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The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.

The provided text describes the ENDOGATOR™ Hybrid Irrigation Tubing, a device for providing irrigation and supplying air/CO2 during GI endoscopic procedures. It compares this device to a predicate device (Universal Irrigation Solution Hybrid, K102855).

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of acceptance criteria and the reported device performance

Biocompatibility Testing:

• Requirements: Evaluated in accordance with ISO 10993-1:2018 for "Surface - Mucosal Membrane" with a contact duration of "Limited (< 24 hours)".
• Tests Performed: Cytotoxicity, Irritation, and Sensitization.
• Reported Device Performance: All evaluation acceptance criteria were met.

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

The document does not explicitly state the sample size for the test set for any of the performance tests. It only lists the tests performed and their outcomes ("Pass").

The data provenance is presented as "Non-clinical testing", which implies lab or bench testing rather than clinical data from human subjects. The document does not specify the country of origin of the data; however, Medivators Inc. is located in Minneapolis, Minnesota, USA, which suggests the testing was likely conducted in the US or under US regulatory standards. The data is retrospective in nature, as it was provided to support a 510(k) premarket notification.

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

Not applicable. This is a medical device (tubing and accessories) that does not involve algorithmic or diagnostic assessment requiring expert ground truth for its performance evaluation (e.g., image interpretation). The performance data cited are objective engineering and material testing results (e.g., flow rates, pressure resistance, pull force, biocompatibility).

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

Not applicable. As described above, the performance tests for this device are objective physical and chemical evaluations, not subjective assessments requiring expert adjudication.

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 is a piece of medical tubing and accessories, not an AI or diagnostic imaging system. Therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This device is not an algorithm or AI system.

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

For the performance tests:

• Water Flow Rate, Insufflation Air & CO2 Flow, Lens Rinsing Flow Rate: Measured values against predefined thresholds relative to the predicate device.
• Backflow Test: Pressure resistance measurement (withstanding at least 10 PSI).
• Durability of glue bonded connections: Axial pull force measurement (meeting or exceeding 10 lbs) and strength/durability requirements after sterilization.
• Biocompatibility: Conformance to ISO 10993-1:2018 standards, evaluated via specific laboratory tests (Cytotoxicity, Irritation, Sensitization).

The "ground truth" here is the objective measurement against established physical and biological standards and performance relative to the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

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The EndoGator Endoscopy Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

The ENDOGATOR Endoscopy Irrigation Tubing is composed of the following: 1) EndoGator™ Irrigation Tubing, and 2) EndoGator™ Irrigation Accessories. The ENDOGATOR Endoscopy Irrigation Tubing is indicated for irrigation during endoscopic procedures by using it in conjunction with an irrigation pump or cautery units, irrigation accessory, endoscope and disposable sterile water bottle. All tubing sets contain a back flow valve at the distal tip that allows irrigation water to travel in one direction, and therefore the risk of cross contamination is significantly reduced. The irrigation tubing sets are for twenty-four hour use and are to be discarded daily. The accessories are single-use devices and are to be discarded between patients. Tubing sets do not come into direct contact with patient tissue.

The provided text describes the 510(k) Summary for the ENDOGATOR Endoscopy Irrigation Tubing. This document details a medical device and its comparison to a predicate device for substantial equivalence with the FDA. It does not contain information about the acceptance criteria and study design for an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML powered medical device, nor can I describe a study proving the device meets said criteria from this document. The document pertains to non-clinical performance testing of irrigation tubing, not an AI/ML diagnostic or therapeutic device.

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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.

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.

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.

Study Information (Based on the provided text):

2. 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.

3. 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.

4. 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.

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 is not an AI-assisted device, nor does the document describe a human reader study.

6. 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.

7. 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).

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device; there is no "training set."

9. 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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The EndoGator™ system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

The Byrne Medical EndoGator™ System is composed of the following:

• 1. EndoGator™ Irrigation Tubing, and
• 2. EndoGator™ Irrigation Accessories

The EndoGator™ System consists of a bottle cap/tube set/connector made from materials that are appropriate for the application. The EndoGator™ Cartridge is a replacement for some predicate device water systems.

The provided text describes a 510(k) premarket notification for the “EndoGator™ System,” a device intended to provide irrigation during GI endoscopic procedures. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement. Therefore, many of the requested elements for a detailed study description are not available in the provided document.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

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

Explanation: The document does not specify quantitative acceptance criteria (e.g., minimum flow rate, maximum pressure deviation). Instead, the primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to existing legally marketed devices (predicates). The reported performance is a qualitative statement that the device was tested for flow and pressure and found to be functionally equivalent.

2. 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. The document only states "representative scopes" were used for flow and pressure testing.
• Data Provenance: Not specified, but likely internal testing by Byrne Medical, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The ground truth for this type of device (a water bottle adapter for irrigation) is physical performance (flow, pressure, material compatibility) rather than diagnostic accuracy requiring expert interpretation.

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

Not applicable. No expert adjudication process is described or implied for the performance testing of this mechanical device.

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 is not an AI-powered diagnostic or assistive tool, so an MRMC comparative effectiveness study involving human readers and AI is irrelevant.

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

Not applicable. This is a mechanical accessory, not an algorithm.

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

The "ground truth" for the performance testing would be established engineering standards and validated measurement techniques for flow rate and pressure, combined with material science evaluations. The document refers to "extensive safety, performance, and validations" and "real-time flow rate data was collected," indicating a focus on physical performance rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

Not applicable. (See #8)

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Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.

The Byrne Medical, Inc., EndoGator Endoscopy Irrigation Pump is used for Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.

The EGP-100 pump will provide an adjustable flow-rate from 0-550ml/min, which is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. A foot pedal activated air switch controls the running or stopping of the purnp motor and a peristaltic pump head. These parts will not cause contamination of sterile water during deliverance.

The provided document states that the Byrne Medical, Inc. EndoGator Endoscopy Irrigation Pump is substantially equivalent to its predicate device, the Meditron Endolav Model EL-100 (K882048), based on a comparison of specifications and the successful completion of EMI and Safety Testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device's performance in the traditional sense of a clinical study. Instead, it compares the specifications of the EndoGator EGP-100 to its predicate device, the Meditron Endovav EL-100, as part of demonstrating substantial equivalence. The "acceptance criteria" here are implied to be achieving comparable or superior performance to the predicate device for relevant parameters, and meeting safety/EMC standards.

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

The document does not describe a "test set" in the context of clinical data or patient samples. The evaluation is based on a comparison of device specifications and the results of engineering tests (EMI and Safety). Therefore, there is no sample size for a test set, nor data provenance (country of origin, retrospective/prospective).

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

Not applicable. As there is no clinical "test set" with ground truth established by experts, this information is not provided. The substantial equivalence relies on comparing technical specifications and engineering test results.

4. Adjudication method for the test set

Not applicable. There is no clinical "test set" requiring an adjudication method.

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 is an irrigation pump, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a mechanical pump, not an algorithm.

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

The "ground truth" for the device's performance, in the context of this 510(k) submission, is established through:

• Comparison to a legally marketed predicate device's established performance and specifications.
• Engineering standards and testing: Specifically, EMI (Electromagnetic Interference) and Safety Testing (referred to as "Test Review" and affirmed in the "Conclusions"). These tests verify the device's electrical and mechanical integrity against recognized standards.

8. The sample size for the training set

Not applicable. This device is a mechanical pump, not a learning algorithm that requires a training set.

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

Not applicable for the same reason as above.

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