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The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during trans and minimal invasive surgery.

The Insuflow® Port (5 mm, 8 mm, 10mm and 12mm) devices have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

The Lexion AP50/30 Insufflator is a microprocessor-controlled CO2 (carbon dioxide) insufflator with multiple operating modes. The insufflator instrumentation is intended for hospital use for Standard/High Flow, Pediatric, and Bariatric laparoscopic procedures used in conjunction with a laparoscope to fill and distend a peritoneal cavity with gas; for trans anal minimal invasive surgery (TAMIS) to fill and distend the rectum and colon using CO2 gas; and for Vessel Harvesting procedures used to create a cavity along the saphenous vein and/or the radial artery during an endoscopic vessel harvesting procedure.

The device incorporates the following major components and features: a metal housing, a world power supply, pressure reducers, a venting system, a gas heater control and a touch screen user interface with various settings and display elements. The software operation includes system checks, user interface, setting adjustments, warning/error messages and service info. The device is equipped with a continuous pressure measurement mode that controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. The AP50/30 Insufflator is designed with several alarms/warnings to inform the operator in case of an overpressure or other malfunctions. The device is to be used with specially designed singleuse tubing sets, the Insuflow® Port, in order to utilize the full capabilities of continuous pressure measurement and gas heating and humidification. (The insufflator can also accept other tubing sets for gas deliver only.)

The Insuflow® Port (5, 8, 10, 12 mm) devices are gas conditioning/access port devices that attach to the outlet of the AP50/30 Insufflator and are designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow® Port consists of an ethylene oxide sterilized, disposable single use tubing set and a path of entry access port device which contains the pressure sensors, a filter, and gas heater/humidifier. The access port device materials are intended for patient contact of less than 24 hours. The Insuflow® Port is connected to the AP50/30 Insufflator via a plug connector cable, which controls the pressure sensing, gas heating and safety circuits for the system. Regulated CO2 gas from the AP50/30 Insufflator flows into the Insuflow® Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity.

The provided text is a 510(k) Premarket Notification for a medical device, the AP50/30 Insufflator with Insuflow® Port. It focuses on demonstrating substantial equivalence to predicate devices, particularly for a newly added operating mode (TAMIS).

Important Note: This document describes the acceptance criteria and study for a hardware medical device (insufflator), not an AI/ML-based device. Therefore, many of the requested fields related to AI/ML (e.g., ground truth establishment for training set, MRMC study, sample size for training set, number of experts for ground truth) are not applicable to this type of medical device submission. The study described is an engineering performance verification and validation.

Here's a breakdown based on the provided text, addressing the applicable criteria for this device:

Acceptance Criteria and Device Performance for AP50/30 Insufflator with Insuflow® Port (TAMIS Mode)

This submission focuses on demonstrating substantial equivalence of the modified AP50/30 Insufflator (with the addition of a TAMIS operating mode) to its predicate devices. The acceptance criteria are implicit in matching the performance specifications of the predicate devices for existing modes and ensuring the new TAMIS mode meets appropriate performance targets comparable to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by matching or demonstrating comparable performance to the predicate devices, particularly the PNEUMOCLEAR Insufflator (K170784) for the TAMIS mode. The tables provided in the document serve as the performance data compare to historical predicate performance.

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

• Sample Size: The document refers to "comparative bench testing" and "design verification testing." It does not specify a numerical sample size in terms of "units tested" or "number of unique test scenarios." This type of engineering testing typically involves a set number of test runs or units to demonstrate specifications are met across operational ranges and conditions.
• Data Provenance: The testing was "performed to demonstrate that the performance of the proposed AP50/30 Insufflator is substantially equivalent to that of the predicate devices." This implies that the data is prospective data generated from testing of the new device intended for submission. The location of testing is not specified, but it would have been conducted by the manufacturer (Lexion Medical LLC) or a contracted test facility.

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

• N/A. For a hardware medical device like an insufflator, "ground truth" as it relates to expert consensus on images or clinical outcomes is not applicable. The device's performance is objectively measured against engineering specifications (e.g., flow rate, pressure accuracy, alarm function). Verification and validation testing is conducted by engineers and technicians against established specifications.

4. Adjudication Method for the Test Set

• N/A. Adjudication methods (like 2+1, 3+1) are relevant for subjective assessments, typically in image interpretation or clinical trial endpoints that require expert consensus. For an insufflator, performance is measured against objective, quantifiable engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• N/A. MRMC studies are specific to evaluating the diagnostic performance of imaging devices or algorithms, usually involving human readers interpreting images. This is a hardware device for surgical procedures (insufflation), not an imaging or diagnostic AI/ML device.

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

• N/A. This is not an AI/ML algorithm. The device has software that controls its functions, which was validated ("The software used in the AP50/30 Insufflator was determined to have a major level of concern, and was developed and successfully validated in accordance with the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005."). This software validation assesses the correct functioning of the control algorithms, which operates autonomously to maintain pressure and flow.

7. The Type of Ground Truth Used

• Engineering Specifications / Predicate Device Performance: The "ground truth" for this device's performance is its ability to meet established engineering specifications (e.g., precise control of gas pressure and flow, accurate alarm triggers) and to perform comparably to its legally marketed predicate devices, particularly for the added TAMIS mode. The performance is quantified through direct physical measurements during bench testing.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device; there is no "training set." The software is designed and programmed based on engineering principles and requirements, not trained on data.

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

• N/A. As there is no training set for an AI/ML model, this question is not applicable. The software ground truth is derived from design requirements and engineering specifications documented during the device development process.

In summary, the provided document details the regulatory submission for a hardware medical device with specific performance characteristics. The "acceptance criteria" revolve around demonstrating that the modified device (with a new operating mode) performs comparably to its predicates and meets all relevant safety and performance standards. The "study" proving this involves comprehensive bench testing and software validation against objective engineering specifications. The concepts of AI/ML-specific evaluations (like training sets, data provenance for AI models, MRMC studies, or multi-expert adjudication for diagnostic ground truth) do not apply to this type of device submission.

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The AP50/30 Insufflator is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard/High Flow, Pediatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.

The Insuflow® Port (5 mm, 8 mm, 10mm and 12mm) devices have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

The Lexion AP50/30 Insufflator is a microprocessor controlled CO2 (carbon dioxide) insufflator with multiple operating modes. The insufflator instrumentation is intended for hospital use for Standard/High Flow, Pediatric, and Bariatric laparoscopic procedures used in conjunction with a laparoscope to fill and distend a peritoneal cavity with gas, and for Vessel Harvesting procedures used to create a cavity along the saphenous vein and/or the radial artery during an endoscopic vessel harvesting procedure.

The device incorporates the following major components and features: a metal housing, a world power supply, pressure reducers, a venting system, a gas heater control and a touch screen user interface with various settings and display elements. The software operation includes system checks, user interface, setting adjustments, warning/error messages and service info. The device is equipped with a continuous pressure measurement mode that conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. The AP50/30 Insufflator is designed with several alarms/warnings to inform the operator in case of an overpressure or other malfunctions. The device is to be used with specially designed single-use tubing sets, the Insuflow Port, in order to utilize the full capabilities of continuous pressure measurement and gas heating and humidification. (The insufflator can also accept other tubing sets for gas deliver only.)

The Insuflow® Port (5, 8, 10, 12 mm) devices are gas conditioning/access port devices that attach to the outlet of the AP50/30 Insufflator and are designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow Port consists of an ethylene oxide sterilized, disposable single use tubing set and a path of entry access port device which contains the pressure sensors, a filter, and gas heater/humidifier. The access port device materials are intended for patient contact of less than 24 hours. The Insuflow® Port is connected to the AP50/30 Insufflator via a plug connector cable, which controls the pressure sensing, gas heating and safety circuits for the system.

The technology for gas conditioning and path of entry for the modified port devices is the same as the predicate Insuflow® Synergy™ Port marketed devices. Regulated CO2 gas from the AP50/30 Insufflator flows into the Insuflow® Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity.

The provided text describes a 510(k) premarket notification for a medical device, the Lexion AP50/30 Insufflator with Insuflow® Port. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study or standalone algorithm evaluation in the way one would for an AI/ML medical device.

The "acceptance criteria" discussed here are primarily in the context of demonstrating equivalence to a predicate device, focusing on functional specifications and safety standards rather than diagnostic performance metrics (like sensitivity, specificity, AUC) typically found in AI/ML device submissions. There is no mention of an AI/ML component in this device.

Therefore, the requested information elements (1-9) which are typically relevant for AI/ML medical device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this 510(k) submission.

However, I can extract the information relevant to how this specific device (a CO2 insufflator) demonstrates its performance and safety, framed within the context of a 510(k) submission:

Demonstrating Performance and Safety for the Lexion AP50/30 Insufflator with Insuflow® Port (Non-AI/ML Device)

The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, the Stryker/WOM 45L CORE Insufflator and Lexion Insuflow® Synergy™ Ports. The "acceptance criteria" are implied by meeting or having comparable performance to these predicates and adhering to relevant safety standards.

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

Since this is not an AI/ML device, the "acceptance criteria" are functional specifications and comparative performance to predicates. There isn't a direct "acceptance criterion" table in the AI/ML sense, but rather a comparison table of key performance specifications between the proposed device and its predicate.

• First Nominal Pressure (15mmHg high flow/bariatric, 10mmHg vessel harvesting, 8mmHg pediatric)
• Venting Valve Status with Veress insufflation on or off, Venting system on or off
• Venting Pressure Limit: set at 3mmHg (cannot be changed)
• Venting Response time: set at 3 sec (cannot be changed)
• Gas Supply: House or Bottle
• Alarm Volume: set between Level 1-3
• Gas Flow Rates: Quick set rate 1-3 (3, 20, 45 LPM high flow; 3, 25, 50 LPM bariatric; 1.0, 4.0, 10.0 LPM vessel harvesting; 0.1 LPM pediatric)
• Maximum Nominal Pressure: setting range 5-30 mmHg for bariatric and high flow; 5-20 mmHg for vessel harvesting and pediatric
• Flow Safety Limit: Limit On or Off
• Warning Signal Occlusion: Signal On or Off
• Language: English, Spanish | Configuration Menus:
• First Nominal Pressure (15mmHg high flow/bariatric, 10mmHg vessel harvesting, 8mmHg pediatric)
• Venting Valve Status with Veress insufflation on or off, Venting system on or off
• Venting Pressure Limit: between 2-5 mmHg
• Venting Response time: between 2-5 sec
• Gas Supply: House or Bottle
• Alarm Volume: set between Level 1-3
• Gas Flow Rates: Quick set rate 1-3 (3, 20, 40 LPM high flow; 5, 25, 45 LPM bariatric; 1.0, 4.0, 10.0 LPM vessel harvesting; 0.1 LPM pediatric)
• Maximum Nominal Pressure: setting range 5-30 mmHg for bariatric and high flow; 5-20 mmHg for vessel harvesting and pediatric
• Flow Safety Limit: Limit On or Off
• Warning Signal Occlusion: Signal On or Off
• Language: English, Spanish | Different; Pressure limits for venting are preset in the subject device, while they can be adjusted in the predicate. Gas flow rates differ to reflect differences in flow range. These differences do not raise different questions of safety and effectiveness. |
  | Error Warnings | Check gas supply, low supply gas pressure, overpressure, venting system active, overpressure/venting system active, occlusion, contamination, contamination/call for service, gas heater/call for service, error message/call for service, device temperature error/turn off device, venting valve non-functioning, continuous pressure sensing deactivated/call for service, flow safety limit, safety limit, valve non-functioning/call for service | Check gas supply, low supply gas pressure, overpressure, venting system active, overpressure/venting system active, occlusion, contamination, contamination/call for service, gas heating defective/call for service, gas temperature >42C, error message/call for service, device temperature error/turn off device, venting valve defective, RTP defective | Different; the minor differences do not raise different questions of safety and effectiveness |
  | Gas Conditioning | Heat and humidify | Heat | Different; the subject device includes humidification with the use of the Insuflow port; this difference does not raise different questions of safety and effectiveness |
  | Tubing Sets | Custom, sterile, single use Insuflow Port | Custom, sterile, single use | Same |

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

• Test Sample Size: Not applicable. Performance was demonstrated through bench testing and adherence to electrical safety and EMC standards.
• Data Provenance: Not applicable. The "data" are results from engineering bench tests and compliance assessments to recognized standards, not from a dataset of patient images or clinical outcomes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant to this device's safety and performance assessment. Assessments were made against engineering specifications and predicate device performance.

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

• Not applicable. There was no need for expert adjudication in the context of this device's evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted device, so an MRMC study is not relevant.

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

• Not applicable. This device does not have a "standalone algorithm" in the AI/ML sense. Its performance is evaluated as an integrated system (insufflator and port). Bench testing focused on its functional performance (e.g., maintaining set pressure, flow rates, handling leaks, overpressure events).

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

• The "ground truth" for this device's performance evaluation refers to established engineering specifications, international safety standards (e.g., IEC 60601 series), and the demonstrated performance of the predicate devices during comparative bench testing. For biocompatibility, the ground truth was adherence to ISO 10993 standards and the results of specified biological tests (cytotoxicity, irritation, sensitization, acute systemic toxicity).

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of AI/ML. Software validation was performed according to FDA guidance for software in medical devices, but this refers to traditional software engineering validation, not AI model training.

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

• Not applicable. See point 8.

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Insuflow Synergy™ Port (5 mm) and Insylow® Synergy™ XL Port (8 mm, 10mm and 12mm) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

The Insuflow® Synergy™ and Insuflow® Synergy™ XL Port devices are gas conditioning devices that attach to the outlet port of an insufflator or other regulated CO2 source and are design and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow® Synergy™ XL Port consist of a sterile, disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the system.

The Insuflow® Synergy™ and Synergy™ XL Port devices and their modifications involve design changes to existing gas conditioning and path of entry devices used in minimally invasive surgery.

Here's an analysis of the acceptance criteria and study information provided:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with specific performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the modified devices perform in accordance with specifications and applicable standards, and are "substantially equivalent" to predicate devices. The performance testing focuses on ensuring that the changes do not negatively impact the established functionalities of the original devices.

Study Details

The provided text describes a submission for a Special 510(k), which is typically used for modifications to a legally marketed device that do not significantly affect its safety or effectiveness. As such, the "study" is primarily a performance testing regimen to validate the design changes rather than a large-scale clinical trial or comparative effectiveness study.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a number of units. The testing was conducted for "the modified Insuflow® Synergy™ (5 mm) and Synergy™ XL (8 mm, 10 mm and 12 mm) Port dual lumen models." This implies that representative samples of each modified size/configuration were tested.
   • Data Provenance: The testing was conducted by the manufacturer, LEXION Medical, LLC, as part of their risk analysis and product development. This would be retrospective in the sense that it's laboratory/bench testing performed after the design changes were implemented, but before market introduction of the modified device. The country of origin for the data is not specified, but the submitter is based in St. Paul, MN, USA.

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

   • Not Applicable. This type of device modification and performance testing (bench testing for flow, pressure, and mechanical integrity) does not typically involve human expert "ground truth" establishment in the way an imaging AI algorithm would. The "ground truth" is defined by engineering specifications and physical measurements.

3. Adjudication method for the test set:

   • None. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in subjective assessments, such as interpreting medical images. For physical device performance testing, objective measurements against engineering specifications are used, removing the need for expert adjudication in this context.

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 is not applicable as this device is a surgical instrument (gas conditioner and port) and not an AI-powered diagnostic or assistive tool for image interpretation.

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

   • Partially Yes (in a different context). The device itself is a standalone medical device that performs its function without a human "in the loop" for its primary operation (gas conditioning, port access). It's not an AI algorithm. The performance tests described (flow/pressure, insertion/removal) are standalone tests of the device's physical and functional properties.

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

   • The ground truth for the performance testing is based on engineering specifications and measurable physical properties. For example, the "ground truth" for flow/pressure performance would be the required flow rates and pressure tolerances as defined by the device design and relevant industry standards. For insertion/removal, it would relate to acceptable forces, ease of use, and lack of damage.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set, there is no ground truth established for it in this context.

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PneuVIEW® XE VeryClear™ Gas Evacuation Cannula has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to evacuate smoke and plume generated during minimally invasive surgery from the surgical cavity to aid visualization.

The PneuVIEW® XE VeryClear™ Gas Evacuation Cannula (Dual and Single Lumen Port) is an integral path of entry access port device with smoke evacuation mechanism intended for use in the surgical cavity during minimally invasive surgery. The PneuVIEW® XE VeryClear™ is a disposable single use device consisting of a path of entry access port device with filter and tubing with a multi-position stopcock valve. The PneuVIEW® XE VeryClear™ can be connected to a vacuum source for smoke evacuation. The integral path of entry access port device is designed and constructed similarly to the ' predicate Insuflow Synergy™ Port access device with a sealed instrument access lumen. Just as the Insuflow® Synergy™ Port, the PneuVIEW® XE VeryClear™ has a dual-lumen or single-lumen path of entry access device 5 mm configuration for surgical instrument manipulation and smoke evacuation.

The provided text describes the PneuVIEW® XE VeryClear™ Gas Evacuation Cannula and its 510(k) summary, aiming to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics in the format requested.

The sections "Discussion of performance testing" and "Conclusion" broadly state that "Extensive performance testing has been conducted to assure that the PneuVIEW® XE VeryClear™ performs in accordance with its specifications and applicable standards. Flow/pressure performance and seal leak integrity testing were successfully completed. Since the access port device is the same size and configuration as the Insuflow Synergy™ Port 5 mm device, the insertion/removal testing previously submitted is directly applicable. In addition, biocompatibility per ISO 10993-1 was demonstrated."

This summary is insufficient to populate the requested table and answer the specific questions regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies for an AI/device performance evaluation. The document focuses on demonstrating substantial equivalence to existing devices rather than a standalone performance study with quantifiable acceptance criteria against a defined ground truth.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to answer based on the limited information and what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified. The studies are referred to as "performance testing," but details on retrospective/prospective nature or country of origin are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not provided. The testing appears to be engineering/laboratory-based performance testing rather than expert-reviewed clinical ground truth.

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

• This information is not provided and is not applicable to the type of performance testing described (flow/pressure, leak integrity, biocompatibility).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was mentioned. This device is a physical medical device (cannula with smoke evacuation), not an AI diagnostic or assistance system. Therefore, this question is not applicable.

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

• This device is not an algorithm. This question is not applicable.

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

• For the physical tests:
  • Flow/Pressure: Likely objective measurements against engineering specifications or established standards.
  • Seal Leak Integrity: Objective measurements against engineering specifications or established standards.
  • Biocompatibility: Conformance to ISO 10993-1, which involves standard materials testing.
  • Insertion/Removal: Assumed based on equivalence to predicate device's prior testing, implying similar objective mechanical performance.
• No clinical "ground truth" (like pathology or outcomes data) is mentioned as part of the performance testing for this device's 510(k). The focus is on physical and material properties.

8. The sample size for the training set:

• This device is not an AI algorithm, so there is no training set in the AI sense. This question is not applicable.

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

• This device is not an AI algorithm, so there is no training set or ground truth for it in that context. This question is not applicable.

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Insuflow® Synergy™ XL Port (10mm and 12mm) and Insuflow® Synergy™ XLR Port (10mm and 12mm with endoscopic cannula seal) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

The Insuflow® Synergy™ XL and XLR Port are a gas conditioning device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ XL and XLR Port consist of a sterile, disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the system. The integral path of entry access device in the Insuflow Synergy™ XL and XLR Port is designed and constructed similarly to the Insuflow® Synergy™ Port but comes in larger sizes just as the predicate EndoPath trocar device. The Insuflow® Synergy™ XL Port and the Insuflow® Synergy™ XLR Port have access devices in 10 mm and 12 mm configurations with a single-lumen working channel configuration for conditioned gas delivery. The access device has a working channel with duckbill and tool seals for instrument entry into the surgical cavity and delivers conditioned insufflation gas through the working channel. The Insuflow® Synergy™ XLR Port has an endoscope compatible configuration that has an additional seal at the bottom of the main cannula, which serves as a means to seal off around the endoscope, forcing all gas flow out of the peripheral gas exhaust ports. This minor change is intended to reduce fogging and improve visualization. The obturator for the Insuflow Synergy™ XL and XLR Port has a transparent optical window at the distal end, which when used with an endoscope, provides visibility of individual tissue layers during insertion.

The provided text describes a 510(k) summary for the Insuflow Synergy™ XL and XLR Port devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert involvement, or statistical analysis typically associated with AI/ML device evaluations.

Therefore, the requested information, particularly regarding specific acceptance criteria with numerical targets, the study proving the device meets them (including sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment for test and training sets), is not present in the provided text.

The text indicates that "Extensive performance testing has been conducted to assure that the Insuflow® Synergy™ XL and XLR Port perform in accordance with its specifications and applicable standards." and lists the types of tests performed. However, it does not provide the results of these tests in a quantifiable way against pre-defined acceptance criteria, nor does it detail the methodology (sample sizes, expert involvement, ground truth) as would be expected for a diagnostic AI/ML device.

What is provided regarding "performance testing" are general categories of tests:

• Flow/pressure performance
• Gas temperature and humidity characterization
• Insertion/removal testing
• Seal leak integrity testing
• A test to confirm that the cannula seal configuration (for the XLR Port) reduces scope fogging and improves visualization.

Conclusion:

Based on the provided text, it's not possible to generate the requested table of acceptance criteria and reported device performance, nor can we answer the subsequent questions about study specifics (sample size, data provenance, expert details, adjudication, MRMC, standalone performance, ground truth establishment) as these details are not included in this 510(k) summary. This document primarily focuses on establishing substantial equivalence to predicate devices through design description and a high-level summary of testing.

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Insuflow® Synergy™ Port has applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.

The Insuflow Synergy™ Port (Dual and Single Lumen) is a gas conditioning device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ Port consists of a disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the svstem. Regulated CO2 gas flows into the Insuflow® Synergy™ Port, through the in-line filter, continues along the tubing to enter the path of entry access device that contains the heating element and humidification media, and through the path of entry access device lumen for delivery into the patient's surgical cavity. The integral path of entry access device is designed and constructed similarly to the predicate trocar device with a sealed instrument access lumen. The Insuflow® Synergy™ Port (Dual and Single Lumen) has a dual-lumen or single-lumen path of entry access device configuration for conditioned gas delivery. Both configurations have a working channel with duckbill and tool seals for instrument entry into the surgical cavity. The single lumen device delivers conditioned insufflation gas through the working channel while the dual lumen configuration has a second outer lumen channel for conditioned gas delivery.

The provided text is a 510(k) summary for the Insuflow® Synergy™ Port, a medical device. This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

This document focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating the device's meeting specific, quantitative acceptance criteria via a performance study with a test set, ground truth and human readers.

Therefore, I cannot fully complete all sections of your request as the information is not present in the provided text. However, I can extract what is available.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The Insuflow® Synergy™ Port is a gas conditioning insufflator accessory device designed to warm, humidify, and filter CO2 gas for insufflation during minimally invasive surgeries, and to establish a path of entry for endoscopic instruments. The regulatory pathway for this device was a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than a direct clinical performance study with specific acceptance criteria in the format you've requested.

The "acceptance criteria" in this context are implicitly related to demonstrating that the Insuflow® Synergy™ Port performs safely and effectively in a manner substantially equivalent to its predicate devices. The study proving this involved extensive performance testing and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative "acceptance criteria" for a clinical performance study (e.g., sensitivity, specificity thresholds) are not explicitly stated in this 510(k) summary, I can only infer what was tested and that the device "successfully completed" these tests, implying they met internal or standard-based criteria.

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

This information is not provided in the summary. The document mentions "extensive performance testing" but does not detail the sample sizes for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective). It is likely these were bench/laboratory tests rather than tests on patient data.

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

This information is not provided. Given the nature of the device (a gas conditioning insufflator and access port) and the type of testing described (flow/pressure, temperature, humidity, insertion/removal, seal leak, biocompatibility), it's highly improbable that "experts to establish ground truth" in the context of diagnostic performance (e.g., radiologists interpreting images) would be relevant or used. The "ground truth" for the performance tests would be instrument measurements and standardized test procedures.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for the type of testing described in this 510(k) summary. Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation of data where consensus is needed for ground truth (e.g., image interpretation).

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, a MRMC comparative effectiveness study was not performed. This device is a surgical instrument accessory, not an AI-powered diagnostic tool, so such a study would not be applicable or relevant to its regulatory approval.

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

This question is not applicable. The Insuflow® Synergy™ Port is a physical medical device, not an algorithm, so a "standalone" algorithmic performance study without human-in-the-loop would not be relevant.

7. The Type of Ground Truth Used

For the performance tests mentioned (Flow/Pressure, Gas Temperature, Humidity, Insertion/Removal, Seal Leak Integrity), the "ground truth" would be established by objective physical measurements using calibrated instruments and adherence to established engineering and medical device standards. For biocompatibility, it would be established by laboratory testing results against ISO 10993-1. Pathology or outcomes data would not directly serve as ground truth for these types of tests.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a physical hardware product, not a software algorithm that requires a "training set."

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

This information is not provided and is not applicable for the reasons stated in point 8.

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Vessel Vapor™ is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular, thoracoscopic, and vessel harvesting surgical procedures.

The Vessel Vapor™ device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the surgical cavity. The Vessel Vapor™ device consists of a disposable tubing set with a filter and heater/humidifier cassette and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Vessel Vapor™ device, through the in-line filter, continues along the tube to enter the Vessel Vapor™ device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.

This document is a 510(k) summary for the Vessel Vapor™ device, a laparoscopic insufflator gas conditioner. It does not contain information about a clinical study with acceptance criteria and device performance. The document focuses on demonstrating substantial equivalence to predicate devices (Vessel Guardian® K102136 and Insuflow® K090456) based on technological characteristics and intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set information.

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Vessel Guardian®is a gas conditioner accessory device for use in endoscopic vessel harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.

The Vessel Guardian® device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the surgical cavity. The Vessel Guardian® device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Vessel Guardian® device, through the in-line filter, continues along the tube to enter the Vessel Guardian® device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.

The provided text describes a 510(k) premarket notification for the "Vessel Guardian®" device, a laparoscopic insufflator gas conditioner. Instead of presenting a detailed study, the submission relies on the concept of "substantial equivalence" to predicate devices already on the market. Therefore, the information typically found in a study demonstrating device performance against acceptance criteria is not present in this document.

Here's an analysis based on the provided text, outlining why certain sections of your request cannot be fulfilled and what information is available:

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

This information is not provided in the document. The submission states: "Extensive performance testing has been conducted to assure that the Vessel Guardian® (i.e., Insuflow ) performs in accordance with its specifications and applicable standards." However, the specific acceptance criteria (e.g., target temperature ranges, humidification levels, filtration efficiency) and the quantitative results of this testing are not detailed.

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

This information is not provided. As the submission relies on demonstrating substantial equivalence rather than presenting an original clinical study with a test set, there are no details about sample sizes, data provenance, or whether data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Establishing ground truth is typically relevant in studies where diagnostic accuracy or similar performance is being evaluated against expert opinion. This document does not describe such a study.

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

This information is not provided. Adjudication methods are specific to clinical trials and diagnostic performance studies, which are not outlined here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. An MRMC study is not relevant for this type of device, which is a physical accessory (gas conditioner) rather than an AI-driven diagnostic or assistive tool for human readers.

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

This information is not provided. This question is not applicable to a physical medical device like the Vessel Guardian®.

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

This information is not provided. Ground truth is not relevant in the context of this 510(k) submission, as it focuses on technological characteristics and equivalence rather than clinical outcomes or diagnostic accuracy requiring ground truth.

8. The sample size for the training set

This information is not provided. Training sets are relevant for machine learning algorithms, which are not described as part of this device.

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

This information is not provided. This question is not applicable for the reasons mentioned in point 8.

Summary of Available Information from the Document:

The core argument for the Vessel Guardian®'s safety and effectiveness is its substantial equivalence to predicate devices.

• Predicate Devices:

  • VasoVapor™, K101320
  • Insuflow®, K090456

• Claim of Equivalence: "Technically, the Vessel Guardian® is identical to the VasoVapor™ and Insuflow devices cleared for market in 510(k) K101320 and K090456, respectively. The indications for use for the Vessel Guardian® are patterned after the predicate devices, being specific to the endoscopic vessel harvesting application."

• Performance Testing (General Statement): "Extensive performance testing has been conducted to assure that the Vessel Guardian® (i.e., Insuflow ) performs in accordance with its specifications and applicable standards." However, the details of this testing, including specific acceptance criteria and results, are not included in the provided summary. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This means the FDA found sufficient evidence in the full submission to support the claim of equivalence, which would include the performance testing mentioned, even if not detailed in this summary.

In conclusion, this document is a 510(k) summary focused on demonstrating substantial equivalence, not a detailed clinical study report. Therefore, most of the specific data points requested regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment are not present in this public summary.

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VasoVapor™ is a gas conditioner accessory device for use in endoscopic vessel harvesting surgical procedures, intended to heat, humidify and filter a CO2 gas stream for insufflation of the surgical cavity.

The VasoVapor™ device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the surgical cavity. The Vaso Vapor™ device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the VasoVapor™ device, through the in-line filter, continues along the tube to enter the VasoVapor™ device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.

This document is a 510(k) premarket notification for the LEXION Medical VasoVapor™ device, a laparoscopic insufflator gas conditioner. It claims substantial equivalence to previously cleared devices (Insuflow®, K063546 and K090456).

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

The document does not provide a table of acceptance criteria and reported device performance for the VasoVapor™ in this submission. Instead, it states that "Extensive performance testing has been conducted to assure that the VasoVapor™ (i.e., Insuflow®) performs in accordance with its specifications and applicable standards. Details of that testing were provided in 510(k) K063546 and K090456 are referenced in Section 5 for completeness."

Therefore, the performance data for VasoVapor™ is referred to previous 510(k) submissions, and is not detailed in this specific document.

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

The document does not provide information on the sample size used for a test set or data provenance for VasoVapor™. It refers to prior 510(k) submissions (K063546 and K090456) for details on performance 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)

The document does not provide information about experts used to establish ground truth or their qualifications. The device is a gas conditioner accessory, and its performance would likely be assessed through physical and engineering tests rather than expert interpretation of medical images or data.

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

The document does not describe any adjudication method. This type of method is generally applicable for studies involving human interpretation (e.g., medical imaging) to resolve disagreements, which is not relevant for a device like a gas conditioner.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical data, often with or without AI assistance. The VasoVapor™ is an accessory device; not a diagnostic or screening tool.

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

A standalone performance evaluation (algorithm only) was not done, as the VasoVapor™ is a hardware device for conditioning gas, not an algorithm. Its performance would be measured by physical parameters (e.g., temperature, humidity, flow rate) rather than algorithm accuracy.

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

The document does not explicitly state the type of ground truth used. For a gas conditioning device, "ground truth" would likely refer to objective measurements of physical parameters such as temperature, humidity, and filtration efficacy, against established engineering specifications and standards.

8. The sample size for the training set

The document does not mention a training set sample size. A training set is typically relevant for machine learning algorithms, which are not applicable to the VasoVapor™ device.

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

The document does not mention a training set or how its ground truth was established, as it is not an AI/ML device.

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The Insuflow® DewHeart™ is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.

The Insuflow DewHeart™ device is a single use blower/mister device that attaches to the outlet port of the Insuflow controller with regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to introduction into the cardiovascular cavity. The Insuflow DewHeart™ device consists of a disposable filter heater/humidifier tubing set and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Insuflow® DewHeart™ device, through the in-line filter, continues along the tube to enter the Insuflow® DewHeart™ device cassette that contains the heating element and humidification media, through a nozzle/wand for directional. localization of a CO2 gas stream entry into the patient's surgical cavity

The provided text is a 510(k) summary for the Insuflow® DewHeart™ device, which is a blower/mister gas conditioner. It states that the device is technically the same as a previously cleared device (Insuflow®, K063546) and substantially equivalent to other predicate devices.

Here's an analysis of the requested information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. It generally states that "Extensive performance testing has been conducted to assure that the Insuflow DewHeart™ performs in accordance with its specifications and applicable standards." However, specific numerical acceptance criteria or performance results are not detailed in this summary.

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

The document does not specify any sample size for a test set. It refers to "Extensive performance testing" but does not provide details on the experimental setup or the data used. Therefore, the data provenance (country of origin, retrospective/prospective) cannot be determined from this text.

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

The document does not describe any study involving human experts to establish ground truth or evaluate the device's performance. The "performance testing" mentioned appears to refer to engineering or laboratory testing against specifications, not clinical or expert-reviewed data.

4. Adjudication Method for the Test Set

As no human expert review or ground truth establishment is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC study is mentioned. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and intended use, rather than comparing performance with human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device described is a physical medical device (blower/mister gas conditioner), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The performance testing refers to the device's physical functions like heating, humidifying, and filtering.

7. The Type of Ground Truth Used

The document discusses "performance testing" against "specifications and applicable standards." This implies the ground truth for evaluating the device's functionality would be engineering specifications and established standards for heating, humidifying, and filtering CO2 gas, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

As this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" is not relevant.

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

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

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