Search Results

The device measures the exhaled breath of a patient, specifically FEV1. The results can be used for the diagnosis of COPD in adult smokers.
The device measures expiratory lung function parameters, specifically FEV1 and conforms to ATS standards for diagnostic devices. The results obtained can be used for screening of COPD in adult smokers.

The PulmoLife is a battery operated hand held portable spirometer. It uses a uni-directional, rotating vane, flow sensing turbine to measure lung function parameters, specifically Forced Expiratory Volume in the 1st second of expiration (FEV1) and FEV1 as a percentage of the predicted value (FEV1 %predicted). Lung age estimation is also given. It is supplied with one way valve safety mouthpieces, carrying pouch and instruction manual.

Here's an analysis of the provided 510(k) summary regarding the PulmoLife device, structured to answer your specific questions.

Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's basic information. It does not contain the detailed study results, acceptance criteria, or ground truth establishment that would typically be found in a comprehensive clinical study report. Therefore, many of your questions cannot be answered directly from the provided text.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

The summary states, "The device measures expiratory lung function parameters, specifically FEV1 and conforms to ATS standards for diagnostic devices." This implies that the device is expected to meet the accuracy and precision requirements set forth by the American Thoracic Society (ATS) standards for spirometry. However, the specific numerical acceptance criteria (e.g., accuracy within X% or Y liters) and the reported device performance against those criteria are not provided in this 510(k) summary.

Without the actual study report, a table cannot be constructed with specific numerical data.

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

This information is not provided in the 510(k) summary. A mention of a clinical study or performance data is absent, other than the general statement about conforming to ATS standards.

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)

This information is not provided in the 510(k) summary. For spirometry, "ground truth" often refers to measurements obtained from highly accurate laboratory spirometers.

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

This information is not provided in the 510(k) summary.

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

The PulmoLife is a diagnostic spirometer, not an AI-assisted diagnostic tool for image interpretation or similar. Therefore, an MRMC study as typically understood in AI/imaging is not applicable here, and no such study is mentioned or implied. The device measures lung function directly.

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

The PulmoLife is a standalone device in that it measures FEV1 directly. The "algorithm" here would be the processing of the flow signal to calculate FEV1. There isn't a human interpreting an "output" from the device in the same way an AI system might provide a result that a human then reviews. The performance of the device itself in generating the FEV1 measurement would be the focus. The summary implies that "standalone" performance was the focus, as it claims conformance to ATS standards for "diagnostic devices."

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

For spirometry, ground truth would typically be established by:

• Reference spirometers: Highly calibrated and accurate laboratory spirometers used to validate the measurements of the new device.
• Simulators: Mechanical or electronic simulators that produce known flow and volume signals.

The summary itself does not specify the ground truth mechanism used, but it's implied to be based on physical measurements and comparisons with established methods (ATS standards).

8. The sample size for the training set

This information is not provided in the 510(k) summary. For a hardware device like a spirometer, there might not be a "training set" in the machine learning sense. The device's calibration and validation would be based on engineering principles and comparison to reference standards.

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

As above, a "training set" in the AI sense is unlikely to apply directly to this device. The establishment of ground truth for device calibration and validation would involve highly accurate physical measurements or simulations, conforming to spirometry standards. The specifics are not detailed in the provided document.

Summary of Limitations based on the provided document:

The provided 510(k) summary is very high-level and serves the purpose of demonstrating substantial equivalence to a predicate device. It does not include the detailed clinical or validation study reports that would contain the specific acceptance criteria, performance data, sample sizes, ground truth methodologies, and expert qualifications for a rigorous assessment. To obtain this level of detail, one would typically need to refer to the full 510(k) submission or any referenced performance studies, which are not part of this snippet.

Ask a specific question about this device