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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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