(35 days)
As orthodontic retainer
everStick™ ORTHO is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ ORTHO is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
The provided text is a 510(k) summary for the everStick™ ORTHO device, a glass fiber orthodontic retainer. It primarily focuses on demonstrating substantial equivalence to a predicate device (everStick™ K011788) rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device submission would.
Therefore, many of the requested fields cannot be directly extracted from this document as the information does not exist within the provided text. This device is a material, not an AI or diagnostic device that would typically have the kind of performance metrics you are asking for.
Here's an attempt to address the request based on the available information, noting where information is absent:
1. Table of acceptance criteria and the reported device performance
Based on the provided K021126 summary, there are no explicit acceptance criteria or reported device performance metrics in terms of sensitivity, specificity, accuracy, or similar measures typically associated with diagnostic or AI devices. The submission focuses on substantial equivalence to a predicate device (everStick™ K011788) based on material composition and intended use.
The key "performance" mentioned is that its composition is "equal with its predicate device, everStick™," with only "the ratio of glass fibers and polymer matrices are slightly different." It states that "everStick ORTHO does not expose the dentist nor the patient to unacceptable risks," which is a safety assertion rather than a performance metric.
| Metric/Criterion | Acceptance Criteria (Not stated as numerical values) | Reported Device Performance (Implied from equivalence) |
|---|---|---|
| Composition | Substantially equivalent to predicate device (everStick™ K011788) | "Equal with its predicate device, everStick™. Only the ratio of glass fibers and polymer matrices are slightly different." |
| Safety | Does not expose to unacceptable risks. | "everStick ORTHO does not expose the dentist nor the patient to unacceptable risks." |
| Intended Use | For use as orthodontic retainer. | Met: Indication explicitly stated as "GLASS-FIBER REINFORCEMENT FOR ORTH-DONTIC RETAINERS". |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. A "test set" in the context of diagnostic device validation (especially AI) is not applicable here as this is a material rather than a diagnostic algorithm. The declaration of substantial equivalence often relies on existing data or literature for the predicate device, not new clinical studies with test sets in the same manner as AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not available. No "ground truth" establishment by experts for a test set is mentioned, as this is a material device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not available. No adjudication method is mentioned for a 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
This information is not applicable and not available. This device is a material product, not an AI system. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not available. This device is a material product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not available. The concept of "ground truth" in the context of diagnostic accuracy is not relevant for this material device submission. The "truth" here relates to material properties and safety, which are typically assessed through laboratory testing or existing literature on similar materials.
8. The sample size for the training set
This information is not applicable and not available. As this is not an AI/diagnostic device, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and not available. As there is no "training set," there is no ground truth established for it.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.