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510(k) Data Aggregation
(127 days)
saremco print BRIDGETEC is a light-curing 3D-printed material intended as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The saremco print BRIDGETEC material is used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. saremco print BRIDGETEC can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
saremco print BRIDGETEC is a resin-based material for the production of permanent and temporary restorations, veneers and artificial teeth on 3D printers. The material is an alternative to traditional heat-cured and auto polymerization resins. It requires a computer-aided and manufacturing (CAD/CAM) system including scanner, design software, additive printer and a post-curing unit.
The provided text describes the regulatory clearance of a dental product, "saremco print BRIDGETEC," based on its substantial equivalence to existing predicate devices. It does not present a study proving the device meets acceptance criteria in the way an AI/ML medical device would be evaluated (e.g., using a test set, ground truth, expert readers, etc.).
Instead, the submission focuses on bench testing and comparison of physical and chemical properties to established standards and predicate devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria in the context of AI/ML evaluation. The information provided is about a material, not a diagnostic or prognostic AI algorithm.
However, I can extract the "acceptance criteria" and "reported device performance" from the document in the context of the material's properties and compliance with standards.
Here's the closest possible interpretation of your request based on the provided text:
Acceptance Criteria and Device Performance (for a Dental Material, not an AI/ML Device)
The "acceptance criteria" for saremco print BRIDGETEC are primarily based on its compliance with international standards for dental materials and its substantial equivalence to existing predicate devices in terms of intended use, material composition, and physical properties.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Property) | Reported Device Performance (saremco print BRIDGETEC) |
|---|---|
| Compliance to ISO Standards: | |
| ISO 4049:2019 – Dentistry – Polymer-based restorative materials | Met applicable requirements |
| ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials | Met applicable requirements |
| ISO 22112:2017 – Dentistry – Artificial teeth for dental prostheses | Met applicable requirements |
| Biocompatibility in compliance with ISO Standards: | |
| ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process | Met biocompatibility requirements |
| ISO 7405:2018 Dentistry - Evaluation of Biocompatibility of Medical Devices Used in Dentistry | Met biocompatibility requirements |
| Physical Property: | |
| Flexural Strength (Comparison to Predicate) | Avg. ≥ 135 MPa (Similar to predicate saremco print CROWNTEC, and comparable to TERA HARZ's 148.73 MPa) |
| Material/Technical Attributes (Equivalence to Predicates): | |
| Product State | Liquid |
| Material Type | Methacrylate based resin |
| Chemical Characterization | Methacrylate-based resins, dental glass-filler, photo initiators, and pigments. |
| Shelf Life | 2 years (Similar to TERA HARZ, different from CROWNTEC) |
| Storage Conditions | Do not expose to light |
| Storage Temperature | 4-28°C (39-82°F) |
| Fabrication Method | Additive 3D printing |
| UV Laser Wavelength | 385 nm |
| Layer Thickness when Printing | 50 µm |
| Polymerization Method | UV Curing Light |
| Sterile | No |
| Single Use | No |
| Intended Use (Equivalence to Predicates): | |
| Intended for both anterior and posterior restorations, including occlusal surfaces. | Yes |
| Used for fabricating permanent restorations such as inlays, onlays, veneers, full crown and 3-part bridge restorations. | Yes |
| Used for permanent 3-part bridge restorations | Yes (Note: Predicate CROWNTEC does not have this indication) |
| Used for the fabrication of artificial teeth | Yes (Note: Predicate TERA HARZ does not have this indication) |
| Used for the fabrication of temporary crowns & bridges. | Yes |
The following points cannot be addressed as they are relevant to AI/ML device studies, not traditional material clearances:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance was based on bench tests of the material, not a "test set" of patient data for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing, not expert interpretation of cases.
- Adjudication method for the test set: Not applicable.
- 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: Absolutely not applicable. This is a material, not an AI assisting human readers. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of saremco print BRIDGETEC."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For material properties, the "ground truth" is derived from physical and chemical measurements performed according to established ISO standards. For the "substantial equivalence" claim, the ground truth is the documented performance and indications of the legally marketed predicate devices.
- The sample size for the training set: Not applicable. This is a manufactured product, not a software algorithm that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details a regulatory submission for a dental material, not an AI/ML medical device. Therefore, the questions related to AI/ML study design, such as ground truth establishment via experts, reader studies, and training/test sets, are not relevant to this content. The "proof" of meeting "acceptance criteria" for this device lies in its compliance with material standards and demonstrating substantial equivalence through bench testing.
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