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The Scone Mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed noninvasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.

The Scone Mask is an externally placed vented respiratory mask. Positive air pressure (PAP) source is directed to the patient's airway non-invasively, via the nose. The mask connects to the positive pressure flow source through conventional air tubing via an industry standard conical connector. The mask is held in place with adjustable head straps.

The Scone Mask comprises 4 subassemblies: headgear, frame, cushion and elbow. The exhaust ports are incorporated into the elbow and cushion assemblies. The cushion and frame are available in various sizes to fit a wide patient population.

The Scone Mask is a prescription device supplied non-sterile.

Here's a breakdown of the acceptance criteria and study details for the Scone Mask, based on the provided document. It's important to note that this is a medical device (mask), not an AI/algorithm-based device, so many of the typical AI/ML study questions (like MRMC, standalone algorithm performance, training set details) are not applicable to this submission. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Acceptance Criteria and Device Performance for Scone Mask

The provided document describes the FDA 510(k) submission for the Scone Mask, a non-invasive positive airway pressure (PAP) therapy mask. The "acceptance criteria" and "device performance" in this context refer to the mask's ability to meet established safety and performance standards for such devices, primarily by demonstrating substantial equivalence to a legally marketed predicate device (AirFit N20, K171212).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in terms of subject counts for a clinical trial, as this was a non-clinical verification and validation study. The "samples" referred to are the actual Scone Mask prototypes and their components used for the various bench and laboratory tests. The number of masks/components tested for each specific test (e.g., CO2 rebreathing, flow resistance, mechanical integrity) is not detailed.
• Data Provenance: This was an internal validation study conducted by ResMed Ltd. The location of the test facility is not explicitly stated beyond ResMed Ltd's address being in Bella Vista, NSW, Australia. The data is non-clinical (bench testing), not collected from human subjects.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This submission is for a medical device (mask) based on non-clinical engineering and performance testing, not an AI/ML device requiring clinical expert review to establish ground truth from medical images/data. The "ground truth" here is objective physical and chemical measurements (e.g., CO2 levels, flow rates, material composition, mechanical properties) against established industry standards (ISO).

4. Adjudication Method for the Test Set

• Not Applicable. As this is a non-clinical device performance study, there's no need for an adjudication method by medical experts. The results are derived from objective measurements and laboratory analyses, compared against predetermined acceptance limits derived from international standards (e.g., ISO 17510, ISO 10993 series).

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

• No. An MRMC study is relevant for diagnostic AI devices where human reader performance is being evaluated with and without AI assistance. This document describes the testing for a PAP mask, which is a physical medical device, not a diagnostic AI.

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

• Not Applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on engineering specifications, industry standards (ISO 17510 for masks, ISO 10993 for biocompatibility), and established scientific principles for device safety and performance. This includes:
  • Objective measurements: CO2 levels, airflow, pressure, mechanical strength, chemical composition.
  • Compliance with published standards: Meeting the specified requirements of ISO standards.
  • Performance equivalence: Demonstrating that the device performs similarly to a legally marketed predicate device under tested conditions.

8. The Sample Size for the Training Set

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

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

• Not Applicable. Given that this is not an AI/ML device, there is no "training set" or "ground truth" in that context.

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