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The Nexcore GI Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

The Nexcore GI Insufflator allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.

The Nexcore GI Insufflator is a reusable electronic medical device that delivers CO2, via a gastrointestinal (GI) endoscope, to provide improved visualization, increase patient comfort, and increase procedure efficiency during GI endoscopic procedures. The insufflator operates by receiving CO2 from a pressurized cylinder or hospital infrastructure supply and regulating it down in stages to a lower pressure by means of primary and secondary regulators. Each stage of pressure, including the output pressure, has a pressure relief valve as a redundant safety backup for the regulator system. The flow rate is controlled by an electronically controlled proportional valve, which utilizes differential pressure across an in-line orifice to measure flow rate. The output flow rate is user adjustable with four pre-defined settings: high, medium, low and ultra-low.

The device contains software that receives inputs from a touchscreen user interface and controls the operation of the device, including the delivery of CO2 to the endoscope. There are no direct patient-contacting components in this device, other than the delivered CO2 gas. The device is reusable and is not sterile. The Nexcore GI Insufflator is used in hospitals and outpatient endoscopy suites. The device operates from mains power.

There is one model (NX-350) of this device. The accessories sold with the device are the line (power) cord and a pin-indexed high pressure hose for CO2 cylinder connection.

The Nexcore GI Insufflator is used with commercially available, separately cleared devices, including a GI endoscope and tube set. The appropriate compatible tube set is intended to provide CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures and must have a ≤0.2 micron hydrophobic filter, check valve, and luer fittings at both ends. The tubing ID must be sufficient to deliver 4L/min.

The provided text describes the Nexcore GI Insufflator, a device designed to use CO2 as a distention medium in the gastrointestinal tract during endoscopic procedures. The document is a 510(k) premarket notification approval, establishing substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might see in a detailed performance study for an AI algorithm. Instead, it describes compliance with various standards and functional equivalence to a predicate device. The "acceptance criteria" are implied by the standards and the comparison to the predicate.

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

The document describes "non-clinical testing" and "performance (bench) testing." It states: "The purpose of the testing was to compare the output the predicate device against the Nexcore GI Insufflator. Follow up non-clinical testing was performed to further focus and define the software's control algorithms. This testing also included a distal pressure test."

• Sample Size: The document does not specify a "sample size" in terms of number of patients or cases, as this is a non-clinical, benchtop device. The testing likely involved multiple repetitions of measurements or simulations, but the exact number of test runs or devices tested is not provided.
• Data Provenance: The data is from non-clinical bench testing. There is no mention of human or animal data, retrospective or prospective studies, or country of origin for such data.

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

This information is not applicable and not provided. The device is an insufflator, a mechanical/electronic medical device. Its performance is evaluated against technical specifications and safety standards, not against human expert diagnoses or interpretations. Therefore, there is no "ground truth" established by experts in the context of diagnostic performance.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for diagnostic studies involving human readers and AI where there might be disagreements in interpretation. This device's performance is measured against objective physical parameters and engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., imaging AI) assessing how AI assistance impacts human reader performance. The Nexcore GI Insufflator is a therapeutic/procedural accessory device.

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

The document describes "non-clinical testing," "software verification and validation testing," and "electrical safety and EMC testing." These are essentially standalone performance evaluations of the device and its embedded software. The device itself operates autonomously to deliver CO2 based on user settings. While it interacts with an endoscope and is controlled by a physician, the performance tests described (e.g., pressure control, flow rate, safety mechanisms, software algorithms) are evaluating the device's intrinsic function without a human-in-the-loop performance measurement.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, recognized national and international safety standards (e.g., IEC, ISO), and the functional parameters of the predicate device. For example:

• Pressure: Measured pressure output against desired settings and safety limits.
• Flow Rate: Measured flow rate against desired settings.
• Software: Code analysis and functional testing against design requirements.
• Electrical Safety/EMC: Compliance with specific limits defined in the IEC standards.
• Biocompatibility: Results of tests against ISO 10993-1 guidelines.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this device's performance as an insufflator.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Nexcore GI Insufflator is not described as an AI/machine learning device that requires a "training set" in the conventional sense. Its "software" controls device operation but is not implied to be a learning algorithm. The software development follows traditional software engineering principles (verification and validation) rather than machine learning model training.

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

This information is not applicable and not provided, as there is no mention of a traditional "training set" for an AI/machine learning model. The software's operational parameters would have been established through engineering design, requirements specification, and validation against known physical principles and safety limits.

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