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The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician.

The PulmOne MiniBoxPFT™ 2.0 is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung volumes). The PulmOne MiniBoxPFT™ 2.0 is to be used by either a physician, respiratory therapist, or technician. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the device.

The MiniBoxPFT™ 2.0 measures all common spirometric measurements as well as relative and absolute lung volumes, including the following (the full list is detailed in Section 11 - Device Description):

Absolute Lung Volumes:
Total lung capacity (TLC) L
Thoracic Gas Volume (TGV) L
Residual volume (RV) L

Relative Lung Volumes:
Inspiratory capacity (IC) L
Expiratory reserve volume (ERV) L

Spirometry:
Forced vital capacity (FVC) L
Forced inspiratory vital capacity (FIVC) L
Slow vital capacity (SVC) L
Slow inspiratory vital capacity (IVC) L
Forced expiratory volume in 1 second (FEV1) L
Forced inspiratory volume in 1 second (FIV1) L
Ratio of FEV1 to SVC (FEV1/SVC) %
Ratio of FEV1 to FVC (FEV1/FVC) %
Forced expiratory volume in 6 seconds (FEV6) L
Ratio of FEV1 to FEV6 (FEV1/FEV6) %
Peak expiratory flow (PEF) L/s
Peak inspiratory flow (PIF) L/s
Forced Expiratory Flow at 50% of FVC (FEF50) L/s
Maximum Voluntary Ventilation (MVV) L/min

Here's a summary of the acceptance criteria and the study details for the PulmOne MiniBoxPFT™ 2.0 device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document mentions "lab and bench tests" and "non-clinical bench testing" which were conducted to verify performance. These are likely mechanical or simulated tests, not human subject tests.
• For the LVM validation test, the study compared the proposed device with the predicate device, but the specific sample size of subjects or data points used in this comparative test is not explicitly stated in the provided text.
• Data Provenance: The tests were conducted internally by the manufacturer ("Laboratory tests were performed") and are non-clinical (bench testing). No information is provided regarding the country of origin of data if human subjects were involved, but given it's bench testing, this is not applicable. The data is from retrospective bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not provided in the document. The ground truth for spirometry and lung volume measurements in bench testing typically comes from established standards (e.g., ATS guidelines) and comparisons against a validated predicate device, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set:

• This information is not provided. Given that the performance validation was through bench testing against standards and comparison with a predicate device, an adjudication method in the context of human expert review is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was conducted to support this application." The studies were non-clinical bench tests comparing the device's measurements against set standards and a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, standalone performance was assessed. The entire document describes the performance of the device itself (PulmOne MiniBoxPFT™ 2.0) in measuring lung function, independently. The summary of non-clinical performance testing clearly details the device's ability to meet spirometry guidelines and its equivalence to the predicate in lung volume measurements. This is a standalone performance assessment.

7. The Type of Ground Truth Used:

• For Spirometry: Established guidelines/standards (ATS guidelines, specifically "Standardization of spirometry; Eur Respir J 2005; 26: 319-338").
• For Lung Volume Measurements (TLC): Comparison against the measurements obtained from the predicate device (PulmOne MiniBoxPFT™ K133051).

8. The Sample Size for the Training Set:

• The document does not mention any training set or machine learning components. This device is a diagnostic spirometer and lung volume measurement device, not an AI/ML algorithm that requires a training set. The performance validation is based on physical and software functionality tests, not on learned patterns from a dataset.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no mention of a training set for an AI/ML component.

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