(137 days)
The Mallinckrodt GoodKnight 418 Series 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 418 Series Devices consist of the following elements: C-PAP Machine; GoodKnight 418 A (GK418A) and GoodKnight 418 P (GK418P) C-PAP Machine. The GoodKnight 418 Series Devices are designed to deliver Continuous Positive Airway Pressure between 4 and 18 cmH2O. The GoodKnight 418 Series Devices can be 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 GoodKnight 418 Series Devices are double-insulated so that grounding is not required. The GoodKnight 418 Series Devices are set up for use by the homecare dealer using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual. The GoodKnight 418 Series Devices rely on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the treatment of various signals from the devices including signals relating to patient cycle detection. The GoodKnight 418 Series Devices can operate in either Constant or Automatic mode. In Constant mode, the main function of each device is to deliver constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 18 cmH3O. In Automatic mode (A-PAP for the GoodKnight 418A and P-PAP for the GoodKnight 418P), the practitioner determines and sets a maximum and minimum pressure range above and below the prescribed reference pressure and between 4 and 18 cmH2O. The pressure is adjusted within the maximum and minimum limits according to the patient's respiratory pattern and the type of 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™2 software. Pressure delivery for the GoodKnight 418 Series Devices is regulated by a pressure sensor which monitors both ambient and output pressure at the patient's mask and provides feedback to the control system. The GoodKnight 418A also uses the signal from the pressure sensor to detect the patient's respiratory cycle and any acoustical vibrations (snoring), However, the GoodKnight 418P has the additional feature of a flow sensor which monitors the patient's respiratory flow, the occurrence of obstructive/open airway apnea, leaks and flow limitation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Mallinckrodt GoodKnight 418 Series.
It's important to note that the provided 510(k) summary is for a CPAP machine, which is a mechanical device, not an AI-powered diagnostic tool. Therefore, many of the typical AI/ML-specific questions (like MRMC studies, training set details, ground truth for training data, etc.) are not applicable here. The focus of the performance testing is on the device's functional integrity and compliance with regulatory standards for medical devices.
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list quantitative "acceptance criteria" in a table format with corresponding "reported device performance" in the way one would expect for a diagnostic algorithm. Instead, the acceptance criteria are implicitly tied to various regulatory and development guidelines, and the performance is reported as successful completion of tests.
Implied Acceptance Criteria & Reported Performance:
| Acceptance Criteria (Implied from text) | Reported Device Performance |
|---|---|
| Functional Specifications: Device capable of meeting stated performance specifications (ee.g., delivering 4-18 cmH2O pressure, operating modes, ramp function, data storage, user interface functionality). | "Functional testing was performed to confirm that the GoodKnight 418 Series Devices are capable of meeting their stated performance specifications. The series passed all tests." |
| Compliance with "Reviewer Guidance for Premarket Notification Submissions" (Nov 1993 draft) | "Testing was performed to confirm that the GoodKnight 418 Series Devices comply with the November 1993 draft 'Reviewer Guidance for Premarket Notification Submissions' published by the Division of Cardiovascular, Respiratory, and Neurological Devices. The devices passed all tests." |
| Software Compliance with "Guidance for the Content of Premarket submissions for Software Contained in Medical Devices" (May 29, 1998) | "All software was tested 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 devices passed all tests." |
| Safety and Effectiveness: Operation safely in intended environment and effective in fulfilling intended use. | "We conclude that the GoodKnight 418 Series Devices meet the stated performance specifications and criteria outlined in the Reviewers Guidance publications referenced above. We conclude that the devices and their accessories will operate safely in their intended environment and will be effective in fulfilling their intended use." (This is a summary conclusion based on the preceding tests). |
Study Details (as applicable for a mechanical device)
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Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or a specific number of devices tested. The performance testing appears to be centered on engineering and regulatory compliance tests performed on the device itself, rather than a clinical trial with a patient cohort used for evaluating an algorithm's diagnostic performance.
- Data provenance for these engineering tests is not mentioned (e.g., country of origin, retrospective/prospective). It would typically be internal laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "test set" does not involve a diagnostic ground truth established by experts. Performance testing would likely have involved engineers and technicians verifying device function against specifications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. There's no mention of a human-adjudicated test set in the context of diagnostic performance. The tests described are functional and regulatory compliance tests.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic accuracy (e.g., radiologists reading images with or without AI assistance). The GoodKnight 418 Series is a CPAP therapy device, not a diagnostic AI tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- While the device uses a microprocessor and software for control and event detection, the summary does not detail a standalone performance evaluation of its "algorithm" in isolation as one would for a diagnostic AI. The "algorithm" here controls the mechanical function and pressure delivery based on detected respiratory patterns. The "passed all tests" statement implies the integrated system performance met specifications.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional and regulatory tests, the "ground truth" would be the engineering specifications and regulatory requirements themselves. For example, a pressure delivery test's ground truth is whether the device accurately delivers the set pressure. This is objective measurement/verification, not a clinical ground truth established by experts.
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The sample size for the training set:
- This is not applicable. The GoodKnight 418 Series is a hardware medical device with embedded control software, not a machine learning model that requires a distinct "training set" of data in the AI sense for learning patterns. The software development follows traditional software engineering principles and testing.
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How the ground truth for the training set was established:
- This is not applicable for the same reasons as point 7. The software's "ground truth" is defined by its designed functionality and control logic, not by a dataset it learns from.
Summary of Device in Context:
The Mallinckrodt GoodKnight 418 Series is a CPAP machine designed to treat Obstructive Sleep Apnea. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (GoodKnight 418G) and compliance with relevant medical device regulations and guidance documents. The performance testing described is primarily functional and regulatory in nature, ensuring the device operates as intended and meets safety standards for a mechanical therapy device. It does not involve AI/ML diagnostic or predictive algorithms in the sense that would require large datasets, expert ground truth, or MRMC studies.
§ 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).