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The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home.

The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.

The Bluebird Single-Use Respiratory Effort Belt (Bluebird) is used to measure chest and abdomen expansion and contraction during respiration. The sensor consists of a sinusoidal wire coil attached along the length of an elastic belt. The inductance of the sensor changes as the belt is stretched. The Bluebird is suitable for connection to the inputs of physiological recording equipment. The Bluebird measures inductance and generates an output signal proportional to the amount of stretch. The elastic belt is held in place by a quick release buckle with a cinch function and the belt is adjusted to fit snugly but comfortably. Electrical connection to the two ends of the embedded coil is through a 1.5mm female touch proof connection jack on each side of belt buckle. The materials are elastics and plastics used in the clothing industry, and fine gauge copper wire for the embedded coil.

The provided text describes a 510(k) summary for the "Bluebird Single-Use Respiratory Effort Belt" (subject device) and its equivalence to a predicate device, the "XactTrace® Single Use Respiratory Effort Belt System."

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format like a clinical trial. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The performance testing outlined serves to demonstrate that the subject device performs comparably to the predicate and meets design requirements.

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

• Sample Size for Test Set: The document does not specify a sample size for the comparative performance testing. It mentions "Performance testing was performed for the Bluebird rip belt connected to a Cadwell recording device and simultaneously to an XactTrace belt." This suggests a comparative test, but the number of devices or data points isn't quantified.
• Data Provenance: The document does not provide information on country of origin or whether the data was retrospective or prospective. It describes non-clinical laboratory testing ("Nonclinical tests were performed on the subject device").

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

• This information is not provided in the document. As this is a non-clinical, performance-based study comparing a physical device to another, the concept of "ground truth" as established by medical experts for diagnostic accuracy studies does not directly apply here. The "ground truth" seems to be the expected physical and electrical performance characteristics of such a device, and its output signal, which were compared against the predicate.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple readers. This information is not applicable/provided as this is a non-clinical performance study comparing two medical devices' physical and electrical outputs.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging devices where human readers interpret patient data. The Bluebird Single-Use Respiratory Effort Belt is a sensor intended to measure respiratory effort, not an interpretive AI tool.
• Therefore, information on the effect size of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone (algorithm only) study was not done. This device is a physical sensor, not an algorithm. Its performance is about accurately capturing a physiological signal.

7. Type of Ground Truth Used

• The "ground truth" in this context is the expected physical and electrical performance of a respiratory effort belt and its output signal, as demonstrated by the legally marketed predicate device.
• The study aimed to show that the subject device's performance, particularly its breathing effort signal output, was equivalent to that of the predicate device. The statement "The resulting waveforms are the same for both belts" indicates that the predicate's output served as the benchmark.

8. Sample Size for the Training Set

• Not applicable. This device is a physical sensor, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As no training set was used for an AI/ML algorithm.

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