(389 days)
The Rainbow Acoustic Monitoring™ sensors and cables are indicated for continuous, noninvasive monitoring of respiratory rate (RRaTM).
The RAS-125 is indicated for adult patients in hospital-type facilities, mobile and home environments.
The RAS-125c is indicated for adult and pediatric patients in hospital-type facilities, mobile and home environments.
The Masimo Acoustic Monitoring Sensor is a single-patient use device consisting of a piezoelectric sensor element and an adhesive strip that is attached to the patient's neck for the purpose of noninvasive respiratory rate monitoring in adult and pediatric patients (> 10 kg). As with the predicate Masimo Acoustic Monitoring Sensor (model RAS-125 for adults only), the RAS-125c for pediatric patients is intended to be attached via cable to a pulse oximeter monitor incorporating the Masimo Rainbow® Acoustic Monitoring™ technology to provide a continuous display of the patient's acoustic respiratory rate. Suitable pulse oximeter monitors include the previously cleared Radical 7 and Rad 87 devices.
Here's a summary of the acceptance criteria and the study details for the Masimo Acoustic Monitoring Sensors, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Stated as "Accuracy Range") | Reported Device Performance (Clinical Validation) |
|---|---|---|
| Breaths per Minute (bpm) (RAS-125) | 4 to 70 ± 1 breath per minute | Up to 30 bpm in adult subjects >30 kg |
| Breaths per Minute (bpm) (RAS-125c) | 4 to 70 ± 1 breath per minute | Up to 30 bpm in adult patients >10 kg; Up to 50 bpm in hospitalized pediatric subjects (age ≥ 2 years, >10kg) |
| Body Weight (RAS-125) | Adult > 30 kg | Adult > 30 kg |
| Body Weight (RAS-125c) | Adult, Pediatric > 10 kg | Adult, Pediatric > 10 kg |
| Application Site | Neck | Neck |
Note: The document states "Accuracy Range 4 to 70 ± 1 breath per minute" in the table under "Breaths per Minute" for both models, implying this is the overall target accuracy. However, the subsequent text specifies the clinical validation ranges achieved within that overall range.*
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Healthy adult volunteers: n=26
- Hospitalized post-surgical adult subjects: n=26
- Hospitalized post-surgical pediatric subjects: n=26
- Data Provenance: The study in hospitalized post-surgical pediatric subjects was conducted at "3 hospital centers in the United States." The provenance for the adult studies is not explicitly stated, but it can be inferred to be from clinical settings given the description of "healthy adult volunteers" and "hospitalized post-surgical adult subjects." All studies are retrospective in nature given that they describe completed studies where data was obtained rather than ongoing collection.
3. Number of Experts and Qualifications for Ground Truth
- The document states "a comparison of a manual count of respiratory rate." This implies that human observers (experts) were used to manually count respirations.
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified. The document only mentions "a comparison of a manual count of respiratory rate," without detailing how discrepancies between multiple manual counts (if any were performed) would be resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly mentioned. The study described focuses on the accuracy of the device against a manual count, not on how human readers' performance might improve with or without AI assistance.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The "Accuracy data was obtained from a comparison of a manual count of respiratory rate in healthy adult subjects and in hospitalized pediatric subjects" directly describes the device's performance (algorithm only, as it's a sensor taking measurements) against a ground truth.
7. Type of Ground Truth Used
- Expert Consensus (Manual Count): The ground truth was established by "a manual count of respiratory rate."
8. Sample Size for the Training Set
- The document does not explicitly state the sample size for a training set. The clinical studies mentioned (n=26 for each group) appear to be for validation/testing.
9. How Ground Truth for the Training Set Was Established
- The document does not provide information about a separate training set or how its ground truth might have been established. The clinical validation studies describe the process for establishing ground truth for the test/validation data.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).