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The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures.

The subject device is composed of Gas Insufflator Unit (Model GVS100) and accessories Highpressure Gas Pipe, Insufflation Tubing Set (Model GI-S001), and power adapter). The Insufflation Tubing Set is provided sterile and disposable. The Gas Insufflator Unit is nonsterile, reusable, and AC-powered (100 - 240 VAC, 50/60 Hz, 200 W).

The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity to generate and maintain pneumoperitoneum during laparoscopic diagnosis and/or surgical treatment. The Gas Insufflator controls gas pressure and flow rate by the solenoid valve. The touchscreen displays the gas pressure and flow output. The Gas Insufflator is insufflate CO2 to a body cavity up to 30 mmHg/40 LPM for Adult mode and 15 mmHg/15 LPM for Child mode.

The Gas Insufflator is for professional healthcare environment use.

The provided text describes the acceptance criteria and the study conducted for the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Gas Insufflator (K221995).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing rather than specific "acceptance criteria" in a tabular format with corresponding reported performance. However, the "Comparison of the technological characteristics" table (Table 1) acts as a de-facto acceptance criteria by demonstrating similarity or equivalence to the predicate device. The "Bench Performance testing" section lists tests conducted to demonstrate performance and safety features.

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

The document describes bench testing, software validation, sterility testing, and electrical safety/EMC testing. There is no mention of a "test set" in the context of patient data or clinical studies. The testing is performed on the device itself or its components (e.g., insufflation tubing set). Therefore, "sample size" in terms of patient data and "data provenance" (country of origin, retrospective/prospective) are not applicable here as this is a medical device clearance for a Gas Insufflator, not an AI/diagnostic software.

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

This information is not applicable as the device is a Gas Insufflator, not a diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable for the same reasons as above.

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:

This information is not applicable as the device is a Gas Insufflator, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable as the device is a physical medical device (Gas Insufflator), not an algorithm or AI.

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

The "ground truth" for this device's performance is established by engineering and regulatory standards (e.g., IEC, ISO, ASTM) and pre-defined performance specifications related to pressure, flow rate, safety alarms, and electrical characteristics. For example, the accuracy of gas pressure is measured against a known standard.

8. The sample size for the training set:

This information is not applicable as the device is a Gas Insufflator, not an AI/machine learning model that requires a "training set."

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

This information is not applicable for the same reasons as above.

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