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The tremoflo C2 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). The tremoflo C2 Airwave Oscillometry System is intended for use with pediativ and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.

The tremoflo C2 Airwave Oscillometry System (tremoflo C2) is a portable lung function testing device that implements methods known per the Forced Oscillation Technique (FOT), or oscillometry, to assess lung function in humans. The Forced Oscillation Technique (FOT) is a non-invasive test that provides a full report of lung mechanics per the FOT. In general, the FOT usually consists of superimposing given external multi-frequency sinusoidal excitation small pressure waves (1-3 cmH₂O peak) onto the normal breathing of the patient through the device and then deriving the mechanical properties from the patient's mouth pressure and airflow response while breathing. The main outcome reported by FOT is the mechanical impedance of the respiratory system which is the complex ratio between pressure and airflow at the given excitation frequencies.

The main tremoflo C2 Unit is a lightweight handheld device. It contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations. The tremoflo software is a complete standalone software package for patient management, testing, result analysis, and presentation.

During use the operator holds the handheld device using the ergonomic handle while the patient is seated, wearing a standard nose clip and with hands on cheeks. To perform the test, the patient then breathes quietly through the device into a standard single use Pulmonary Function Testing (PFT) filter connected at the front of the C2 Unit via the PFT filter interface. The tremoflo C2 is not intended to be used as a stand-alone diagnostic device.

The provided text describes the Thorsys tremoflo C2 Airwave Oscillometry System and its substantial equivalence to a predicate device (tremoFlo C100 Airwave Oscillometry System) as determined by the FDA. The document outlines changes made to the device and provides performance data to support its claims.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" against "reported device performance" in the typical sense of numerical thresholds for clinical endpoints. Instead, it focuses on demonstrating equivalence to a predicate device, primarily through technical specifications and verification/validation testing against established standards and recommendations.

However, based on the "Performance Data" section and the comparison table, we can infer some criteria and reported performance:

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The PulmoScan is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). PulmoScan is intended for use with pediatic and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers, similarly trained personnel and patients in hospitals, clinics, private physician offices or home.

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This is an FDA 510(k) clearance letter for a medical device called PulmoScan. The letter confirms that the device is substantially equivalent to legally marketed predicate devices. The provided text, however, does not contain details about acceptance criteria or a study proving the device meets those criteria.

The document primarily covers:

• The FDA's decision to clear the device (K191876).
• The trade/device name (PulmoScan) and regulatory information (Regulation Number, Name, Class, Product Code).
• General regulatory requirements for marketed devices.
• Indications for Use for the PulmoScan device.

To answer your request, I would need additional information, specifically from a section of the 510(k) submission that details the performance testing and acceptance criteria. This information is typically found in the "Performance Data" or "Clinical Data" sections of a 510(k) summary or the full submission, which is not included in the provided FDA clearance letter.

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The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). tremoFlo C-100 Airwave Oscillometry System is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.

The tremoFlo C-100 Airwave Oscillometry System (AOS) is a portable lung function testing device that implements methods known per the Forced Oscillation Technique (FOT) to assess lung function in humans. The Forced Oscillation Technique (FOT) is a non-invasive test that requires minimal patient effort and cooperation and provides a full report of lung mechanics per the FOT. In general, the FOT usually consists of superimposing given external multi-frequency sinusoidal excitation small pressure waves (1-3 cmH2O peak to peak) onto the normal breathing of the patient through the device and then deriving the mechanical properties from the patient's mouth pressure and airflow response while breathing. The main outcome reported by FOT is the mechanical impedance of the respiratory system which is the complex ratio between pressure and airflow at the given excitation frequencies.

The tremoFlo C-100 Unit is a lightweight handheld device connected to a cradle unit. The handheld unit contains electronics, pressure and flow sensors, and the actuator providing the forced oscillations which is connected to the cradle unit via a custom cable. The tremoFlo software is a complete stand-alone software package for patient management, testing, and result analysis and presentation.

The provided text describes the Tremoflo C-100 Airwave Oscillometry System, a medical device used to measure respiratory system impedance. Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a table format with corresponding "reported device performance." However, it presents a Predicate Product Comparison table that lists various technical features and specifications of the Tremoflo C-100 and compares them to its predicate device, the Resmon PRO FULL. The "Comparison" column in this table effectively acts as an assessment against benchmarked performance (the predicate device) or relevant standards (ERS FOT recommendations).

Below is a summary derived from the provided comparison, highlighting what could be interpreted as acceptance criteria based on equivalence or standards, and the TremoFlo's reported performance against these.

Table: Derived Acceptance Criteria and Reported Device Performance

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The Resmon PRO FULL is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). Resmon PRO FULL is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics. and private physician offices.

Resmon PRO FULL is a device for the assessment of the mechanical impedance based on the Forced Oscillation Technique (FOT).

FOT is a non-invasive lung function test for measuring the mechanical properties of the respiratory system. It consists in applying very small pressure oscillations (1-3 cmH2O peak-to-peak) of a given frequency/frequencies (usually below 40Hz) at the patient's mouth while she/he is breathing normally. During the test, the device measures pressure at the mouth and airflow to calculate respiratory impedance in real-time. Impedance is the complex ratio between pressure and airflow estimated at the frequency of the stimulating waveform. Common stimulating waveforms range from a simple sinusoid wave to a composite of different frequencies or impulses. The first approach is utilized for tracking swift changes in respiratory impedance. Examples of this include breath changes in lung mechanics or outcome measurements of specific interventions. The latter is used to assess the frequency dependency of impedance (related to the degree of lung heterogeneity) and identify the parameters of mathematical models of the respiratory system.

FOT allows for measurement during a patient's normal breathing pattern, with no forced effort required, making it suitable for monitoring non-cooperative patients, such as elderly patients, children or very severely ill patients with limited forced capacity. The test is usually performed with the subject seated, wearing a nose-clip (to prevent airflow leaks from the nose during normal breathing) and with hands on cheeks (to prevent the shunt of the pressure stimulus in the upper airways). The device is not intended to be used as a stand-alone diagnostic device.

Resmon PRO FULL consists of a main unit which has been designed to be used stand-alone, without the need of any personal computer, and an adjustable holder with a clamp to fix such unit to a table/desk and to regulate its height and orientation to the patient during an FOT test.

The provided text describes the regulatory clearance of the Resmon PRO FULL device. However, it does not include detailed information regarding specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy) or a study that rigorously proves the device meets these criteria in the typical sense of a clinical performance study for an AI/ML powered device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Carefusion MasterScreen IOS K101873) through technological comparison and non-clinical performance testing. The "performance testing" described is primarily about reproducibility, repeatability, and a comparative analysis of measured parameters against the predicate, rather than a clinical effectiveness study.

Based on the provided text, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not state explicit acceptance criteria in the form of thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating "substantial equivalence" to a predicate device. The performance is assessed through reproducibility, repeatability, and comparison of measured parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Comparative testing was done with the subject device and the predicate across the range of parameters and performance specifications."

• Sample Size: Not specified. It only mentions "Multiple units were tested" for reproducibility/repeatability. There is no information on the number of subjects or types of data used for the comparative testing with the predicate.
• Data Provenance: Not specified (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a measurement device for physiological parameters (respiratory impedance). Its performance is evaluated against physical standards and comparison with another device, not against expert-labeled ground truth for diagnosis/interpretation.

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

Not applicable, as there is no expert adjudication mentioned or required for this type of device evaluation.

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. This device is a diagnostic spirometer using the Forced Oscillation Technique (FOT) to measure respiratory impedance. It is not an AI-assisted diagnostic imaging device or an AI application with a "human-in-the-loop" for interpretation that would typically undergo an MRMC study. It is stated that "The device is not intended to be used as a stand-alone diagnostic device."

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

Yes, in a sense. The performance tests ("Hardware Verification," "Software and System Verification and Validation," "Reproducibility and Repeatability," "Comparative testing") evaluate the device's ability to accurately measure and report physiological parameters according to its specifications and in comparison to a predicate device. This is the "standalone" performance of the measurement system itself. There are no algorithms described beyond the calculation of respiratory impedance from pressure and airflow.

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

The "ground truth" for this device's performance evaluation would be:

• Physical calibration standards/simulators: Used to verify accuracy, resolution, and range of flow, pressure, and volume measurements.
• Predicate device measurements: For comparative testing, the predicate's measurements serve as a reference point for demonstrating statistical equivalence in measured parameters.
• Established scientific principles: The device's operation based on the Forced Oscillation Technique (FOT) adheres to these principles.

8. The sample size for the training set

Not applicable. This document does not describe the development of an AI/ML algorithm that requires a training set. The device appears to be a hardware-based measurement system with embedded software for calculations, not a learnable model.

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

Not applicable (as above).

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