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AirSeal iFS System: The ConMed AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis, and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

AirSeal dV Solution: The AirSeal Robotic Solution (ARS) is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci X Cannula and Cannula Seal to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various laparoscopic and thoracoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. The Cannula Cap is indicated for use with or without visualization. The ARS System must be used with the Intuitive da Vinci X 8mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal iFS in AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.

The ConMed AirSeal iFS System consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a microprocessor-controlled insufflation, recirculation and filtration unit. The cannula, trocar and tube sets are sterile, single-use products. The AirSeal iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode (Adult and Pediatric); or (c) Smoke Evacuation Mode. The ConMed AirSeal dV Solution (or AirSeal Robotic Solution) consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator (in standard and long lengths), and (2) AirSeal® Bifurcated Filtered Tube Set. The cannula cap, obturator and tube set are sterile, single-use products. The AirSeal dV Solution, in conjunction with Intuitive daVinci XiX Cannula and Cannula Seal, is operated in the Airseal Mode with the AirSeal iFS System to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. The ConMed AirSeal dV Solution is a sterile, single use device, primarily composed of polycarbonate, and stainless steel.

The provided FDA 510(k) summary describes the AirSeal iFS System and AirSeal dV Solution, which are laparoscopic insufflators. This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. As such, the "acceptance criteria" and "device performance" in this context refer to engineering and regulatory compliance testing rather than clinical performance metrics typically associated with AI/ML algorithms.

Here's an analysis based on the provided text, addressing your questions where applicable and noting when particular information is not present in this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance data categories. The specific quantitative acceptance criteria and detailed reported performance values for each test are not explicitly provided in this summary document. This level of detail is typically found in full test reports submitted to the FDA but is summarized for the 510(k) public abstract.

Study Proving Acceptance Criteria Met:

The study proving the device meets the acceptance criteria consists of benchtop testing and non-clinical testing. The document states:

• "Benchtop testing was completed to support substantial equivalence to the predicate as it relates to safety and effectiveness."
• "The following tests were conducted to support substantial equivalence for the expanded indication..." (followed by the list in the table above).
• "Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject AirSeal iFS System and AirSeal dV Solution are substantially equivalent to the predicate PneumoSure (K063367)."

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

This document does not specify sample sizes for individual tests. The testing conducted is primarily engineering verification and validation (V&V) on device prototypes or production units. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for these types of engineering tests.

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

This type of information is not relevant to the described studies, as they are engineering performance tests of a physical medical device, not clinical studies involving expert interpretation of data or images. "Ground truth" in this context refers to established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against predefined engineering specifications and regulatory standards, not subjective interpretations 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

An MRMC comparative effectiveness study was not done. This device is not an AI/ML algorithm that assists human readers; it is a laparoscopic insufflator.

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 medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described would be established engineering specifications, design requirements, and recognized international standards (e.g., ISO, IEC) to which the device's performance is compared. For example, for "set pressure," the ground truth is the specified pressure values the device is designed to maintain.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm developed with a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke.

It is indicated to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

The SurgiQuest AirSeal®iFS System (cleared as AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000) consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor-controlled insufflation, recirculation and filtration unit (the "AirSeal" iFS"). The cannula, trocar and tube sets are sterile, single-use products. The AirSeal iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode. The device contains software. The device is designed for use in Medical Centers, hospitals and medical clinics.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SurgiQuest AirSeal iFS System

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the device's functional and performance specifications, ensuring it operates as intended. The "Results" column in the table below directly indicates compliance.

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

The test set for clinical/in vivo and simulated use testing involved a total of 71 patients across four cited studies.

• Cerfolio et al. 2016: 8 patients
• Gonde et al. 2017: 10 patients
• Kneuertz et al. 2017: 20 patients
• Suda et al. 2014: 33 patients

The text does not explicitly state the country of origin for these clinical studies. It also doesn't specify if they were retrospective or prospective, though the nature of supporting clinical evidence often leans towards prospective or a mix. The phrase "real-world clinical evaluation" suggests observation in actual clinical settings.

For the bench/in vitro verification testing, the sample size is not quantified in terms of units tested, but it's stated that "extensive bench testing" was performed to confirm "all functional and performance attributes."

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

This information is not provided in the document. The clinical studies are referenced by author names and publication years, but details on how the ground truth (e.g., successful procedure, absence of complications) was established by experts, or the qualifications of those experts, are absent. The mention of "testimonial letter from the author" for Cerfolio et al. 2016 confirms the study's findings but doesn't detail the expert review process within the study itself.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth in the clinical studies is not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This aspect is not applicable to the SurgiQuest AirSeal iFS System. This device is an insufflation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not performed.

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

This aspect is not applicable. The SurgiQuest AirSeal iFS System is a physical medical device with software control, but it's not a standalone algorithm/AI system whose performance would be measured without human interaction. It's an instrument used by surgeons.

7. The Type of Ground Truth Used

For the clinical/in vivo testing, the ground truth appears to be based on clinical outcomes and observations during surgical procedures, specifically the successful use of the device without reported adverse events. This implies confirmation by the physicians performing the procedures.

For the bench/in vitro verification testing, the ground truth was established by meeting predefined engineering specifications and requirements for functional and performance attributes. Compliance with recognized industry standards also serves as a ground truth baseline for safety and performance characteristics.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" in the context of machine learning or AI. The device contains software ("The device contains software"), but it is not described as an AI/ML device that requires a separate training set for its algorithms to learn. Its software likely orchestrates control functions (e.g., pressure regulation, mode switching) based on hard-coded logic and control loops, rather than learned patterns from a training dataset.

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

Since no training set for AI/ML is mentioned, this information is not applicable. The software's "ground truth" or correct functioning would have been established through traditional software verification and validation, ensuring it correctly implements its design specifications and requirements.

Ask a specific question about this device

The SurgiQuest AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. It is indicated to facilitate the use of various laparoscopic instruments by filling the abdominal cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument is used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

The SurgiQuest AirSeal® iFS System (cleared as AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000) consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "AirSeal® iFS"). The cannula, trocar and tube sets are sterile, single-use products. The AirSeal® iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal® iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode. The device contains software. The device is designed for use in hospitals and clinics.

The provided text describes the SurgiQuest AirSeal® iFS System, a laparoscopic insufflator. Here's a breakdown of the requested information, based solely on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, accuracy against a threshold). Instead, it discusses the device's adherence to various engineering and quality standards, and the results of a bench test demonstrating "substantial equivalence."

However, we can infer some "performance" from the bench test mentioned:

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

• Sample Size for Test Set: Not applicable in the context of this document. The study described is an "engineering in-vitro bench test," not a human clinical trial or a dataset of patient cases.
• Data Provenance: Not applicable. The "data" comes from an in-vitro bench test, not from patient data (e.g., country of origin, retrospective/prospective).

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

• This information is not provided in the document, as the "ground truth" for an engineering bench test is typically defined by the physical parameters being measured and the established performance of a predicate device, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical data (e.g., image interpretation), which is not the nature of the described engineering bench test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This document does not mention an MRMC study. The device described is a physical medical device (laparoscopic insufflator), not an AI-powered diagnostic or therapeutic tool that would assist human readers in interpreting medical cases.

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

• Not applicable. The AirSeal® iFS System is a physical device with embedded software for its operation, but it is not an "algorithm only" device in the sense of an AI/ML diagnostic or predictive algorithm. Its performance is evaluated through engineering tests, not standalone clinical performance as an AI algorithm.

7. The Type of Ground Truth Used

• For the described engineering bench test, the "ground truth" or reference for comparison appears to be the performance of a legally marketed predicate device (Olympus High Flow Insufflation Unit UHI-4) in a controlled in-vitro environment, as well as adherence to various industry standards (IEC for electrical safety, ISO for sterilization, biocompatibility, etc.). The goal was to demonstrate "substantial equivalence" to this predicate.

8. The Sample Size for the Training Set

• Not applicable. The device described is a physical medical device. It does not involve a "training set" in the context of machine learning algorithms.

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

• Not applicable. There is no training set for this type of device.

Summary of the Study Discussed:

The document primarily describes an engineering in-vitro bench test (Engineering Test No. 0206151530 01) comparing the SurgiQuest AirSeal® iFS System with its predicate device, the Olympus High Flow Insufflation Unit UHI-4. This test was conducted in a "small cavity" to demonstrate substantial equivalence in performance for the purpose of maintaining pneumorectum. The study concluded that the AirSeal® iFS System is "safe and effective in creating and maintaining pneumorectum" and that its performance is "substantially equivalent" to the predicate. The document also lists adherence to numerous ISO and IEC standards for various aspects of the device (sterilization, biocompatibility, electrical safety, etc.).

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