(174 days)
The intended use of the GoodKnight 418 is to provide Continuous Positive Airway Pressure (CPAP) between 4 and 18 cmH,O to spontaneously breathing patients over 30 kg for the treatment of Obstructive Sleep Apnea in a homecare environment.
The GoodKnight 418 CPAP System is indicated for use in treating obstructive sleep apnea patients weighing over 30 kg within a homecare environment.
The GoodKnight 418 CPAP System is a device used to provide Continuous Positive Airway Pressure between 4 and 18 cmH2O.
The device is powered by AC Mains from 96 to 138 VAC, 60 Hz. The blower motor nominal voltage is 160 VDC, which is obtained by rectifying and filtering the nominal mains power voltage of 120 VAC. The device is double-insulated so that grounding is not required.
The device is set up for use by the homecare dealer using the Set-up Instructions provided with the device. It is operated by following directions in the Patient Guide. Pocket Cards are also provided for both the patient and the homecare dealer as a convenience.
The pressure is set to the prescription with the use of a patient circuit, with the pressure being measured at the patient end of the circuit. By using this method, losses associated with the patient circuit are compensated for and, thus, the device does not require a pressure transducer.
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 418 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
The accessories, i.e., the patient tubing, patient masks and headgear are the same ones used with the GoodKnight 318.
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.
The device is electrically operated.
The device complies with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and CAN/CSA C22.2 No. 601.1-M90 (1994).
The provided document, a 510(k) summary for the Nellcor Puritan Bennett GoodKnight 418 CPAP System, outlines the device's characteristics and its claim of substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology (like sample sizes, expert qualifications, or ground truth establishment) typically associated with such studies.
The document states that no clinical studies were required for the substantial equivalence determination. Instead, performance testing was conducted based on published guidance documents.
Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Device Performance
The document does not explicitly list specific numerical acceptance criteria (e.g., "pressure must be within X% of target"). Instead, it generally states that the device "passed all tests" related to its stated performance specifications and compliance with guidance documents.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meets stated performance specifications | Device passed all tests. |
| Complies with Nov 1993 draft "Reviewer Guidance for Premarket Notification Submissions" (ARDB) | Device passed all tests. |
| Complies with Aug 1991 "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review" | Device passed all tests. |
| Operates safely in its intended environment | Concluded that it will operate safely. |
| Effective in fulfilling its intended use | Concluded that it will be effective. |
Additional Information on the Study:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "functional testing" and "software testing" but does not specify sample sizes for these tests or the nature of the data/conditions used.
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)
- Not applicable/Not provided. Since no clinical studies were required or reported, there's no mention of expert-established ground truth for a test set. The testing performed was technical/functional validation against internal specifications and regulatory guidance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/None mentioned. Given the nature of the testing (functional and software compliance), an adjudication method as described (typically for clinical outcome evaluation) is not relevant or reported.
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 MRMC comparative effectiveness study was done. The device is a CPAP system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The "algorithm" here refers to the embedded software controlling the CPAP device, not an AI for diagnosis or interpretation. The performance discussed is the device operating according to its design, which is inherently "standalone" in its mechanical/electronic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in terms of "ground truth" for a clinical study. The "ground truth" for the device's technical performance would be its design specifications and the requirements outlined in the referenced regulatory guidance documents. The device's operation was compared against these predefined functional expectations.
8. The sample size for the training set
- Not applicable/Not provided. This device is a CPAP system based on established technology, not a machine learning or AI system that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).