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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

Study Details

1. 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..."

2. 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.

3. 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.

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:

   • N/A. This is a CPAP device, not an AI-assisted diagnostic tool.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • N/A. Not applicable.

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The intended use of the GoodKnight 420 Series Devices is to provide Continuous Positive Airway Pressure (C-PAP) between 4 and 20 cmHxO 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 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 420 Series Devices consist of the following elements:

• GoodKnight 420G (GK420G) C-PAP Machine;
• GoodKnight 420S (GK420S) C-PAP Machine.

The GoodKnight 420 Series Devices are designed to deliver Continuous Positive Airway Pressure between 4 and 20 cmH2O.

The GoodKnight 420 Series Devices 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 420 Series power supply is double-insulated so that grounding is not required.

The GoodKnight 420 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 420 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 420 Series devices operate only in either Constant mode. In Constant mode, the main function of the device is to deliver constant positive airway pressure to the patient at a fixed level prescribed by the practitioner and between 4 and 20 cmH2O.

Pressure delivery for the GoodKnight 420 Series Devices is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.

The GoodKnight 420 Series Devices use the same pass over humidifier and masks as those approved for use with the GoodKnight 418G. The GoodKnight 420 Series Device tubing is equivalent to that of the GoodKnight 418G with the exception of an additional internal tube used for measuring the pressure at the patient's mask on the 420S model.

The GoodKnight Control clinical remote is also available for use with the GoodKnight 420S Device. The remote is used by the practitioner to configure the devices from a distance via a serial link.

The GoodKnight 420S Device can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the Silverlining™2 software which is required for downloading and displaying compliance data stored in the device memory.

The GoodKnight 420 Series Devices are not for use in life-sustaining situations. The devices and/or their accessories are not intended for sterile use.

The GoodKnight 420 Series Devices and the air filter are for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.

The GoodKnight 420 Series Devices are for use by prescription only and display the appropriate labeling.

The GoodKnight 420 Series Devices are for use in a hospital and homecare environment.

The GoodKnight 420 Series Devices do not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen.

The GoodKnight 420 Series Devices are not part of a kit.

The GoodKaight 420 Series Devices use software to set the various device parameters such as the prescription pressure and the ramp starting pressure.

The GoodKnight 420 Series Devices are electrically operated.

The GoodKnight 420 Series Devices comply with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and IEC 60601-1.

The provided 510(k) Summary for the Puritan Bennett GoodKnight 420 Series is for a CPAP machine and does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (number of experts, adjudication methods, MRMC studies, training set details) are not applicable.

Here's the breakdown of the available information:

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

The submission refers to "stated performance specifications" without detailing them in a table format. However, it indicates compliance with recognized standards and general functional performance.

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is functional, standards-compliance, and software validation. It's not clear where these tests were conducted, but the submitter is based in France.

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)

N/A. This is not an AI/ML device, and no ground truth in this context was established for a test set.

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

N/A. Not applicable to the type of device and testing described.

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

N/A. Not applicable. This is not an AI/ML device.

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

N/A. Not applicable. The device is a CPAP machine, not an algorithm.

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

N/A. The testing involves functional testing, compliance with standards, and software validation, not clinical ground truth in the way it's defined for AI/ML devices. The "ground truth" for these tests would be the predefined specifications and regulatory requirements.

8. The sample size for the training set

N/A. Not applicable, as this is not an AI/ML device and therefore has no "training set."

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

N/A. Not applicable.

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