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The Viasys Masterscreen CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The Masterscreen CPX system allows the monitoring of metabolic parameters. The Masterscreen CPX system is intended to use with adults and children over the age of 14 years.

The Viasys Masterscreen CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The Masterscreen CPX system allows the monitoring of metabolic parameters.

This document is a 510(k) clearance letter for the Masterscreen CPX and Oxycon CPX pulmonary function data calculators. It does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets them.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA found the device "substantially equivalent" to existing devices already on the market, not that a specific study was performed to meet novel acceptance criteria for this particular device. The 510(k) process primarily relies on demonstrating equivalence to predicates, not necessarily on a new full-scale efficacy study with detailed acceptance criteria as you might find for a PMA (Premarket Approval) device, or a de novo classification.

Therefore, I cannot provide the requested information from this document. It does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
3. Information on MRMC comparative effectiveness studies or standalone algorithm performance.
4. Details on the type of ground truth used or sample sizes/methods for establishing ground truth for a training set.

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