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The Advantage TM is used with commercially available CPAPs to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA) for adults weighing more than 66 lb (30 Kg) used at home, hospital or other clinical settings per order of a physician.

The CPAP/Pro Interface with Advantage ™ is available for upper and lower teeth. As such, it utilizes two typical "boil & bite" devices to be placed in patient's upper and lower dental arches. They are then affixed to one another anteriorly to limit the mouth opening, while still permitting a degree of mouth opening through spacers and resiliency. The upper member is slotted and slides forward and backward on a fixed post for patient comfort. Additionally, it allows lateral movement with the post as a pivot point. The CPAP/Pro Interface with Advantage TM, similar to chin straps or mouth tapes, minimizes the mouth breathing but provides comfort and ease of use for patients. The device is used for adult patients at home or clinical facilities, such as hospitals or sleep labs.

The provided text describes the CPAP/Pro Interface with Advantage™, a device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). Based on the information available, a detailed acceptance criteria table and study breakdown can be presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a specific "test set" in the context of a clinical study or performance evaluation for the Advantage™ component. The summary mentions "Bench testing was performed" and "Validation was also satisfactory completed," but does not provide details on the number of subjects or cases involved in these validations for the new device. Instead, it relies heavily on the substantial equivalence to the predicate device (CPAP/PRO, K992384).

The data provenance is largely retrospective in the sense that the new device's safety and effectiveness are supported by "Post-market studies of CPAP/Pro [the predicate device]." There is no mention of a prospective clinical trial specifically for the Advantage™ component to establish its independent performance metrics.

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

This information is not provided in the document. As the evaluation relies on bench testing, validation, and equivalency to a predicate, the concept of "ground truth established by experts" in a clinical setting for a test set is not directly applicable or reported here.

4. Adjudication Method for the Test Set

This information is not applicable as there is no described clinical test set involving human interpretation that would require an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for the CPAP/Pro Interface with Advantage™ as described in this document. The submission focuses on demonstrating substantial equivalence through bench testing, validation, and material/design similarities to the predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, if we interpret "standalone performance" as the device functioning independently to meet its design specifications and demonstrating performance (e.g., material properties, fit, mechanical function), then this aligns with the "Bench testing" and "Validation" mentioned. These tests would evaluate the device itself, without human interpretation or real-time clinical assessment beyond general use.

7. The Type of Ground Truth Used

The "ground truth" for the Advantage™ device appears to be primarily based on:

• Engineering specifications and design requirements: For bench testing and validation where the device's physical and functional properties are assessed against predetermined criteria.
• Predicate device's established safety and effectiveness: The new device's safety and effectiveness are inferred by its substantial equivalence to a legally marketed predicate device, for which post-market studies had already supported its performance.

8. The Sample Size for the Training Set

This information is not applicable as the device is a mechanical medical product, not an AI/ML algorithm that requires a training set.

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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The CPAP/PRO® CPAP Interface is intended to treat adult obstructive sleep apnea(OSA).

The CPAP/PRO® CPAP Interface consists of a boil & bite type dental appliance or a bracket, which may be professionally fitted to a custom dental appliance. With either mouth appliance, a small bracket extends beyond the lips to attach to a pair of corrugated nasal tubes. The paired nasal tubes are made from corrugated polyethylene and are pressure tested. The paired tubes combine to form a "Y", The lower arm of which attaches to a CPAP machine using a fitting connected to standard respirator tubing. The upper arms of the "Y" shaped nasel tubes terminate in soft silicone nasal inserts. The inserts provide a soft, comfortable seal against the nostrils.

The CPAP/PRO® consists of the following major components:

1. Boil & bite molded dental appliance with integral tubing clamp.
2. CPAP/PRO® tubing clamp for use with professionally fitted dental appliance.
3. Polycarbonate dual lumen respiratory tubing connector.
4. Corrugated 15mm (nominal diameter) polyethylene tubing with 1/8m " vent holes.
5. Silicone elastomer nasal inserts.
6. Dual lumen (polycarbonate) tubing/appliance bracket .

The provided document, K992384, is a 510(k) Premarket Notification for the CPAP/PRO® CPAP Interface. It details the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria. The acceptance criteria are therefore inferred from regulatory requirements for a 510(k) submission, which hinge on similarity to already approved devices.

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

The document does not specify a sample size for any "test set" in the context of clinical trials or performance evaluations with human subjects. The comparative testing mentioned in Section 7 (airflow and dead-space) likely refers to bench testing or engineering testing comparing the physical properties of the CPAP/PRO® with the predicate devices.

• Sample Size for Test Set: Not specified, and likely not applicable in the sense of human subject clinical data.
• Data Provenance: Not specified, but given the nature of the comparative testing, it would be laboratory-based rather than from a specific country or clinical setting. It is not labelled as retrospective or prospective.

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

This information is not provided in the document. The "ground truth" for the comparative testing (airflow and dead-space) would be based on established engineering or physiological standards and measurement techniques, not typically "expert consensus" in the clinical sense.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the type of testing described (bench/engineering comparison). Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or image interpretation studies to resolve discrepancies among expert readers.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not done, nor is it applicable to this device. This device is a physical CPAP interface, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no mention of human readers improving with or without "AI assistance" and no "effect size" information.

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

A standalone performance study was not done in the context of an algorithm. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the comparative testing (airflow and dead-space) would be based on objective physical measurements using scientific instruments and established protocols, comparing the CPAP/PRO® against the known performance characteristics of the predicate devices. It is not based on expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable to this device. "Training set" typically refers to data used to train machine learning models, which are not involved here.

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

This information is not applicable to this device as there is no training set for a machine learning model.

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