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The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is indicated for continuous, noninvasive monitoring of respiratory rate (RRa®). The Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo is intended for use with infant and neonatal patients, in hospitals, hospital-type facilities, home environments, and transport within healthcare facilities.

The rainbow Acoustic Monitoring® sensors are not indicated for Apnea monitoring.

The subject device, the Masimo Acoustic Respiration Sensor RAS-45 Inf/Neo, is a noninvasive, disposable, single-use device comprising a piezoelectric sensor element and an adhesive strip that is attached to the patient's chest for the purpose of noninvasive respiration/respiratory rate monitoring in infant and neonatal patients (< 10 kg). Like the predicate (K120984), the RAS-45 Inf/Neo sensor is a rainbow Acoustic Monitoring® sensor intended to be used with, and attached via dual cable to, pulse oximeter monitors incorporating the Masimo rainbow® Acoustic Monitoring technology to provide a continuous calculation and display of the patient's acoustic respiration/respiratory rate (RRa®).

Here's a breakdown of the acceptance criteria and study details for the Masimo Acoustic Respiration Sensors, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: A "convenience sample of infant and neonatal patients" was used. The exact number of patients is not specified in the document.
• Data Provenance: The document does not explicitly state the country of origin.
• Retrospective or Prospective: The study appears to be prospective as "production equivalent sensors...were applied to a convenience sample of infant and neonatal patients to gather raw acoustic data."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Described as "clinicians." No further specific qualifications (e.g., years of experience, specialty) are provided.

4. Adjudication Method for the Test Set

• The document states that the raw acoustic data was "compared against clinicians manually annotating the raw acoustic data." This implies a form of human expert review and labeling, serving as the reference standard. No specific adjudication method like "2+1" or "3+1" is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not explicitly done. The study compared the device's performance against a manual/auditory reference method and also made a comparison to a capnography device. It did not directly assess how much human readers improve with AI vs without AI assistance as part of an MRMC study.

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

• Yes, a standalone performance assessment was done. The "RAS-45 Inf/Neo algorithm" processed the raw acoustic data, and its output (accuracy) was compared to the ground truth established by clinicians. This is a direct assessment of the algorithm's performance without a human in the loop interpreting the algorithm's results.

7. The Type of Ground Truth Used

• Expert Consensus/Manual Annotation: The ground truth for the device's accuracy assessment was established by "clinicians manually annotating the raw acoustic data" and by a "manual/auditory reference method."
• Comparison to another device: Clinical performance was also assessed by comparison to a capnography device, which serves as another form of reference.

8. The Sample Size for the Training Set

• The document does not provide information on the sample size for the training set for the RAS-45 Inf/Neo algorithm. The study details only describe the clinical testing performed to assess the device's performance.

9. How the Ground Truth for the Training Set was Established

• The document does not provide information on how the ground truth for the training set was established.

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