Search Results

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.

Ask a specific question about this device

The OxyconAlpha with option ECG 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 OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older,

The OxyconAlpha with option ECG 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 OxyconAlpha with option ECG 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 OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill.

This document is a marketing clearance letter for a medical device (OxyconAlpha with Option ECG) and does not contain the specific information required to complete your request about acceptance criteria and a study that proves the device meets those criteria.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This letter primarily focuses on the FDA's determination of substantial equivalence (510(k) clearance) to a legally marketed predicate device, indicating that the device can be marketed. It describes the device's intended use and classification but does not detail the specific performance studies and their results.

Ask a specific question about this device

The OxyconAlpha is used as a predictive pulmonary function value calculator (Product code BTY). It is a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters.

It is the intention to determine on patients a cardiopulmonary limitation and to test on sport athlets their training level. The different load levels for both groups can be generated over a bicycle ergometer or over a treadmill. The patient population is age 4 and older. The environment of use is indoor.

The OxyconAlpha interfaces to a testsubject via mouthpiece or a face mask. The OxyconAlpha interfaces to peripheral equipment and is therefore available in a variety of configurations from a standard controlled ergospirometry unit to a fully expandable laboratory system with blood pressure monitor, treadmill and ergometer. The OxyconAlpha interacts with the ECG signal (recorded by another device) only to the extent of extracting the patient's heart rate from the ECG signal. Other uses such as displaying or further analyzing the ECG waveforms are not included in the present submittal.

The device is not intended for use as a diagnostic pulmonary-function interpretation calculator.

The OxyconAlpha is a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters. It interfaces to a testsubject via mouthpiece or a face mask and to peripheral equipment such as a bicycle ergometer or treadmill. It can interact with an ECG signal (recorded by another device) to extract the patient's heart rate.

I'm sorry, but this document does not contain the information requested in the prompt. The document is a clearance letter from the FDA for a medical device (OxyconAlpha), and it describes the device's indications for use and regulatory classification. It does not include details on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device