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The EndoGator Advantage Irrigation Pump is indicated for endoscopic irrigation for use with washing catheters, integral endoscope water jet channels and endoscope working channels.

Device Description

The EndoGator Advantage Irrigation Pump EGA-500 is the second generation development of the current Byrne Medical EGP-100 Irrigation Pump. The EndoGator Advantage provides for a slightly higher flow rate of endoscope irrigation water and contains an attached water bottle heater to afford the clinician the option of performing water irrigation with warmed water as compared to room temperature.

The EndoGator Advantage Irrigation Pump works by turning a peristaltic roller pump head to move liquid through a tube set and into an endoscope system. The pump head will not operate if the pump head is open, and will cease to operate if the pump head is opened while the motor is activated. The unit incorporates a "Prime" feature which allows the unit to operate for a predetermined period of time.

The device includes a water bottle warming cradle that is intended to maintain a bottle of sterile water for irrigation at a target temperature of 37°C with a tolerance of ±3°C. The water bottle heating element is attached to the underside of the aluminum cradle which then conducts heat through the bottle to warm the water. The heating element is controlled by dual temperature sensors for redundancy and safety.

AI/ML Overview

This document describes the EndoGator Advantage Irrigation Pump EGA-500, a medical device. The information provided is primarily for a 510(k) submission, focusing on establishing substantial equivalence to predicate devices, rather than a study proving the device meets explicit acceptance criteria in the context of AI/algorithm performance.

Therefore, many of the requested items related to AI/algorithm performance, such as test set sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or cannot be extracted from the provided text.

However, based on the non-clinical performance data and device description, we can infer some aspects related to acceptance criteria and how they were addressed.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/algorithm-based device and the document describes a 510(k) submission for an irrigation pump, the "acceptance criteria" are derived from the performance claims and testing conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" reflects the successful outcomes of these tests.

Acceptance Criteria Category	Specific Criteria (Inferred from testing)	Reported Device Performance/Conclusion
Flow and Pressure	Equivalent or acceptable flow and pressure characteristics compared to predicate devices.	"Flow and pressure comparison" was performed, implying that the EGA-500 demonstrated comparable or acceptable performance to the predicate EndoGator EGP-100 and Olympus AFU-100.
Water Temperature	Maintain target temperature of 37°C ±3°C for sterile water for irrigation.	"Water temperature consistency and distribution" and "Heater performance" testing were conducted. The device aims to maintain water at a target temperature of 37°C ±3°C, and the testing supports this capability. The added water warming feature is deemed acceptable as it introduces water heated to approximately the same temperature as surrounding GI tissues.
Pump Performance	Reliable and consistent operation of the peristaltic roller pump head.	"Pump performance" testing was conducted to ensure the pump operates consistently and reliably. The description notes safety features like the pump head not operating when open and ceasing operation if opened during activation, and a "Prime" feature.
Safety - Electrical	Compliance with IEC 60601-1 (Electrical safety).	The device meets "Electrical safety IEC 60601-1" standards, indicating it passed relevant electrical safety tests.
Safety - EMC	Compliance with IEC 60601-1-2 (Electromagnetic compatibility).	The device meets "Electromagnetic compatibility IEC 60601-1-2" standards, indicating it passed relevant EMC tests.
Simulated Use	Safe and effective operation in simulated clinical settings.	"Simulated-use" testing was performed, suggesting the device functioned as intended under conditions mimicking its intended use.
Risk Analysis	Identification and mitigation of potential risks.	"Risk analysis" was conducted. The document states that "Any additional risks presented by the added water warming feature on the subject device are acceptable because it is simply being used to introduce water that is heated to approximately the same temperature as the surrounding tissues in gastrointestinal (GI) tract," implying that identified risks were assessed and deemed acceptable or mitigated.
Indications for Use	Equivalent indications for use as predicate devices.	The device has "equivalent indications for use as the predicate devices." All devices share the same intended performance and method of sterile water irrigation during GI endoscopy.

Study Information (Based on the provided text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. Bench testing was performed on the device itself.
- Data Provenance: Not specified. Testing was conducted by Medivators, a US-based company, likely implying testing occurred in the USA. The data would be prospective as it was generated specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a non-AI medical device; "ground truth" in the context of expert consensus on images or outcomes is not relevant here. Device performance criteria were likely established by engineering and regulatory standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is typically relevant for studies involving human interpretation or subjective assessments, not for bench testing of device performance against engineering specifications.
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 is not an AI-assisted device, nor does the document describe a human reader study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (irrigation pump), not an algorithm. The "standalone" performance here refers to the device operating on its own as designed, which is inherent in the "bench testing" mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the conventional sense. For this device, the "ground truth" or reference for assessment would be:
  - Engineering specifications and design requirements: For pump performance, flow rates, and pressure.
  - Regulatory standards: Such as IEC 60601-1 and IEC 60601-1-2 for electrical safety and EMC.
  - Predicate device performance: For comparative equivalence of function.
  - Thermodynamic principles/specifications: For temperature control (37°C ±3°C).
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device; there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.

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