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The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output. The product is designed for use on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers under the supervision of a healthcare provider.

The Vitalograph Spirotrac Model 7000 provides a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject.

Spirotrac integrates and reads / displays information from compatible Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices.

Its primary functions are:

Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and its subdivisions. The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc.), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift).

Record subject demographic data as input.

Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database.

Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

The Vitalograph Spirotrac Model 7000 is a PC-based software application intended to function as a spirometer or connect to compatible devices to acquire, view, store, and print device output. It is designed for use on adults and pediatrics (5 years and older) in professional healthcare settings.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided document does not explicitly list acceptance criteria in a table format with specific quantitative thresholds. Instead, it states that "Performance testing demonstrated that the subject device met its acceptance criteria" and details the standards and guidance documents followed. The acceptance criteria can be inferred from the compliance with these standards and regulatory guidance.

The device's performance is reported as meeting the requirements of:

• ATS/ERS (2005) waveform simulator testing
• ISO 23747:2015 - Anaesthetic and respiratory equipment -- Peak expiratory flow meters
• ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans.

Inferred Acceptance Criteria & Reported Performance:

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

The document describes non-clinical testing involving waveform simulator testing (ATS/ERS) and compliance with ISO standards (ISO 23747, ISO 26782). These are typically bench tests using standardized simulated waveforms, not patient data. Therefore, there is no sample size of human subjects mentioned for the test set, nor is there information on data provenance (country, retrospective/prospective), as the testing appears to be entirely technical/engineering in nature (software V&V, bench testing against standards).

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)

Since the testing involved bench testing against international standards and simulated waveforms, there were no human experts establishing ground truth in the typical sense of clinical interpretation. The "ground truth" for these tests is implicitly defined by the parameters and specifications of the ATS/ERS and ISO standards themselves.

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

As the testing was non-clinical and involved compliance with technical standards and simulated waveforms, there was no adjudication method described or likely needed for human discrepancies. The performance was measured against predefined technical specifications.

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 MRMC comparative effectiveness study was done. The device is a diagnostic spirometer software, not an AI-assisted diagnostic tool that aids human readers in interpreting complex images or data. Its primary function is to acquire, display, store, and print spirometry data, and interface with existing medical devices. The document does not suggest any AI components that perform diagnostic interpretation requiring human-in-the-loop studies.

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

The entire performance evaluation described is essentially a standalone (algorithm/software only) assessment against technical standards and simulator outputs. The V&V of the software itself and its ability to process and display data in compliance with ATS/ERS and ISO standards represents its "standalone performance."

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

The ground truth used for the performance testing was based on international technical standards and simulated waveforms:

• ATS/ERS (2005) waveform simulator
• ISO 23747:2015 specifications
• ISO 26782:2009 specifications

These standards define the expected correct output for various spirometry maneuvers and parameters.

8. The sample size for the training set

This device did not undergo a training phase in the context of machine learning or AI. It is a software application whose functionality is based on established algorithms for spirometry and data management. Therefore, there is no training set sample size described.

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

As there was no training set in the context of machine learning, there is no information on how ground truth for a training set was established. The software's "knowledge" or "rules" are based on the implementation of well-established medical and engineering principles for spirometry and data processing, not on learning from a labeled dataset.

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The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients. The device is a PC based software application which is intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Spirotrac shall provide a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. Spirotrac will integrate and read / display information from Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices. Its primary functions are: 1. Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and it's subdivisions, The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift). 2. Record subject demographic data as input. Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database. 3. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

Here's a breakdown of the acceptance criteria and study information for the Vitalograph Model 7000 Spirotrac, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically a detailed clinical study report proving device performance against specific, pre-defined acceptance criteria in the same way a PMA or de novo submission might. Therefore, some information, especially regarding detailed sample sizes, expert qualifications, and specific "reported device performance" metrics against acceptance criteria (beyond general compliance checks), is not explicitly stated in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device underwent validation testing to ensure performance according to its specifications against current standards. The mentioned standards serve as the de-facto acceptance criteria. The "Reported Device Performance" is generally stated as "All tests and validations demonstrated satisfactory results." Specific numerical performance metrics against each standard are not provided in this summary.

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

The document does not specify a sample size for any clinical test set. The validation appears to be primarily engineering and bench testing against international standards, rather than a clinical study with a patient cohort.

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified, but likely from laboratory testing and calibration rather than patient data from a specific country or retrospective/prospective study type, given it's a spirometer software.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the validation described is against established international technical standards for spirometry. There wasn't a ground truth established by human experts in the typical sense of a diagnostic imaging study.

4. Adjudication Method for the Test Set

Since the validation is described as performance testing against international standards, an "adjudication method" in the context of expert review for ground truth determination is not applicable or described. The standards themselves define the criteria for "correctness" or acceptable performance.

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

An MRMC study was not mentioned or performed. The device is a spirometer software application; its performance is typically evaluated for measurement accuracy and consistency, rather than its impact on human reader interpretation.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance evaluation was done. The document explicitly states: "The Vitalograph Model 7000 Spirotrac underwent validation testing to ensure performance according to its specifications against current standards." This refers to the software's ability to accurately acquire, process, and display spirometry measurements as determined by the listed ISO and ATS/ERS standards.

7. Type of Ground Truth Used for the Test Set

The ground truth for the test set was defined by international technical standards and norms for spirometry (ISO 26782, ATS/ERS 2005, ISO 23747). This implies that the device's measurements were compared against established reference values or methods defined by these standards, likely using simulated lung functions or calibrated devices.

8. Sample Size for the Training Set

The document does not mention a training set size. This device is a spirometer software, and its primary function is measurement and data handling. While it might include algorithms for interpretation (e.g., predicted values, flagging out-of-range results), these are typically based on well-established physiological models and clinical guidelines, not necessarily a machine learning model that requires a "training set" in the modern AI sense.

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

Since a "training set" in the machine learning sense is not mentioned, the method for establishing its ground truth is not applicable or described. The algorithms and computations within the spirometer software would be based on established physiological principles and clinical guidelines rather than learned from a labeled dataset.

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