(94 days)
The FloCHANNEL is intended for use during sleep disorder studies to detect respiratory airflow onto a physiological recorder. A filtered disposable nasal/oral cannula attaches to the patient and connects into the input of the FloCHANNEL device. The outputs of the device provide low-voltage signals that are intended to be input into a physiological recorder.
The FloCHANNEL device can be used for pediatric patients, two years and older and adult patients including geriatric patients. The device is not intended for pediatrics and infants below two years of age for the purpose of respiration or SIDS monitoring.
The FloCHANNEL, FC-100, Sleep Diagnostic Device accomplishes its intended purpose by providing a measure nasal airflow resistance effects. The device simultaneously measures relative airflow of isolated left, right, and oral passages. The FloCHANNEL, FC-100, provides analog voltage out hardware amplified analog voltages from three all now sensors, hardware analog voltages to aid in scoring the respiration of a patient. The outputs provided an have a summed output, and two microprocessor all now sensors, hardware analog voltages to aid in scoring the respiration of a patient.
The FloCHANNEL, FC-100, is dependent on the patient interface unit to be able to compute and detect the respiration patterns of the patient. This accessory is three air compute and delove the respirately pannula. The cannula is of one-piece construction that allows independent pneumatic fluid connection between the FloCHANNEL, FC-100, that the patient's left nasal airway, right nasal airway, and oral airway. The filter shall arra the patient of on habat all ways greater than or equal to 0.1 microns in size between prevent the transfer or partiountios groater and filter per channel on the patient interface unit with independently sealed chambers to prevent cross flow between pneumatic channels.
The FloCHANNEL has an output selection switch that is accessible from the outside of the enclosure and to a lour pockibility in the output options to be able to configure to a the switch to to ano it signal conditioners. With this switch there is the ability to create four different output voltage ranges.
There are six (6) output connectors on the FloCHANNEL, FC-100. All output connectors are Nort Julier. This re Nasal Processed Airflow, Oral Airway Processed Airflow, Sum r 10003500 Airflow and Right Nasal Processed Airflow, Relative Tidal Volume, and IE Marker.
The provided text does not contain specific acceptance criteria or a detailed study report with performance metrics. The document is a 510(k) summary for the Dormio Tech FloCHANNEL Model FC-100, focusing on demonstrating substantial equivalence to a predicate device.
However, I can extract the information requested as much as possible based on the available text, and note where information is not present.
Acceptance Criteria and Device Performance Study in 510(k) Summary for Dormio Tech FloCHANNEL Model FC-100
The provided 510(k) summary for the Dormio Tech FloCHANNEL Model FC-100 states that "The FloCHANNEL passed all of the tests and acceptance criteria as outlined in the test procedures. Test data demonstrates equivalence to the predicate device." However, the document does not explicitly define the specific acceptance criteria or provide the detailed reported device performance against those criteria. It focuses on claiming substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Concept) | Reported Device Performance |
|---|---|
| Performs as intended | Passed all established test criteria and design verification/validation activities. Clinically equivalent or superior to the predicate device. |
| No new issues regarding safety or effectiveness | Differences from predicate device do not raise new safety or effectiveness issues. Utilizes filtered cannula; low-powered; no direct electrical contact with patient. |
| Equivalence to predicate device | Passed all tests and acceptance criteria. Test data demonstrates equivalence. |
| Output voltage ranges | Ability to create four different output voltage ranges. |
| Airflow sensor resolution | State-of-the-art airflow sensor provides output signals that exceed the resolution of the predicate device. |
| Filter efficacy | Patient interface unit filter prevents transfer of particles greater than or equal to 0.1 microns in size. |
Missing Information: The document does not provide quantitative acceptance criteria (e.g., specific accuracy thresholds, signal-to-noise ratios, or other performance specifications) nor does it provide quantitative performance data (e.g., specific numerical results from tests).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document states "All risk assessment, design verification and validation activities were conducted in accordance with the device product requirements" and "The FloCHANNEL was proven clinically equivalent or superior to the predicate device." This suggests validation data was collected, but details on the nature (retrospective/prospective, country of origin, etc.) are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not mentioned. The submission focuses on device equivalence, not human reader improvement with AI assistance. The device is a "Breathing Frequency Monitor" (ventilatory effort recorder), which typically involves direct physiological measurement rather than image interpretation by human readers.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study: The device itself is a standalone hardware device that provides analog voltage outputs. "Standalone performance" in the context of an algorithm or AI is not applicable here as the device is a sensor and signal conditioner for direct physiological measurement, without embedded AI for interpretation. It outputs raw data ("low-voltage signals") to a physiological recorder for subsequent analysis by other systems or human experts.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. For a breathing frequency monitor, ground truth would typically refer to highly accurate reference measurements of airflow or ventilatory effort, likely from established medical equipment or gold-standard methodologies, which the device's output signals are compared against.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a hardware sensor and signal conditioner, not a machine learning model that requires a training set.
9. How Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as 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).