(8 days)
The Nellcor Puritan Bennett GoodKnight 418G is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare environment.
The GoodKnight 418G is a device used to provide Continuous Positive Airway Pressure between 4 and 18 cmH2O. The device is powered either by AC mains (115 VAC or 230 VAC nominal) or by an external 24 VDC battery. The blower motor nominal voltage is 24 VDC, which is obtained directly from the external battery or by rectifying and filtering the nominal mains power. The device is double-insulated so that grounding is not required. The device uses a microprocessor to set the various control parameters, turn features on and off and view the set parameters. Pressure regulation is accomplished by maintaining a constant motor speed. This is done by the microprocessor counting the motor RPM pulses and then changing the motor speed voltage supplied to the motor drive circuit as required to maintain constant speed. The GoodKnight 418G has the following functions: On/Off, Calibration, Set Prescription Pressure, Check Prescription Pressure, Enable/Disable Ramp Feature, Set Ramp Starting Pressure, Start Ramp Feature, Enable/Disable Altitude Compensation Feature, Compensating for Changes in Altitude, Check Compliance Meter, Reset Compliance Meter, Check Hour Meter. The device is not for use in life-supporting or life-sustaining situations. Neither the device nor its accessories are sterile. The device itself and the air filter are for multiple use. The other accessories, i.e. the patient circuit and nasal masks are for single patient use. The device is for prescription use and contains appropriate labeling. The device is for use in a homecare environment. The device does not contain a drug or biological product as a component. However, it can be used to provide the patient with supplemental oxygen. The device is not part of a kit. Software is used to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to enable/disable the ramp and altitude compensation features. Software is also used to increase the hour meter and the compliance meter. The device is electrically operated.
The provided 510(k) summary for the NELLCOR PURITAN BENNETT GoodKnight 418G CPAP machine indicates that its acceptance criteria primarily revolve around meeting stated performance specifications and compliance with relevant regulatory guidance documents. This is a medical device, and the focus is on safety and effectiveness through engineering and regulatory standards rather than clinical performance metrics in the way AI/ML devices are typically evaluated.
Here's an breakdown of the information as requested, though some categories may not be directly applicable due to the nature of this device (CPAP machine vs. AI/ML software):
Acceptance Criteria and Device Performance for Nellcor Puritan Bennett GoodKnight 418G
| Acceptance Criteria Category | Specific Criterion / Standard | Reported Device Performance and Compliance |
|---|---|---|
| Functional Performance | Capable of meeting its stated performance specifications for Continuous Positive Airway Pressure (CPAP) between 4 and 18 cmH2O. This includes accurate pressure regulation, proper functioning of On/Off, Calibration, Set/Check Prescription Pressure, Ramp Feature (Enable/Disable, Set Starting Pressure, Start), Altitude Compensation (Enable/Disable, Compensate for Changes), Compliance Meter (Check/Reset), and Hour Meter. | The device passed all functional tests. |
| Voluntary Standards Compliance | Compliance with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. | The device passed all tests. |
| Compliance with IEC 601-1 (likely related to electrical safety and general requirements for medical electrical equipment). | The device complies with IEC 601-1. | |
| Software Validation | Software testing in accordance with the May 29, 1998 "Guidance for the Content of Premarket submissions for Software Contained in Medical Devices" published by the Office of Device Evaluation. | The device passed all software tests. |
| Labeling | Appropriate labeling for prescription use. | Device contains appropriate labeling. |
| Intended Use | Provides CPAP between 4 and 18 cmH2O to spontaneously breathing patients over 30 kg for the treatment of Obstructive Sleep Apnea in a homecare environment. (This is the intended use, and the functional testing supports this). | Supported by functional testing. |
| Safety | Double-insulated, not for use in life-supporting/life-sustaining situations, not sterile. | Device is double-insulated. |
Here's additional information based on your requested categories:
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A table of acceptance criteria and the reported device performance: Provided above.
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Sample size used for the test set and the data provenance:
- The document does not specify a sample size for the functional, standards compliance, or software testing. These types of tests typically involve testing a representative number of units to ensure consistency and compliance rather than a "test set" of patient data in the way AI/ML models are evaluated.
- Data provenance: Not applicable in the context of device design and engineering tests mentioned. The testing involves the device itself, not patient data from a specific country. This is a design and manufacturing verification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device involves engineering specifications, electrical safety standards, and software validation protocols, which are established by regulatory bodies and engineering teams, not clinical experts for diagnostic accuracy in the way AI is.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for resolving discrepancies in expert labeling or diagnoses, which is not relevant to the functional and standards compliance testing of a medical device like a CPAP machine.
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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: Not applicable. The GoodKnight 418G is a CPAP machine, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in essence, the "standalone" performance of the device was assessed. The functional testing, standards compliance, and software testing all evaluate the device's inherent capability to meet its specifications without human-in-the-loop clinical intervention in the testing process beyond operating the device as intended.
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The type of ground truth used: For this device, the "ground truth" is primarily based on:
- Engineering Specifications: Design documents and functional requirements for pressure output, ramp function, display accuracy, etc.
- Regulatory Standards: IEC 601-1 and specific FDA guidance documents (e.g., draft ARDB Reviewer Guidance for Premarket Notification Submissions, Guidance for Software Contained in Medical Devices).
- Predicate Device Equivalence: Comparison to the Nellcor Puritan Bennett GoodKnight 418 CPAP System (K980365) forms a basis for determining substantial equivalence, implying that if the predicate device met its safety and effectiveness criteria, and the new device is sufficiently similar and meets its own specifications, it is also safe and effective.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set of data.
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How the ground truth for the training set was established: Not applicable. No training set for an AI/ML model was used for this device.
§ 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).