(121 days)
The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 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 Sensors Non-Contact Respiratory Rate Spot Check Model 100 is not intended to monitor vital signs. This device is not an apnea monitor.
The Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 ("Kai RSpot 100") is a reusable sensor for measuring respiratory rate during vital sign spot checks. The Kai RSpot 100 uses a low-power radar to sense chest displacement in order to obtain a respiratory rate. When the hardware module is operating and facing a patient, the Doppler radar transmits a low-power radio-frequency signal and receives the signal after it has reflected off the patient's torso. The receiver detects a phase shift on the signal due to chest displacement and converts this phase shift into a voltage that is digitized and sent to the computer portable computer via USB. The portable computer runs the Kai RSpot 100 software, which determines a respiratory rate from the chest motion (respiratory effort) signal and provides the display, user interface, and power source for the device. The portable computer can operate on battery power or on wall power through outlets when used with the supplied power cord.
The provided 510(k) summary for the Kai Sensors Non-Contact Respiratory Rate Spot Check Model 100 (K090273) states that bench and clinical performance data demonstrate the device is as safe and effective as its predicate devices and operates within its specifications, including accuracy over the range of measured respiratory rates. However, the document does not include specific acceptance criteria values (e.g., minimum accuracy percentages or statistical thresholds) or detailed results from the supporting study to populate a table of acceptance criteria and reported device performance.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's a summary of what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy over the range of measured respiratory rates (Specific threshold for accuracy is not provided in the document) | "Clinical testing of the device demonstrated its ability to generate respiratory rate information of sufficient accuracy for its intended use." (Specific quantitative performance metrics are not provided.) |
| Safety and Effectiveness compared to predicate devices | "The bench and clinical performance data demonstrates that the Kai RSpot 100 is as safe and effective as its predicate devices." |
| Operates within specifications (Specific technical specifications are not provided) | "The bench testing of this device demonstrates that the Kai RSpot 100 operates within its specifications." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance (e.g., country of origin, retrospective or prospective): Not specified in the provided text. The study is referred to as "clinical testing," implying a prospective study, but details are lacking.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided in the document.
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 mention of an MRMC study or comparative effectiveness study involving human readers with and without AI assistance is present. The device is a standalone spot-check respiratory rate monitor, not an AI-assisted diagnostic tool for interpretation by human readers.
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. The document explicitly states: "The Kai RSpot 100 software... determines a respiratory rate from the chest motion (respiratory effort) signal" and "Clinical testing of the device demonstrated its ability to generate respiratory rate information." This indicates the algorithm's performance in generating the respiratory rate independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document implies that the ground truth for respiratory rate was established against which the Kai RSpot 100's measurements were compared. However, the method for establishing this ground truth (e.g., manual counting by experts, comparison to another gold-standard device) is not specified. It can be inferred that it would be another established method for measuring respiratory rate.
8. The sample size for the training set
- This information is not provided in the document. The document primarily discusses performance testing, not details of model training.
9. How the ground truth for the training set was established
- This information is not provided, as details about a training set are not mentioned.
In summary, while the submission states that testing was performed to demonstrate "sufficient accuracy" and substantial equivalence to predicate devices, the specific quantitative details regarding acceptance criteria, sample sizes, ground truth methods, and expert involvement are not included in the provided 510(k) summary. This is common for older 510(k) summaries which often contained less granular data than more recent submissions.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).