(88 days)
The Respironics SmartRecorder is a multichannel recording system designed to record and store physiologic signals acquired from adult and infant patients during sleep. SmartRecorder is designed for use in the home or hospital.
Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder and/or monitoring or therapeutic device connected to the recorder.
Use of the associated Synergy S (host) software facilitates retrieval of data recorded by SmartRecorder via direct PC connection; remotely via internal modem; or by transferring data directly from the removable PCMCIA memory card to a PC. Once downloaded, the recorded data can be analyzed for physiological events.
Synergy S allows the clinician can display, review, edit and print analyzed data as well as configure / customize all reports to best meet individual needs.
SmartRecorderTM is a software-controlled device, which utilizes the same "engine" as Healthdyne Technologies' Alice®4 Sleep Diagnostic system. SmartRecorder is a scaled down version of Alice 4, having fewer channels and weighing less than three pounds. SmartRecorder acquires, records and stores up to seven dedicated channels of sensor-input physiologic data, and provides the capability to interface with Respironics infant monitoring devices and sleep therapy devices to record ECG and respiration signals, or pressure and flow signals, respectively. Additionally, SmartRecorder acquires analog data through four auxiliary channels. SmartRecorder includes built-in Masimo SET® oximetry technology.
The acquired data is recorded and stored in non-volatile removable PCMCIA flash memory, and can be retrieved by direct PC connection: remotely via internal modem; or by transferring the data directly from the memory card to a PC.
A graphic LCD display provides feedback and instruction to the clinician to assist in setup of a patient.
The associated Host software, Synergy S™, allows the HealthCare Professional (user) to access the stored data for subsequent validation and editing of all events, and provides reporting capabilities that are fully user-configurable. Synergy S is a Windows-based application, which also facilitates remote titration of CPAP / BiPAP settings via modem.
The SmartRecorder™ MULTICHANNEL RECORDING SYSTEM is a software-controlled device for acquiring, recording, and storing up to seven dedicated channels of sensor-input physiologic data, and interfacing with other Respironics devices. It also acquires analog data through four auxiliary channels, includes built-in Masimo SET® oximetry technology, and utilizes a graphic LCD display for patient setup. The associated Host software, Synergy S™, allows healthcare professionals to access stored data for validation, editing, and reporting, and facilitates remote titration of CPAP/BiPAP settings.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Operational and Performance Testing | System level and module/integration level tests verified all defined hardware and software requirements. |
| Environmental Testing | Testing confirmed functionality under various environmental conditions. |
| EMC Testing | Testing confirmed electromagnetic compatibility. |
| Functionality, Safety, and Effectiveness | Cumulative test results demonstrated functionality, safety, and effectiveness. |
| Substantial Equivalence to Predicate Device | Demonstrated substantial equivalence to the predicate device (Healthdyne Technologies' Alice 4 System). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, though the document refers to "bench testing utilized simulated data" (Page 3). This implies that a controlled set of simulated data was used for testing, rather than a clinical patient sample.
- Data Provenance: The data used for testing was "simulated data," implying it was artificially generated or controlled in a lab setting, not derived from human subjects. The country of origin is not directly relevant for simulated data in this context. The study was a retrospective bench test, not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Since the study used "simulated data" for bench testing, there was no need for experts to establish ground truth in the traditional sense of clinical interpretation. The ground truth would have been based on the predefined parameters of the simulated data itself, which was designed to test specific hardware and software functionalities.
4. Adjudication Method for the Test Set
Not applicable. As no human interpretation of results against a "true" condition was involved (due to simulated data), there was no adjudication method needed. The testing would have involved comparing the device's output against the expected output of the simulated data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No Clinical testing was performed." The study was focused on engineering and performance verification using simulated data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance assessment was effectively done. The "System Qualification Test Plan," which included Operational, Performance, Environmental, and EMC testing, along with Hardware and Software Test Plans, evaluated the device and its associated software primarily in a standalone capacity using simulated data. There was no human-in-the-loop performance evaluation reported.
7. The Type of Ground Truth Used
The ground truth used was based on simulated data. This means the "true" signals, parameters, and expected outputs were defined programmatically or by design specifications for the purpose of testing the device's hardware and software functionalities.
8. The Sample Size for the Training Set
Not applicable. The document does not describe the use of machine learning or AI models that would require a distinct "training set." The SmartRecorder™ seems to be a deterministic system based on predefined algorithms and hardware, rather than a system that "learns" from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).