(88 days)
The Acrylic is intended for the fabrication of temporary dental prostheses like temporary crowns and bridges, flippers, orthodontic retainers, and occlusal guards using the Inovativ, LLC Acrylic resin.
The Acrylic material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
The provided text is a 510(K) summary for the "Inovativ Acrylic" device. This document is a premarket notification for a medical device which aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on demonstrating similar design, materials, technological characteristics, and intended use, rather than presenting a study with specific acceptance criteria and performance metrics in the way that, for example, an AI diagnostic device would.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided text. The document asserts "substantial equivalence" based on similar fundamental characteristics and physical properties to a predicate device, rather than defining specific performance acceptance criteria and reporting against them.
2. Sample size used for the test set and the data provenance:
This information is not present. No specific "test set" or clinical study data is described. The submission is based on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present. No ground truth establishment by experts is described as this is not a diagnostic device and no clinical data is presented in this summary.
4. Adjudication method for the test set:
This information is not present.
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 is not applicable. The device (Inovativ Acrylic) is a thermoplastic resin for dental prostheses, not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is not an algorithm.
7. The type of ground truth used:
This information is not present. No ground truth for performance is established in the document. Substantial equivalence is based on physical and chemical properties as compared to a predicate device.
8. The sample size for the training set:
This information is not present. The device is not an AI algorithm and does not have a training set.
9. How the ground truth for the training set was established:
This information is not present.
Summary of what is present:
- Device Name: Acrylic
- Manufacturer: Inovativ, LLC.
- Predicate Device: Health-Dent International, Inc. "Dent-Temp Acrylic"
- Basis for Equivalence: Similar in design, function, physical properties, chemical composition, handling characteristics, and intended use to the predicate device.
- Intended Use: Fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges (later expanded to include flippers, orthodontic retainers, and occlusal guards).
- Regulatory Classification: Class II, Temporary Crown and Bridge Resin (21 CFR 872.3770).
This document serves to demonstrate substantial equivalence to an existing legally marketed device, meaning it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. It does not typically involve the type of performance studies with acceptance criteria and ground truth typical of novel diagnostic devices or AI applications.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.