(109 days)
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
| Test Performed | Standard | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Material Properties | |||
| Tensile Strength | ASTM D638 | Not explicitly stated, but "Yes" implies meeting a predefined threshold. | Yes |
| Flexural Strength | ASTM D790 | Not explicitly stated, but "Yes" implies meeting a predefined threshold. | Yes |
| Flexural Modulus | ASTM D790 | Not explicitly stated, but "Yes" implies meeting a predefined threshold. | Yes |
| Elongation | ASTM D638 | Not explicitly stated, but "Yes" implies meeting a predefined threshold. | Yes |
| Shore D Hardness | ASTM D2240 | Not explicitly stated, but "Yes" implies meeting a predefined threshold. | Yes |
| Biocompatibility | |||
| Cytotoxicity (in vitro) | ISO 10993-5:2009 | Cell morphology graded greater than 2 is considered to have a cytotoxic effect. | Yes (Implies cell morphology was graded 2 or less) |
| Sensitization (in vivo) | ISO 10993-10:2010 | Any skin reaction scores greater than the scores received by the negative control group were considered to represent sensitization. | Yes (Implies skin reaction scores were not greater than negative control) |
| Irritation (in vivo) | ISO 10993-10:2010, ISO 10993-23:2021 | The requirements are met if the difference between the test article extract average score and the control average score is 1.0 or less and the test does not fail at any observation period. | Yes (Implies these conditions were met) |
| Wear and Abrasion Resistance | |||
| Longevity against "bruxing" cycles | Not explicitly stated, implied to be a comparative metric. | Not explicitly stated as a numerical criterion, but the subject devices should demonstrate comparable or superior performance to predicate devices. | Both subject devices lasted an order of magnitude longer than the DenTek™ Professional-Fit™ Dental Guard (Pro-Fit). Abrasion results were comparable to the primary and reference predicate devices. |
Study Details
The provided text describes several types of studies performed, primarily comparative evaluations.
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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.
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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).
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Adjudication method:
- Not applicable as no human assessment or consensus-based ground truth establishment is described.
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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.
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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.
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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.
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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.
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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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