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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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