(286 days)
The POD® is for the amelioration of clenching associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
The POD® is a prescription only, removable dental mouthguard worn on the mandibular arch during sleep. The one-piece device is fabricated for the mandibular arch and can be customized for each patient based on the clinician prescription. The dentist obtains a dental impression, prescribes the design, and once laboratory fabricated, delivers the custom-made device at the dental office to be used in the home setting.
Materials: Polymethyl methacrylate (PMMA Acrylic Resin - Orthocryl®) and medical grade stainless steel wire. Only the PMMA has body contact as the SS wire is embedded within the PMMA and does not contact the body.
Duration and type of contact: Surface device with a limited duration (
Here's an analysis of the provided text regarding the device's acceptance criteria and studies, organized by your requested information:
Device: The POD® (K182820)
Indication for Use: Amelioration of clenching and bruxing associated with TMD, and to aid in the relief of symptoms of TMD/TMJ.
1. Table of Acceptance Criteria and Reported Device Performance
This device appears to be a medical device, and the provided document is a 510(k) summary for premarket notification. The "acceptance criteria" here refers to the performance benchmarks the device needed to meet to demonstrate substantial equivalence to a predicate device, rather than patient outcomes. The acceptance criteria for this device are primarily based on non-clinical testing against recognized standards.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Physical Properties | Flexural strength (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria |
| Flexural modulus (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Maximum stress intensity factor (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Fracture toughness (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Water sorption (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Water solubility (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Residual monomer (ISO 20795-2:2013) | Complies with pre-defined pass/fail criteria | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Meets predetermined pass/fail criteria |
| Sensitization (ISO 10993-10) | Meets predetermined pass/fail criteria | |
| Mucosal Irritation (ISO 10993-10) | Meets predetermined pass/fail criteria | |
| Risk Management | Risk Analysis (ISO 14971) | No new concerns found for the subject device |
2. Sample size used for the test set and the data provenance
The document indicates that non-clinical tests were performed. These typically involve material samples rather than a "test set" of patients. Therefore, information about patient sample size, country of origin, or retrospective/prospective nature is not applicable as no clinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set involving human subjects requiring expert ground truth establishment was performed. The evaluation was based on non-clinical bench testing against established standards.
4. Adjudication method for the test set
Not applicable. As no clinical test set was used, there was no need for an adjudication method by experts.
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
Not applicable. No MRMC study was mentioned or performed. This device is a physical dental appliance, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was based on established international standards (e.g., ISO 20795-2:2013 for physical properties, ISO 10993-5 and -10 for biocompatibility). The device's materials were tested to ensure they met the specifications outlined in these standards.
8. The sample size for the training set
Not applicable. As no AI or machine learning component is involved, there is no training set in the conventional sense. The "training" for this device's development would be in material science and engineering, not data processing.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth to establish for it.
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