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510(k) Data Aggregation
(94 days)
OBSIDIAN CERAMIC BLOCKS
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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