(20 days)
Lava Ultimate restorative is indicated for inlays, onlays, veneers, full crown restorations, including implant supported crowns, permanent three unit bridges in the anterior region and permanent three unit bridges in the premolar region up to the second premolar as the terminal abutment. The bridge consists of two full crown abutments supporting a pontic between them; the two abutments may be either two teeth or two implants.
Lava Ultimate restorative is not indicated for uses other than those listed.
The product is a strong, wear-resistant and highly esthetic mill block that provides a fast and easy-to-use alternative to porcelain blocks for milling CAD/CAM indirect restorations. The material is specially processed to enhance its properties for use in CAD/CAM milling procedures.
The provided text does not describe a study involving an AI/CAD device. It pertains to a dental material called "Lava™ Ultimate CAD/CAM Restorative." The 510(k) submission is for a new dental material, not an AI or CAD system that provides diagnostic or prognostic information.
Therefore, many of the requested details about acceptance criteria, study design with AI, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not applicable.
However, I can extract the relevant information regarding the device's performance evaluation and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "This 510(k) submission includes data from in-vitro testing of prepared anterior bridges to evaluate the performance of Lava™ Ultimate CAD/CAM Restorative compared to Ivoclar Vivadent AG's IPS e.max Press (K982616)."
While specific acceptance criteria (e.g., "must meet X MPa flexural strength") are not explicitly detailed in the provided text, the implied acceptance criterion is that the performance of the Lava™ Ultimate CAD/CAM Restorative is comparable to or superior to the predicate device (Ivoclar Vivadent AG's IPS e.max Press) in in-vitro testing for anterior bridges. The submission indicates this equivalence was demonstrated.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance comparable to predicate device (IPS e.max Press) in "in-vitro testing of prepared anterior bridges." | Demonstrated substantial equivalence through in-vitro testing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text. The text only mentions "in-vitro testing of prepared anterior bridges."
- Data Provenance: In-vitro testing (laboratory-based). The location of the testing is not specified, but the manufacturer is 3M ESPE Dental Products in St. Paul, MN, USA. The study design is not specifically "retrospective" or "prospective" as it's in-vitro testing of materials, not a clinical study on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a material science evaluation, not a diagnostic or prognostic study requiring expert ground truth for interpretation. The "ground truth" would be the objective measurements from the in-vitro mechanical testing.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This is not an AI/CAD diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental restorative material, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this material would be objective physical and mechanical properties measured through validated in-vitro testing methods, likely including tests for strength, wear resistance, and esthetics, as implied by the device description.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/CAD system that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.