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The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 is intended for a one-time measurement of respiratory rate, as part of a vital signs assessment. The device is indicated for hospital or clinical use in adult patients. The device is intended to be operated by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.

The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 is not intended to monitor vital signs. This device is not an apnea monitor

The sensor includes a 2.4 GHz Doppler radar, data acquisition circuitry, processing, user interface, and touch-screen display. The touch-screen display provides the display and user interface. The device is powered over the USB connection, either by a PC, with a wall-power adapter, or with an external battery. If desired, the Kai Spot KMS 200 has the capability to communicate via its USB interface with a personal computer (PC) using select Kai Spot data management software applications. The sensor uses Doppler radar to detect respiratory effort, and the respiratory effort signal is analyzed to provide a respiratory rate. A radio wave in the 2.4 GHz ISM band is emitted from the antenna included in the hardware module. The Kai Spot KMS 200 sensor enclosure includes screw holes in a VESA mounting pattern (VESA is a standard mounting configuration), which can be used to connect to any VESA mount, including stands, carts, wall-mounts, or adapters to other stands or carts. A stand is not included with the device; the customer's Biomedical Engineering Department or maintenance service should install the device on a medical-grade stand used for vital signs measurement equipment. Screws to be used for mounting are provided with the device.

The Kai Medical Non-Contact Respiratory Rate Spot Check Model KMS 200 is intended for a one-time measurement of respiratory rate in adult patients in a hospital or clinical setting.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "bench performance data."

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

The document does not provide details on the number of experts used to establish ground truth or their qualifications. The study described focuses on bench performance and comparison to a predicate device, not a human reader study.

4. Adjudication Method for the Test Set:

No information is provided regarding an adjudication method. The performance assessment appears to be a direct comparison of the device's measurements against specified technical criteria.

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

No, an MRMC comparative effectiveness study was not done. The document describes a bench performance study demonstrating the device's adherence to its specifications and substantial equivalence to a predicate device, not a study involving human readers with and without AI assistance.

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

Yes, a standalone study was done. The "bench performance data" and the reported "device performance" (accuracy, range, resolution) are indicative of the algorithm's performance without human intervention. The device itself is designed for standalone measurement of respiratory rate.

7. The Type of Ground Truth Used:

The ground truth used appears to be the defined technical specifications for respiratory rate measurement (e.g., a "true" respiratory rate within certain parameters) against which the device's performance was evaluated. This would likely involve a validated method for generating known respiratory rates in a bench setting.

8. The Sample Size for the Training Set:

The document does not specify a training set or its sample size. This is likely because the device's underlying technology (Doppler radar detecting chest displacement) and signal processing are based on established physical principles rather than a machine learning model that typically requires a large training dataset.

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

As no training set is indicated, there is no information on how its ground truth would have been established. The device's performance is gauged against its technical specifications.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is referred to as "bench performance data."

• Study Description: The submission states, "The bench performance data demonstrates that the Kai Spot KMS 200 is as safe and effective as the Kai RSpot 100. Bench performance data further demonstrates that the Kai Spot KMS 200 operates within its specifications, including accuracy over the range of measured respiratory rates."
• Methodology (Inferred): While the detailed methodology is not provided, "bench performance data" typically involves testing the device in a controlled laboratory environment against known or simulated conditions. For respiratory rate measurement, this would likely include:
  • Using a呼吸模拟器 (respiratory simulator) or controlled mechanical setup that can generate precise respiratory rates within the specified range (8 to 48 breaths/minute).
  • Measuring the output of the Kai Spot KMS 200 at various simulated respiratory rates.
  • Comparing the device's reported respiratory rate to the "true" simulated rate.
  • Verifying that the measured values fall within the specified accuracy (±2 breaths/minute) and resolution (0.5 breath/minute) across the operational range and at different sensor-to-subject distances (0.2 to 1 meter).
• Result: The bench performance data confirmed that the Kai Spot KMS 200 operates "within its specifications." This directly correlates to meeting the acceptance criteria outlined in the table.

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