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510(k) Data Aggregation
(245 days)
The CID is indicated as an aid in reducing temporomandibular disorder (TMD) pain.
The CID is comprised of a pair of small, hollow, ear inserts made of medical grade polymers that is custom-fit to each subject's ear canals. It is constructed from methacrylate polymers and similar rigid plastics that have been safely used in commercially available hearing aids for decades. The CID is designed to rest in the outer third of the ear canal and has a small retraction post that allows for ease of removal of the device from the ear canal. It is designed to conform to the shape of the ear canal when the jaw is in a slightly open position.
Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
K091880: Clayton Intra-aural Device (CID) - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for device performance. Instead, it demonstrates the CID's non-inferiority to a predicate device (stabilization splint) and statistically significant reductions in pain and dysfunction. Therefore, the "acceptance criteria" are inferred from the study's primary and secondary efficacy objectives, which are to show non-inferiority for CMI reduction and significant pain reduction.
| Performance Metric / Acceptance Criteria (Inferred) | Reported Device Performance (CID) | Comparison to Predicate (Stabilization Splint) |
|---|---|---|
| Primary Efficacy Objective: Non-inferiority to stabilization splint in reduction of Craniomandibular Index (CMI) scores from baseline to 3 months. | Demonstrated statistically significant non-inferiority to the stabilization splint (p=0.0096). Average percentage change in CMI scores from baseline to 3 months: 45% reduction. | Average percentage change in CMI scores from baseline to 3 months: 41% reduction. Differences between study groups did not rise to the level of statistical significance, but CID showed higher percentage reduction. |
| Secondary Efficacy Objective: Statistically significant reductions from baseline in TMD pain (VAS scores). | In-office VAS scores showed statistically significant reductions: - 1 month: 46% reduction (p<0.0001) - 2 months: 51% reduction (p<0001) - 3 months: 58% reduction (p<0.0001) | In-office VAS scores showed statistically significant reductions: - 1 month: 31% reduction - 2 months: 47% reduction - 3 months: 49% reduction Differences between the three groups (CID, splint, exercise) were not statistically significant. |
| Safety Objective: Characterize safety profile; no unanticipated adverse device effects or serious adverse events. | No unanticipated adverse device effects or serious adverse events reported. No ear drainage, allergic reactions, swelling, changes to mouth, ear, or jaw, or diminished hearing acuity. Most frequent non-serious adverse event: discomfort or pain (6.7%). | The CID's safety profile was not statistically significantly different from the stabilization splint (p-value = 0.688). Most frequent non-serious adverse event: discomfort or pain (9.4%). |
| Patient Satisfaction | 100% of subjects indicated either excellent (71%) or good (29%) overall satisfaction. | Not explicitly compared for the predicate device, but the overall conclusion highlights "high levels of patient satisfaction" for CID. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Sizes:
- CID group: 60 patients
- Stabilization Splint group: 64 patients
- Jaw Exercise Regimen group: 28 patients
- Total patients: 152
- Data Provenance: Prospective, open-label, three-arm, randomized, unblinded clinical trial. The country of origin of the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided text does not mention the use of experts to establish ground truth for the test set. The clinical trial directly measured outcomes (CMI scores, VAS pain scores) from patients based on their TMD diagnoses.
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method for the test set beyond the direct clinical measurements and assessment of diagnoses based on RDC/TMD criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted/mentioned. The study was a direct clinical trial comparing device effectiveness in patients, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only) performance study was not conducted/mentioned. The Clayton Intra-aural Device (CID) is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. Type of Ground Truth Used
The "ground truth" for the effectiveness of the device was established through patient-reported outcomes and objective clinical measures in a randomized controlled trial:
- TMD diagnoses: RDC/TMD criteria (Research Diagnostic Criteria for Temporomandibular Disorders) were used for patient inclusion.
- Efficacy measures: Craniomandibular Index (CMI) scores and Visual Analog Scale (VAS) pain scores were used to quantify reduction in pain and dysfunction.
- Safety assessment: Recording of adverse events.
8. Sample Size for the Training Set
The provided text does not mention a training set. This is a physical medical device undergoing a clinical trial for substantial equivalence, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (since this is not an AI/ML device), this information is not applicable.
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