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AirFit F30i Mask System
The AirFit F30i mask has two product variants:
· AirFit F30i mask is intended for single-patent reuse in the home environment.
• AirFit F30i SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment. Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

AirFit F30i NM Mask System
The AirFit F30i Non Magnetic mask has two product variants:
· The AirFit F30i Non Magnetic variant is intended for single-patient reuse in the home environment.
· The AirFit F30i Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multipatient reprocessing and must be reprocessed if reused between patients.

Arcadia Mask System
The Arcadia has two product variants:
· Arcadia mask is intended for single-patient reuse in the home environment.
· Arcadia SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.
These masks are intended for patients weighing more than 66 lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

The AirFit F30i, AirFit F30i NM and Arcadia mask systems are full-face conduit masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or non-life supporting ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.
The AirFit F30i, AirFit F30i NM and Arcadia mask systems each have two product variants:

• . AirFit F30i Mask/ AirFit F30i NM Mask/ Arcadia Mask: This is the home use variant that is intended for single patient re-use.
• . AirFit F30i SLM/ AirFit F30i NM SLM/ Arcadia SLM (sleep lab mask): This is intended for multipatient re-use and must be reprocessed if reused between patients using the disinfection guide
  The AirFit F30i, AirFit F30i NM and Arcadia mask systems are made up of the following four main component assemblies: Cushion, conduit frame, elbow and headgear. The cushion and conduit frame are available in various sizes to allow for adequate mask fit over the intended patient population.
  The AirFit F30i, AirFit F30i NM and Arcadia mask systems are prescription devices supplied non-sterile.

The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in the format requested. The document is a 510(k) summary and FDA clearance letter, which outlines the device's substantial equivalence to a predicate device based on various performance and safety tests. However, it does not provide the specific "acceptance criteria" (e.g., minimum sensitivity, specificity, or accuracy thresholds) or the detailed methodology and results of a single study with the requested metrics.

Instead, the document lists several non-clinical data submitted, which include performance and safety tests in accordance with ISO standards and other bench tests. The conclusion states that "Non-clinical verification and validation assessment/testing demonstrated that AirFit F30i NM and Arcadia mask systems met all intended performance requirements." and "Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate AirFit F30i mask system (K183512)."

Therefore, I can extract the types of tests performed and the comparison to the predicate device, but I cannot fill in the table or answer all sub-questions as the specific numerical acceptance criteria and a single "study" proving it with the requested detail are not present.

Here's what can be extracted based on the provided text, with an explanation for missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative (e.g., "met all intended performance requirements") and tied to ISO standards or established performance of the predicate device. Specific numerical thresholds for acceptance are not explicitly listed in the 510(k) summary, except for some comparative parameters.

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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.

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The Whitsundays Mask System has two product variants:
• Whitsundays mask
· Whitsundays SLM (Sleep Lab Mask)
Both masks are intended for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Whitsundays mask is intended for single-patient reuse in the home environment and the Whitsundays SLM is intended for multi-patient reuse in the hospital/institutional environment. The Sleep Lab Mask (SLM) is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

The Whitsundays Mask System is an accessory to deliver airflow 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 ventilatory support (non-life support). It delivers the treatment pressure from the source to the patient's upper airway by providing an air seal between the PAP device and the bottom of the patient's nose.
The Whitsundays mask system has two product variants:

• Whitsundays mask This is the home use variant that is intended for single patient re-use.
• . Whitsundays SLM (Sleep Lab Mask) This is the SLM variant that is intended for multi-patient re-use and must be reprocessed if reused between patients.
  The Whitsundays Mask System is made up of 4 main component assemblies: nasal cushion, conduit frame, elbow, and headgear. The nasal cushion and conduit frame are available in various sizes to allow for adequate mask fit in the intended patient population.
  The Whitsundays Mask System is a prescription device supplied non- sterile.

The provided text describes the ResMed Whitsundays Mask System and its substantial equivalence to a predicate device, the Scone mask (K180497). The document focuses on non-clinical data and acceptance criteria based on recognized standards.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

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