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The ABCA-NT is a continuous flow Gas Isotope Ratio Mass Spectrometer (GIRMS) System intended for use in the measurement of stable isotopes of carbon, nitrogen, and oxygen in gas samples. For this purpose, the system is comprised of a gas sampling module, a gas purification module, and an isotope ratio mass spectrometer which are synchronously coupled by means of an external computer which also collects and archives data.

The ABCA-NT is an acronym for a configuration of modules intended for use in analysis 13C and 18O in CO2 and 15N in N2 and N2O gas samples. The ABCA-NT System includes, as physically separate modules:

• The Europa 20-20 continuous flow IRMS
• The Europa ABCA-G gas purification module (Gas Chromatograph)
• A Gilson (or equivalent) autosampler
• An IBM (or compatible) personal computer for system control, data analysis and data storage

This 510(k) summary does not contain the information required to answer the questions regarding acceptance criteria and the study that proves the device meets the acceptance criteria. The document focuses on establishing substantial equivalence to a predicate device based on technological similarities, rather than presenting a performance study with specific acceptance criteria.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance: This document states that "The technical specifications of the systems are essentially equivalent" to the predicate device. However, it does not explicitly define any specific numerical acceptance criteria (e.g., accuracy thresholds, precision ranges) for the ABCA-NT device itself, nor does it present a table comparing such criteria to the reported performance of the new device.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document describes the principle of operation, calibration methods (using reference gas of known isotopic composition), and calculation of results. It discusses how the ABCA-NT is "faster and more convenient" than the predicate due to its triple-collector system and continuous flow. However, it does not describe any clinical or technical study that specifically evaluated the ABCA-NT's performance against predefined acceptance criteria. There is no mention of a test set, training set, ground truth, experts, or any kind of statistical analysis for performance metrics. The comparison is entirely at a conceptual and design level to argue for substantial equivalence.

In summary, the provided 510(k) summary focuses on demonstrating equivalence to an existing, pre-amendment device based on similar technology and principles, without presenting a specific performance study with clearly defined acceptance criteria and results.

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