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The Respiree Cardio-Respiratory Monitor is a respiratory monitor intended for hospitals and hospital-type facilities in non-ICU settings and home settings.

The Respiree Cardio-Respiratory Monitor is indicated for the non-invasive spot checking of respiration rate (RR) for adult patients.

The Respiree Cardio-Respiratory Monitor System comprised of the following devices:

• Respiree Cardio-Respiratory Monitor
• Respiree Gateway and accessories (Antenna, charging cable)
• Respiree Dashboard

The Respiree Cardio-Respiratory Monitor is a wearable respiratory monitor. For measurement of respiration rate (RR), the device is affixed to the chest using a disposable adhesive patch with a hook-and-loop fastener to attach to the monitor. The device uses a vertical-cavity surface-emitting diode to emit optical light directed toward the skin. An integrated photodetector in a nearby position senses the diffused collected light. An adaptive signal processing method is used to enhance the device respiratory rate measurements by splitting the signal processing optimizations across different respiratory rate bands.

The monitor is powered by a 3.7V rechargeable, lithium-ion battery and is charged using the gateway provided. The Respiree Cardio-Respiratory Monitor transmits respiration rate raw data to the gateway via AES 256 encrypted Bluetooth wireless technology, and the latter uploads the data to the fixed secured cloud server either via Wi-Fi or LTE.

The Respiree Dashboard is a web application user interface that enable healthcare professional to access recorded respiration rate information for spot patient monitoring. The data from the Respiree Cardio- respiratory Monitor are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

The provided FDA 510(k) clearance letter and summary for the Respiree Cardio-Respiratory Monitor System (K250934) indicate that clinical studies were not required for this specific submission, as there was "no change in the respiration rate software algorithm cleared in the previous version of the device (K223681)." This implies that the performance data for the respiration rate measurement itself was established in a prior submission (K223681).

Therefore, I cannot extract specific details about new clinical studies for K250934 that would directly prove the device meets acceptance criteria for respiration rate measurement within this document. The document primarily focuses on demonstrating substantial equivalence based on the updated hardware, expanded use environment (home setting), and data presentation methods, leveraging the previous clearance for the core measurement accuracy.

However, I can infer information about the acceptance criteria for the respiration rate measurement and the reported device performance based on the comparison table with the predicate devices. The other requested information (sample size, experts, adjudication, MRMC, standalone, ground truth, training set details) is typically found in the clinical study report itself, which is not part of this 510(k) summary for K250934.

Inference from K250934 Document (based on predicate comparison):

1. Table of Acceptance Criteria and Reported Device Performance (Inferred from Predicate Comparison)

Explanation of Inferences:

• The document explicitly states that the subject device "uses the identical technology (i.e., same sensor units and algorithms) for measuring respiratory rate compared to the primary predicate."
• The "Performance Accuracy (Arms)" and "Performance Range" are listed as identical for the subject device and the primary predicate, implying that these are the established performance characteristics for the core respiration rate measurement, and these values serve as the reported device performance and implicitly, the acceptance criteria derived from the predicate.

Information NOT available in the provided document for the core respiration rate measurement (as no new clinical study was conducted for K250934 to re-evaluate RR accuracy):

2. Sample size used for the test set and the data provenance: Not present for a new RR accuracy study. This information would have been part of the K223681 submission.
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): Not present for a new RR accuracy study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present for a new RR accuracy study.
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: Not applicable for a spot-checking respiration rate monitor. This device measures a physiological parameter, not for interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Performance Accuracy (Arms) < 3rpm" implies a standalone performance measure of the algorithm against a reference standard. However, the details of how this was established (e.g., specific study design, reference standard) are not in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in this document for the RR measurement. For respiration rate, this typically involves a highly accurate reference method like capnography, impedance pneumography, or manually adjudicated observation.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

Additional Study Information Available in the Document for K250934:

The document highlights the studies conducted to support the changes in the device (home use, hardware modifications, data presentation), rather than re-validating the core RR measurement where the algorithm remained unchanged:

• Software verification and validation: Confirmed acceptability for intended use.
• Biocompatibility testing: According to ISO 10993-5 and -10 for patient-contacting components.
• Human factors and usability testing: Conducted by intended users to support acceptability of risks associated with clinical use.
• Electrical, EMC, and Wireless Coexistence requirements: Meeting IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and C63.27:2021.

In summary, the provided document leverages the prior clearance (K223681) for the respiration rate measurement accuracy, focusing the current submission (K250934) on demonstrating substantial equivalence for design changes and the expanded use environment.

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