(186 days)
SleepFLO is intended for use during sleep disorder studies to detect up to five breathing signals: airflow, body position, thoracic effort, abdominal effort and snore.
The SleepFLO device is a compact breathing sensor used during sleep disorder diagnosis procedures. The device senses airflow, snore (derived from the airflow), body position, thoracic effort, and abdominal effort. The device consists of two enclosures - a sensor unit and a battery unit, and two respiratory effort belts. A 7-foot, eight-conductor cable connects the sensor unit and the battery unit; a 1-foot two-conductor cable connects each of the respiratory sensor belts to the sensor unit.
The sensor unit houses the airflow pressure sensor, the body position sensors, and the connectors for both effort belts (abdominal and thoracic). Airflow is measured using a pressure-based technique. Patients wear a nasal cannula that carries breathing air fluctuations to a pressure sensor inside the sensor unit. The cannula attaches to the sensor unit via a luer lock. The pressure measurements are used to indicate airflow and to derive the snore output. The cannula is a one-time use device and contains a 0.2-micron filter. The position sensors utilize miniaturized ball switches that detect five body positions: upright, supine, prone, left, and right. The effort belt connectors (thoracic and abdominal) are used to pass the signal of the effort belts to the polysomnograph system (PSG) device.
The two respiratory effort belts use a piezoelectric sensor attached to an elastic belt. The elastic sensor belt is held in place with a Velcro® strap about the thorax and abdomen.
The battery unit houses the snore detection circuitry, the connectors to the PSG, and the batteries that power the device (both the sensor unit and the battery unit). The sensor unit signals (airflow, thoracic effort, abdominal effort, and body position) are passed to the battery unit via the interconnecting eight-conductor cable. The battery unit receives these signals and delivers them to the appropriate output cables, which are connected to the PSG. In the case of the snore, the airflow signal is band pass filtered to generate a snore signal, which is then passed to the PSG via the snore output cable.
The connections to the PSG junction box are accomplished via five (5) pairs of cables. All five-cable pairs are terminated with standard PSG pluqs (1.5 mm recessed). The battery compartment can be attached to the junction box with Velcro®.
The provided 510(k) summary for the BIOMEC SleepFLO device (K020607) focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study to meet acceptance criteria with quantitative performance metrics.
However, based on the information provided, we can infer the acceptance criteria and the nature of the "study" that supports the device meeting those criteria.
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Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The SleepFLO device was used in place of the predicate devices in laboratory and clinical testing. These tests showed that the electrical output signals from the SleepFLO device provided equivalent informational content as the electrical output signals from the predicate devices. The testing compared respiratory airflow and effort along with body position and snore."
This indicates that the acceptance criterion was functional equivalence to the predicate devices for each of the measured parameters. The "reported device performance" is a qualitative statement of equivalence rather than specific numerical metrics.
Acceptance Criterion (Inferred from "Safety and Effectiveness" section) Reported Device Performance (From "Safety and Effectiveness" section) Electrical output signals provide equivalent informational content as predicate devices for: - Respiratory Airflow - Provided equivalent informational content as the electrical output signals from the predicate devices. - Respiratory Effort (Thoracic & Abdominal) - Provided equivalent informational content as the electrical output signals from the predicate devices. - Body Position - Provided equivalent informational content as the electrical output signals from the predicate devices. - Snore - Provided equivalent informational content as the electrical output signals from the predicate devices. The "Summary of Technological Characteristics" table further supports the claim of equivalence by highlighting similar intended use, patient population, channels, connection methods, safety characteristics, re-use status, and sensor technology. While not explicit performance metrics, the consistent comparison across these parameters implicitly serves as acceptance criteria.
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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. The document vaguely refers to "laboratory and clinical testing" but does not provide details on the number of subjects, cases, or recordings.
- Data Provenance: Not specified regarding country of origin. The testing included both "laboratory and clinical" components, suggesting a mix of controlled experimental data and real-world patient data. It is implied to be prospective for the purpose of this submission, as the device "was used" in these tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The 510(k) summary does not mention the use of experts to establish ground truth for performance evaluation in the context of human interpretation of signals. The focus is on the device's electrical output providing equivalent "informational content" to predicate devices, implying a more direct technical comparison of signal characteristics rather than subjective human interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Given the nature of the evaluation (comparing electrical output signals for "informational content"), multi-reader adjudication methods typically used for image interpretation or diagnosis are not relevant here.
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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. An MRMC study was not described or implied. The device is a sensor, not an AI interpretation tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this was effectively a standalone performance evaluation in the sense that the device's output signals were compared to predicate device outputs. There isn't an "algorithm" in the sense of AI; rather, it's the raw signal generation by the sensor. The comparison was for the device's output directly, independent of a human interpreting those outputs (although humans would eventually interpret the final sleep study data).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was the output signals from legally marketed predicate devices. The new device's output was compared to these established devices known to provide valid physiological information. This is a common approach for demonstrating substantial equivalence for sensor devices.
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The sample size for the training set:
- Not applicable/Not specified. This is a sensor device, not an AI/machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. As noted above, there is no training set for this type of device.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).