(67 days)
Intended for use as a fiber reinforced root canal post
everStick™ POST is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ POST is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
This submission pertains to the everStick™ POST, a glass fiber root canal reinforcement device. The 510(k) summary provided does not contain the detailed performance study information typically found in a clinical study report for evaluating acceptance criteria and device performance in the context of an AI/ML medical device.
The document is a traditional 510(k) premarket notification for a medical device (a physical product) and therefore does not include the elements you've requested that are specific to AI/ML device studies.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria & Reported Performance: The document states that the device is substantially equivalent to a predicate device (everStick™ K011788) with the same composition and technological characteristics, save for a slight difference in fiber/matrix ratio. It also states that the second predicate device (Ribbond K913040) has the same intended use but different technological characteristics that "do not raise new questions of safety and effectiveness." This implies that the acceptance criteria are primarily related to safety and effectiveness demonstrated through substantial equivalence to existing, legally marketed devices, rather than specific performance metrics from a comparative study. No specific numerical performance metrics are provided.
- Sample Size (Test Set) and Data Provenance: Not applicable, as this is not a study involving a test dataset for an AI/ML model.
- Number of Experts & Qualifications (Ground Truth): Not applicable. The ground truth for this type of device is established through material science testing and clinical experience with similar products, not expert consensus on image interpretation.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device, not an algorithm.
- Type of Ground Truth: For this device, the "ground truth" would be established through material property testing (e.g., strength, stiffness, biocompatibility) and clinical data/experience with the predicate devices. The document explicitly mentions comparing ingredients to "existing data available from dental polymerizable material" to state it "does not expose the dentist or the patient to unacceptable risks."
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
Summary based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety: Device attributes (composition, materials) do not raise new questions of safety compared to predicate devices. | "everStick™ POST does not expose the dentist or the patient to unacceptable risks." (Based on comparison with existing dental polymerizable material data and composition similarity to predicate everStick™) |
| Effectiveness: Similar intended use and technological characteristics to predicate devices. | Substantially equivalent to everStick™ (K011788) and Ribbond (K913040) for glass fiber reinforcement in dentistry and as a fiber reinforced root canal post. |
| Technological Characteristics: Composition and physical properties are comparable to predicate devices. | "Composition of everStick™ POST is equal with its predicate device, everStick™ with the same technological characteristics. Only the ratio of glass fibers and polymer matrices are slightly different." |
2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a test dataset in the context of AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Implied "ground truth" is based on material science testing, compositional analysis compared to approved predicate devices, and existing clinical data/experience with similar dental polymerizable materials and fiber reinforcement products.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
In conclusion, the K030820 submission is a standard 510(k) for a physical dental device. The "study" referenced for meeting acceptance criteria is implicitly the demonstration of substantial equivalence to predicate devices through compositional comparison and existing safety/effectiveness data for those predicates and similar materials, rather than a clinical trial with specific performance metrics against a defined ground truth derived from expert consensus or pathology, as would be common for AI/ML devices.
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.