(150 days)
As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances. As reinforcement for temporary and/or permanent plastic/composite inlays, onlays and bridges. As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or for orthodontic therapy.
everStick™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStick™ is made of unidirectional fibers which increase the strength and stiffness of the final product perpendicular to the direction of the fibers.
This submission describes the "everStick™" device, a glass fiber reinforcement material for dental applications. However, the provided text does not contain a study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics.
Instead, the submission is a 510(k) premarket notification for substantial equivalence, where the new device (everStick™) is compared to a predicate device (fibreStick™, K003333). The core of this type of submission is to demonstrate that the new device is as safe and effective as a legally marketed predecessor, not necessarily to set and meet new performance benchmarks through a dedicated clinical study.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: Not explicitly stated as quantifiable performance targets. The acceptance criterion for this 510(k) submission is "substantial equivalence" to the predicate device.
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Reported Device Performance:
- "Testing which has been performed on everStick™ indicates that the device has the same intended use but somewhat different technological characteristics."
- "everStick™ is a polymer/resin impregnated unidirectional continuous glass fiber whereas fibreStick™ is a polymer pre-impregnated unidirectional continuous glass fiber."
- "The different technological characteristics of everStick™ does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device."
- "Test results indicate that there are no hazards presented with the use of everStick™ as compared with the predicate device."
Note: While tests were performed, the specific results (e.g., tensile strength, bond strength, flexural modulus, etc.) and their comparison to specific numerical acceptance criteria are not provided in this summary. The "performance" is primarily described in terms of its equivalence to the predicate and the absence of new safety concerns.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate device (fibreStick™) in safety and effectiveness. | "device is as safe and effective as the predicate device." |
| No new questions of safety and effectiveness raised by technological differences. | "The different technological characteristics of everStick™ does not raise new questions of safety and effectiveness." |
| No new hazards presented compared to predicate device. | "Test results indicate that there are no hazards presented with the use of everStick™ as compared with the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. This document only mentions "testing" and "test results" without detailing the number of samples or specimens used in any specific test.
- Data Provenance: Not specified. The country of origin of the testing data is not mentioned. Given the applicant is from Finland, it's possible testing occurred there. The nature (retrospective/prospective) of the data collection is also not specified, though typically engineering or bench testing is prospective for a new device.
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)
- Not Applicable. This type of information is generally relevant for studies involving human interpretation or clinical endpoints that require expert assessment to establish ground truth (e.g., image-based diagnostic devices). This submission is for a material used in dentistry, and the evaluation relies on physical/mechanical testing, not expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, adjudication methods are for resolving discrepancies in expert interpretations, which is not relevant for the type of testing implied for this dental material.
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. This is a dental material, not an AI-assisted diagnostic device. Therefore, MRMC studies and AI improvement effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: The "ground truth" in this context would likely be established through standard engineering and materials science methods. For example, a universal testing machine would measure material properties (e.g., flexural strength, modulus) which are considered objective physical properties, not subject to expert interpretation for ground truth. Comparison would be made to the predicate device's known properties or established industry standards for dental materials.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set for AI.
§ 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.