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The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit, and (2) a disposable tube set.

The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25 mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.

This appears to be a 510(k) premarket notification summary for a medical device, the EVA15 insufflator with an AutoEvac accessory. The document describes the device, its intended use, technological characteristics, and a comparison to a predicate device, as well as non-clinical testing performed.

However, the provided text does not contain information related to an AI/ML driven device study, nor does it detail acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

The EVA15 insufflator is a physical medical device (a laparoscopic insufflator) with a new accessory (AutoEvac) that automatically activates/deactivates smoke evacuation based on sensing surgical energy. The core technology involves gas insufflation and venturi-based smoke evacuation, not AI/ML algorithms that require complex efficacy studies based on ground truth, expert readers, or MRMC studies.

Therefore, I cannot extract the information requested in your prompt because it is not present in the provided document. The questions you've asked (e.g., sample size for test/training set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth) are typically relevant for AI/ML medical devices, especially those for diagnostic or prognostic purposes, which this device is not.

The "Non-clinical Testing" section mentions:

• "Performance testing of the insufflator has demonstrated the ability to activate and de-activate smoke evacuation when electrosurgical energy is switched on and off."
• "including testing to IEC 60601-1:2005/AMD1:2012 / AMD 2:2020 (Edition 3.2) - Medical Electrical Equipment - Part 1: General Requirements For Safety"
• "and IEC 60601-1-2:2014 / A1:2020 (Edition 4.1) – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests."

These are standard electrical safety and EMC (Electromagnetic Compatibility) tests for medical devices, which are functional performance tests, not AI/ML model validation studies.

In summary, the provided text describes a traditional medical device modification for which the acceptance criteria and study described in your prompt are not applicable.

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The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.

The EVA5 insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. It is indicated to facilitate the introduction of various endoscopic instruments by filling the alimentary canal with gas to distend it. The EVA5 Insufflator is used in an operating room or endoscopic suite. It consists of the following major component (1) a micro-processor-controlled insufflation flow control system.

The EVA5 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate the alimentary canal via an endoscope. The EVA5 is powered by AC and uses a compressed 50 psi CO2 gas supply to supply the pneumatic circuitry for insufflation.

The EVA5 Insufflator is a medical device intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas. The document provides information regarding its non-clinical testing to demonstrate substantial equivalence to its predicate devices.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is non-clinical, focusing on the device's technical specifications.

3. Number of Experts and Qualifications

This information is not provided as the described testing is non-clinical performance testing of the device's mechanical and electronic functions, not human interpretation of medical images or data.

4. Adjudication Method

This information is not applicable as the testing described is non-clinical performance testing, not involving human interpretation or adjudication.

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

No MRMC comparative effectiveness study was mentioned. The EVA5 Insufflator is a mechanical device, and its performance is evaluated based on technical specifications rather than human reader accuracy.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm (the insufflator's flow control system). The "Non-clinical Testing" section states: "Performance testing of the insufflator demonstrated that the subject device met its acceptance criteria..." This refers to the device's intrinsic mechanical/electronic performance.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance testing would be the precise, calibrated measurements of flow rate and timing. These would be established using validated testing equipment and methodologies.

8. Sample Size for the Training Set

This information is not applicable. The EVA5 Insufflator is a hardware device with a micro-processor-controlled insufflation flow control system. It is not an AI/ML algorithm that is "trained" on a large dataset in the conventional sense. Its "training" or calibration would occur during its manufacturing and quality control processes based on engineering specifications.

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

As noted in point 8, the concept of a "training set" and "ground truth" for a training set is not directly applicable to a hardware device like an insufflator. The device's operational parameters are designed and calibrated based on engineering principles and established medical device standards. The "ground truth" for its performance would be defined by these engineering specifications and validated through rigorous testing against calibrated measuring instruments.

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The EVA 15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.

The laparoscopic tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 25mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.

This document describes the 510(k) submission for the EVA15 Insufflator, emphasizing the modifications and the non-clinical testing performed to demonstrate substantial equivalence to its predicate device (K202799 - Palliare EVA15).

Here’s a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the device met its acceptance criteria, which were the "same acceptance criteria as applied to the predicate" (K202799). However, specific numerical acceptance criteria are not detailed for all tests. The performance reported indicates successful completion of these tests.

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

The document does not specify a "test set" in terms of subject data (e.g., patient data for an AI algorithm). The testing described is non-clinical performance testing of the device itself (hardware and software). Therefore, specific sample sizes for a data-driven test set are not applicable here. The provenance of any data used for testing (e.g., country of origin, retrospective/prospective) is not mentioned as the testing focuses on device function.

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

This information is not applicable as the document describes non-clinical performance testing of a medical device (an insufflator), not an AI algorithm that requires expert-established ground truth from images or patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

No MRMC study was performed or mentioned. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for an insufflator device.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of the device was performed in the form of non-clinical testing (static and dynamic conditions). This is not an "algorithm only" study in the typical AI context; rather, it refers to the performance of the integrated device system. The document states: "Performance testing of the insufflator in the revised pressure range demonstrated that the subject device met its acceptance criteria... Testing included: Static condition (Pressure accuracy), Dynamic condition (Simulated leak, Smoke evacuation)."

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing would be the engineering specifications and established functional requirements for insufflators. For example, pressure accuracy would be compared against a calibrated standard, and smoke evacuation effectiveness against predefined thresholds. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable as the device is a hardware/software system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable for the same reasons as point 8.

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The END-200 Tubeset is intended to be used with the EVA15 insufflator, to supply CO2 to an endoscope during gastrointestinal endoscopic procedures.

The END-200 Tubeset is a dual lumen tube with clips that attach to the outside of an endoscope. It connects to a CO2 gas source and is used to insufflate the cavity during an endoscopic procedure, and to provide a line to monitor pressure. It is single use, disposable and provided non-sterile similar to the predicate. The ENDO-200 Tubeset is offered in Small and Medium sizes.

The document provided is a 510(k) summary for the END-200 Tubeset, a medical device. It does not describe a study involving an AI algorithm or its performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device. Therefore, most of the requested information about AI study design and performance criteria is not applicable to this document.

However, I can extract the non-clinical testing performed and the general acceptance of the device based on that testing.

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

Based on the provided document, specific numerical acceptance criteria are not explicitly stated. Instead, the document mentions that the device "met its performance acceptance criteria" after testing.

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: This information is not specified in the document for any of the non-clinical or animal testing.
• Data Provenance: Not specified. The document only mentions "Bench Testing" and "Animal Testing."

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 applicable as the document describes non-clinical and animal testing for a physical medical device, not an AI algorithm requiring expert ground truth for image interpretation or similar.

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

This information is not applicable as the document describes non-clinical and animal testing for a physical medical 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

This information is not applicable as no AI algorithm is mentioned or studied in the provided document.

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

This information is not applicable as no AI algorithm is mentioned or studied in the provided document.

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

For the non-clinical testing:

• Bench Testing: The ground truth would be established by the engineering specifications and measurement standards for pressure accuracy.
• Animal Testing: The ground truth would be based on direct observation of the device's function, attachment, maneuverability, and assessment of tissue for injury by qualified animal study personnel (e.g., veterinarians, pathologists).
• Biocompatibility Testing: The ground truth is laboratory testing results conforming to ISO 10993 standards.

8. The sample size for the training set

This information is not applicable as no AI algorithm is mentioned or studied in the provided document.

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

This information is not applicable as no AI algorithm is mentioned or studied in the provided document.

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The EVA15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.

There are 3 operating modes:

• (a) Continuous Flow (similar to a traditional endoscopic insufflator) delivers a fixed flow between 0 and 15 standard liters per minute (SLPM)
• (b) Intermittent Pressure Insufflation (similar to traditional laparoscopic insufflation) a pressure is targeted, but the flow delivered in targeting that pressure is limited to 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
• (c) Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is limited to 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).

The tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation respectively.

The provided text is a 510(k) summary for the EVA15 Insufflator. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria, especially in an AI/software context.

This document is for a medical device (insufflator), not an AI/software device. The regulatory filings for traditional medical devices like this typically focus on demonstrating substantial equivalence to a predicate device through engineering specifications, performance testing (often physical and bench testing), and adherence to recognized standards, rather than clinical studies with human readers or AI performance metrics.

Therefore, I cannot extract the requested information in the format provided because it is not present in the document. The document explicitly states:

• "As the subject device is identical in design to the predicate, performance data from the predicate device were leveraged to support the performance of the subject device." This indicates that no new performance study was conducted for this specific 510(k) submission, as the design is unchanged from the predicate.
• The comparison table focuses on physical characteristics, operating modes, and basic performance parameters (flow, pressure range), not on metrics like sensitivity, specificity, or reader improvement with AI.

In summary, the provided text does not contain any information relevant to acceptance criteria and studies for an AI/software device. This type of document would not typically include the details requested in your prompt.

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The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, colon or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflation is intended to use in hospital. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.

There are 3 operating modes:

• Flow Mode (1) delivers a fixed flow, settable between 0 and 15 standard liters per minute (SLPM)
• Pressure Modes (2) -
  • Intermittent Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
  • Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).

The tubeset is a sterile, single-use product. The tubeset is made of PVC and polyethylene. The A VA 15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation, respectively.

The provided text describes the EVA15 Insufflator, a medical device, and its 510(k) submission to the FDA. However, it does not contain information about a study involving AI assistance for human readers, nor does it detail a study for an AI algorithm's standalone performance. The document focuses on the substantial equivalence of the EVA15 Insufflator to a predicate device (SurgiQuest AirSeal iFS System) based on non-clinical performance testing of mechanical and electrical aspects.

Therefore, many of the requested details, especially those related to AI model evaluation (like sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable or present in this document.

Here's an analysis of the available information based on your request:

Acceptance Criteria and Device Performance (Bench Testing Summary):

The document provides a summary of non-clinical performance testing. The "acceptance criteria" are generally stated as "predefined acceptance criteria" without specific numerical thresholds, and the "reported device performance" is a qualitative statement that the device met these criteria.

Information Not Available in the Document:

1. Sample size used for the test set and the data provenance: The document details bench testing, which implies a test set, but it does not specify the sample size (e.g., number of units tested, number of simulated scenarios). It also does not discuss data provenance in the sense of patient data (e.g., country of origin, retrospective/prospective), as this is a physical device rather than an AI/imaging diagnostic.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the testing involves objective measurements of pressure, flow, and filtration, not expert human interpretation for establishing ground truth like in medical imaging.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for engineering bench testing.

4. 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 document is for a medical device (insufflator) approval, not an AI diagnostic/assistance tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance testing consists of physical measurements against engineering specifications and validated standards (e.g., pressure readings, flow rates, filtration efficiency).

7. The sample size for the training set: Not applicable as this is not an AI/machine learning model that undergoes training.

8. How the ground truth for the training set was established: Not applicable.

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