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PureSleep® (OTC) is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep

The PureSleep® device for Over-the-Counter (OTC) use is an intraoral mandibular repositioning device that increases the pharyngeal space to improve the user's ability to exchange air and to decrease air turbulence, a causative factor in snoring. The device consists of two dental trays designed to conform to the shape of the upper and lower jaws.

The provided text details a 510(k) summary for the PureSleep® (OTC use) device and its FDA clearance. However, it does not contain the specific acceptance criteria, detailed study design, or performance metrics that would typically be found in a comprehensive study report.

The submission focuses on demonstrating substantial equivalence to a predicate device (PureSleep® Rx) and a reference device (SnoreRx®) primarily based on technological characteristics and intended use. The supporting evidence mentioned is limited to non-clinical testing.

Here's an analysis of the requested information based only on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Study Details (Based on provided text)

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria or quantitative device performance metrics are provided in the text. The submission focuses on demonstrating equivalence rather than meeting predefined performance thresholds.

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

• Test Set Sample Size: Not specified.
• Data Provenance: The text mentions "real-world data gleaned from actual use of the PureSleep® Rx predicate device" and a "Human Factors and Usability Engineering (HFE/UE) study."
  • The origin of the "real-world data" (e.g., country, retrospective/prospective) is not specified.
  • The HFE/UE study's detailed provenance is not specified beyond its purpose for OTC environment use.

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

• Not specified. The text does not describe a process for establishing ground truth for a test set in the context of clinical performance. The HFE/UE study would likely involve participants, but they are users, not typically "experts" establishing ground truth for clinical endpoints.

4. Adjudication Method for the Test Set

• Not specified. No clinical trial or test set with explicit adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC study was done. This device is an anti-snoring device, not an AI-powered diagnostic imaging tool that would typically involve human readers or AI assistance in interpretation. The provided text does not mention any AI component or human-in-the-loop interaction in its functionality.

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

• No standalone algorithm performance study was done (or none is mentioned). This is not an algorithmic device. Its performance is related to its mechanical function as a mandibular repositioning device.

7. The Type of Ground Truth Used

• The concept of "ground truth" as typically defined for diagnostic or AI performance studies (e.g., pathology, outcomes data) is not applicable or addressed for this device in the provided text. The "real-world data" mentioned would likely pertain to user experience, effectiveness in reducing snoring, or safety outcomes, but the specific "ground truth" methodology is not detailed.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical intraoral device, not an algorithm that requires a training set.

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

• Not applicable. As above, this is not an algorithmic device requiring a training set or associated ground truth.

Summary of Device Acceptance and Evidence:

The provided 510(k) summary indicates that the PureSleep® (OTC use) device was accepted by the FDA based on the following:

• Substantial Equivalence: The primary argument for acceptance is the device's substantial equivalence to the predicate device (PureSleep® Rx, K113022) and a reference device (SnoreRx®, K170825). The devices are "identical in all their technological characteristics (design, materials, functionality, principles of operations, etc.)."
• Non-Clinical Testing:
  • Biocompatibility: Materials meet ISO 10993-1 requirements for surface devices contacting mucosal membranes for prolonged durations.
  • Human Factors and Usability Engineering (HFE/UE) Study: Performed to support safe and effective use in an OTC environment without professional assistance. This study likely assessed ease of use, understanding of instructions, and ability for users to properly fit and use the device. The text does not provide specific outcomes or criteria for this study.
  • Risk Analysis: Conducted per ISO 14971:2007, addressing issues from FDA guidance. Risks were mitigated through design, verification/validation, or labeling.
• Clinical Performance Testing: The text states "Real-world data is included in support of this submission." This data was "gleaned from actual use of the PureSleep® Rx predicate device." No specific study design, sample size, or quantitative results from this real-world data are presented in the summary. The purpose of this data was to support the clinical safety of the device for OTC use.

In conclusion, the document's focus is on demonstrating similar characteristics and safety to previously cleared devices, rather than presenting a detailed clinical study with specific acceptance criteria related to a novel performance claim. The "study that proves the device meets the acceptance criteria" largely refers to the demonstration of substantial equivalence through non-clinical testing and leveraging existing real-world data from the predicate device, rather than a new, independent clinical trial with predefined performance endpoints for the OTC version.

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