(236 days)
The Oxycon Pro is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes.
The Oxycon Pro interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The Oxycon Pro interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older.
The Oxycon Pro is capable of performing computerized ECG interpretation during resting condition.
The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar areas. It is intended to be used by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.
The Oxycon Pro is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes.
The Oxycon Pro interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The Oxycon Pro interfaces to a peripheral ergometer or treadmill.
This document is a 510(k) clearance letter from the FDA for a device called "Oxycon Pro." It primarily focuses on the regulatory approval process and doesn't contain detailed information about specific acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics.
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.
Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment is not present in the provided text.
To provide the requested information, one would typically need access to the actual 510(k) submission documentation, which would include detailed performance data, validation studies, and the acceptance criteria established by the manufacturer and reviewed by the FDA.
Based on the provided text, I can only state that:
- Acceptance Criteria and Reported Device Performance: This information is not available in the provided FDA clearance letter. The letter confirms substantial equivalence but does not detail the specific performance metrics or acceptance criteria used to demonstrate this equivalence.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of these details are provided in the regulatory letter. These are typically found in the scientific and clinical studies submitted as part of the 510(k) premarket notification.
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).