(63 days)
Ribbond-Triaxial is intended to provide reinforcement to acrylic or composite resins used for dental restorations. It is used by dentists and dental technicians. It can be used for the following applications:
As reinforcement in manufacturing and/or repairing full or partial-dentures as well as overdentures, night-guards and orthodontic appliances.
To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges.
To reinforce splints used to immobilize teeth.
Ribbond-Triaxial is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecular-weight polyethylene (UHMW). The fibers are braided using a triaxial braid and subjected to a plasma treatment to improve its ability to bond to resins.
This document is a 510(k) summary for Ribbond-Triaxial, a dental fiber reinforcement material. The core of the submission revolves around demonstrating substantial equivalence to a predicate device, Ribbond (cleared under K913040), rather than outlining explicit acceptance criteria and an independent study for novel performance.
Therefore, the requested information relies heavily on interpretation of the provided text, as a traditional "acceptance criteria vs. reported device performance" table is not explicitly present in the format typically seen for novel device submissions. The submission focuses on design characteristics and their impact on load-carrying capacity, using the predicate device as a benchmark.
Here's the breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety equivalent to predicate device | No new hazards presented as with the predicate device. |
| Effectiveness equivalent to predicate device | The different design characteristics... demonstrates that the device is as safe and effective as the predicate device. |
| Specific Performance Metric: Greater load carrying capacity compared to Ribbond (predicate device, leno-weave) | Ribbond-Triaxial has greater load carrying capacity than the leno-weave. |
| Ability to bond to resins similar to or improved over predicate | Subjected to a plasma treatment to improve its ability to bond to resins. |
Study Details
It's important to note that the document describes "tests" rather than a formal, detailed "study" with explicit methodologies, sample sizes, and statistical analysis as would be expected for a de novo device. The information provided is very limited.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Tests show that Ribbond-Triaxial has greater load carrying capacity." This implies tests were conducted, but the number of samples tested is not mentioned.
- Data Provenance: Not specified. It can be inferred that the tests were conducted by the manufacturer, Ribbond, Inc., but the location or whether it was retrospective/prospective is not stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "tests" mentioned are for mechanical properties (load carrying capacity), not diagnostic accuracy requiring expert interpretation of ground truth.
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Adjudication method for the test set:
- Not applicable, as the tests relate to mechanical properties, not expert-based assessment.
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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:
- No. This is not an AI-enabled device, nor is it a diagnostic device that would typically undergo an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical material, not an algorithm.
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The type of ground truth used:
- For the "load carrying capacity" test, the ground truth would be the objectively measured mechanical force required to cause failure or deformation, as per standard engineering and material testing protocols. This is a direct measurement, not an interpreted "ground truth" derived from experts or pathology in a medical context.
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The sample size for the training set:
- Not applicable. This is a physical material with mechanical properties undergoing direct testing, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.