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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 DEFENDO™ Y-Opsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

The DEFENDO™Y-Opsy Irrigator is a sterile, disposable, single patient use, biopsy valve with a side port backflow valve for irrigation. It provides access for endoscopic device passage, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy channel during endoscopic procedures. The backflow valve prevents the potential of cross contamination between patients the device's diaphragm (slit) minimizes leakage from the biopsv channel while reducing the healthcare professional's exposure to biomaterials as endoscopy instruments are withdrawn.

Here's an analysis of the acceptance criteria and supporting studies for the DEFENDO™ Y-Opsy Irrigator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparative bench testing rather than defining explicit acceptance criteria for novel performance claims. The "acceptance criteria" are implied by the performance of the predicate devices.

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

• Flow Rate Study: The sample size for the devices tested in the flow rate study is not explicitly stated, only that it utilized "two separate manufacturers' endoscopes." The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
• Functional Criteria Study: The sample size for the devices tested in the functional criteria study is not explicitly stated. The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
• Leak Testing: The sample size for the leak testing is described as "100% of the DEFENDO™ Y-Opsy Irrigators tested." The exact number (e.g., N=X) is not provided, but implies a comprehensive test of a batch. The provenance of this data is retrospective (bench testing results conducted by the manufacturer).
• Country of Origin: Not specified but implicitly conducted by Byrne Medical Inc. in Conroe, Texas, USA.

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

Not applicable. This device is a medical accessory, and the "ground truth" for its performance is established through measurable physical properties (flow rate, leakage, functional criteria) through bench testing, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the evaluation is based on objective bench testing measurements, not expert review or adjudication of subjective data.

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

Not applicable. This is not a diagnostic imaging device or an AI-assisted device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device, not an algorithm or software. The performance studies are standalone to the device itself.

7. The Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Predicate Device Performance: The established performance characteristics of the legally marketed predicate devices (Byrne Medical Endogator® System Y-Connector and Byrne Medical DEFENDO™ Biopsy Valve).
• Objective Bench Test Measurements: Quantifiable measurements such as flow rate (volume over time) and pressure capabilities, as well as qualitative assessments of functional equivalence during simulated use.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so 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 DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

The DEFENDO™ Disposable Suction Valve is a disposable device that attaches to the suction cylinder of an endoscope. When the valve is depressed, the suction function on the endoscope is activated, allowing for the suctioning of fluid through the stem of the valve where it flows into the Suction Pump Canister.

Here's a breakdown of the acceptance criteria and the study details for the DEFENDO™ Disposable Suction Valve, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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The DEFENDO™ Disposable Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The Byrne Medical DEFENDO™ Disposable Air/Water Valve is substantially equivalent to the Olympus® MH-438 Air/Water Valve.

The submitted document, K107409, describes the Byrne Medical DEFENDO™ Disposable Air/Water Valve and compares it to a predicate device, the Olympus® MH-438 Air/Water Valve (K001241). The primary goal of the submission appears to be to demonstrate substantial equivalence to the predicate device, rather than to prove the device meets specific acceptance criteria through a clinical study. The performance data presented focuses on comparative bench testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a clinical study. Instead, it aims to demonstrate substantial equivalence to a predicate device, which implies that its performance should be comparable to the predicate. The performance reported is from comparative testing against the predicate device for water flow.

Study Proving Acceptance Criteria:

The study proving the implied acceptance criteria is a comparative performance (bench) test.

• Study Type: Comparative Bench Testing (Water Flow Test)
• Objective: To compare the water flow rates of the Byrne Medical DEFENDO™ Disposable Air/Water Valve with the Olympus® MH-438 Air/Water Valve.

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

• Sample Size (Test Set):
  • Overall Water Flow Test: 10 Byrne Medical 100304 Air/Water valves and 10 Olympus MH-438 Air/Water valves. Measurements were taken over a time period of 0 to 40 seconds, yielding an 'n' of 188 for correlation analysis.
  • 0-7 Second Interval Water Flow Test: Although the same number of valves were likely used, the analysis focused on a shorter time period, resulting in an 'n' of 36 for correlation analysis.
• Data Provenance: The data is generated from bench testing (in-vitro performance testing) and not from human subjects. Therefore, concerns like country of origin for patient data or retrospective/prospective status are not applicable.

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

• Not Applicable. This study is a bench test comparing physical device performance (water flow) under controlled conditions. It does not involve human interpretation or subjective assessment that would require expert consensus for a "ground truth" as typically defined in diagnostic studies. The "ground truth" here is the measured performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a bench test measuring physical parameters, there is no need for an adjudication method by experts. The measurements are objective and quantitative.

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

• No. An MRMC study was not conducted. This is a bench test of physical device performance, not a study involving human readers interpreting clinical cases.

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

• No. This device is a physical medical instrument (an air/water valve), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Bench Test Measurement/Predicate Performance: The "ground truth" in this context is the measured performance of the legally marketed predicate device (Olympus® MH-438 Air/Water Valve). The Byrne Medical device's performance is compared directly against these objective measurements.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device, not a machine learning algorithm. Hence, there is no "training set."

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

• Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

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The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Not Found

This document does not contain the detailed information necessary to complete the request regarding acceptance criteria and a study proving a device meets them. The provided text is a 510(k) clearance letter and summary for the "Endo SmartCap™," which primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results or acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or details about the ground truth establishment for a test set.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Results from a standalone algorithm performance study.
• Sample size for a training set or ground truth establishment for a training set.

The document primarily states the intended use of the device and its regulatory classification. It lists predicate devices but does not delve into their performance or comparison in detail.

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The ERBELIFT Hand Pump in conjunction with an ERBELIFT Flexible Probe is indicated for the induction of sterile normal saline into the submucosa to lift polyps or other mucosal lesions using direct visualization through a flexible endoscope.

The ERBELIFT™ Hand Pump and Flexible Probe are used for the delivery of pressurized sterile normal saline to the submucosa to lift polyps or other mucosal lesions. A control syringe is filled with sterile normal saline. The filled syringe is attached to the Flexible Probe via a hub with a standard luer lock and loaded into the Hand Pump. The Flexible Probe is primed with the saline and then the distal end of the Probe is placed down the working channel of the endoscope. Under direct visualization, the Probe's tip is placed against the target tissue without puncturing the mucosa. Then, the trigger of the Hand Pump is squeezed to produce the pressurized saline from the control syringe and through the Probe into the bed of the polyp or lesion to achieve a desired tissue lift.

The Hand Pump is made of nylon and stainless steel. It is 8-3/4" (22 cm) long, 6" (15 cm) wide, and having a thickness of 2-1/2" (6 cm). The Pump per squeeze of the handle delivers approximately 0.75 ml of normal saline. The Flexible Probe is made of Polyetheretherketone (PEEK) and nylon (Note: Medical grade inks and reducer are used to imprint logos on the device.). It has a 1.3 mm Outer Diameter and length of 260 cm. The distal tip is tapered to approximately 0.005" and delivers a jet stream of 120 um. The Hand Pump with the Flexible Probe can generate pressures in the approximate range of 145 to 650 psi which correlates to flow rates of 17 to 38 ml/minute.

The Hand Pump is reusable with the Flexible Probe being provided as sterile and single use.

The provided 510(k) summary for the Byrne Medical Incorporated ERBELIFT™ Hand Pump and Flexible Probe does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance with quantitative metrics. The document focuses on demonstrating substantial equivalence to predicate devices through similarities in intended use, materials, and form, and briefly mentions functional bench and animal lab testing. However, it does not provide specific acceptance criteria or performance metrics from these tests.

Therefore, the following sections will indicate where the information is not available in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document states that "Functional bench and animal lab testing has demonstrated that the ERBELIFT Hand Pump and Flexible Probe lifts the submucosa safely and effectively," but it does not provide specific acceptance criteria or quantitative performance results for these tests. Therefore, this table cannot be fully completed from the given 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 for Test Set: Not specified in the provided document. The document mentions "Functional bench and animal lab testing" but does not give details on the number of samples, animals, or tests conducted.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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)

• This information is not available in the provided 510(k) summary. The document mentions "Functional bench and animal lab testing" but does not detail how ground truth or performance assessment was established, nor does it refer to human expert involvement in establishing ground truth for the device's functional performance.

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

• This information is not available in the provided 510(k) summary. Given that the testing mentioned is "functional bench and animal lab testing" for a medical device's physical performance, an adjudication method for human interpretation is unlikely to be applicable or described here.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The ERBELIFT™ Hand Pump and Flexible Probe is a physical medical device for injecting saline, not an AI-powered diagnostic or interpretive tool. Therefore, a study comparing human readers with and without AI assistance is not relevant to this device and is not mentioned.

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

• No, standalone algorithm performance testing is not applicable as this device is a physical medical instrument, not a software algorithm. The device's operation involves a human user (endoscopist) directly.

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

• The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For this physical device, the "truth" would be objective measurements and observations from the "Functional bench and animal lab testing." This would likely involve:
  • Bench Testing: Direct physical measurements (e.g., pressure, flow rate, volume delivered, jet stream characteristics) and visual inspection of fluid delivery.
  • Animal Lab Testing: Direct visualization of submucosal lift, potentially histological analysis of tissue for damage, and observation of overall safety and effectiveness in an in-vivo model.
• The document implies that the "truth" for safety and effectiveness was derived from these direct experimental observations rather than expert consensus on interpretation of data.

8. The sample size for the training set

• Not applicable / Not available. The ERBELIFT™ Hand Pump and Flexible Probe is a physical medical device, not a machine learning model, so there is no "training set" in the context of data used for algorithm development. The development process would have involved design, prototyping, and testing, but not training data for an algorithm.

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

• Not applicable / Not available. As explained in item 8, there is no "training set" for this physical medical 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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The DEFENDO™ Disposable Biopsy Valve is indicated for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

Not Found

Here's an analysis of the provided text regarding the DEFENDO Biopsy Valve, focusing on the requested information:

This document is a 510(k) clearance letter for a medical device (DEFENDO™ Biopsy Valve). It primarily focuses on the regulatory determination of substantial equivalence to a predicate device, rather than a detailed report of a clinical study with specific acceptance criteria and performance metrics for a novel algorithm or AI device.

Therefore, I cannot provide a complete answer to all your questions as the information is not present in the provided text. The document describes a device (biopsy valve), not a diagnostic algorithm or AI. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices. This typically means the manufacturer performed a series of tests to demonstrate that their device functions similarly and is as safe and effective as existing, legally marketed devices. However, the details of these tests, specific acceptance criteria, or a "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm are not described.

Let's address what can be extracted from the document:

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

This information is not provided in the document. The FDA letter is a regulatory clearance, not a detailed technical report of performance metrics. For a device like a biopsy valve, acceptance criteria would likely relate to biocompatibility, fluid sealing, ease of use, durability, and compatibility with specific endoscopes, but these specifics are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. As this is a physical medical device, "test set" would likely refer to the number of devices tested or the number of simulated procedures performed, but no such details are given.

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)

This information is not provided. This concept of "ground truth" and expert review is typically relevant for diagnostic algorithms or AI that interpret medical images or data. For a biopsy valve, the "ground truth" would be established through engineering specifications and functional testing, not expert consensus on medical findings.

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

This information is not provided. Adjudication methods are relevant for studies where multiple readers interpret data, which is not described here.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as described in this document. This type of study is specific to AI or diagnostic imaging interpretation. The device being reviewed is a physical biopsy valve, not an AI system.

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

No, this is not applicable. The DEFENDO™ Biopsy Valve is a physical accessory used during an endoscopy procedure, not a standalone algorithm.

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

This information is not explicitly stated in the document. For a physical device like a biopsy valve, "ground truth" would generally be established through engineering specifications, material safety standards, and functional performance benchmarks (e.g., ability to maintain insufflation, resist leakage, allow instrument passage).

8. The sample size for the training set

This information is not provided. This concept is relevant for machine learning models, which is not what the DEFENDO™ Biopsy Valve is.

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

This information is not provided. This concept is relevant for machine learning models, which is not what the DEFENDO™ Biopsy Valve is.

In summary:

The provided document is an FDA 510(k) clearance letter for a physical medical device (biopsy valve). It confirms the device's substantial equivalence to existing devices but does not contain the detailed technical or clinical study data typically found in reports for AI or diagnostic algorithms, including specific acceptance criteria, performance metrics, ground truth establishment, or study designs like MRMC or standalone performance evaluations. For such a device, the "study" demonstrating its safety and effectiveness would involve engineering tests (e.g., mechanical durability, fluid integrity), biocompatibility testing, and functional assessments, which are not outlined in this regulatory letter.

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