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The intended use of the 318 Plus Nasal CPAP System is to provide Continuous Positive Airway Pressure (CPAP) between 3 and 18 cm H2O to spontaneously breathing adult patients for the treatment of Obstructive Sleep Apnea in a homecare environment. This is the same intended use as for the C314 Nasal CPAP System.

The 318 Plus Nasal CPAP System is a device used to provide Continuous Positive Airway Pressure between 3 and 18 cm H2O. The device is a modification to the Puritan-Bennett C314 Nasal CPAP System, which adds some additional features. The device is powered by AC Mains from 100 to 240 VAC, 50/60 Hz by utilizing a standard automatic switching power supply similar to the one in the PB335 Respiratory Support System. The device is set up for use by the homecare provider using the Set-up Instructions provided with the device. It is operated using the Patient Guide. 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 motor maintains a constant speed through the feedback loop from the motor to the motor drive circuit. The device has a ramp function. This allows the patient to reduce the pressure when first going to bed to make it more comfortable to fall asleep. The available ramp times are 0, 5, 10 or 20 minutes. The ramp duration is set up by the homecare provider by use of the Ramp Duration Switches. The ramp starting pressure can be adjusted by the patient using the Ramp Starting Pressure Adjustment switches. The ramp feature can be activated and deactivated by pressing the Ramp Button. Both the prescription pressure and the ramp pressure can be seen in the Pressure Display on the top housing. The optional Compliance Meter measures patierit compliance by measuring changes in the motor current as the patient breathes on the device. The accessories, i.e., the patient tubing, patient masks and headgear are the same ones used with the C314 and PB335. The device is not for life-supporting or life-sustaining situations. The device is for prescription use. The device itself, the air filter and the humidifier are for multiple use. The other accessories, i.e., the patient tube, nasal masks and headgear are for single patient use. The device is not software-driven. Neither the device nor its accessories are sterile

The provided text is a 510(k) summary for the Puritan-Bennett 318 Plus Nasal CPAP System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a novel study design. Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document, as it outlines a non-clinical equivalency study.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific, quantified acceptance criteria in the manner one might see for a novel device performance study. Instead, the acceptance criterion for the 318 Plus Nasal CPAP System was "substantially equivalent performance to the primary predicate device (Puritan-Bennett C314 Nasal CPAP System) in terms of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of human data. The "test set" here refers to the device itself being subjected to various engineering and functional tests. The document implies a single device (or a representative sample of devices) was tested for engineering performance.
• Data Provenance: The tests were conducted internally by Puritan-Bennett Corporation (a US company). This constitutes internal, non-clinical engineering test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. This was a non-clinical, engineering performance study. No experts were used to establish "ground truth" in the sense of clinical diagnoses or interpretations. The "ground truth" for the engineering tests would be the established engineering standards and specifications the device was tested against.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, this was a non-clinical engineering study, not a clinical trial requiring adjudication of patient outcomes or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. The document explicitly states: "(8) Clinical Tests Submitted: None." Therefore, no MRMC study was conducted.

6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Yes, in a sense. The non-clinical tests performed were "standalone" performance evaluations of the device itself (electrical, mechanical, environmental, pressure testing) without human interaction influencing the measurement of performance. The device is not "software-driven" in the way an AI algorithm would be, but its functional performance was evaluated objectively.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was engineering standards and specifications. For example, electrical performance would be compared against relevant safety standards, and pressure output against calibrated measurement equipment. The primary "ground truth" for demonstrating substantial equivalence was the performance of the predicate device (C314), which the 318 Plus was expected to match or exceed.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as there is no training set for this type of device.

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