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The Merit Medical INTELLISYSTEM II MONITOR is for use only with the disposable INTELLISYSTEM25 Syringe. It may be used to monitor the pressure of interventional devices as well as measure injectate pressures in various areas of the body.

The Merit Medical IntelliSystem comprises a disposable inflation/pressurizing syringe with an integral pressure transducer, an electronic monitor for displaying and storing data which is connected to the syringe via a disposable interface cable, a printer for producing a hard copy of data collected during the procedure, and mounting accessories with which the monitor is attached to the procedure table or an IV pole.

The provided text describes a 510(k) premarket notification for the IntelliSystem II Angioplasty Inflation Device. However, it does not contain any information regarding acceptance criteria, study design, or performance data beyond stating substantial equivalence to a predicate device.

Therefore, I cannot fulfill most of your request from the given text.

Here's what I can extract based on the available information:

1. A table of acceptance criteria and the reported device performance

The provided document does not specify any acceptance criteria or reported device performance data. The submission only asserts "substantial equivalence" to a predicate device (K884913, INTELLIFLATORTM).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided text.

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)

This information is not present in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device described is a monitor for an angioplasty inflation device, not an AI-assisted diagnostic tool for human readers.

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

This information is not present in the provided text. The device is a monitor displaying physical parameters, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text.

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

This information is not present in the provided text.

In summary, the provided document focuses on the administrative aspects of a 510(k) submission, specifically demonstrating substantial equivalence to a predicate device, rather than detailing the technical studies and performance data that would typically include acceptance criteria and ground truth establishment.

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