Search Results

The Resmon PRO FULL is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Resmon PRO FULL is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics. and private physician offices.

Resmon PRO FULL is a device for the assessment of the mechanical impedance based on the Forced Oscillation Technique (FOT).

FOT is a non-invasive lung function test for measuring the mechanical properties of the respiratory system. It consists in applying very small pressure oscillations (1-3 cmH2O peak-to-peak) of a given frequency/frequencies (usually below 40Hz) at the patient's mouth while she/he is breathing normally. During the test, the device measures pressure at the mouth and airflow to calculate respiratory impedance in real-time. Impedance is the complex ratio between pressure and airflow estimated at the frequency of the stimulating waveform. Common stimulating waveforms range from a simple sinusoid wave to a composite of different frequencies or impulses. The first approach is utilized for tracking swift changes in respiratory impedance. Examples of this include breath changes in lung mechanics or outcome measurements of specific interventions. The latter is used to assess the frequency dependency of impedance (related to the degree of lung heterogeneity) and identify the parameters of mathematical models of the respiratory system.

FOT allows for measurement during a patient's normal breathing pattern, with no forced effort required, making it suitable for monitoring non-cooperative patients, such as elderly patients, children or very severely ill patients with limited forced capacity. The test is usually performed with the subject seated, wearing a nose-clip (to prevent airflow leaks from the nose during normal breathing) and with hands on cheeks (to prevent the shunt of the pressure stimulus in the upper airways). The device is not intended to be used as a stand-alone diagnostic device.

Resmon PRO FULL consists of a main unit which has been designed to be used stand-alone, without the need of any personal computer, and an adjustable holder with a clamp to fix such unit to a table/desk and to regulate its height and orientation to the patient during an FOT test.

The provided text describes the regulatory clearance of the Resmon PRO FULL device. However, it does not include detailed information regarding specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy) or a study that rigorously proves the device meets these criteria in the typical sense of a clinical performance study for an AI/ML powered device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Carefusion MasterScreen IOS K101873) through technological comparison and non-clinical performance testing. The "performance testing" described is primarily about reproducibility, repeatability, and a comparative analysis of measured parameters against the predicate, rather than a clinical effectiveness study.

Based on the provided text, here's what can be extracted and what is missing:

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

The document does not state explicit acceptance criteria in the form of thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device. The performance is assessed through reproducibility, repeatability, and comparison of measured parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Comparative testing was done with the subject device and the predicate across the range of parameters and performance specifications."

• Sample Size: Not specified. It only mentions "Multiple units were tested" for reproducibility/repeatability. There is no information on the number of subjects or types of data used for the comparative testing with the predicate.
• Data Provenance: Not specified (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 (e.g. radiologist with 10 years of experience)

Not applicable. This device is a measurement device for physiological parameters (respiratory impedance). Its performance is evaluated against physical standards and comparison with another device, not against expert-labeled ground truth for diagnosis/interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no expert adjudication mentioned or required for this type of device evaluation.

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

No. This device is a diagnostic spirometer using the Forced Oscillation Technique (FOT) to measure respiratory impedance. It is not an AI-assisted diagnostic imaging device or an AI application with a "human-in-the-loop" for interpretation that would typically undergo an MRMC study. It is stated that "The device is not intended to be used as a stand-alone diagnostic device."

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

Yes, in a sense. The performance tests ("Hardware Verification," "Software and System Verification and Validation," "Reproducibility and Repeatability," "Comparative testing") evaluate the device's ability to accurately measure and report physiological parameters according to its specifications and in comparison to a predicate device. This is the "standalone" performance of the measurement system itself. There are no algorithms described beyond the calculation of respiratory impedance from pressure and airflow.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation would be:

• Physical calibration standards/simulators: Used to verify accuracy, resolution, and range of flow, pressure, and volume measurements.
• Predicate device measurements: For comparative testing, the predicate's measurements serve as a reference point for demonstrating statistical equivalence in measured parameters.
• Established scientific principles: The device's operation based on the Forced Oscillation Technique (FOT) adheres to these principles.

8. The sample size for the training set

Not applicable. This document does not describe the development of an AI/ML algorithm that requires a training set. The device appears to be a hardware-based measurement system with embedded software for calculations, not a learnable model.

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

Not applicable (as above).

Ask a specific question about this device

The Express Series uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.

The Express Series uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.

The Express Series can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

The Express Series is a cardiopulmonary exercise or resting metabolic measurement system with an integrated touch screen computer that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.

The provided text is a 510(k) Special Summary for the Medgraphics Express Series, an Oxygen Uptake Computer. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a novel AI device might.

Based on the provided text, here's an analysis of the information requested. Many fields will be marked "Not Applicable" or "Not Provided" because the document is a summary for a traditional medical device (an oxygen uptake computer) and not an AI/ML device, and thus doesn't include the type of detailed study information typically found in submissions for AI products.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 10 systems (for laboratory and clinical testing).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal "Laboratory and clinical testing."

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

• Number of Experts: Not applicable/Not provided. The ground truth appears to be established by comparison to the predicate device's output, not by expert interpretation.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not provided. The study compares a new device's measurements to a predicate device's measurements, not human interpretations requiring adjudication.

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

• MRMC Study: No. This is not an AI device, and the study design is not an MRMC study.

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

• Standalone Performance: Yes, in the sense that the device itself (the Express Series) was tested against the predicate device (Ultima System) in a "tandem gas exchange system validator studies." This evaluates the device's measurement capabilities directly.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this substantial equivalence study is the performance and data output of the predicate device, the Medgraphics Ultima System (K061731). The study aimed to show that the new device's measurements (VO2, VCO2, tidal volume) had less than 5% variability when compared to the predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not provided. This is not an AI/ML device, so there isn't a "training set" in that sense. The device is a measurement system.

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

• Ground Truth for Training Set Establishment: Not applicable/Not provided.

Ask a specific question about this device

The Ultima system uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.

The Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.

The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

The Ultima system is a cardiopulmonary exercise system that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.

The Medgraphics Ultima System, categorized as an Oxygen Uptake Computer, has been found substantially equivalent to its predicate device, the Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer (K955432).

Here's an analysis of the acceptance criteria and the study that supports the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: 11 Ultima systems were used for laboratory testing.
• Data Provenance: The document does not explicitly state the country of origin. It is implied to be internal laboratory testing conducted by Medical Graphics Corporation. The study is retrospective, as it compares the new Ultima system to a previously marketed predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

• The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The study relies on direct comparison to the predicate device's output and internal laboratory testing.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method for the test set. The evaluation focuses on the direct comparison of performance metrics (VO2, VCO2, tidal volume) between the Ultima system and the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a device for physiological measurement (Oxygen Uptake Computer), not an imaging or diagnostic AI system requiring human interpretation comparison. This device provides quantitative data, not interpretations that would be compared to human readers.

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

• Yes, the study primarily represents standalone algorithm/device performance. The laboratory testing assessed the device's output and precision independently, comparing it to a predicate device. While a human operates the device, the performance evaluation itself is based on the device's measured outputs compared to established benchmarks or the predicate.

7. The Type of Ground Truth Used:

• The ground truth in this study is based on the performance and output of the legally marketed predicate device (Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer, K955432), as well as the inherent physiological measurements (VO2, VCO2, tidal volume) for which the device is designed to accurately measure. The "less than 3% variability" indicates an acceptable deviation from the predicate's established measurements.

8. The Sample Size for the Training Set:

• The document does not mention a separate "training set" in the context of machine learning or AI development. For a physiological measurement device like this, the "training" would typically refer to the calibration, design, and internal validation processes during its development, which are not detailed as a distinct "training set" here.

9. How the Ground Truth for the Training Set Was Established:

• As a "training set" is not explicitly mentioned, the method for establishing its ground truth is not provided. For a device of this nature, the "ground truth" during development and calibration would likely rely on established physiological models, controlled gas mixtures, and comparison to highly accurate reference instruments.

Ask a specific question about this device

Ask a specific question about this device