(339 days)
For protection against teeth grinding, and jaw clenching; protections from injury due to bruxism or clenching; relief of bruxism related headaches, migraines and pain; short-term relief from muscle spasm due to occlusal interference; prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscles; and temporary treatment of temporal mandibular disorder (TMD) along with the relief of associated headaches and pains in adults 18 years of age or older.
The Myoaligner appliance is a customized, removable dental device which is designed to overlay the existing dentition without the need for any alterations done to the receiving dentition. The appliance is a plural piece intra-oral removable appliance, which is designed and delivered to the patients by a licensed practitioner such as a dentist (Rx only). The dentist can prescribe a device that fits over the 4-6 front teeth, back teeth on both sides of the dental arch or all of the teeth in the dental arch both on the upper or lower jaw. The appliance is held in place by mechanical retention. The Myoaligner appliance can be worn on either the top or bottom teeth or both. It is intended for use in adults 18 years of age and older.
The provided text describes the FDA's 510(k) clearance for the Myoaligner Appliance. However, it does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a more comprehensive summary of performance data.
Specifically, the document mentions "Performance Testing" but does not provide a table of acceptance criteria and reported device performance for the Myoaligner Appliance itself as typically seen for AI/ML device clearances. It states:
- "Performance testing confirmed the Myoaligner anterior segment retention is equivalent to reference device NTT-TSS, the Myoaligner posterior segments are equivalent to the predicate Gelb Appliance."
- "Performance testing was also done to show the effects of repeated use (insertion and removal) and articulating paper to show interdigitation and canine guidance."
This suggests comparative testing against reference/predicate devices for mechanical properties (retention, repeated use endurance, interdigitation/canine guidance), but it does not detail specific quantitative acceptance criteria or the actual results obtained for these tests. The document's primary focus is on establishing substantive equivalence based on shared indications for use, technological characteristics, materials (PMMA), and mechanism of action, rather than demonstrating meeting specific performance metrics through a detailed clinical or standalone study as would be seen for an "AI/ML" device. This device appears to be a physical appliance, not an AI/ML software device, which changes the nature of the expected performance data.
Therefore, I cannot fully complete the requested table or answer all questions based on the provided text. I will complete what is possible and note where information is missing.
Device Name: Myoaligner Appliance
Device Type (based on context): Physical Medical Appliance (mouthguard/splint), not an AI/ML software device. This significantly impacts the expected type of "study" and "acceptance criteria." The performance testing described is mechanical, not related to an algorithm's diagnostic or predictive accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a physical medical appliance, the "acceptance criteria" appear to be related to its mechanical and material properties, demonstrating equivalence to predicates. The document does not provide specific quantitative acceptance criteria or raw performance data in a table format. Instead, it makes qualitative claims of equivalence.
| Performance Metric (Acceptance Criteria Implied) | Reported Device Performance |
|---|---|
| Material Conformance (ISO 10477) | "The PMMA material conforms to ISO 10477." |
| Anterior Segment Retention (Equivalent to NTI-TSS) | "confirmed the Myoaligner anterior segment retention is equivalent to reference device NTT-TSS" |
| Posterior Segment Retention (Equivalent to Gelb Appliance) | "the Myoaligner posterior segments are equivalent to the predicate Gelb Appliance" |
| Effects of Repeated Use (Insertion/Removal) | "Performance testing was also done to show the effects of repeated use (insertion and removal)" (No specific results provided, implies acceptable performance.) |
| Interdigitation and Canine Guidance (via articulating paper) | "Performance testing was also done to show... articulating paper to show interdigitation and canine guidance." (No specific results provided, implies acceptable performance.) |
Note: The document focuses on demonstrating equivalence to existing devices rather than establishing novel quantitative performance targets. The "study" mentioned is performance testing, likely bench testing, not a clinical trial evaluating diagnostic accuracy or patient outcomes against specific statistical endpoints.
2. Sample Size Used for the Test Set and Data Provenance
The document describes "performance testing" and "biocompatibility assessment" but does not specify sample sizes for these tests. It does not mention a "test set" in the context of a dataset for an AI/ML algorithm.
- Sample Size: Not specified. (Likely related to number of appliance samples or material samples for mechanical/biocompatibility testing).
- Data Provenance: Not applicable in the context of patient data for an algorithm. The testing appears to be laboratory-based on the device material/design.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. This is not an AI/ML device relying on expert image annotation or diagnosis for ground truth.
- Qualifications of Experts: Not applicable. The "ground truth" (or basis for comparison) is conformance to ISO standards and mechanical properties of predicate devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no mention of human readers or adjudication processes for interpreting outputs, as this is a physical device and not an AI/ML algorithm.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC Study done? No. This type of study is specifically for evaluating the effectiveness of AI systems (often in medical imaging) on human reader performance. Given that the Myoaligner is a physical appliance, an MRMC study is not relevant to its clearance.
- Effect Size of Human Reader Improvement: Not applicable.
6. Standalone (Algorithm Only) Performance
- Was a Standalone Study done? No, because this is not an algorithm. The performance testing refers to the physical properties of the appliance.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the performance claims appears to be:
- Material Specifications/Standards: Conformance to ISO 10477 for PMMA.
- Mechanical Properties of Predicate/Reference Devices: Retention equivalence to NTI-TSS and Gelb Appliance, and observations of repeated use effects and interdigitation/canine guidance (which are functional properties of the device).
- Biocompatibility: Based on the material composition (PMMA) of the predicates.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" as it is a physical appliance, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. No training set for an algorithm is involved. The "ground truth" in the context of device validation relies on established material standards, predicate device characteristics, and engineering principles for mechanical testing.
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