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The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction in mild to moderate obstructive sleep apnea (OSA) and/or snoring.
The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction of snoring.

The SleepRight Snore Aid is a customizable adjustable, in 1mm increments up to 6mm total, intraoral mandibular advancement device (MAD). An adjustable stop moves the lower tray, which moves the mandible, to the desired user setting of a position that increases (opens) the pharyngeal space (airway), which aids in minimizing air obstruction and aids in the reduction of snoring during sleep.

The SleepRight Snore Aid consists of two independent, customizable moldable, via hot (not boiling) water and bite method, removable, thermoplastic resin injection molded trays, fitted into the user's mouth, that fit separately over the upper (maxillary) and lower (mandibular) dental arches. The upper tray is provided with an adjustable advancement stop mechanism, one on each side of the rear of the upper tray, that provides the incremental 1mm up to 6mm total adjustment. The lower tray is provided with a fin, one on each side of the tray. As the adjustable advancement stop mechanism on each side of the upper tray is incrementally adjusted, the adjustable advancement stop mechanism on each side of the upper tray engages the fin, in a mating position on each side of the lower tray, stabilizing the mandible in a neutral posture or advances the mandible forward until the desired position that opens the airway and aids in a reduction of snoring during sleep is obtained by the user. Because the mandible is attached to the Oropharynx airway tissues (throat), and its posterior movement collapses the airway, stabilizing the mandible in a neutral or advanced forward position opens the airway for improved breathing. Having two independent dental arch trays allows for freedom of movement of the jaw musculature resulting in more user comfort, compliance and efficacy. Necessary Inspiratory and expiratory rapid expulsion of air is also improved.

Based on the FDA 510(k) Clearance Letter for the SleepRight Snore Aid (K250122), here's an analysis of the acceptance criteria and the study proving the device meets them:

Overall Conclusion: The provided text does not describe a study involving device performance, efficacy, or AI assistance. Instead, the clearance for the SleepRight Snore Aid is based on demonstrating substantial equivalence to previously cleared predicate and reference devices. This means the manufacturer did not conduct new clinical efficacy studies to prove the device meets performance criteria, but rather demonstrated that its design, materials, and intended use are sufficiently similar to devices already recognized as safe and effective.

Therefore, many of the requested criteria regarding performance studies, sample sizes, expert involvement, and ground truth establishment are not applicable in this specific context, as these types of studies were not performed for this 510(k) submission.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative performance acceptance criteria (e.g., a certain percentage reduction in AHI score or snore events) or measured device performance data. The "acceptance criteria" for this 510(k) appear to be based on demonstrating equivalence to predicate devices, particularly in terms of design, materials, manufacturing, intended use, labeling, and a general understanding of safety and efficacy derived from the predicates.

The Study that Proves the Device Meets the Acceptance Criteria

The study described is primarily a non-clinical bench testing and material characterization study in conjunction with a comparative analysis for substantial equivalence.

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

• Test Set Sample Size: Not applicable in the context of a clinical performance study. For non-clinical testing, it would refer to material samples.
• Data Provenance:
  • Material Biocompatibility: Data derived from previous testing on the same materials used in other Splintek products (SleepRight Pro Rx, SleepRight Advance Dental Mouthguard) and predicate/reference devices. This suggests a mix of historical data and potentially some internal material identification (Fourier Transform Infrared Spectroscopy).
  • Physical Properties: Data primarily from manufacturer-supplied technical data sheets (TDS) for the raw materials. This data is likely from materials suppliers rather than specific testing of final device components by Splintek for this submission, although the phrasing "These tests were conducted by the material manufacturers" supports this. The provenance would be the material manufacturers' laboratories.
  • Retrospective/Prospective: The use of existing data (prior test results, TDS) suggests a retrospective approach to assembling the non-clinical evidence. No prospective clinical data was generated for this 510(k).

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

• Not applicable. This was not a human-in-the-loop or clinical performance study requiring expert consensus for ground truth. The "ground truth" for material properties is established by standardized test methods (ISO, ASTM) and material specifications from manufacturers.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication was described or required for the substantial equivalence demonstration using material and physical property data.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not conducted as the SleepRight Snore Aid is substantially equivalent to the predicate and reference devices in relation to design, materials, manufacturing, intended use, labeling and function."
• Effect Size: Not applicable as no such study was performed.

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

• Not applicable. This device is a physical intraoral appliance, not a software algorithm.

7. The Type of Ground Truth Used

• For Biocompatibility: The "ground truth" was whether the materials passed the specified ISO 10993 standards (e.g., no cytotoxicity, no sensitization, no irritation). This is a laboratory-based, in vitro and in vivo (for sensitization/irritation) standardized testing ground truth.
• For Physical Properties: The "ground truth" was whether the material properties (e.g., flexural strength, hardness) met or exceeded the established benchmark acceptance criteria for intraoral use, as measured by ASTM standards. This is a laboratory-based, standardized physical property testing ground truth.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device requiring training sets.

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

• Not applicable. This is not an AI/machine learning device.

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The SleepRight® Select-Comfort™ Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

The SleepRight® Select-Comfort™ Dental Guard is indicated for the protection against teeth grinding, bruxism, and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

The subject device is the second-generation to the SleepRight® Select-Comfort™ Dental Guard, also referred to as the SleepRight® Original (K100545) back in 2010. The SleepRight® Select-Comfort™ Dental Guard is a self-adjustable partial coverage protector that acts as a barrier between the upper and lower posterior teeth to protect the teeth against bruxism or nighttime teeth grinding. The guard contains two adjustable bite pads that are connected by a thermal band (also referred to as the strap). The bite pads contain an internal core that is fully encapsulated by a thermoplastic material; and can be adjusted in five settings: extra-small, small, medium, large, and extra-large. No boiling or microwaving is required to fit the guard to the teeth, it is ready for use right out of the package. The bite pads may be adjusted to five settings that accommodate different dental arch sizes, where the front edge of the bite pad should rest between the upper third tooth (cuspid) and the fourth tooth (premolar). For a larger fit, the bite pads can be adjusted backward; and for a smaller fit, the bite pads can be adjusted forward. The thermal band should rest between the lower lip, cheek, and gums.

The provided text describes a 510(k) premarket notification for a medical device, the SleepRight® Select-Comfort™ Dental Guard. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparative evaluation of materials, physical properties, biocompatibility, and wear/abrasion resistance. It does not describe a study involving an AI/algorithmic device or a human-in-the-loop study as detailed in the prompt's request.

Therefore, I cannot provide a response that includes:

• A table of acceptance criteria and the reported device performance for an AI/algorithmic device. The acceptance criteria and performance data provided are for biocompatibility testing of a physical dental guard.
• Sample size used for the test set and data provenance for an AI/algorithmic device. The data provenance described relates to material and physical property comparisons.
• Number of experts used to establish the ground truth for an AI/algorithmic device.
• Adjudication method for an AI/algorithmic device test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study and its effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used for an AI/algorithmic device.
• Sample size for the training set for an AI/algorithmic device.
• How the ground truth for the training set was established for an AI/algorithmic device.

The document is about a physical dental guard, not an AI/software device. The performance data presented are for the physical properties and biocompatibility of the dental guard.

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Protection against bruxism or nighttime teeth grinding
Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding
Protection against teeth grinding, bruxism, and jaw clenching
Short-term pain relief from muscle spasm due to occlusal interference
Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle

The subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706) are the second-generation quard to the SleepRight® ProRx™ Custom Dental Guard (K172223). Both subject devices (K212706) are completely identical to each other, except for the material that makes up the internal core of each guard. The subject devices (K212706) are both a full occlusal custom formable protector that acts as a barrier between the upper and lower teeth to protect the teeth against bruxism or nighttime teeth grinding. The subject devices (K212706) both contain the exact same horizontal core design with a vertical sectional lattice structure, primarily wrapping around the labial and buccal side of the teeth, as well as around the lingual posterior side of the teeth. The core and lattice are fully encapsulated by a moldable thermoplastic material in both guards. The guards are designed to be fit using the exact same method to heat the guard in hot (not boiling) water until it becomes malleable and can be formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls/lattice are gently pushed to surround the teeth. The lattice retains the malleable material up against the teeth until the device hardens in approximately four minutes.

The provided text describes performance testing for the SleepRight® ProRx® + Custom Dental Guard and SleepRight® ProRx® Custom Dental Guard.

Here's an analysis of the acceptance criteria and supporting studies:

Acceptance Criteria and Reported Device Performance

Study Details

The provided text describes several types of studies performed, primarily comparative evaluations.

1. Sample size used for the test set and the data provenance:

   • Material Properties (Tensile Strength, Flexural Strength, Flexural Modulus, Elongation, Shore D Hardness): The document reports that these tests were performed on "the subject devices" and "predicate devices." No specific sample sizes for these tests are mentioned. The provenance of the data is not specified (e.g., country of origin, retrospective/prospective).
   • Biocompatibility (Cytotoxicity, Sensitization, Irritation): No specific sample sizes (e.g., number of cell lines, animal subjects) are given. The provenance of the data is not specified.
   • Wear and Abrasion Resistance: The "longevity of the guards was evaluated by comparing the number of 'bruxing' cycles that the guards could withstand before failure." No specific sample size (i.e., number of guards tested) is provided. The provenance of the data is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the involvement of experts for establishing ground truth in any of the described tests. The tests appear to be laboratory-based evaluations against established standards (ASTM, ISO) or comparative performance evaluations, where the "ground truth" is defined by the test procedure itself (e.g., cytotoxicity grade, skin reaction score, number of bruxing cycles to failure).

3. Adjudication method:

   • Not applicable as no human assessment or consensus-based ground truth establishment is described.

4. 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:

   • An MRMC study is not relevant here as the device is a dental guard, not an AI-assisted diagnostic or decision support system for human readers.

5. 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. The reported performance refers to the device itself.

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

   • For material properties and biocompatibility, the "ground truth" is defined by the validated testing methodologies and acceptance criteria specified in international standards (ASTM, ISO).
   • For wear and abrasion resistance, the "ground truth" is defined by the number of "bruxing" cycles to failure observed during the test, with comparative analysis against other devices.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

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· Protection against bruxism or nighttime teeth grinding
· Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding
· Protection against teeth grinding, bruxism, and jaw clenching
· Short-term pain relief from muscle spasm due to occlusal interference
· Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle

The SleepRight® ProRx® Custom Dental Guard (K193577) is the second-generation guard to the predicate SleepRight® ProRx™ Custom Dental Guard (K172223). The SleepRight® ProRx® Custom Dental Guard (K193577) is a full occlusal custom formable protector that acts as a barrier between the upper and lower teeth to protect the teeth against bruxism or nighttime teeth grinding. The guard contains a horizontal core with a vertical sectional lattice structure, primarily wrapping around the labial and buccal side of the teeth, as well as around the lingual posterior side of the teeth. The core and lattice are fully encapsulated by a moldable thermoplastic material. The guard is heated in hot (not boiling) water until it becomes malleable and can be formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls/lattice are gently pushed to surround the teeth. The lattice retains the malleable material up against the teeth until the device hardens in approximately four minutes.

The provided text describes the SleepRight® ProRx® Custom Dental Guard (K193577) and its performance testing for FDA 510(k) clearance. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

The document mentions "biocompatibility testing" and "comparative wear and abrasion resistance testing."

• Biocompatibility Testing: The specific sample sizes for in vitro cytotoxicity, in vivo sensitization, and in vivo irritation are not explicitly stated in the provided text. The provenance is also not specified (e.g., country of origin, retrospective/prospective), but these are typically lab-based tests.
• Comparative Wear and Abrasion Resistance Testing: The sample size for this test is not explicitly stated. The data provenance is also not specified.

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

This information is not provided in the document. The tests performed are laboratory-based and do not involve expert consensus on subjective interpretations like image analysis.

4. Adjudication Method for the Test Set:

This information is not provided in the document, as the tests are primarily objective laboratory assessments rather than subjective assessments requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study and the effect size of human improvement with AI assistance are not applicable to this device. The SleepRight® ProRx® Custom Dental Guard is a physical dental guard, not an AI-powered diagnostic or assistive tool.

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

Standalone algorithm performance is not applicable to this device, as it is a physical dental guard.

7. The Type of Ground Truth Used:

• Biocompatibility Testing: The ground truth for these tests is established through standardized laboratory procedures and measurements as defined by ISO 10993. This involves observing cell morphology, skin reactions, and irritation scores, which are objective biological responses.
• Comparative Wear and Abrasion Resistance Testing: The ground truth is established through mechanical testing measuring the number of "bruxing" cycles until failure and abrasion results.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device. This is a physical medical device, not an AI or machine learning algorithm that requires training data.

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 SleepRight® ProRx® Custom Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Protection against teeth grinding, bruxism and jaw clenching.

Short-term pain relief from muscle spasm due to occlusal interference.

For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

The SleepRight® ProRx® Custom Dental Guard is a full occlusal custom formable protector that provides a barrier between the upper and lower teeth. Contains a hard core material enveloped by a moldable thermoplastic. The guard is heated in hot (not boiling) water until it becomes malleable and then formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls are gently pushed up to surround the teeth. The material hardens in roughly one minute. The SleepRight® ProRx® Custom Dental Guard has a tensile strength of 29 Mpa and a Shore D hardness value comparable to the primary predicate device, the ProTech Dent®.

The provided text describes a 510(k) submission for a dental guard. It does not contain information about a medical device that uses artificial intelligence or requires a study with acceptance criteria and reported device performance in the way typically expected for AI/ML-based devices (e.g., sensitivity, specificity, AUC).

Instead, the document details a comparative evaluation of physical properties, wear and abrasion resistance, and biocompatibility of the SleepRight® ProRx® Custom Dental Guard against predicate devices. The "performance data" section states:

• "Comparative evaluation of the physical properties of the materials of construction of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device, the ProTech Dent®."
• "Comparative wear and abrasion resistance testing of the SleepRight® ProRx® Custom Dental Guard and the primary predicate device the ProTech Dent®"
• "Biocompatibility testing: Cytotoxicity (ISO 10993 - 5), Sensitization and Irritation (ISO 10993 - 10)"

The conclusion states that the device "has the same indications for use, same materials of construction, same technological characteristics, and the same principles of operation as the predicate devices," thereby establishing substantial equivalence.

Given this, I cannot provide the requested information formatted for AI/ML device studies because the provided document does not pertain to such a device or study type. The "acceptance criteria" and "device performance" are focused on material properties and biological safety as compared to predicate devices, not on diagnostic accuracy metrics.

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