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The ENDOFLOW® II Irrigation, Warming and Suction System is indicated for use in medical facilities under direction of a trained physician during endo-urology, hysteroscopy and laparoscopy procedures in order to fill and/or wash different operating cavities.

The ENDOFLOW® II System includes the electro medical device and a full range of disposables dedicated to perform endoscopic procedures for Endo-urology, Hysteroscopy and Laparoscopy surgerv. The ENDOFLOW® II System is a complete fluid management system permitting, all-in-one, the control of the Irrigation, the temperature of the fluid and the suction. The ENDOFLOW® II permits a continuous and non-pulsating liquid flow to inflate and clean the surgical field and to improve the surgeon's visibility. With the ENDOFLOW® II system, the indicated pressure on the machine is identical to the pressure in the cavity. The ENDOFLOW® II heats and maintains the fluid bag at 38°C during the entire procedure. The user can disable this function. The ENDOFLOW® II, in its double chamber version, MEN02PUS, offers an aspiration system that can be activated with the touch screen and/or a footswitch.

The provided text is a 510(k) summary for the device ENDOFLOW II – Irrigation, Warming and Suction System. It outlines the device's intended use and compares its technological characteristics and functions to predicate devices to establish substantial equivalence.

However, the document does not contain specific details about acceptance criteria, reported device performance figures, sample sizes, data provenance, expert qualifications, ground truth establishment methods, or the results of any multi-reader multi-case (MRMC) or standalone comparative effectiveness studies.

The "H. Performance Data" section merely states: "Performance testing have been executed to validate the performance and safety of the devices. Verification and validation activities were conducted to establish the performance and safety characteristics of the ENDOFLOW® II. The results of these activities demonstrate that the ENDOFLOW® II is safe and effective when used in accordance with its intended use and labeling." This is a general statement and does not provide the requested detailed information about the study or its outcomes.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, and data provenance based on the provided text. The document confirms that performance testing was performed and that the device was found safe and effective, but it doesn't offer the detailed evidence of that testing.

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The EndoGator® Advantage CO2 Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

The EndoGator Advantage CO2 Insufflator EGA-501 is indicated to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. It is intended to be used for delivery of CO2 via an endoscope system to provide improved visualization during gastrointestinal endoscopic procedures.

The EndoGator Advantage CO2 Insufflator operates by receiving CO2 from a pressurized source and requlating it down to a lower pressure and flow rate by means of a two-stage pressure regulator and flow restrictor system. The device controls delivery of CO2 to an endoscope system for eventual use as a distention media in endoscopic procedures.

The output flow rate is user adjustable and can be set at low, medium or high settings. Flow is controlled by a system of electrical solenoid flow restrictors. The device contains a pressure relief safety valve as a redundant safety backup to the pressure regulator system.

The EndoGator Advantage CO2 Insufflator includes a CO2 warming feature that allows the clinician to modulate and control delivery of CO2 that has been warmed to a target temperature of 37°C. The insufflator warms CO2 using a flow-through heating element with built-in dual redundant resistance temperature detector sensors and an added safety thermostat.

The device design also contains an optional feature that allows for connection of an externally attachable water bottle warmer accessory. The water bottle warmer system design is identical to the design used in the related Endogator Advantage Irrigation Pump EGA-500 (K113119). The feature was included in the insufflator design to provide the user with the option for warm water irrigation in the event that they choose to use an alternative irrigation pump to the EGA-500.

The provided text is a 510(k) summary for a medical device, the EndoGator Advantage CO2 Insufflator EGA-501. It details the device's description, indications for use, comparison to a predicate device, and a summary of non-clinical performance data. However, it does not describe acceptance criteria for specific performance metrics or the detailed study results that prove the device meets these criteria. It lists types of non-clinical tests performed, but not the quantitative outcomes or acceptance thresholds.

Given the information provided, I cannot fulfill all parts of your request. Specifically, the document is a regulatory submission summary, and typically these summaries do not include precise acceptance criteria tables or detailed study results with sample sizes, expert qualifications, or ground truth establishment methods for specific performance metrics. These details would be in the full submission, which is not provided.

Therefore, I can only provide information based on what is available in the text.

Here's what can be extracted and formatted, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance results. It states that "evaluation and testing has been performed to demonstrate that the differences do not impact device safety or performance, and any risks associated with the differences are acceptable." It also lists the types of tests conducted:

Explanation for Missing Details: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device ("E-Z-EM Endoscopic CO2 Regulator"). For such submissions, detailed quantitative performance thresholds and results are often contained in the full submission, not in the publicly available summary. The summary confirms that "testing has been performed to demonstrate that the differences do not impact device safety or performance, and any risks associated with the differences are acceptable," indicating that the device did meet unstated acceptance criteria.

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

The document does not specify sample sizes for any of the non-clinical tests performed. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). Given that the tests are described as "bench testing," they would be performed in a laboratory setting, not with patient data.

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

This information is not applicable and therefore missing. The document describes "bench testing" of a physical device, not an algorithm that requires expert-established ground truth from images or clinical data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore missing. The tests are for a physical device's performance, not an interpretative algorithm requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is a 510(k) submission for a physical medical device (CO2 insufflator), not an AI algorithm that would typically undergo MRMC studies.

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

This question is not applicable. The device is a physical insufflator, not an algorithm. Therefore, "standalone" performance in this context refers to the device operating by itself, which is implicitly what the "bench testing" covers.

7. The Type of Ground Truth Used

For a physical device, "ground truth" typically refers to established engineering specifications, validated measurement techniques, and industry standards. The testing described (e.g., CO2 flow, pressure, temperature, electrical safety) would be validated against these objective physical measurements and standards (e.g., IEC 60601-1). It does not involve "expert consensus, pathology, or outcomes data" in the way an AI diagnostic tool would.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical insufflator, not an AI algorithm that requires a training set.

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

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

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