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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.

Detailed numerical acceptance criteria for each test (e.g., "CO2 rebreathing must be less than X%") are not explicitly provided, but the document confirms that the devices "met all intended performance requirements" and "predetermined acceptance criteria." The performance characteristics are compared to the predicate device, often indicating "Equivalent" or "Identical."

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for any of the tests. The document refers to "non-clinical verification and validation assessment/testing."
• Data Provenance: Not specified. These appear to be laboratory-based bench tests or in-house engineering tests. There is no indication of country of origin for data or if it's retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable as the tests described are non-clinical, bench-top performance and safety evaluations, not typically requiring expert-driven ground truth establishment in the way clinical studies with diagnostic devices might.

4. Adjudication method for the test set

• This information is not applicable for the non-clinical, bench-top tests 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

• This information is not applicable. The device is a CPAP mask system, not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI are not relevant.

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

• This information is not applicable. The device is a physical medical device (CPAP mask system), not a software algorithm or AI.

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

• For the non-clinical tests described, the "ground truth" is typically defined by established engineering standards (e.g., ISO 17510:2015 parameters, pressure measurements, flow rates, CO2 concentration readings) and reference methods. For biocompatibility and reprocessing, it's based on validated test methods and safety thresholds defined by relevant ISO and AAMI standards.

8. The sample size for the training set

• This information is not applicable. The device is a physical medical device; there is no indication of a "training set" in the context of an algorithm or AI.

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

• This information is not applicable for the same reason as point 8.

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