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Intended use for the Flowmate II PLUS is for Pulmonary Function Testing (measuring a person's ability to move air into and out of their lungs). The volume and flow rates measured for the effort and then reported as numerical results with a printout of the results if selected.

Indications For Use: Pulmonary Function Testing

Diagnostic

To evaluate symptoms, signs, or abnormal laboratory tests

• Symptoms: dyspnea, wheezing, orthopnea, cough, phlegm production, chest pain
• Signs: diminished breath sounds, overinflation, expiratory slowing, cyanosis, chest deformity, unexplained crackles
• Abnormal laboratory tests: hypoxemia, hypercapnia, polycythemia, abnormal chest radiographs

To measure the effects of disease on pulmonary function

To screen individuals at risk of having pulmonary diseases

• Smokers
• Individuals in occupations with exposures to injurious substances
• Some routine physical examinations
• To assess preoperative risk
• To assess prognosis (lung transplant, etc.)
• To assess health status before enrollment in strenuous phsical activity programs

Monitoring

To assess therapeutic interventions

• Bronchodilator therapy
• Steroid treatment for asthma, interstitial lung disease, etc.
• Management of congestive heart failure
• Other (antibiotics in cystic fibrosis, etc.)
• To describe the course of diseases affecting lung function
• Pulmonary diseases
• Obstructive airways diseases
• Interstitial lung diseases
• Cardiac diseases
  Congestive heart failure
• Neuromuscular diseases
  Guillain-Barré

To monitor persons in occupations with exposure to injurious agents

To monitor for adverse reactions to drugs with known pulmonary toxicity

Disability / Impairment Evaluations

To assess patients as part of a rehabilitation program

• Medical
• Industrial
• Vocational

To assess risks as part of an insurance evaluation

To assess individuals for legal reasons

• Social Security or other government compensation programs
• Personal injury lawsuits
• Others

Public Health

Epidemiologic surveys

• Comparison of health status of populations living in different environments
• Validation of subjective complaints in occupational / environmental settings Derivation of reference equations

Flow sensing pneumotach and base that measures differential pressure as air passes through it (the same principle as the Flowmate LTE, Flowmate, and PC Flow + devices)
Desktop design molded from high impact UL rated ABS plastic
Automatic calculations of test results, and best test selection based on American Thoracic Society (ATS) criteria
Testing capabilities include; FVC, FEV1, FEV3, FEV1/FVC%, FEF.2-1.2, FEF25-75%, FEF75-85, PEF, FEF50, FIVC, FEF50/FIF50, PIF, MVV, Methacholine Challenge, and Lung Age
Testing Capabilities: Capacity 10 Liters
Volume Accuracy +/- 3% Max. Flow Rate +/- 16 L/s
Back Pressure Less than 1.5 cm H2O
Population Predicted Normals included: Composite Knudson - 1976 Knudson - 1983 Crapo (ITS) ECCS Hsu Lam
Customization allows user to change report format, input temperature and barometric readings, and select internal / external printer and associated driver for printer selected
Reports printed on thermal paper 112mm wide or standard 8 1/2 " x 11" paper
Field calibration with a 1 to 9 Liter calibration syringe
Cross-contamination control via external filter system

The provided document is a 510(k) summary for the Flowmate II PLUS diagnostic spirometer. It describes the device's intended use, its substantial equivalence to predicate devices, and the performance testing conducted.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The primary acceptance criteria are based on conformance with the American Thoracic Society (ATS) 1994 Spirometry criteria. The document explicitly states: "Performance Standard: None applicable from FDA, used conformance with American Thoracic Society (ATS) 1994 Spirometry criteria."

Note: The document only states that the device "exceeded" ATS recommendations for FVC, FEV1, FEF25-75, and PEF accuracy and precision, rather than providing specific numerical targets for the ATS criteria. For MVV, it states "acceptable results compared with the ATS criteria." The specific numerical acceptance criteria from ATS 1994 are not detailed in this document.

Study Information

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

• Sample Size:
  • For FVC, FEV1, FEF25-75, and PEF accuracy and precision: 24 waveforms (under BTPS conditions), and 26 PEF waveforms.
  • For FVC, FIVC, PEF, and PIF accuracy and precision (exponential waveforms): Four progressively faster exponential waveforms.
  • For MVV testing: Not explicitly stated, but implies multiple tests with simulated MVV waveforms.
• Data Provenance: The tests were conducted using a "Pulmonary Waveform Generator (PWG)." This indicates the data is simulated/synthetic (generated by a machine), not from human subjects. The country of origin of this simulated data is not specified, but it's likely created in the US given the company's location.

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

• No human experts were used to establish the ground truth for the test set. The ground truth was established by the known inputs/outputs of the Pulmonary Waveform Generator (PWG) and physical measurements (e.g., a 3-liter syringe for volume accuracy).

3. Adjudication method for the test set:

• Not applicable/None. The ground truth was based on the objective outputs of the PWG and known physical inputs, not on expert consensus requiring adjudication.

4. 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 is a performance study for a diagnostic spirometer, which primarily measures physiological parameters. It is not an AI-assisted diagnostic tool that would involve human readers interpreting images or data alongside AI. Therefore, an MRMC study is not relevant here.

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

• Yes, implicitly. The entire performance testing described was "standalone." The device (Flowmate II PLUS) was tested against a Pulmonary Waveform Generator (PWG) and physical inputs (like a calibration syringe) to assess its accuracy and precision in measuring various spirometric parameters. This represents the algorithm/device's performance without human interaction in the measurement process itself, beyond setup and data collection.

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

• Known physical inputs/outputs and pre-defined standards.
  • For volume accuracy, a known 3-liter syringe input was used.
  • For waveforms (FVC, FEV1, PEF, etc.), the "known" characteristics of the waveforms generated by the Pulmonary Waveform Generator (PWG) served as the ground truth.
  • The ATS 1994 Spirometry criteria served as the benchmark for acceptable performance.

7. The sample size for the training set:

• Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its functionality is based on physical principles (differential pressure measurement) and programmed calculations, not learned patterns from data.

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

• Not applicable, as there is no training set for this type of device.

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