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The Oran Park mask is intended for use in the home or hospital/institutional environment on patients weighing more than 661b (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy.

Only the Sleep Lab Mask (SLM) variant is intended and validated for multi-patient reuse and must be reprocessed if reused between patients.

The Oran Park Mask is an accessory to deliver air flow and positive air pressure generated by positive airway pressure (PAP) devices such as CPAP or bi-level flow generator systems to the patient's airway, for the treatment of Obstructive Sleep Apnea (OSA) or ventilator support (non-life support). It delivers the treatment pressure from the source device to the patient's upper airway by providing an air seal between the PAP device and under the patient's nose and mouth.

There are 2 variants to the Oran Park Mask:

• . Oran Park Mask (Home Use) Intended for single patient re-use (SPMU) for home use. It is configured with a diffused venting port located on the elbow, known as the QuietAir elbow.
• . Oran Park SLM (Sleep Lab Mask)

Intended for multi-patient re-use (MPMU) and must be reprocessed if reused between patients. It is configured with a non-diffused venting port located on the elbow, known as the Multihole elbow.

The Oran Park mask comprises of 4 sub-assemblies: headgear, frame, cushion and elbow. The venting ports and anti-asphyxia valve are incorporated into the elbow assembly. There are four magnets incorporated in the Oran Park mask – two magnets in the frame assembly and 2 magnets in the lower headgear clips – with a magnetic field strength up to 400 mT. The mask help facilitate attaching and detaching the headgear to the mask frame when regularly fitting the mask for use. The cushion and headgear are available in various sizes to fit a wide patient population. Soft wraps, which are attached to the Oran Park mask frame, are available as an optional accessory for patient's comfort.

The Oran Park mask is a prescription device and is supplied non-sterile.

The Oran Park Mask is a medical device accessory used to deliver airflow and positive air pressure from PAP devices for the treatment of Obstructive Sleep Apnea or ventilator support. The device underwent non-clinical testing to demonstrate its performance and safety, aiming to prove substantial equivalence to the predicate device, AirFit F20 (K153563).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents a comparison table between the predicate device (AirFit F20, K153563) and the subject device (Oran Park Mask System) for various design parameters and features. The "Comments" column often indicates the acceptance criteria for the subject device by stating "Equivalent," "Identical," or referencing compliance with specific ISO standards.

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

The document describes non-clinical verification and validation testing. This type of testing typically involves bench tests on manufactured devices rather than studies on human subjects. Therefore, the concept of "test set" in the context of patient data, sample size of patients, and data provenance (country of origin, retrospective/prospective) is not applicable here. The tests are performed on the device prototypes or production samples in a laboratory setting. No information is provided regarding the number of units tested for each non-clinical test.

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

This information is also not applicable as the study described is non-clinical, involving engineering and performance testing against established standards and predicate device performance, not clinical interpretation requiring expert ground truth establishment.

4. Adjudication Method (2+1, 3+1, none) for the Test Set:

This information is not applicable for the same reasons as points 2 and 3. Non-clinical bench testing does not involve adjudication methods used in clinical studies.

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:

This is not applicable. The device, an Oran Park Mask, is a physical patient interface for respiratory therapy. It is not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human reader performance with and without AI assistance would not be relevant.

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

This is not applicable. The device is a physical mask, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" or reference for acceptance was primarily:

• International Standards: Specifically ISO 17510:2015 (Medical devices – Sleep apnoea breathing therapy – Masks and application accessories), ISO 10993 series (Biocompatibility), ISO 18562 series (Biocompatibility of breathing gas pathways), ISO 5356-1 (Conical connectors), etc.
• Performance of the Predicate Device: The AirFit F20 (K153563) served as a direct comparison for various parameters to establish substantial equivalence.
• Predetermined Acceptance Criteria: These are likely internal specifications derived from the standards and predicate device performance, ensuring safety and effectiveness.

8. The Sample Size for the Training Set:

This is not applicable as there is no "training set" in the context of non-clinical device testing for a physical mask. Device design and validation follow engineering and regulatory processes, not machine learning training.

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

This is not applicable for the reasons stated in point 8.

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