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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 AirSeal® dV Solution, AirSeal Cannula Cap and AirSeal Bifurcated Filtered Tube Set, is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci Xi and da Vinci X Cannula to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstructionfree path of entry for endoscopic instruments, and to evacuate surgical smoke.

It is indicated for use in abdominal, thoracic, and pediatric (≥ 20kg) procedures where insufflation is desired to facilitate the use of various 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. The obturator of the Cannula Cap is indicated for use with or without visualization.

The AirSeal Cannula Cap and Bifurcated Filtered Tube Set must be used with the Intuitive da Vinci X 8 mm Instrument Cannula, an Inturtive Cannula Seal and the 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 procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Seal to the AirSeal iFS.

The ConMed AirSeal dV Solution consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator, 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 Xi\X 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, polypropylene, and stainless steel.

The provided text is a 510(k) premarket notification for a medical device (AirSeal dV Solution). It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance data.

However, it does not contain information about a study that proves the device meets specific acceptance criteria based on numerical performance metrics tied to AI or algorithmic detection, human reader improvement, or detailed ground truth establishment. This document focuses on demonstrating substantial equivalence to a predicate device through:

• Indications for Use Comparison: Showing similar intended use.
• Technological Characteristics Comparison: Highlighting similarities in product code, gas flow, pressure, smoke evacuation levels, and use environment, while noting differences like cannula inner diameter and system components that are accounted for through testing.
• Non-Clinical Performance Data: Biocompatibility, shelf-life, and benchtop testing (penetration force, flow rate, pressure/leak testing).

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text. The questions seem to be geared towards an AI/ml device study, which is not what this document describes.

Here's what I can extract based on the provided text, and where the information is missing for your specific request:

Acceptance Criteria and Reported Device Performance (Table)

Missing Information/Not Applicable to this Document Type:

1. Sample size used for the test set and the data provenance: Not applicable. The document describes benchtop testing and biocompatibility, not clinical data or a "test set" in the context of an AI/ML study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical outcomes is not established in this document.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: No, an MRMC study was not described. This is not an AI/ML device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. The "ground truth" here is engineering specifications and standardized biological tests.
7. The sample size for the training set: Not applicable; there is no AI/ML training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document details a 510(k) submission for a medical device that facilitates laparoscopic procedures, not an AI/ML diagnostic or prognostic tool. The "acceptance criteria" here relate to engineering performance, material safety (biocompatibility), and shelf-life, rather than clinical efficacy or diagnostic accuracy derived from a data-driven model.

Ask a specific question about this device

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 (≥ 20kg) 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.

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 provided text describes the 510(k) summary for the ConMed AirSeal iFS System, which is a medical device intended for insufflation during endoscopic procedures. While it details performance testing, it does not explicitly state acceptance criteria in the form of thresholds or goals. Instead, the performance testing section focuses on demonstrating substantial equivalence to predicate devices through comparisons of measured parameters.

Therefore, I cannot provide a table of acceptance criteria and reported device performance as requested, because specific acceptance criteria values are not present in the document. The document describes what was measured and how it was compared to predicate devices, but not the quantitative criteria for acceptance.

However, I can extract the available information regarding the study that demonstrates the device meets its performance goals, based on the provided text:

Study Details for ConMed AirSeal iFS System (K190303)

The study described is a benchtop performance testing comparison study, demonstrating substantial equivalence to predicate devices. It involved utilizing an abdominal and thoracic pediatric (≥ 20kg) test model.

This section does not contain information about the following:

• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set (as this is a benchtop study, not an AI/ML algorithm that typically uses a training set).
• How the ground truth for the training set was established.

Benchtop Performance Testing Conducted:

In addition to the above, Design verification testing was performed to demonstrate compliance with applicable sections of AAM/ANSI ES60601-1 and IEC 60601-1-2. Software and system verification test results were evaluated for:

• Pressure and flow settings, display, increments.
• System response at various insufflation conditions.
• GUI settings and responses for various insufflation modes.
• System recognition and interaction with accessories.

Ground Truth (for Benchtop Testing):
The "ground truth" in this context refers to the expected physical measurements and operational parameters based on standard engineering principles and the performance of established predicate devices. For instance, "set pressure" is the defined target pressure, and "pressure deviation" is measured against this target.

Standalone Performance (Algorithm Only):
Yes, a form of standalone performance was done for the device itself. The entire performance testing outlined above aims to characterize the device's intrinsic mechanical and software-controlled performance without explicit human intervention (beyond setting initial parameters in the benchtop environment). The device operates based on its internal algorithms and controls to maintain specified pressure, compensate for leaks, and manage flow.

Conclusion stated by ConMed:
Analyses of these activities conclude the benefits associated with the use of the AirSeal iFS System outweigh the residual risks. The subject AirSeal iFS System is safe and effective for its intended use and is substantially equivalent in design, intended use, principles of operation, and technical characteristics to the Stryker PneumoSure and predicate AirSeal iFS System.

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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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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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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 provided text is a 510(k) summary for the SurgiQuest AirSeal® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000. It describes the device, its indications for use, and some of the testing performed to demonstrate its safety and effectiveness.

However, the document does not contain specific acceptance criteria values or detailed study results (like sample sizes, ground truth establishment, expert qualifications, or MRMC study details) that would allow for a comprehensive answer to your request regarding acceptance criteria and performance studies. The "TESTING" section briefly mentions the device's ability to create and maintain a port of entry, maintain pneumoperitoneum, and aid in smoke evacuation, but it doesn't quantify these abilities with specific metrics or acceptable ranges.

The only specific performance detail mentioned is related to sterilization:

• Sterilization: Achieves a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137:2006 and AAMI TIR 27:2001.

Therefore, based only on the provided text, a complete table of acceptance criteria and device performance as requested, along with details about sample sizes, experts, adjudication, and specific study types (like MRMC or standalone), cannot be fully generated.

Here's what can be extracted and what is missing, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for pneumoperitoneum maintenance, smoke evacuation, and port of entry are descriptive ("adequate," "aid in," "ability to create and maintain") rather than quantifiable metrics with specific thresholds. The document does not provide the numerical results or the specific acceptance thresholds for these aspects beyond stating that they were tested successfully.

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

• Sample size for test set: Not specified in the provided text.
• Data provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The testing is generally referred to as "simulated laparoscopic surgery."

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

• Not specified in the provided text. The testing mentioned in the document appears to be primarily laboratory/technical testing rather than human-expert-driven ground truth establishment for a diagnostic algorithm.

4. Adjudication method for the test set

• Not applicable/Not specified in the provided text. (No diagnostic algorithm or expert review for ground truth described).

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/Not specified in the provided text. This is a medical device (trocar and insufflator), not an AI-assisted diagnostic tool.

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

• Not applicable/Not specified in the provided text. This is a medical device, not an algorithm. The device itself performs functions.

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

• For Sterility: Established based on compliance with ISO 11137:2006 and AAMI TIR 27:2001 standards.
• For Functional Performance (Pneumoperitoneum, Smoke Evacuation, Port of Entry): The text implies that the ground truth was based on the device's ability to perform these functions during "simulated laparoscopic surgery" in a manner deemed "adequate" or successful. No further details on how "adequacy" or "success" were quantitatively defined and measured are provided.

8. The sample size for the training set

• Not applicable/Not specified in the provided text. There is no mention of a "training set" as this device is not an AI/machine learning solution.

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

• Not applicable/Not specified in the provided text. No training set is mentioned.

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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 Device Description: System with integrated Insufflator DPIS 2000 (the "DPIS System") consists of of the following 2000 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 DPIS 2000 Unit is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent for a comprehensive understanding:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes various tests and standards met by the device, rather than explicit "acceptance criteria" presented as quantitative thresholds. However, we can infer the performance statements from what was tested and validated.

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The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions.

SurgiQuest AirSeal™ Optical Trocar & Cannula System

This document is a 510(k) premarket notification from the FDA, primarily concerned with establishing substantial equivalence for the SurgiQuest AirSeal™ Optical Trocar & Cannula System to legally marketed predicate devices. It does not contain the detailed information required to answer your specific questions regarding acceptance criteria and study data.

My analysis of the provided text confirms that the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, nor data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect sizes.
6. Results from a standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any study.
8. The sample size for a training set.
9. Information on how ground truth for a training set was established.

This document is a regulatory approval letter based on substantial equivalence, not a detailed technical report of device performance studies. Therefore, it lacks the specific study design and results information you are looking for.

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The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke. The trocar may be used with or without visualization for primary and secondary insertions. (Note: This Indication has been expanded to include smoke evacuation)

The subject is a surgical trocar and cannula composed of medical grade materials. The device is used to create and maintain a port of entry during endoscopic surgery and evacuate surgical smoke. It incorporates a gas seal utilizing CO2, to maintain pneumoperitoneum during the course of surgery. It is supplied with a re-circulation and filtration pump designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.

This 510(k) submission does not describe a study involving an AI/ML device, but rather a medical device (trocar and cannula system). Therefore, some of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) is not applicable in this context.

Here's an analysis of the provided text in relation to your request, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions various tests but largely defines them by their purpose rather than explicit quantitative acceptance criteria with corresponding performance metrics. It indicates adherence to standards as the form of "acceptance."

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

Not applicable as this is a physical medical device, not an AI/ML system tested on a dataset. The "tests" described are functional and safety verification tests. The document does not specify the number of units tested for functional performance.

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

Not applicable. Ground truth as typically defined for AI/ML does not apply here. Performance for a physical device is assessed through engineering tests and adherence to standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable.

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/ML device or an imaging device requiring human interpretation, so an MRMC study is irrelevant.

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

Not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the functional aspects, "ground truth" would be established by direct measurement of physical parameters (e.g., CO2 pressure for pneumoperitoneum, smoke particle reduction for evacuation) against predefined engineering specifications. For safety and sterility, it's compliance with established international standards (IEC, ISO, AAMI).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable.

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