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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)

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The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires callbration using an FDA-cleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.

The Biobeat BB-613-BPM includes a sensor device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device is designed to measure systolic and diastolic blood pressure and pulse rate, in adults, using a noninvasive technique using a light source (LEDs), and sensor array on the backside of the device. Identical to the method cleared in K190792 and in K222010, the LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of pulse rate, and noninvasive blood pressure. The device is a pre-programmed 24-hour blood pressure monitor (BPM), prompting the use to take measurements at fixed intervals every 15 minutes. In addition, the data is transmitted to a mobile application via Bluetooth and then uploaded to the cloud, accessed through the Biobeat platform for review by a healthcare professional. In addition, the data could be downloaded as a report. The device does not contain any alarms. The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.

The provided text is a 510(k) summary for the Biobeat BB-613-BPM. It outlines the device, its indications for use, technological characteristics, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain specific details about acceptance criteria, the study design (e.g., sample size, data provenance, expert qualifications, adjudication methods), or performance data results that would be typically found in a clinical study report.

The document explicitly states: "The Biobeat BB-613-BPM uses the same hardware as the cleared Biobeat Platform-2 and the BB-613WP Patch but features some software changes. The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device. Additional testing was conducted on the updated product features, including: . Software validation per FDA guidance..."

This indicates that the primary focus of the new submission (K241066) was on software validation for the new feature (24-hour, patient-initiated measurements with notifications), rather than extensive new clinical performance studies for blood pressure or pulse rate accuracy, as those were already established for the predicate devices utilizing the same sensor unit and algorithm.

Therefore, many of the requested details about a study proving the device meets acceptance criteria are not present in the provided text. I will answer based on the information that is available.

Here's an attempt to answer your questions based only on the provided text, flagging where information is missing:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison table of technological characteristics, including measurement ranges and accuracies, which can be interpreted as performance specifications inherited from the predicates and serving as acceptance criteria.

Note: The document states, "The device contains the same sensor unit and uses the same algorithm to compute pulse rate and blood pressure. Therefore, these signals' evaluation testing, which was submitted in K222010 and K190792, remains applicable to the subject device." This implies that the BB-613-BPM is expected to meet the same accuracy standards as its predicates for PR and BP. The primary new "performance data" mentioned is "Software validation per FDA guidance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in this document. The document refers to prior testing for pulse rate and blood pressure (from K222010 and K190792) and software validation.
• Data Provenance: Not specified.
• Retrospective/Prospective: Not specified.

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)

• This information is not applicable or not provided. The ground truth for blood pressure and pulse rate measurements in medical devices like this is typically established using established reference methods (e.g., intra-arterial measurements, or a validated oscillometric device for calibration as mentioned in the Indications for Use). Expert readers are typically not used to establish ground truth for physiological measurements like BP or PR.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable or not provided, as this is not a study involving human reader interpretation or adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this document. This type of study is relevant for AI systems that aid human interpretation (e.g., radiology AI), which is not the primary function described for this blood pressure measurement system's new feature.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document implies that standalone performance for pulse rate and blood pressure was established and deemed acceptable in prior submissions (K222010 and K190792) because the subject device uses the "same sensor unit and uses the same algorithm to compute pulse rate and blood pressure." The new submission focuses on software changes related to the 24-hour monitoring feature and notifications, rather than core measurement algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For blood pressure and pulse rate measurements: The Indications for Use state, "The BB-613-BPM tracks changes in blood pressure and requires calibration using an FDA-cleared oscillometric blood pressure monitor." This strongly suggests that an FDA-cleared oscillometric blood pressure monitor serves as the ground truth or reference method for calibration and presumably for performance validation in the previous submissions.

8. The sample size for the training set

• Not specified. This document only pertains to a 510(k) submission, not a full scientific publication detailing model development.

9. How the ground truth for the training set was established

• Not specified. As noted above, the ground truth for physiological measurements typically involves comparison to a gold standard or reference method. However, details of the training set (if any specific to this submission's new features beyond the core algorithm) are not provided. The phrase "pre-programmed" suggests the algorithms are fixed, not adaptively learning from ongoing data.

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