As such, the information typically found for novel device approvals regarding acceptance criteria, performance studies with specific statistical metrics (like sensitivity, specificity, AUC), training/test set details, ground truth establishment, and MRMC studies, is not present in the provided text. The FDA 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot fulfill all parts of your request as the information is not contained within the provided document.

Here's an analysis based on the available information:

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

The document does not explicitly state acceptance criteria or report performance in terms of statistical efficacy metrics (e.g., sensitivity, specificity, accuracy) like a new diagnostic or prognostic device would. Instead, the submission focuses on demonstrating substantial equivalence to existing devices.

The "Indications For Use" section provides the desired operating range for the device's primary function:

• Acceptance Criteria (Implicit from Indications For Use): The device should warm gas to a temperature range of 95-106°F / 35-41°C.
• Reported Device Performance: The document states, "THE NORTECH GAS WARMING UNIT IS INDICATED FOR WARMING GAS (95-106°F / 35-41°C)..." This implies that the device is designed and demonstrated to operate within this range, meeting its intended function. However, no specific performance data from a clinical trial or bench test is provided in this summary.

2. Sample size used for the test set and the data provenance

Not applicable. This is a 510(k) submission for a physical device, not an AI or diagnostic algorithm that would typically involve a test set of data/images. The "studies" for such a device would likely involve engineering verification and validation tests (e.g., temperature accuracy, flow rate stability, durability) rather than a clinical dataset. The document does not provide details of such tests.

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

Not applicable. As noted above, this is a physical medical device, not a diagnostic or AI system requiring expert-adjudicated ground truth.

4. Adjudication method for the test set

Not applicable.

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. This device does not involve human readers or AI assistance.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

Not applicable in the context of diagnostic performance. For a device like this, ground truth would refer to accurately measured physical parameters (e.g., gas temperature measured by a calibrated thermometer). The document implicitly suggests that the device's output temperature would be compared against these calibrated measurements to ensure it falls within the specified range.

8. The sample size for the training set

Not applicable. This is not a machine learning model.

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

Not applicable.

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