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The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lung volumes and diffusing capacity). The PulmOne MiniBox+ is to be used by a physician, respiratory therapist, or technician in a hospital or clinic setting

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

The MiniBox+ measures all common spirometric measurements as well as relative and absolute lung volumes and diffusing capacity.

The MiniBox+ is equipped with a diffusing capacity module which is embedded into the MiniBox+ enclosure and located in the upper end of the device. This feature allows easy measurement of the volumes and concentrations (CO and CH4) of inspired and expired breath, of the test gas mixture and patient sample respectively, making possible the calculation of the diffusion capacity [DLco]. MiniBox + DLco [diffusing capacity factor of the lung for carbon monoxide (CO)] module uses the single breath concept and enables the measurements by setting and controlling the maneuver stages as defined in ATS/ETS DLco guidelines.

Here's a breakdown of the acceptance criteria and study information for the PulmOne MiniBox+ device, based on the provided document:

Acceptance Criteria and Device Performance

The document describes the performance and technical specifications of the MiniBox+ and compares them to predicate devices. The MiniBox+ is a pulmonary function data calculator, and its performance is evaluated against established standards for spirometry, lung volumes, and diffusing capacity measurements.

Table of Acceptance Criteria and Reported Device Performance

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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:

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

The MiniBoxPFT™ is a table-top pulmonary function testing (PFT) device that measures both spirometry and lung volumes. It is developed and manufactured by PulmOne Advanced Medical Devices, Ltd. The MiniBoxPFT™ is composed of two modules: an OEM 510(k) cleared Spirometry module and a Lung Volume Measurement (LVM) module. A single-use, disposable viral-bacterial filter separates the patient from the internal components of the modules.

The PulmOne MiniBoxPFT is a pulmonary function testing (PFT) device that measures spirometry and lung volumes. The pivotal study aimed to demonstrate that the Total Lung Capacity (TLC) measured by the device's Lung Volume Measurement (LVM) module is substantially equivalent to the TLC measured by the ZAN 500 Plethysmograph (predicate device).

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "pre-defined success criterion was established from scientific literature that reported on the accuracy of FDA-cleared devices that measure TLC and compared these devices to TLC measured with body plethysmography." However, the specific numerical acceptance criteria (e.g., a specific percentage agreement or correlation coefficient) and the exact reported performance metrics (beyond "successfully met its primary success criterion for accuracy" and "no erroneous results") are not explicitly detailed in the provided text.

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

• Sample Size: The document does not specify the exact sample size for the pivotal study. It states that the study "randomized subjects (healthy and non-healthy) of varying age, sex, and race."
• Data Provenance: The study was "multi-centered," implying data was collected from multiple locations. The country of origin of the data is not specified. The study was prospective as subjects were measured on both the proposed device and the predicate device within the context of the study.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided in the document. The ground truth for the test set was the TLC measurements from the predicate device (ZAN 500 Plethysmograph).

4. Adjudication Method:

The document does not describe an adjudication method for the test set. The comparison was directly between the MiniBoxPFT™ and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement between the new device and a predicate device for measuring physiological parameters, not on the improvement of human readers with AI assistance.

6. Standalone Performance Study:

Yes, a standalone study (algorithm only without human-in-the-loop performance) was performed. The pivotal study directly evaluated the MiniBoxPFT™'s ability to measure TLC by comparing its results to a predicate device. This is a standalone evaluation of the device's core function.

7. Type of Ground Truth Used:

The ground truth used for the pivotal study was the Total Lung Capacity (TLC) measurements obtained from the ZAN 500 Plethysmograph, which is the predicate device. This represents a reference standard for TLC measurement.

8. Sample Size for the Training Set:

A "feasibility study was conducted to determine the ability of the device to measure TLC and to develop the algorithm for measuring TLC." However, the sample size for this training set is not provided.

9. How Ground Truth for Training Set was Established:

The document states that the feasibility study was used "to develop the algorithm for measuring TLC." It implies that data collected during this feasibility study was used to train or refine the algorithm. However, it does not explicitly detail how the "ground truth" for this training data was established within the feasibility study (e.g., whether it was also compared to a reference standard like plethysmography, or if it was based on expert-defined physiological parameters).

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