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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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