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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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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 Universal Irrigation Solution Hybrid™ (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 aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.

The Universal Irrigation Solution Hybrid™ (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 aCO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit. It is a disposable, sterile device.

Acceptance Criteria and Study for Byrne Medical, Inc., Universal Irrigation Solution Hybrid™

This document analyzes the provided information regarding the Byrne Medical, Inc., Universal Irrigation Solution Hybrid™ to extract the acceptance criteria and details of the study supporting its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a comparison to two predicate devices rather than explicit acceptance criteria in the traditional sense (e.g., specific thresholds for accuracy, sensitivity, or specificity). Instead, the performance of the Universal Irrigation Solution Hybrid™ is deemed acceptable if it meets or exceeds the performance of the predicate devices for each function.

2. Sample Size for Test Set and Data Provenance

The provided text does not explicitly state the sample size used for the comparative testing. It refers to "comparative testing" and "data results generated" but does not quantify the number of tests, devices, or procedures involved.

The data provenance is also not specified. The document does not indicate the country of origin of the data or whether the study was retrospective or prospective. It appears to be an internal performance evaluation for the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not mention the use of experts to establish ground truth for the test set. The study focuses on direct performance comparisons against predicate devices rather than expert interpretation of results.

4. Adjudication Method

The provided text does not describe an adjudication method. Since the study appears to be a direct performance comparison, there is no indication of expert review or consensus building for results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information details a technical comparison of device performance against predicates, not a study involving human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

The device described is a medical instrument (tubing and accessories for irrigation/insufflation during endoscopy), not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted. The study assesses the physical performance of the device itself.

7. Type of Ground Truth Used

The "ground truth" for this type of device comparison is based on the objective performance characteristics of the predicate devices. The new device's performance (e.g., flow rate, delivery speed) is measured and compared directly to the established performance of the legally marketed predicate devices. This represents a form of empirical performance data from the predicate devices.

8. Sample Size for Training Set

This question is not applicable as the device is not an AI/ML algorithm that requires a training set. The study concerns the physical performance of a medical device.

9. How Ground Truth for Training Set was Established

This question is not applicable as the device is not an AI/ML algorithm that requires a training set.

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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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The Byrne Medical Irrigation Channel Tubing is used with the Byrne Medical Endo Gallerian Channel The Bear The bythe Medical Inigation Chambr Tablish of an and goes down the channel of an Endoscope. The Byrne Connical Irrigation Channel Tubing is provided sterile and is labeled for single use only.

100135 – Byrne Medical Irrigation Channel Tubing provides extension tubing to 100135 – Byrne Medical Inigation Onanor Tubing provides with System is utilized the Endodator - Gyor to clean the Endoscope lens area. to provide libio (water) to clouit the Endoospop as a steriie, single patient use The Endo Gallor ™ System labing solo are cold as a strile, In with product label affixed to the clear side of the package.

The provided text describes a 510(k) premarket notification for an "Irrigation Channel Tubing System" (Model 100135) by Byrne Medical, Inc. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and device performance metrics as would typically be found in an AI/software device submission.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets are not applicable to this type of regulatory submission. This document describes a physical medical device, not a software algorithm.

However, I can extract the relevant information regarding the testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical data. The testing described is bench testing of the physical device.

• Sample Size: Not explicitly stated how many units were tested for flow and pressure, nor how many "pump cycles" were performed. It generally refers to "the system" being tested.
• Data Provenance: N/A (Bench testing, not human data).

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

N/A. This was bench testing of a physical device, not an AI/software device requiring expert-established ground truth for interpretation.

4. Adjudication Method for the Test Set

N/A. This was bench testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This was bench testing of a physical device, not an AI/software device. No human readers or comparison with/without AI assistance was performed.

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

N/A. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the bench tests was derived from empirical measurements against engineering specifications and the performance of the known predicate devices.

• Flow Rate: Measured volume over time.
• Pressure: Observation of leaks/failures.

8. The Sample Size for the Training Set

N/A. This is a physical device, not an algorithm or AI model that requires a training set.

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

N/A. Not applicable as there is no training set for a physical device.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study described is bench testing conducted by Byrne Medical, Inc. on their Irrigation Channel Tubing System, Model 100135.

• Testing Method:
  • Bench testing utilized Meditron UGI-3000B™ GI Endoscopy Pumps and EndoGator™ Cartridge and tubing sets.
  • Flow testing: Measured total volume over time at minimum and maximum pump settings.
  • Pressure testing: The system was tested to a pressure of 10 PSI.
• Results:
  • Flow testing demonstrated flow rates of 155 ml/min at the minimum pump setting and 650 ml/min at the maximum pump setting, with a measurement error of +/- 4%.
  • Pressure testing showed the system withstood 10 PSI without leaking or any other failure, exceeding the pump manufacturer's stated maximum pressure of 4.4 PSI.
• Conclusion: Based on these bench tests, the manufacturer concluded that the Byrne Medical Endo Gator™ Irrigation Channel Tubing system is equivalent in safety and efficacy to its predicate devices.

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The Endo Gator Irrigation Tubing is intended as sterile, disposable water bottle tubing with cap and back-flow device that supplies sterile water to irrigation pumps and cauterizing units.

The Endo Gator Cartridge is intended as a replacement cartidge for irrigation pumps or cauterizing units for use with the Endo Gator disposable water bottle tubing and cap.

The Auxiliary Water-port tubing for the Olympus Endoscopes is intended as a replacement for the existing water-port tubing make by Olympus for the 160 Series of Endoscopes.

The Byrne Medical Endo Gator System consists of the following assemblies:

• 100125 Endo Gator Irrigation Tubing A sterile, disposable water bottle A tubing with cap and back-flow device which supplies sterile water to irrigation pump or cauterizing units. Works only with the Endo Gator Cartridge.
• 100110 Endo Gator Cartridge Replacement cartridge for imgation pump(s) A or cauterizing units. The cartridge hub is designed to seat the Endo Gator Tubing and replace the existing cartridge from the pump manufacturer.
• 2 100115 Auxiliary Water-port Tubing for Olympus Scopes A sterile, disposable water irrigation tubing that replaces the existing water-port tubing made by Olympus for the 160 Series of scopes.
  The Endo Gator System tubing sets are sold as a sterile, single patient use devices. It is packaged in a Chevron-style sterile barrier pouch with product label affixed to the clear side of the package. The Endo Gator Cartridge is reusable and is sold not sterile.

The provided text is a 510(k) summary for the "Endo Gator System" by Byrne Medical, Inc. It describes the device, its intended use, and a comparison to predicate devices, along with some test data. However, the document does NOT contain a formal study that proves the device meets specific acceptance criteria in the way a clinical trial or a performance study for an AI/diagnostic device would.

The "Study" section below is based on the "Test Data" provided, which is limited to bench testing. The document does not describe a clinical study, a multi-reader multi-case study, or a standalone performance study with human subjects or radiologists.

Here's the information extracted and formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test (flow, pressure). The "Endo Gator System" (tubing sets and cartridge) was used in the bench tests, but the number of units tested is not provided.
• Data Provenance: Retrospective bench testing. No country of origin for data is specified, but the manufacturer is based in the USA.

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

Not applicable. The ground truth was established through physical measurements (flow rate, pressure integrity) in a laboratory/bench testing setting, not through expert interpretation of data.

4. Adjudication method for the test set

Not applicable. The tests involved physical device performance measurements, not interpretative assessments requiring 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

No. An MRMC comparative effectiveness study was not performed. This device is an accessory (tubing and cartridge) for endoscopes and irrigation pumps, not an AI or diagnostic imaging device.

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

Yes, in a sense, bench testing represents a standalone performance evaluation of the physical device components. The tests focused on the device's ability to maintain flow and pressure independently of human interaction beyond setup. However, it's not an "algorithm only" study as no algorithm is mentioned.

7. The type of ground truth used

For the bench tests described:

• Flow Rate: Measured actual water flow over time.
• Pressure Testing: Observation of leakage or failure at specified pressures.

8. The sample size for the training set

Not applicable. This device is a physical medical accessory, not an AI or machine learning model that requires a training set.

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

Not applicable, as no training set was used.

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