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The XIumena NAVIX Access IDevice is intended for useras an accessory to cannulate the transgastric or transduodenal wall into a pancreativ oseudocyst. When it is visibly bulging into the gastrointestinal tractic furing endoscopic procedures

The NAVIX Access Device is a multi-lumen catheter device that enables the physician to create and dilate an access tract through adjacent tissues. The NAVIX Access Device is exchange-free in that it delivers multiple tools without the need to exchange these tools over a guidewire. The NAVIX Access Device includes a trocar, an anchor balloon, and a dilation balloon,

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the NAVIX Access Device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined acceptance criteria for a new clinical study.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states:
"Design durability was tested in the laboratory, and animal studies were used to validate performance of the system in a simulated clinical environment as well as verify the performance to design specifications."
This indicates testing was performed, but specific acceptance criteria (e.g., success rates, complication rates, measurement tolerances) and corresponding performance metrics are not listed.

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

• Test set sample size: Not explicitly stated for any human or clinical testing. The document mentions "animal studies."
• Data provenance: "Animal studies" were used. No information on country of origin of data or whether it was retrospective or prospective.

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

Not applicable, as no human clinical test set with ground truth established by experts is described. The "animal studies" would likely have their "ground truth" established by veterinary pathology or surgical observation.

4. Adjudication method for the test set

Not applicable, as no human clinical test set is described.

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

Not applicable. The device is a physical access device, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. The NAVIX Access Device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the animal studies: "performance of the system in a simulated clinical environment as well as verify the performance to design specifications." This suggests the ground truth was based on the physical observable performance of the device and whether it met its engineering specifications in a biological (animal) context.

8. The sample size for the training set

Not applicable. No "training set" in the context of an algorithm or AI is described. The mention of "design durability was tested in the laboratory" implies engineering testing, which might involve iterative design and testing, but not a "training set" in the machine learning sense.

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

Not applicable, as no training set (for an algorithm) is mentioned. For the laboratory testing, "ground truth" would be established by engineering measurements and stress tests against predefined specifications.

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