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The Ventlab Pressure-Chek Disposable Column Manometer provides visual indication of a patient's airway pressure during ventilation. It may be connected to the manometer or proximal ports on ventilator devices such as resuscitation bags, hyperinflation systems, CPAP masks and CPAP circuits. This device is a single patient use, non-sterile device that is indicated in both hospital and homecare applications.

Ventlab Pressure-Chek Disposable Column Manometer

Analysis of Ventlab Pressure-Check Disposable Column Manometer (K120118)

This document is a 510(k) clearance letter from the FDA. It declares the Ventlab Pressure-Check Disposable Column Manometer substantially equivalent to a predicate device. However, it does not contain details about the specific acceptance criteria or a study proving the device meets those criteria.

FDA 510(k) clearance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The detailed study data outlining performance metrics against specific acceptance criteria is usually submitted by the manufacturer as part of their 510(k) submission, but this information is not typically included in the public-facing clearance letter.

Therefore, based solely on the provided text, I cannot answer most of your questions as the requested information is not present. The document focuses on the regulatory clearance process rather than specific performance study details.

Here's what I can extract from the provided text and what I cannot:

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

• Cannot provide. The document does not specify acceptance criteria or report specific device performance metrics from a study.

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

• Cannot provide. The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective).

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

• Cannot provide. The document does not describe any expert ground truth establishment process or qualifications.

4. Adjudication method for the test set:

• Cannot provide. The document does not describe any adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Cannot provide. This device is a manometer (a physical device for measuring pressure), not an AI algorithm. Therefore, an MRMC study related to AI assistance would not be applicable or expected for this type of product.

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

• Cannot provide. As noted above, this is a physical manometer, not an algorithm.

7. The type of ground truth used:

• Cannot provide. The document does not describe the specific ground truth used for any testing. For a manometer, ground truth would typically involve reference pressure measurements from calibrated equipment.

8. The sample size for the training set:

• Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, there is no training set for this type of device.

In summary, the provided FDA clearance letter confirms the regulatory status of the Ventlab Pressure-Check Disposable Column Manometer but does not contain the detailed technical study information you are requesting. That information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in its entirety.

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