(198 days)
The indications for use are the same as the Vmax Series to which this product is an option. Quotation from the Indications for Use section of the Vmax premarket notification: "Basically, this involves performing physicianprescribed pulmonary function and metabolic testing. More-specific intended uses are shown in the table below, along with the predicate SensorMedics product model with the same intended-use labeling."
The Static and Dynamic Compliance option is indicated specifically for Evaluation of medication effects, Pulmonary Function testing in adults & children, Pulmonary disability evaluation, Industrial surveillance and Bedside lung function.
The Static and Dynamic Compliance software product option is identical in safety and effectiveness to the predicate devices listed in the last section. The technique of placing an esophageal balloon and derived measurements are also the same as the predicate devices.
Static and dynamic compliance are measurements of pulmonary function. also commonly referred to as Respiratory Mechanics. The mechanical properties of the respiratory system are important to breathing effectively. In healthy people, the elastic recoil and compliance of the lung are easily managed by the respiratory muscles allowing normal breathing. In some common respiratory diseases, there are changes in recoil and compliance. Static and dynamic compliance are easily measured and can be valuable in determining the effects of lung disease on breathing.
Static and dynamic compliance are performed by having the patient swallow an esophageal balloon that is connected to a calibrated pressure transducer, The patient breathes quietly on a mouthpiece connected to a flow meter. while mouth pressure, esophageal pressure, flow rate and volume changes are measured. The balloon is placed in the esophagus just above the diaphragm. This position is determined by having the patient breath through a flow meter, while the operator views a display of esophageal pressure, inspiratory flow and expiratory flow on a computer monitor. The operator looks for a negative pressure-tracing concomitant to a positive flow tracing. If the pressure tracing is positive, the balloon has passed the level of the diaphragm and needs to be pulled back until a positive tracing is displayed.
When measurements are made under no-airflow conditions, Static Compliance is calculated. When the measurements are made under flow conditions, Dynamic Compliance is calculated.
The provided text describes the Static and Dynamic Compliance software product option and states it is "identical in safety and effectiveness to the predicate devices listed in the last section." It also notes that "The technique of placing an esophageal balloon and derived measurements are also the same as the predicate devices."
However, the document does not describe a study to prove the device meets acceptance criteria. Instead, it relies on substantial equivalence to predicate devices. Therefore, I cannot generate a table of acceptance criteria with reported device performance or information about a specific study for this device.
Here's what I can extract based on the provided text, highlighting the absence of a study and related details:
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A table of acceptance criteria and the reported device performance: Not available. The document asserts identity to predicate devices rather than presenting specific acceptance criteria and performance data for the device itself.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new study testing the device's performance is described.
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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. No new study testing the device's performance is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new study testing the device's performance is described.
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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: Not applicable. This device is not an AI-assisted diagnostic tool; it's software for pulmonary function measurements. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No standalone performance study details are provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No new study testing the device's performance is described.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. Its functionality is based on established physiological measurements and calculations.
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How the ground truth for the training set was established: Not applicable.
In summary, the document does not contain details of a de novo study or performance data for this specific device. It establishes substantial equivalence to predicate devices, inferring that its performance matches those established devices.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).