(27 days)
The intended use of the GoodKnight 420 Evolution is to provide Continuous Positive Airway Pressure between 4 and 20 cmHzO to spontaneously breathing patients over 30 Kg for the treatment of Obstructive Sleep Apnea in a hospital and homecare environment.
The Puritan Bennett GoodKnight 420 Evolution is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.
The GoodKnight 420 Evolution is designed to deliver Continuous Positive Airway Pressure between 4 and 20 cmHzO. Power may be supplied either through AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The GoodKnight 420 Series is double-insulated so that grounding is not required. The GoodKnight 420 Evolution is set up for use by the homecare dealer using the Clinician Manual provided and operated according to the instructions contained in the Patient Manual. The GoodKnight 420 Evolution relies on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the interpretation of various signals from the device including signals relating to patient cycle detection.
The GoodKnight 420 Evolution can operate in either Constant or Automatic mode. In Constant mode, the device delivers a constant positive airway pressure to the patient at a fixed level prescribed by the practitioner between 4 and 20 cmHzO. In Automatic mode (APAP mode), the practitioner sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 20 cmHzO. The pressure is adjusted within this range according to the patient's respiratory pattern and the type of respiratory events detected. Data concerning the type of events detected, their frequency and duration, etc. is stored in the device data memory and can be accessed by the practitioner through the use of the optional Silverlining™ software. Pressure delivery for the GoodKnight 420 Evolution is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.
The GoodKnight 420 Evolution and accessories are not intended for sterile use. The GoodKnight 420 Evolution and the air filter are intended for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.
The GoodKnight 420 Evolution uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure. The device can also be connected to a computer via an RS232 serial port, and can be configured from the computer using the optional Silverlining" software which is required for downloading and displaying compliance data stored in the device memory.
The GoodKnight 420 Evolution is not for use in life-supporting or life-sustaining situations. However, the device can be used to provide the patient with supplemental oxygen. The device is for use by prescription only and displays the appropriate labeling. The device is intended for use in a hospital or homecare environment. The GoodKnight 420 Evolution complies with the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993), IEC 60601-1 and EN ISO 17510-1.
Here's an analysis of the provided 510(k) summary for the PURITAN BENNETT GoodKnight 420 Evolution, focusing on the acceptance criteria and supporting studies as requested:
This 510(k) summary primarily focuses on establishing substantial equivalence for a medical device (CPAP system) that has explicit performance specifications rather than a diagnostic AI/ML algorithm. Therefore, many of the requested categories pertaining to AI/ML model validation (e.g., sample sizes for training/test sets, expert qualifications for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable (N/A) in this context. The "device performance" reported is about meeting engineering and safety standards, not diagnostic accuracy.
The document highlights functional testing and compliance with regulatory guidance documents.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Notes |
|---|---|---|---|
| Functional Performance | Deliver Continuous Positive Airway Pressure between 4 and 20 cmHzO. | Device is "capable of meeting its stated performance specifications." | Tested for both Constant and Automatic (APAP) modes. |
| Electrical Safety | Compliance with IEC 60601-1 and EN ISO 17510-1. | GoodKnight 420 Evolution "complies with" these standards. | These are international standards for medical electrical equipment. |
| Software Validation | Compliance with May 29, 1998 "Guidance for the Content of Premarket submissions for Software Contained in Medical Devices." | "All software was tested in accordance with" this guidance. | Ensures software reliability and safety. |
| Regulatory Guidance | Compliance with November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" (ARDB). | GoodKnight 420 Evolution "complies with" this guidance. | General guidance for premarket submissions. |
| Equivalence (APAP mode) | Clinical equivalence of APAP mode to the GoodKnight 418P (predicate device). | "Clinical evaluation... was performed to demonstrate equivalence of the APAP mode to that of the GoodKnight 418P." | This is a key comparison for the new APAP functionality. |
| Intended Use | Treat Obstructive Sleep Apnea in spontaneously breathing patients over 30 Kg in hospital/homecare environment. | Stated to meet its "intended use" safely and effectively. | Implied by meeting other performance and safety criteria. |
| Life Support Status | Not intended for life-supporting or life-sustaining situations. | "Not for use in life-supporting or life-sustaining situations." | This is a limitation and a safety classification. |
Study Details
-
Sample size used for the test set and the data provenance:
- N/A. This device underwent functional performance testing and a clinical evaluation for equivalence, not a diagnostic accuracy study with a specific test set of patient data in the AI/ML sense. The "clinical evaluation" mentioned for APAP mode equivalence did involve human subjects but the specific sample size and detailed provenance (country of origin, retrospective/prospective) are not provided in this summary. It states "Clinical evaluation of the GoodKnight 420 Evolution was performed to demonstrate equivalence..."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. For the engineering and regulatory compliance tests, experts would be engineers and regulatory compliance officers. For the "clinical evaluation" demonstrating equivalence of the APAP mode, the ground truth would be the clinical performance of the predicate device (GoodKnight 418P) as a benchmark, assessed by clinicians, but the number and qualifications are not detailed in this summary.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This summary does not describe an adjudication process typical for AI/ML diagnostic studies.
-
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:
- N/A. This is a CPAP device, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an AI algorithm. The device itself (a CPAP system) operates "stand-alone" in delivering therapy; its performance is what was tested.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For functional and electrical tests: Engineering specifications, regulatory standards, and established test protocols.
- For the APAP mode equivalence: The "ground truth" would be the established clinical performance and safety profile of the predicate device (GoodKnight 418P), which the new device aimed to demonstrate equivalence to. This would likely involve patient physiological data and clinical assessments.
-
The sample size for the training set:
- N/A. This is not an AI/ML device that requires a "training set" in the computational sense.
-
How the ground truth for the training set was established:
- N/A. Not applicable.
§ 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).