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KoKoMate is a diagnostic spirometer for use in the primary-care setting to measure and report the following spirometric values: Peak Expiratory Flow (PEF), One-Second (FEV1) and Six-Second (FEV6) Forced Expiratory Volumes, Forced Expiratory Flow averaged from 25 - 75% of total volume (FEF25-75%), and the ratio of FEV1/FEV6.

KoKoMate is a hand-held, self-contained spirometer with disposable mouthpiece designed specifically to measure a few simple expiratory spirometry values in the primary-care setting for diagnostic and screening purposes. The meter features a 4-line by 16-character LCD display; four control buttons; a port to accept its mouthpiece/flow-tube; and an IR data-transfer port.

The device measures expiratory breath flow through its mouthpiece, which is designed for single use. For a maximal expiratory effort, the meter determines peak expiratory flow (PEF), one-second forced expiratory volume (FEV1), six-second forced expiratory volume (FEV6), and average forced expiratory flow from 25 - 75% of total volume (FEF25-75%). It reports these values plus the ratio of FEV1/FEV6 and an indication of how these values compare to recognized predicted values. In addition, the meter processes the signals from each expiratory maneuver to help determine the quality of the maneuver to aid the clinician or patient in determining whether the reported values are valid.

Along with the spirometer, the KoKoMate system can include one of two optional accessory products. These accessories act as data transfer conduits transferring data streams across optic and serial interfaces as they cradle the meter. One cradle is designed to couple the meter to a PC for data storage, printout, or analysis; the other links the meter directly to a printer for direct printout of a simple spirometry report.

Here's an analysis of the provided 510(k) summary for the KoKoMate Office Spirometer, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: The summary describes two primary "effectiveness" tests:
  • Bench Testing: An ATS-compatible automatic waveform generator was used. The specific number of waveforms or test runs is not provided.
  • Simulated Clinical Setting Study: This involved patients and clinicians, but the sample size for patients and clinicians is not specified.
• Data Provenance:
  • Bench Testing: The data provenance is not explicitly stated in terms of country of origin. It was conducted "In-house and third-party testing."
  • Simulated Clinical Setting Study: The location and country of origin for this simulated primary-care setting are not specified.
  • Retrospective/Prospective: Neither study is explicitly labeled as retrospective or prospective, but the simulated clinical setting implies a prospective study involving human interaction.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Bench Testing (ATS-compatible automatic waveform generator): For this automated testing, the "ground truth" is typically defined by the precise, controlled output of the waveform generator itself, which is designed to meet established ATS standards. No human experts are explicitly mentioned as establishing ground truth for the test values in this context. The "experts" would be the designers and validators of the ATS standards and the waveform generator.
• Simulated Clinical Setting Study: No explicit mention of experts defining "ground truth" for patient or clinician performance; rather, the study assessed the usability and effectiveness of the device in actual use conditions.

4. Adjudication Method for the Test Set

• Bench Testing: No adjudication method is mentioned. The assessment would likely involve direct comparison of the device's measured values against the known, precise outputs of the waveform generator.
• Simulated Clinical Setting Study: No adjudication method is explicitly stated. The evaluation was likely based on direct observation and possibly user feedback, but details on how effectiveness or safety was formally "adjudicated" are absent.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This document primarily describes the standalone performance and usability of the KoKoMate device, not its comparative effectiveness with or without AI assistance involving multiple readers. The device itself is a spirometer, not an AI-assisted diagnostic tool in the typical MRMC context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance assessment was conducted for the device's measurement capabilities. The "Effectiveness" section details "In-house and third-party testing, using an ATS-compatible automatic waveform generator, demonstrated that the measurement performance of the spirometer met or exceeded requirements..." This is a standalone assessment of the device's ability to accurately measure spirometry values without human interpretation of raw data. The device's ability to "identify measurements of suspect quality appropriately" also falls under standalone performance.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth for spirometry measurements (PEF, FEV1, etc.) was established by an ATS-compatible automatic waveform generator. This represents an objective, standardized, and highly controlled "true" value for the tested parameters, based on recognized industry standards (American Thoracic Society standards).
• Simulated Clinical Setting Study: The "ground truth" here is more about effective and safe usage in a real-world context, rather than a definitive medical diagnosis. It's implicitly based on ** direct observation of user interaction and outcomes within the simulated environment**, relative to accepted practices for device usability and patient safety.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. This 510(k) summary describes a physical medical device (spirometer) that performs direct measurements, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's "training" would be its design, calibration, and engineering, which are not typically quantified in terms of a data "training set" like an AI model.

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

• Not Applicable / Not Provided. As noted above, the concept of a "training set" and associated ground truth is not relevant to this type of device and its regulatory submission as described.

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