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510(k) Data Aggregation
(161 days)
K Den No: K121272
· 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:
| Test Performed | Standard | Acceptance Criteria | Acceptance Criteria Met |
|---|---|---|---|
| Cytotoxicity (in vitro) | ISO 10993-5:2009 | Cell morphology graded greater than 2 is considered to have a cytotoxic effect | Yes |
| 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 |
| Irritation (in vivo) | ISO 10993-10:2010 | 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 |
| Comparative Wear and Abrasion Resistance (against DenTek™ Professional-Fit™ Dental Guard) | Not specified (Comparative testing) | The subject device (ProRx) should last an order of magnitude longer than the comparator (Pro-Fit) in "bruxing" cycles. Abrasion results should be comparable to the primary predicate device (K172223). | Yes |
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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