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The Micro Diary Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. Specifically, the Micro Diary Spirometer measures the following lung function parameters: FEV1, FVC, FEV6 and PEF. The device also records the test data for later review and has the ability to transfer these test records to a compatible computer.

The Micro Diary Spirometer is a compact, hand held, and battery operated recording spirometer. The device features a five button keypad and an LCD display. The device utilizes a digital volume transducer. As a patient's exhaled breath is passed through the transducer, the vane rotates. The number of rotations is proportional to the volume of air passed through the transducer, and the frequency of rotation is proportional to the flow rate.

Here's an analysis of the acceptance criteria and study information for the Micro Diary Spirometer, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document states that the device was tested to assure it "accurately measures lung function across the following standard spirometric measures: FEV1, FVC, FEV6, and PEF." It then explicitly states "All tests were passed successfully." No specific numerical thresholds for accuracy are provided in this summary.

Study Information

The provided document describes a non-clinical study to demonstrate substantial equivalence to a predicate device. No clinical studies were conducted or submitted.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "All tests were passed successfully," suggesting an adequate number of tests were performed to demonstrate compliance with accuracy requirements for the measured parameters (FEV1, FVC, FEV6, PEF).
• Data Provenance: Not explicitly stated, though being a non-clinical test, it would have been generated in a laboratory setting, likely in the US where the company is based.

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

• Not applicable. This was a non-clinical test comparing the device's measurements against established standards for spirometric accuracy, not against expert interpretation of medical images or data.

4. Adjudication method for the test set:

• Not applicable. As a non-clinical test, there was no expert adjudication involved. The device's measurements were compared against objective reference values from a calibrated system.

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. An MRMC study was not conducted as this is a diagnostic spirometer, not an AI-assisted diagnostic tool for interpretation.

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

• Yes, a standalone non-clinical study was performed. The spirometer's accuracy was tested independently in a laboratory setting against objective standards for FEV1, FVC, FEV6, and PEF.

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

• Objective reference values / calibrated standards. For non-clinical spirometry testing, the ground truth is established by highly accurate and calibrated equipment that simulates lung function parameters or directly measures them to a high degree of precision.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. Its function is based on physical measurement principles (turbine rotation) and engineering design.

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

• Not applicable. As mentioned above, there is no "training set" for this device.

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