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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.

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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