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510(k) Data Aggregation
(173 days)
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
The Bio-logic Airflow Pressure Transducer is intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is battery-powered, using a single-use, disposable nasal cannula which attaches to the patient and plugs into the Airflow Pressure Transducer device. The cannula cannot be adequately cleaned for re-use. The outputs of the device provide low-level electrical signals for input to a physiological recorder (such as the Bio-logic Sleepscan product),
The Bio-logic Airflow Pressure Transducer is indicated for use during sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is a battery-powered device, with a disposable nasal cannula which attaches to the patient and plugs into the Airflow Pressure Transducer device. The outputs of the device provide low-level voltage signals which are intended to be input to a physiological recorder (such as the Bio-logic Sleepscan product).
The Bio-logic Airflow Pressure Transducer is a small interface device which converts low levels of air pressure to corresponding low levels of voltage which can be recorded on any physiological recorder intended to record low-level electrical signals. There is one pneumatic input for air pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. These electrical outputs are: ACT (the active or positive output), REF (the reference or negative output), and COM (the electrical common). Within the device itself, the REF and COM are connected together. However, three leads are brought out for connection to a physiological recorder (such as the Bio-logic Sleepscan product), so the ACT and REF can be inputs to a differential amplifier, and COM can be connected to the system common.
For the airflow pressure input, this device uses a disposable nasal cannula which attaches to the patient and connects to the pressure input labeled "NASAL CANNULA". The electrical outputs connect to the corresponding AC-coupled inputs of the system's patient connection module. For the Bio-logic Sleepscan system, the connection is made to one of the bipolar input channels on the electrode jack box labeled INI(A) & IN2(R), for ACT and REF respectively. The COM is connected to the common jack on the headbox. The jacks on both the interface device and the electrode jack box are 1.5mm "safety" jacks, and the electrical connections are made with a reusable wire set with "safety" plugs on both ends.
This device consists of a two-part plastic enclosure measuring approximately 105 x 58 x 18.5 cm. The material is a composite of ABS and PMMA, color off-white. It is battery powered with two standard 1.5v AAA cells. The estimated battery life is 100 hours, and an on-off switch is provided for conserving battery life when the unit is not in use. Batteries can be replaced by removing two screws on the battery compartment of the unit.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, the performance is demonstrated through a comparison to a predicate device, focusing on equivalence and general specifications. The "acceptance criteria" here are implied by achieving similar or exceeding performance compared to the predicate.
| Parameter for Comparison | Bio-logic Airflow Pressure Transducer Performance | Implied Acceptance Criteria (relative to Predicate Device) |
|---|---|---|
| Intended Use | No differences noted. | Equivalent to predicate device. |
| Population | No differences noted. | Equivalent to predicate device. |
| Safety Characteristics | Provides patient isolation through plastic tubing and approved safety jacks. Maximum voltage: 3V DC. Maximum output voltage: +/- 150 mV; signal range for normal breathing: +/- 1 mV. No direct electrical connection to patient. | Equivalent or superior patient isolation and electrical safety compared to predicate. |
| Informational Content of Electrical Signals | Equivalent informational content to signals recorded using the predicate device. In some instances, specifications exceed those of the predicate. | Equivalent or superior informational content compared to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "Laboratory testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention using experts to establish ground truth or their qualifications for any test set. The comparison is based on device-to-device performance in a laboratory setting.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for a test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or described in the document. The study focused on device-to-device equivalence rather than human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
A standalone study was conducted, focusing on the device's performance in generating electrical signals. The "algorithm" in this context refers to the device's internal mechanism for converting air pressure to voltage. The study concluded that the "electrical signals recorded using the Bio-logic Airflow Pressure Transducer provide equivalent informational content to the signals recorded using the predicate device."
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established by comparison to a predicate device's output for respiratory airflow monitoring. The predicate device's output served as the benchmark for "equivalent informational content."
8. Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This device is a hardware sensor, not an AI/machine learning algorithm that typically requires training data.
9. How the Ground Truth for the Training Set Was Established
As this is a hardware device and not an AI/machine learning algorithm, the concept of a "training set" and establishing its ground truth as typically understood for AI systems does not apply. The device's functionality is based on its physical design and engineering principles rather than learned data.
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