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The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

The SnoreRx is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth.

The provided text does not describe specific acceptance criteria and detailed study results in the common format of medical device clinical trials (e.g., sensitivity, specificity, or performance metrics against a numerical threshold). Instead, this document is a 510(k) summary for a re-submission of an existing device (SnoreRx) to change its classification from prescription use to Over-The-Counter (OTC) use, based on substantial equivalence to its own predicate device.

The "studies" mentioned are primarily non-clinical and related to demonstrating usability and safety for OTC use, rather than proving performance against specific clinical or diagnostic metrics.

Here's an attempt to extract and frame the information requested, with notable limitations due to the nature of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Irritation (ISO 10993)
• Sensitization (ISO 10993) | All materials "determined to be biocompatible in accordance with ISO 10993." |
  | Material Properties | - Flexural modulus & strength (ISO 178)
• Stress & strain at break (ISO 527)
• Water absorption (ISO 62)
• Melting point (ISO 3146)
• Density & melt flow rate (ISO 1183) | "All materials met device specifications." |
  | OTC Usability & Safety | - User's understanding of device labeling and Instructions for Use (IFU) in an OTC environment.
• Ability of OTC consumer to appropriately prepare, fit, and adjust the SnoreRx without professional assistance.
• Low incidence of tooth movement, breakage, and other side effects for intraoral devices (retrospective review). | "A human factors assessment was also performed for the use of SnoreRx in the OTC environment."
  "A usability study was performed to assess the OTC consumer's understanding... and to demonstrate that the OTC consumer can appropriately prepare, fit, and adjust the SnoreRx without assistance from a dental professional."
  "A retrospective study was conducted to gain insight on the user's experience with the predicate device, including incidence of tooth movement, breakage, and other side effects..." |
  | Substantial Equivalence | No substantial new questions of safety or effectiveness are raised by the OTC indication for use compared to the predicate. | "The OTC indication for use does not raise substantial new questions of safety or effectiveness. Therefore, the new device (SnoreRx) is determined to be substantially equivalent to the predicate device." |

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

• Retrospective Study (User Experience with Predicate Device): Not specified.

• Human Factors Assessment: Not specified.

• Usability Study (OTC Consumer): Not specified.

• Data Provenance: Not explicitly stated (e.g., country of origin). The retrospective study was for "gain insight on the user's experience with the predicate device," implying existing data, likely from real-world usage. The human factors and usability studies were likely prospective, specifically designed for this submission.

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

This type of information is not provided in the document. The studies conducted are primarily focused on material properties, biocompatibility, and user usability for an OTC product, not on diagnostic accuracy requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided. The studies detailed do not appear to involve complex interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an intraoral appliance to reduce snoring, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done

No, a standalone algorithm performance study was not done. This device is a physical intraoral device, not a software algorithm.

7. The Type of Ground Truth Used

• Biocompatibility & Material Properties: Ground truth was established by adherence to recognized international standards (ISO 10993, ISO 178, ISO 527, ISO 62, ISO 3146, ISO 1183) and meeting internal "device specifications."
• OTC Usability: "Ground truth" for usability would be the objective assessment of whether participants could successfully perform the tasks (prepare, fit, adjust) and understand the IFU, typically measured by task completion rates and comprehension scores.
• Retrospective User Experience: "Ground truth" was the reported incidence of adverse events (tooth movement, breakage, other side effects) from users of the predicate device.

8. The Sample Size for the Training Set

This information is not applicable/provided. There is no "training set" as the device is not an AI algorithm requiring machine learning.

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

This information is not applicable/provided for the same reason as above.

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The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

The SnoreRx is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth.

The provided text describes a 510(k) premarket notification for the SnoreRx device, which is an intraoral device for the reduction of snoring. The document primarily focuses on establishing substantial equivalence to a predicate device (SnoreRx NS 9.0) rather than presenting a detailed clinical study with pre-defined acceptance criteria and reported device performance against those criteria.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document. The document emphasizes nonclinical testing for biocompatibility and physical properties to demonstrate that minor material differences do not raise new safety or effectiveness concerns.

Here's a breakdown of the information that can be extracted or explicitly stated as not available based on the provided text:

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

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device based on technological aspects and nonclinical testing, not on clinical performance against specific acceptance criteria.

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

This information is not provided. The document describes nonclinical testing of materials, but not patient-based testing with a "test set" in the context of clinical performance.

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)

This information is not applicable/not provided. There is no mention of a "test set" requiring expert ground truth in the context of clinical performance. The evaluation is based on nonclinical material properties and a comparison to a predicate device.

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

This information is not applicable/not provided. There is no mention of a "test set" requiring an adjudication method.

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 and not provided. The device is an anti-snoring intraoral device, not an AI-assisted diagnostic tool that would involve human readers.

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

This information is not applicable and not provided. The device is an anti-snoring intraoral device, not an algorithm.

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

This information is not applicable/not provided in the context of clinical performance or a test set. The "ground truth" implicitly used for the device's safety and effectiveness relies on the established safety and effectiveness of the predicate device and the nonclinical testing of the new device's materials and design.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of a "training set" as the device is not algorithm-based.

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

This information is not applicable/not provided.

Summary of available information regarding compliance/testing:

The document focuses on nonclinical testing to support substantial equivalence.

• Nonclinical Testing Performed:
  • Biocompatibility Testing: The SnoreRx materials were tested for cytotoxicity, irritation, and sensitization in accordance with ISO 10993 and were determined to be biocompatible.
  • Physical Properties Testing:
    • Tray material: Tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62).
    • Liner material: Tested for melting point (ISO 3146), and density and melt flow rate (ISO 1183).
  • Results: "All materials met device specifications." (Specific specifications are not detailed in this summary).

The core argument for acceptance is that the device is "substantially equivalent" to the predicate device (SnoreRx NS 9.0) because:

• They are "nearly identical in design and functionality."
• They both are mandibular repositioning devices, use a "boil and bite" method for molding, and allow jaw adjustment.
• Minor differences in material (polycarbonate resin with higher tensile strength, copolymer with slightly different durometer) and manufacturing (streamlined process, larger frontal airway opening) "do not raise any new questions of safety or effectiveness."

In essence, the "acceptance criteria" here are met by demonstrating that the new device's materials are biocompatible and meet physical property specifications, and that the overall design and intended use are sufficiently similar to a legally marketed predicate device such that no new safety or effectiveness concerns are raised. No specific clinical performance metrics (e.g., reduction in AHI, reduction in snoring incidence by a certain percentage) are presented for the new device.

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The Consumer Health Products "SnoreRx NS 9.0" is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

The Consumer Health Products SnoreRx NS 9.0 is an intraoral device used at night to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth. This interface, and thus this device, functions as a mandibular anterior repositioner, which acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep

The provided text describes the SnoreRx NS 9.0 device, its intended use, a comparison to predicate devices, and the results of non-clinical performance testing. However, it explicitly states: "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices."

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for a study proving the device meets acceptance criteria cannot be extracted from this document, as no such clinical study was conducted or relied upon for this submission.

Here's a breakdown of what can be extracted and what cannot:

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

Since no clinical study was performed or cited for the SnoreRx NS 9.0 to evaluate its performance against specific acceptance criteria for snoring reduction, this table cannot be generated. The document focuses on non-clinical performance (biocompatibility and material characterization).

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

• Sample Size for Test Set: Not applicable, as no clinical efficacy study was conducted.
• Data Provenance: Not applicable, as no clinical efficacy study was conducted.

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 clinical efficacy study with a ground truth was conducted.

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

• Not applicable, as no clinical efficacy study with expert adjudication was conducted.

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. This device is an anti-snoring mouthpiece, not an AI-assisted diagnostic or imaging device used by "human readers."

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable, as no clinical efficacy study with a ground truth was conducted. For the non-clinical tests, the "ground truth" is established by the standard protocols of the ISO tests performed (e.g., cell viability for cytotoxicity, skin reaction for irritation).

8. The sample size for the training set:

• Not applicable, as no machine learning algorithm or clinical training data was used for this submission.

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

• Not applicable, as no machine learning algorithm or clinical training data was used for this submission.

In summary: The submission for the SnoreRx NS 9.0 relied on demonstrating substantial equivalence to predicate devices based on intended use, design, operating principle, mechanism of action, and technological characteristics. Non-clinical performance data (biocompatibility, material characterization, dimensional conformance, visual inspections, and airway passage equivalency) were provided to support the device's safety and fundamental function, but no clinical data or studies proving its efficacy in reducing snoring were included or deemed necessary for this 510(k) clearance.

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