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The KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).

The KeyPort AR System is a reusable device used for creating and maintaining an artificial access port to body cavities including the necessary pneumoperitoneum. The KeyPort AR System allows multiple instruments and /or camera access during minimally invasive procedures, which include anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision). This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons. The KeyPort AR System is comprised of KeyPort silicone sealing insert (1), KeyPort AR trocar sleeve (2), and KeyPort trocar (3). The KeyPort AR System is used in conjunction with CO2 insufflator, Pump for smoke gas evacuation, and required instruments which are selected in accordance with the indications as well as the surgeon's requirements. Unless otherwise specified, all components of the KeyPort AR System are reusable and require sterilization before use. Methods of cleaning, disinfection, and sterilization are detailed in Instruction Manual GA-B 253-2 USA.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the KeyPort AR System:

1. Table of acceptance criteria and the reported device performance:

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

• Sterilization validation: The sample size is not explicitly stated, but the results indicate that "All acceptance criteria were met."
• Gas-tight seal testing: The sample size is not explicitly stated.
• Preclinical test (incision size): The sample size is not explicitly stated, but it was conducted using "pigs."
• Data Provenance: The document does not specify the country of origin for the sterilization and gas-tight seal tests. The preclinical test used "pigs," implying an animal model study, which is typically prospective.

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

This information is not provided in the document. The tests performed (sterilization, gas-tight seal, preclinical incision size) do not typically involve human expert ground truth for their evaluation.

4. Adjudication method for the test set:

This information is not provided as the types of tests described do not involve adjudication by multiple experts in the same way clinical studies or image-based AI studies would.

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 MRMC comparative effectiveness study was done. The device is a surgical access system, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used:

• Sterilization validation: The ground truth would be established by specific performance standards for sterilization effectiveness (e.g., sterility assurance level), likely measured through microbiological assays.
• Gas-tight seal testing: The ground truth would be established by quantifiable pressure measurements and leakage rates against predefined thresholds.
• Preclinical test (incision size): The ground truth would be a direct observation of the surgical outcome (sufficiency of the incision) in the animal model.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, there is no training set for a physical medical device.

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