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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.

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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 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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The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.

The SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") 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 "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable. The subject device of this filing is a modification to the original filing. The modification is to allow the operation of two trocars simultaneously, one AirSeal trocar and one conventional trocar. The predicate filing was a modification to allow the simultaneous operation of two AirSeal* trocars.

Here's a summary of the acceptance criteria and study information for K132169, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes general functionalities that the device's testing aimed to demonstrate.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The text refers to "Engineering Test summaries" but does not provide details on the number of units or test runs.
• Data Provenance: The tests are described as "Engineering Tests." It's highly probable these were conducted internally by SurgiQuest, Inc. in the US (Milford, CT is their location). The data is prospective in nature, as it involves active testing of the device's performance.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. The tests described are engineering performance tests, not clinical studies requiring expert interpretation of medical data.

4. Adjudication Method for Test Set

Not applicable, as this was an engineering performance study, not a clinical study requiring adjudication of expert interpretations.

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

Not applicable. This submission concerns an insufflator and trocar system, and the studies mentioned are engineering performance tests, not studies analyzing human reader performance with medical images.

6. Standalone Performance Study

Yes, the studies described ("Engineering Test 0627131045 01" and "Engineering Test 0627131059 01") are standalone performance studies. They assess the device's technical capabilities (e.g., smoke evacuation, CO2 consumption) directly.

7. Type of Ground Truth Used

The ground truth for these engineering tests would be derived from:

• Measured physical parameters: Data obtained from sensors and instruments measuring aspects like gas flow, pressure, CO2 consumption, and smoke evacuation rates during simulated procedures.
• Engineering specifications and standards: Adherence to established performance parameters as defined by internal design specifications and relevant industry standards (e.g., ISO for sterility).

8. Sample Size for Training Set

Not applicable. This is an engineering device, not an AI/machine learning algorithm that requires a training set of data.

9. How Ground Truth for Training Set Was Established

Not applicable.

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