(58 days)
Procera® AllCeram Bridge Material is composed of Procera® AllCeram Connection Material (a premixed suspension of aluminium oxide I rooff - Tiroerant of the particles, binder of the particles and deionised water) and Procera® AllCeram Fusing Material (a suspension of glass material and water) Procera® AllCeram Bridge Material is used to fuse together the sections of the core material in densely sintered aluminium oxide of a dental bridge.
Procera® All Ceram Bridge Material is composed of Procera® AllCeram Connection Material (a premixed suspension of aluminium oxide particles, dispersant of the particles, binder for the particles and de-ionized water) and Procera® AllCeram Fusing Material (a suspension of glass material and water). Procera 8All Ceram Bridge Material is used to fuse together sections of core material in densely sintered aluminium oxide of a dental all ceramic bridge.
The provided text describes a 510(k) summary for the "Procera® AllCeram Bridge Material" and its comparison to a predicate device. The core of the submission revolves around demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparing technological characteristics and performance, particularly concerning fracture resistance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission are generally not explicitly stated as numerical targets like in a clinical trial. Instead, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device is as safe and effective as the predicate, either through identical technological characteristics or, if different, by demonstrating that the new characteristics do not raise new questions of safety or effectiveness and are at least as effective as the predicate.
In this specific case, the performance metric highlighted is fracture resistance.
| Acceptance Criteria (Implied) | Reported Device Performance (Procera® AllCeram Bridge Material) |
|---|---|
| Substantial Equivalence to Predicate Device (Procera® AllCeram Fusing Material) | Claimed substantially equivalent (K020269) |
| Fracture Resistance | Between 24% to 47% increased strength compared to predicate |
| Intended Use | Same as predicate |
| Fusing Temperature | Same as predicate |
| Chemical Composition (glass phase) | Same as predicate |
| Chemical Composition (overall) | Contains aluminum oxide particles, predicate does not |
| Sintered Structure | Reinforced with aluminum oxide particles, predicate is not |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the fracture resistance testing or the data provenance (e.g., country of origin, retrospective/prospective). It only states the comparative performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not mention using experts to establish ground truth for a test set. The evaluation seems to be based on direct material property testing (fracture resistance) rather than expert interpretation of data like images or clinical outcomes.
4. Adjudication Method for the Test Set
Since the evaluation appears to be based on direct material property testing rather than subjective assessments, an adjudication method like 2+1 or 3+1 for establishing ground truth is not applicable and not mentioned in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
An MRMC study is typically used for diagnostic imaging devices where human readers interpret medical images. The Procera® AllCeram Bridge Material is a dental material/device, and the provided information focuses on its material properties. Therefore, an MRMC study was not done, and there is no mention of human readers improving with AI vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the device's performance in this context is based on material property testing, specifically fracture resistance (strength). This is a direct measurement of the device's physical capabilities, not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic or therapeutic devices. The ground truth for chemical and structural composition would be derived from analytical chemistry and microscopy, respectively.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant to machine learning or AI models. Since this is a dental material and not an AI system, there is no training set in the context of the provided information.
9. How the Ground Truth for the Training Set was Established
As there is no training set, this question is not applicable.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.