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The Puritan Bennett GoodKnight 425 is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

The GoodKnight 425 is designed to deliver Positive Airway Pressure between 3 and 20 cmH2O in CPAP mode or between 3 and 25 cmH2O in bi-level mode (EPAP maximum 20 cmH2O). The GoodKnight 425 can be powered either by 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 425 is double-insulated so that grounding is not required. The GoodKnight 425 is 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 425 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. Pressure delivery for the GoodKnight 425 is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKnight 425 uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 420S. The GoodKnight 425 tubing is equivalent to that of the GoodKnight 420S. The GoodKnight 425 can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the SilverLining™ software which is required for downloading and displaying compliance data stored in the device memory. The GoodKnight 425 is not for use in life-supporting or life-sustaining situations. The devices and/or their accessories are not intended for sterile use. The GoodKnight 425 is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 425 is for use by prescription only and display the appropriate labeling. The GoodKnight 425 is for use in a hospital and homecare environment. The GoodKnight 425 does not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen. The GoodKnight 425 is not part of a kit. The GoodKnight 425 uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.

This document is a 510(k) summary for the Puritan Bennett GoodKnight 425, a Noncontinuous Ventilator. It details the device's technical characteristics and claims substantial equivalence to a predicate device. The information provided is not from a study involving AI or machine learning models. Instead, it refers to regulatory compliance and functional performance testing of a physical medical device.

Therefore, many of the requested details about acceptance criteria, study types, ground truth, and expert involvement are not applicable to this kind of regulatory submission for a traditional medical device.

Here's an attempt to answer the questions based only on the provided text, highlighting where the information is not present or relevant:

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

The document does not explicitly present a table of specific numerical acceptance criteria for performance against which the device's numerical performance is reported. Instead, it states that "Functional testing was performed to confirm that the GoodKnight 425 is capable of meeting its stated performance specifications. The device passed all tests."

The primary "acceptance criteria" mentioned are:

• Compliance with its "stated performance specifications" (not detailed in this summary).
• Compliance with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices.
• Compliance with relevant standards: IEC 60601-1 and EN ISO 17510-1.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is functional and compliance testing of the physical device, not a study involving patient data or test sets in the context of AI/ML.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. There is no "ground truth" establishment in the context of patient data analysis for this submission. The "ground truth" for functional testing would be the engineering specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically relevant for clinical studies or reviews of diagnostic interpretations, which this is not. The testing involves engineering verification and validation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools, which this device is not. This is a physical medical device (ventilator).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/provided. This is not an algorithm-only device in the AI/ML sense. The device's "brain" is a microprocessor that controls mechanical functions based on set parameters and sensor feedback. The "performance" being evaluated is of the integrated system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" as typically discussed in AI/ML contexts (e.g., expert consensus on images, pathology reports) is not applicable here. For this device, the "ground truth" for functional testing would be:

• Engineering design specifications.
• Regulatory standards (e.g., IEC 60601-1, EN ISO 17510-1).
• Draft "Reviewer Guidance for Premarket Notification Submissions" requirements.

8. The sample size for the training set

This information is not applicable/provided. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided. No training set in the AI/ML sense.

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