Search Results

The PMP4 Spiro Pro is intended for pulmonary function testing for use in hospital, clinic or home settings. It allows patients to display and transmit their pulmonary function data via a communication device to medical professionals in a remote server.

PMP4 Spiro Pro is a portable spirometer designed to accurately measure lung ventilatory functions during the Forced Vital Capacity (FVC) tests. The system records the following: Volume-Time and Flow-Volume curves, FVC, Forced Expiratory Volume: FEV1, FEV3, Peak Expiration Flow (PEF), Forced Expiratory Flow: FEF75%, FEF50%, FEF25%, FEF25/75. PMP4 Spiro Pro operates in two modes: PDA and Stand-alone. In the PDA mode the test data is transmitted through a Bluetooth or infrared link to a PDA. In this mode all necessary calculations are performed by the PDA's software. In the stand-alone mode the Spiro Pro calculates all parameters and displays the results on its LCD. In conjunction with the pulmonary receiving station PMP4 Spiro Pro provides an important tool for monitoring COPD patients.

The provided text describes the PMP4 Spiro Pro, a portable spirometer. However, it does not contain details about a specific study or acceptance criteria with reported device performance metrics. The document is a 510(k) summary for premarket notification to the FDA, focusing on substantial equivalence to predicate devices and adherence to standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets these criteria as the information is not present in the provided text.

Here's what I can extract based on the information given, and indicate what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the document with quantitative thresholds for performance. The document generally states that the device "meets the requirements of the following Standards, Regulations and Guidances" and that "performance tests according to the Thoracic society standardization were performed and assured the safety and efficacy of the device."
• Reported Device Performance: Not provided in the document.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document mentions "laboratory testing," but no specifics about the data used for performance claims.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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: Not applicable. This device is a spirometer for measuring lung function, not an AI-assisted diagnostic tool that would typically involve human "readers" or AI improvement.
• Effect Size of AI Improvement: Not applicable.

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

• The PMP4 Spiro Pro operates in two modes:
  • Stand-alone mode: "the Spiro Pro calculates all parameters and displays the results on its LCD." This indicates standalone performance of the device's inherent algorithms for calculating spirometry parameters.
  • PDA mode: "In this mode all necessary calculations are performed by the PDA's software." This also reflects an algorithmic standalone calculation, albeit on an external device.
• However, the document does not provide performance metrics specifically from these standalone calculations, only that they occur. It states "performance tests according to the Thoracic society standardization were performed," which implies a standalone evaluation of the device's accuracy in measuring various respiratory parameters.

7. The type of ground truth used

• The document states "performance tests according to the Thoracic society standardization were performed." The American Thoracic Society (ATS) guidelines for spirometry typically define the gold standard for measurements using calibrated volume-time sources (e.g., syringes) and/or clinically validated reference spirometers.
• Therefore, the implied ground truth would be measurements from a calibrated reference standard or another highly accurate spirometer adhering to ATS guidelines.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable / Not specified. This device describes a spirometer for direct measurement, not an AI/ML algorithm that typically requires a large training set of data.

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

• Ground Truth for Training Set Establishment: Not applicable / Not specified. As above, this device does not appear to employ AI/ML in a way that would necessitate a "training set" in the conventional sense for a prediction model. Its function is based on direct physical measurement and calculation.

Ask a specific question about this device