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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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PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults.

PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults. It advances the lower jaw and tongue forward so the airway will remain open during sleep. The PureSleep device has three adjustments for forward mandibular advancement, 4mm apart anteriorly, while maintaining a 9mm inferior placement for patient comfort. The PureSleep device is formed to the upper and lower teeth similar to an athletic mouth guard. When boiled, the outer resin holds its shape, while the inner resin softens, which adapts to the teeth when bitten. To prepare for the fitting, the upper and lower components are attached at the proper setting depending on the patient's bite, using either the two holes closest to the front of the device, the center holes, or the two holes closest to the back of the device. The device is boiled in water for one minute, allowed to cool for 14 to 18 seconds. Holding the mouth open and lower jaw forward, the patient places the PureSleep device in the mouth and bites down firmly for 45 seconds. Upon removal of the device, excess material can be trimmed for greater comfort. The device can be re-boiled up to three times to achieve the best impression. PureSleep is simple to fit and does not require impressions or lab-fabrication.

The provided K113022 document for the PureSleep device does not contain a study with acceptance criteria or reported device performance in the format typically used for studies demonstrating diagnostic accuracy or efficacy against specific metrics for new medical devices.

Instead, this 510(k) submission primarily relies on substantial equivalence to predicate devices and published literature to support the expanded indications for use.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of acceptance criteria for device performance (e.g., sensitivity, specificity for diagnosing sleep apnea, or specific metrics for snoring reduction) nor does it report specific device performance data from a clinical study for these indications.

The key performance information mentioned is:

• Biocompatibility testing: "Biocompatibility testing was performed, according to ISO 10993 Parts 5 and 10, on the proposed device and all tests met specification." This indicates the materials are safe for use, but it's not a performance metric related to the therapeutic effect (snoring or sleep apnea).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No specific test set or clinical study data is presented for the PureSleep device regarding its efficacy in reducing snoring or treating sleep apnea. The submission relies on the "mechanism of action" being unchanged from the predicate device and on "published scientific studies that have shown mandibular repositioning devices effective in treating snoring and mild to moderate obstructive sleep apnea." This implies a reliance on existing literature and clinical evidence for the class of devices, rather than a de novo clinical trial for the PureSleep device itself for these expanded indications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new clinical study data with a test set requiring ground truth establishment by experts is presented for the PureSleep device in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study data with a test set is presented.

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

Not applicable. The PureSleep device is a physical intraoral device, not an AI or imaging diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. The PureSleep device is a physical device, not an algorithm.

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

Not applicable, as no new clinical study data with a test set requiring ground truth is presented for the PureSleep device itself. The basis for efficacy for the expanded indications appears to stem from the general understanding and previous studies on mandibular repositioning devices (as indicated by "Published literature and the cleared predicate devices justify the rationale for expanding the intended use to treat mild to moderate obstructive sleep apnea"). For such literature, the ground truth for sleep apnea diagnosis would typically be established by polysomnography interpreted by sleep specialists.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm requiring a training set.

Summary of Acceptance Criteria and Study Approach for K113022:

The K113022 submission for the PureSleep device did not involve a specific clinical study with predefined acceptance criteria and reported performance data for the device itself to evaluate its efficacy for snoring reduction or treatment of mild to moderate obstructive sleep apnea.

Instead, the FDA determined substantial equivalence based on the following:

• Identical Design (with one exception): "With the exception of the molding resin used for the upper intraoral piece, the design of the proposed PureSleep device is identical to the currently marketed PureSleep (formerly known as SnoreMaster K954128)."
• Biocompatibility: The new molding resin met ISO 10993 Parts 5 and 10 specifications, ensuring material safety.
• Unchanged Mechanism of Action: The device's fundamental way of working (mandibular repositioning) remained the same as the previously cleared predicate device.
• Reliance on Published Literature: The expanded indication for treating mild to moderate sleep apnea was justified by "published scientific studies that have shown mandibular repositioning devices effective in treating snoring and mild to moderate obstructive sleep apnea." This means the submission leveraged existing clinical evidence for the class of devices rather than providing new clinical evidence specifically for the PureSleep device's expanded use.
• Substantial Equivalence to Predicates: The sponsor successfully argued that the PureSleep device is substantially equivalent to the currently marketed PureSleep device (K954128) and the SomnoGuard (K061688), both of which are intraoral devices for snoring and obstructive sleep apnea.

In essence, the "study" demonstrating the device meets "acceptance criteria" here is not an individual clinical trial with specific performance outcomes, but rather the demonstration of substantial equivalence to legally marketed predicate devices, supported by general scientific understanding and existing literature on the efficacy of the device type for the stated indications, and direct biocompatibility testing of any new materials.

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