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510(k) Data Aggregation
(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.
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(94 days)
The device is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM or hot-press methods.
The device is comprised of dental porcelain powder in the nature of a lithium silicate glass ceramic that is used in the form of ceramic blanks. The device has excellent casting and machining properties and can be used to obtain highly esthetic dental restorations with desirable characteristics including improved density and flexural strength compared to predicate devices.
The provided text describes Obsidian™ Ceramic Blocks, a dental porcelain powder used to fabricate ceramic dental prostheses. The document outlines the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them, presented in the requested format:
Acceptance Criteria and Device Performance Study for Obsidian™ Ceramic Blocks
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | Demonstrated by substantial equivalence to predicate devices (e.max CAD-K051705 and IPS Empress 2 - K982616) and lack of new safety concerns due to minor material differences. |
| Effectiveness | Demonstrated by substantial equivalence to predicate devices and positive clinical outcomes in a small investigational study. Adherence to physical properties as determined in nonclinical testing. |
| Functionality | Predicted to function similarly to other comparative devices. |
| Biocompatibility | Implicitly accepted through substantial equivalence to legally marketed dental ceramic materials. |
| Physical Properties (Strength & Density) | Increased final density and higher values of flexural strength compared to predicate lithium disilicate glasses. |
| Esthetics | "Excellent esthetics" observed in clinical cases. |
| Durability/Performance over time | All 28 restorations in the clinical study performing as expected with no replacements required. (9 restorations 6-9 months in place, 23 restorations >3 months in place). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data): 28 custom-made restorations (27 crowns and 1 inlay) for 16 patients.
- Data Provenance: Retrospective clinical observation of restorations placed from October 2, 2009, through May 4, 2010. The geographical origin of the patients/clinic is not specified, but it can be inferred to be within the US given the context of a 510(k) submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth in the clinical evaluation. It mentions "All of the restorations were placed...demonstrating excellent esthetics...All 28 restorations are performing as expected based on the physical properties...with no replacements required." This suggests that the assessment of performance and esthetics was likely made by the treating dentists or possibly an internal team at Prismatik Dentalcraft, Inc., based on their clinical judgment. There is no mention of external, independent expert review to establish a formal ground truth.
4. Adjudication Method for the Test Set
No formal adjudication method (e.g., 2+1, 3+1) is described for the clinical data. The assessment appears to be a direct observation of clinical outcomes by the practitioners involved or the device manufacturer, rather than an adjudicated review.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The clinical data provided is an observational study of restorations made with the subject device, without direct comparison against human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical dental material (ceramic blocks) for fabricating prostheses, not an AI or software algorithm. Therefore, there is no "standalone algorithm performance" to evaluate.
7. The Type of Ground Truth Used
The ground truth for the clinical data was based on:
- Clinical Outcomes/Performance: Direct observation of the restorations' structural integrity and functionality in the oral cavity, including the absence of failures or replacements.
- Clinical Esthetics: Subjective assessment of the esthetic appearance of the restorations, described as "excellent esthetics."
- Correlation with Physical Properties: The clinical performance was deemed to be "as expected based on the physical properties of the subject device as determined in the nonclinical testing."
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical material, not an AI or machine learning model that requires a "training set." The development of the ceramic material would involve material science research and engineering, not data training in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8. The "ground truth" for the material's development would be established through material science principles, laboratory testing (e.g., flexural strength, density measurements), and chemical analysis, rather than a "training set" with established ground truth labels as typically seen in AI development.
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