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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:

Study Details (as applicable for a mechanical device)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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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

Here's additional information based on your requested categories:

1. A table of acceptance criteria and the reported device performance: Provided above.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set of data.

9. 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.

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