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The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.

The EVA5 insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. It is indicated to facilitate the introduction of various endoscopic instruments by filling the alimentary canal with gas to distend it. The EVA5 Insufflator is used in an operating room or endoscopic suite. It consists of the following major component (1) a micro-processor-controlled insufflation flow control system.

The EVA5 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate the alimentary canal via an endoscope. The EVA5 is powered by AC and uses a compressed 50 psi CO2 gas supply to supply the pneumatic circuitry for insufflation.

The EVA5 Insufflator is a medical device intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas. The document provides information regarding its non-clinical testing to demonstrate substantial equivalence to its predicate devices.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is non-clinical, focusing on the device's technical specifications.

3. Number of Experts and Qualifications

This information is not provided as the described testing is non-clinical performance testing of the device's mechanical and electronic functions, not human interpretation of medical images or data.

4. Adjudication Method

This information is not applicable as the testing described is non-clinical performance testing, not involving human interpretation or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The EVA5 Insufflator is a mechanical device, and its performance is evaluated based on technical specifications rather than human reader accuracy.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm (the insufflator's flow control system). The "Non-clinical Testing" section states: "Performance testing of the insufflator demonstrated that the subject device met its acceptance criteria..." This refers to the device's intrinsic mechanical/electronic performance.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance testing would be the precise, calibrated measurements of flow rate and timing. These would be established using validated testing equipment and methodologies.

8. Sample Size for the Training Set

This information is not applicable. The EVA5 Insufflator is a hardware device with a micro-processor-controlled insufflation flow control system. It is not an AI/ML algorithm that is "trained" on a large dataset in the conventional sense. Its "training" or calibration would occur during its manufacturing and quality control processes based on engineering specifications.

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

As noted in point 8, the concept of a "training set" and "ground truth" for a training set is not directly applicable to a hardware device like an insufflator. The device's operational parameters are designed and calibrated based on engineering principles and established medical device standards. The "ground truth" for its performance would be defined by these engineering specifications and validated through rigorous testing against calibrated measuring instruments.

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