(268 days)
The Maestro CRC is an optional accessory that provides remote control capabilities when used in coniunction with Respironics Aria CPAP and Virtuoso Smart CPAP Systems and is intended for use by a qualified clinician (any individual trained to perform sleep study diagnoses) in hospital/sleep laboratory settings where adult patients suffering from OSA are diagnosed and treated.
The Maestro CRC (Figure 16-1) incorporates a control panel with a display screen and two user kevpads (for Function and Setting buttons, respectively) on top. Eight DC signal output ports (five of which are active: two of which will be usable with the Aria and Virtuoso Systems covered in this premarket notification), a power supply connector, and two communications connectors (one of which will be usable with the Aria and Virtuoso Systems covered in this premarket notification) are located on the back of the unit. A contrast adjustment control and a power on/off control accompanied by a Light Emitting Diode (LED) power on indicator are provided on its right side section. An annunciator and microprocessor are contained within the Maestro CRC enclosure. The enclosure measures 9 1/2" x 2" x 7 3/4" (W x H x D).
Here's a summary of the acceptance criteria and study information for the Maestro Clinical Remote Control, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 601-1 (General Requirements Safety of Medical Electrical Equipment) | Found compliant and certified |
| Electromagnetic Compatibility (EMC) | IEC 801-1 (EMC for Industrial Process and Measurement and Control Equipment. Part 1) | Found compliant and certified |
| IEC 801-2 (Electrostatic Discharge Requirements) | Found compliant and certified | |
| IEC 801-3 (Radiated Electromagnetic Field Requirements) | Found compliant and certified | |
| IEC 801-4 (Electrical Fast Transients/Burst Requirements) | Found compliant and certified | |
| CISPR 11 (Limits and Methods of Measurement of Radio interference Characteristics of Industrial, Scientific, and Medical Equipment) | Found compliant and certified | |
| CISPR 16 (Specification for Radio Interference Measuring Apparatus and Measurement Methods) | Found compliant and certified | |
| Mechanical & Environmental Endurance | IEC 68-2-6 (Basic Environment Test Procedures. Part 2: Tests. Test Fc and Guidance: Vibration (Sinusoidal)) | Found compliant and certified |
| IEC 68-2-27 (Basic Environment Test Procedures. Part 2: Tests. Test Ea and Guidance: Shock) | Found compliant and certified | |
| IEC 68-2-37 (Basic Environment Test Procedures. Part 2: Tests. Test Fdc: Random Vibration Wide Band - Reproducibility Low) | Found compliant and certified | |
| MIL-STD-461D (Requirements for Control of Electromagnetic Interference Emissions and Susceptibility) | Found compliant and certified | |
| MIL-STD-462D (Measurements of Electromagnetic Interference Characteristics) | Found compliant and certified | |
| MIL-STD-810E (Environmental Test Methods) | Found compliant and certified | |
| Functional Equivalence | Performance in its intended environment is as safe and effective as predicate devices (Puritan-Bennett Companion 318 Nasal CPAP Diagnostics System (K910194) and Respironics REMstar Choice Clinical Remote Control (K920699)) | Verified through performance-related testing |
| Intended Use | Provides remote control capabilities for Respironics Aria CPAP and Virtuoso Smart CPAP Systems for qualified clinicians in hospital/sleep laboratory settings for adult OSA patients. Not for life support. | This is the stated intended use for which the device's performance was evaluated. |
| Claims | Provides data monitoring, alphanumeric/graphical representation of patient data, interfaces with polysomnograph. | Implied to be met by the device's design and features as described. |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a sample size in terms of patient data or typical "test set" in the context of machine learning. The testing appears to be primarily focused on engineering and regulatory compliance of the device itself (electrical, EMC, mechanical, environmental) rather than a clinical performance study using patient data.
- Data Provenance: Not applicable in the context of clinical data. The device itself was tested against international and military standards.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The "ground truth" for this device's performance is defined by adherence to established engineering and safety standards (e.g., IEC, CISPR, MIL-STD). The compliance was likely assessed by qualified test engineers and regulatory personnel, but no specific "experts" or their qualifications for establishing ground truth in a clinical sense are mentioned.
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Adjudication Method for the Test Set:
- Not applicable. The testing described is against objective, quantifiable technical standards, not involving subjective interpretation requiring adjudication among experts.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document describes testing for safety and effectiveness relative to predicate devices through engineering compliance, not a clinical trial with human readers assisted by AI. The device is a remote control, not an AI diagnostic tool.
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Standalone (Algorithm Only) Performance Study:
- No, a standalone algorithm only performance study was not conducted in the context of AI. The Maestro Clinical Remote Control is a hardware and software system for remote operation and monitoring, not an AI algorithm for diagnosis. The "standalone" performance here refers to the device's ability to function independently according to its design specifications when connected to target CPAP systems.
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Type of Ground Truth Used:
- Engineering and Regulatory Standards Compliance: The primary ground truth is established by the specified international and military technical standards (IEC, CISPR, MIL-STD). The device's ability to meet these objective criteria defines its "ground truth" for safety and effectiveness.
- Functional Equivalence to Predicate Devices: The implicit ground truth for its functional performance is that it should operate in a manner that is "as safe and effective as" the predicate devices in its intended environment.
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Sample Size for the Training Set:
- Not applicable. This device does not use machine learning, so there is no "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).