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510(k) Data Aggregation
(167 days)
RESPIRONICS SIMPLYCLEAR DEVICE
The Philips Respironics SimplyClear device promotes airway clearance by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing.
The Philips Respironics SimplyClear device may be used either with a facemask or mouthpiece, or with an adapter to a patient's endotracheal or tracheostomy tube. It is for use on adult or pediatric patients having difficulty with secretion clearance and/or inability to cough.
The SimplyClear device is for use in a hospital, institutional environment or in the home.
The Philips Respironics SimplyClear device promotes airway clearance by loosening, mobilizing and clearing secretions. The loosening and mobilization occurs by gradually applying air pulse generated high frequency oscillatory vibrations on the positive and negative pressures applied to the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization. The positive to negative shift in pressure produces a high expiratory flow from the lungs, promoting the clearance of the mobilized secretions via coughing.
The SimplyClear device combines the loosening and mobilization functionality of the Vest Airway Clearance System (K024309) with the secretion clearance functionality of the CoughAssist device (K002598), Dima Italia Negavent DA-3 Plus Pegaso (K072292) and the CoughAssist T70 device (K121955).
Here's a breakdown of the acceptance criteria and the study information for the Philips Respironics SimplyClear device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format requested. Instead, it describes various "performance testing" and "verification activities" against "design input specifications" and "product requirements." The acceptance criteria are broadly implied by the successful completion of these tests.
However, based on the Testing Summary table and the Performance Data section, we can infer the tested features and their successful verification:
| Device Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| User Interface | Meet product requirements; proper display functions, user controls, and informational messages; display correct data and therapy information. | Verified to meet product requirements. All display functions, user controls, and informational messages performed as intended. Displayed proper data and expected therapy information. |
| Delivered Pressure & Flow Stability | Deliver accurate pressure for intended duration (insufflation, exsufflation, pause); demonstrate pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions. | Verified to deliver accurate pressure for the intended duration. Demonstrated pressure and flow stability across all patient test cases, including extreme flow rates and sensor malfunctions (inaccuracies and/or complete drop out). |
| CoughTrak | Meet product specifications with defined patient case simulations; availability, operation, and triggering performance across patient cases. | Verified to meet product specifications with each defined patient case simulation. Availability, operation, and triggering performance verified across the range of patient cases. |
| Oscillations | Meet product specifications; bench testing at extreme therapy settings (waveform testing on maximum duration, extreme settings). | Verified to meet product specifications. Bench testing at extreme therapy settings conducted, including waveform testing on maximum duration of therapy at extreme therapy settings. Oscillations waveforms compared against predicate device waveforms with no oscillations. |
| Data Management | Meet product specifications for SD card data integrity. | Verified to meet product specifications for SD card data integrity through software verification, code reviews, and software verification testing. |
| Oximetry Accessory | Proper display of SpO2 and heart rate data received. | Tested to verify the behavior of pulse oximetry data and proper display of data received. |
| Wired Remote Control | Availability and operation of the device. | Verification testing conducted to verify availability and operation. |
| External Suctioning Accessory Interface | Provide power to a suctioning accessory as specified. | Verified to demonstrate that the device provides power to a suctioning accessory as specified. |
| Power Management | Properly interface with detachable battery; display battery information; charge battery; indicate low battery; compatible with external DC power supply; display power supply information; indicate low external battery. | Verified to properly interface with the detachable battery, properly display battery information, properly charge the battery, and indicate a low battery charge. Verified to be compatible with an external DC power supply, to properly display the power supply information, and to properly indicate a low external battery. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices or patient cases. The testing involved "defined patient test cases" but the quantity isn't specified.
- Data Provenance: The study was a non-clinical bench testing study. It used simulated patient test cases and "worst-case scenario inputs" rather than actual patient data. Therefore, there's no country of origin for patient data (as none was used) and it is not retrospective or prospective in the human-subjects sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical bench testing study where "ground truth" was established by the device's design input specifications and expected performance, rather than expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. As a non-clinical bench testing study, there was no need for adjudication by experts to establish a ground truth. Performance was assessed against predefined engineering specifications.
5. 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
Not applicable. This device is a powered percussor for airway clearance, not an AI-assisted diagnostic or interpretation tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The "performance data" describes standalone validation of the device's algorithms and hardware performance against specifications using "black-box" and "white-box" bench testing. This confirms the algorithm and system's functional integrity independent of a human operator's assessment of patient outcomes during therapy, although a human is operating the device.
7. The Type of Ground Truth Used
The "ground truth" for this non-clinical testing was based on the device's design input specifications and product requirements. This would include engineering specifications for pressure, flow, timing, oscillation parameters, user interface functionality, data integrity, and power management.
8. The Sample Size for the Training Set
Not applicable. This document describes a traditional medical device (hardware and embedded software) verification and validation process, not a machine learning or artificial intelligence (AI) device that would involve a "training set" for an algorithm. The software algorithms were designed and tested, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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