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510(k) Data Aggregation
(127 days)
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework.
- Fully anatomical crowns and bridges -
- Partial-veneered and fully veneered crowns and bridges -
- Dentine core crowns and bridges -
- Maryland bridges -
- Telescopic crowns (primary part) -
BeCe CAD Zirkon HT+ consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations. BeCe CAD Zirkon HT+ is available as milling blank and is processed by milling technique.
The provided text describes a dental product, "BeCe CAD Zirkon HT+", and its substantial equivalence to a predicate device based on meeting certain industry standards. However, it does not contain information about acceptance criteria for an AI/ML device, a study proving an AI/ML device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document is a 510(k) summary for a dental material (zirconia powder), not an AI/ML device. Therefore, it does not address any of the specific points requested in the prompt regarding AI/ML device evaluation.
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(84 days)
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.
BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.
This appears to be a 510(k) premarket notification document for a dental alloy, BegoPal+. This document does not contain information about software, or a device that would require the kind of performance study details (acceptance criteria, training/test sets, expert adjudication, MRMC studies) you've requested.
The document discusses:
- Device Description: BegoPal+ is a palladium-containing cobalt-chromium alloy for dental restorations.
- Processing: It's processed by selective laser melting (SLM).
- Indications for Use: Porcelain-fused-to-metal (PFM) noble alloy for crown and bridge restorations.
- Predicate Devices: Lists similar alloys (Wirobond C, Wirobond C+, Callisto CP+).
- Comparison to Predicate Devices: States substantial equivalence based on indications, technical parameters, and biocompatibility, despite differences in product shape, processing, and material composition.
- Testing: Mentions test results according to ISO 22674, ISO 9693-1, ISO 10271, and ISO 10993 which demonstrate safety and effectiveness.
Therefore, it is impossible to extract the information you requested from this document as it pertains to a physical material, not a software or AI-driven medical device.
If you are looking for an example of a 510(k) submission for a software or AI device, you would need a different document.
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(137 days)
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
BeCe PRESS Ceramic system permits restorations of natural teeth in the form of metal-ceramic crowns and bridges. The pressable ceramics can be pressed to frames made of precious or non-precious alloys with a CTE of 14.6 x 10-6 K-1 (20ºC to 500ºC) after application of opaquer. Applications range from single tooth crowns to various size bridges.
BeCe PRESS is a dental ceramic system for veneering metal copings and frameworks using a press on alloy technique. The pressing ingots are composed of a two-phase leucite reinforced silicate ceramic. The restoration is processed according to the lost wax technique. The opaqued mteal framework is first waxed-up in the desired shape an function and invested. After burning out of the wax the heated, ductile BeCe PRESS ceramic is pressed into the previously created hollow space by a special ceramic press-furnace. After devesting, the restoration can be individually characterized by shade/stains and glaze materials with accompanying liquids
This document describes the premarket notification (510(k)) summary for BeCe Press, a dental ceramic system.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the BeCe Press ceramic system is "substantially equivalent" to a legally marketed predicate device, "IPS InLine PoM System" (K071848). For a 510(k) submission, "substantial equivalence" is the primary acceptance criterion. This means the device has the same intended use and technological characteristics as the predicate device, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.
Specific performance criteria for the BeCe Press are provided, and they are compared implicitly to the predicate device or industry standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance (BeCe Press) |
|---|---|---|
| Intended Use | Restorations of natural teeth in the form of metal-ceramic crowns and bridges; pressable ceramics on precious or non-precious alloys (CTE 13.8 to 14.6 x 10-6 K-1). | BeCe Press ceramic system permits restorations of natural teeth in the form of metal-ceramic crowns and bridges. Pressable ceramics can be pressed to frames made of precious or non-precious alloys with a CTE of 14.6 x 10-6 K-1 (20ºC to 500ºC) after application of opaquer. Applications range from single tooth crowns to various size bridges. |
| Material Composition | Two-phase leucite reinforced silicate ceramic for veneering metal copings and frameworks. | Composed of a two-phase leucite reinforced silicate ceramic. |
| Coefficient of Thermal Expansion (CTE) | Compatible with metal frameworks (CTE of 14.6 x 10-6 K-1 from 20ºC to 500ºC for alloys). | CTE after 2 firings: 13.0*. CTE after 4 firings: 13.0*. *It's important to note the discrepancy: the intended use states CTE of alloys (14.6 x 10-6 K-1) and the device performance shows its own CTE (13.0). The implication is that a compatibility study or standard has deemed this difference acceptable for clinical use, or the value for the alloys is the critical acceptance criteria for device compatibility rather than the ceramic itself. Without the predicate's detailed performance, direct comparison here is limited. The Indications for Use section provides a range of 13.8 to 14.6 x 10-6 K-1 for alloys, further suggesting a compatibility range. |
| Chemical Solubility | Industry standard for dental ceramics (typically ≤ 20 µg/cm²). | ≤ 20 µg/cm² |
| 3-point Flexural Strength | Industry standard for dental ceramics (typically > 100 MPa). | > 100 MPa |
| Processing Method | Compatible with lost wax technique and ceramic press-furnace. | Processed according to the lost wax technique, pressed by a special ceramic press-furnace. |
| Contraindications | Established for safe use (e.g., metal substructure required). | Intended solely for dental applications, used by dental technicians/trained people. Not designed to be used with restorations without a metal substructure or frame. Recommends using BEGO-approved frameworks. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for performance testing (e.g., for CTE, chemical solubility, flexural strength). It provides the results of these tests.
Data provenance (country of origin, retrospective/prospective) is also not specified in this summary. However, given that the manufacturer is Bego Bremer Goldschlägerei GmbH in Bremen, Germany, it is highly probable that the testing was conducted in Germany, likely in a laboratory setting. The typical nature of these material science tests suggests they are prospective, conducted as part of the product development and regulatory submission process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This category is not applicable to the type of performance data presented. The "ground truth" for material properties like CTE, solubility, and flexural strength is established through standardized physical and chemical testing protocols (e.g., ISO standards for dental materials), not expert consensus. These are objective measurements rather than subjective interpretations.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the data are objective material property measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being assessed. BeCe Press is a dental material, not a diagnostic or interpretive device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
Yes, standalone performance was demonstrated through the reported material properties. The CTE, chemical solubility, and 3-point flexural strength values are intrinsic properties of the BeCe Press material itself, measured independently of any human interpretation or intervention beyond the testing procedure.
7. Type of Ground Truth Used:
The ground truth used for performance evaluation consists of objective physical and chemical measurements obtained through standardized laboratory testing of the BeCe Press material. This includes:
- Coefficient of Thermal Expansion (CTE)
- Chemical Solubility
- 3-point Flexural Strength
These measurements are compared against established industry standards or specifications for dental ceramics to demonstrate fitness for intended use and substantial equivalence.
8. Sample Size for the Training Set:
This information is not provided because BeCe Press is a physical dental material, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of this traditional medical device (dental material).
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(56 days)
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy. It is a medical device in accordance with Regulation 93/42 EEG. Class IIa according to Annex IX. The CE seal is a declaration by the manufacturer that the regulation requirements are met.
BegoPal 300 is a crown and bridge metal to ceramic type 4 alloy.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy called "BegoPal 300". It states that the device is substantially equivalent to legally marketed predicate devices and is classified as a Class II medical device.
However, this document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established. It is purely a regulatory approval document.
Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study proving device performance based on the provided input.
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