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510(k) Data Aggregation
(90 days)
Night Guard is indicated for protection against bruxism or nighttime teeth grinding. It creates a barrier between upper and lower dentition to protect the patient's overall occlusion.
Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or facial muscle pains are common side effects of bruxing or clenching the teeth. These patients specific devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching, while protecting teeth from daily wear and tear. Night Guard is shipped non-sterile.
The provided text describes the acceptance criteria and the study that proves the "Night Guard" device meets these criteria. The study focuses on non-clinical performance tests to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Objective of the Test | Reference Standard | Acceptance Criteria | Results |
|---|---|---|---|---|
| Rigidity | The printed device is rigid enough to stay on the patient's dentition | NA | When fitting the splint onto the master dentition, does it feel sufficiently rigid to stay in place and immobilize the teeth? | Pass |
| Toughness | Printed device is tough enough to withstand breaking | ASTM D695 Compressive Properties | Does the material survive 180 times of flexing cycles? (180 flex cycles is based on a daily insertion of a dry splint for 6 months). Was the maximum compressive stress of the material over 77MPa before break? The material is expected to survive 77MPa of compression stress. | Pass |
| Avg: 159.6 MPa | ||||
| Std Dev: 1.698 | ||||
| Fit | Ensure the device will fit snugly to a patient's dentition and not move. | NA | By visual examination through the splint itself, does the splint seat all the way down onto the occlusal table and/or incisal edge of the metal simulated dentition? Does the splint stay on metal dentition when turned upside down? After applying light pressure to each quadrant of the splint after it is seated on the metal simulated dentition. Does the splint stay in place without another section of the splint separating from the occlusal surfaces or incisal edges of the teeth? Does the splint stay in place without shifting after attempting to rotate the splint back and forth. | Pass |
| Wear Resistance | Devices are sufficiently wear-resistant to withstand teeth wear against the patient's opposing dentition. | ISO 14569 | After 10,000 cycles of abrasion in a 37°C water bath samples must not show signs of cracking or wear to a degree that would jeopardize the efficacy or safety of the device. | Pass |
Additionally, Biocompatibility testing per ISO 10993-1 was passed for cytotoxicity, sensitization, acute systemic toxicity, subacute/subchronic toxicity, genotoxicity, and implantation.
Process Flow validation was performed to ensure that the finished device matches the software output specifications, and the Night Guard met these specifications.
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size for each test. However, for the "Toughness" test, the acceptance criteria mention "180 times of flexing cycles," and for "Wear Resistance," it mentions "10,000 cycles of abrasion," indicating the number of iterations or repetitions for these specific tests on material samples. The data provenance is not specified in terms of country of origin or whether it's retrospective or prospective; it appears to be internal testing conducted by 3D Diagnostix Inc.
3. 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 use of experts or their qualifications for establishing ground truth for the performance tests. The "Rigidity" and "Fit" tests rely on visual examination and manual assessment, but the "expert" status is not defined.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No adjudication method is mentioned for the test set.
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:
No MRMC comparative effectiveness study was done. This document describes the testing of a physical medical device (night guard), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the subject device is a physical night guard, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance tests (Rigidity, Toughness, Fit, Wear Resistance) is based on compliance with predefined acceptance criteria derived from internal requirements and/or relevant standards (ASTM D695, ISO 14569). It's a combination of objective measurements (e.g., compressive stress for toughness) and subjective assessment against established criteria (e.g., "feels sufficiently rigid," "stays on metal dentition when turned upside down" for fit). For biocompatibility, the ground truth is established by adherence to ISO 10993-1.
8. The sample size for the training set:
This section is not applicable. The Night Guard is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This question is not applicable, as there is no training set for a physical device.
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