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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

Study Information

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

   • DLco human comparative testing: Not specified in the provided text.
   • DLco human reproducibility testing: Not specified in the provided text.
   • No other "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are mentioned for non-clinical or clinical studies in this document. The focus of the non-clinical testing appears to be on simulator and comparative studies rather than a large clinical test set.

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

   • Not specified. The document mentions "DLco human comparative testing" and "DLco human reproducibility testing," but does not detail how ground truth was established for these or the number/qualifications of experts involved.

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

   • Not specified.

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 MRMC study was mentioned. The device is a "Pulmonary-Function Data Calculator," and the documentation does not describe an AI component that would assist human readers in interpreting images or data in an MRMC setting. It's for direct measurement and calculation.

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

   • The document implies standalone performance testing for the device's measurement accuracy, particularly for DLco using a simulator ("DLco performance verification against simulator [Hans Rudolf]"). However, the "human comparative testing" and "human reproducibility testing" suggest interaction with humans, but not necessarily in an AI-assistive role. The core function is measurement and calculation, which is inherently "standalone" in its data generation, regardless of human interaction for the test.

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

   • For the DLco gas analyzer, ground truth was established through OEM manufacturer verification (linearity) and testing against a DLco gas simulator [Hans Rudolf, Inc.].
   • For human measurements, the ground truth was implied to be established through internal repeatability measurements and comparison against the predicate device, ZAN Function Lab [ZAN-500]. This suggests that the ZAN 500's measurements served as a de-facto ground truth for comparative purposes.

7. The sample size for the training set:

   • Not applicable as this device is a measurement and calculation device, not a machine learning model that requires a training set in the conventional sense. Its "training" or calibration would involve ensuring its sensors and algorithms accurately reflect physical properties.

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

   • Not applicable for the same reasons as above. The internal algorithms are based on established scientific principles of pulmonary function testing (e.g., ATS/ETS guidelines, Boyle's law for lung volume calculation) and calibrated against known standards and other validated devices.

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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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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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