Search Results
Found 3 results
510(k) Data Aggregation
(139 days)
CEREC Cercon 4D™ Abutment System is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.
The system comprises three parts:
- CEREC Cercon 4D™ Abutment Block
- TiBase
- CAD/CAM system
The CEREC Cercon 4D™ ceramic structure cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.
The CEREC Cercon 4D Abutment Blocks, which are used for fabrication of a ceramic structure, two-piece hybrid abutments (meso-structure and crown) and abutment crowns, that are cemented to a TiBase (titanium base) used with dental implant systems. The CEREC Cercon 4D Abutment Blocks are not provided as the finished, fully assembled dental implant medical devices. The abutment blocks are materials supplied to dental professionals that must be further processed/manufactured using CAD/CAM technology and they are not intended to be reused as in the context of direct patient-applied devices and materials.
CEREC Cercon 4D™ Abutment Block are Yttria-doped zirconia blocks suitable for chairside and lab side use in fabrication of single cement-retained restorations. CEREC Ceron 4D™ Abutment Block are designed with a pre-drilled screw access channel and anti-rotation feature. The design allows for fabrication of a ceramic structure, two-piece hybrid abutments (mesostructure and crown) and abutment crowns, that are cemented to theBase (Titanium base) used with dental implant systems.
The provided document describes the substantial equivalence of the CEREC Cercon 4D™ Abutment Blocks and System, primarily focusing on non-clinical performance and material characteristics, rather than an AI/ML-based device. Therefore, many of the requested elements pertaining to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document.
However, I can extract information related to the acceptance criteria and study that proves the device meets those criteria from the perspective of a medical device (specifically, a dental abutment system), even without AI elements.
Here's the information based on the provided text, with Not Applicable (N/A) for fields that relate to AI/ML studies and are not covered in this document.
Acceptance Criteria and Device Performance for CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
The device under review is primarily a dental abutment system, and its performance is evaluated based on material properties, mechanical strength, and software integration, not on diagnostic accuracy or AI assistance.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Performed | Test Method/Applicable Standards | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|---|
| Flexural Strength | ISO 6872:2015 Amd 1. 2018 Dentistry-Ceramic Materials | >1,100 MPa | Pass |
| Fatigue Testing | ISO 14801:2016 Dentistry-Implants-Dynamic loading test for endosseous dental implants | (Implied: Meets requirements) | Pass |
| Sterilization Validation | ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ | Validated |
| Biocompatibility | ISO 10993 standard series (specifically ISO 10993-5, -10, -23) | Meets ISO 10993 requirements | Meets requirements |
| Software Validation (Angulation) | Internal software integration requirements for the addition of the proposed device | Max angulation of 20° (User cannot proceed if outside) | Meets requirements |
| Software Validation (Wall Thickness) | Internal software integration requirements for the addition of the proposed device | Minimal wall thickness of 0.5 mm (User cannot proceed if outside) | Meets requirements |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- For Flexural Strength (Table 8.1): Not explicitly stated, but typically involves a certain number of samples to ensure statistical significance as per ISO 6872.
- For Fatigue Testing (Table 8.2): "New fatigue testing was conducted on the worst-case combinations relating to the greatest angulation, the platform size and the gingival height for the proposed Dentsply Sirona TiBase/Dentsply Sirona Implant Systems and Third Party TiBase/Third Party Implant Systems (Camlog) combinations." The exact number of samples per test condition is not specified in the document, but standardized tests like ISO 14801 would stipulate a minimum.
- For Sterilization Validation, Biocompatibility, and Software Validation: Not explicitly specified in terms of sample count in this summary.
- Data Provenance: The document does not specify the country of origin of the data. The tests are described as "non-clinical tests" and "performance bench testing," indicating laboratory-based studies. The document does not mention if the data is retrospective or prospective, as this distinction is more relevant for clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar. The "ground truth" (or more accurately, established performance standards) for this device is based on mechanical properties and ISO standards, which are objective and do not require expert human interpretation in the way an AI diagnostic system would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human expert interpretation or consensus review is involved in the performance testing of this device (e.g., physical strength, material composition).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device; therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. Its "system" aspect refers to the combination of the abutment block, TiBase, and CAD/CAM system for fabrication, not an AI algorithm. The performance described is of the physical components and the software's ability to constrain design parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international consensus standards (e.g., ISO 6872, ISO 14801, ISO 10993, ISO 17665-1) for dental materials and implants, along with internal software integration requirements. These are objective, quantitative measures rather than subjective human interpretations or clinical outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not have a "training set" in the context of machine learning.
Ask a specific question about this device
(392 days)
Nucleoss T6 Dental Implants are intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients' chewing function. Nucleoss T6 Dental Implants are intended for delayed loading after 12 weeks.
Nucleoss Abutments and Prosthetic parts are intended for use with Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures for edentulous or partially edentulous patients.
The Nucleoss T6 Dental Implant is a bone level implant constructed of unalloyed titanium (ISO 5832-2). The surface of the T6 implant is a sand-blast and acid-etch (SLA) surface treatment.
T6 Implants: Nucleoss T6 implants have a cylindrical form design, with a double lead thread form and two helical anti-rotation grooves. The thread structure is a reverse buttress. The internal structure is designed as a conical internal hex connection with 140 degrees.
The Nucleoss Dental Abutments are intended for use with the Nucleoss T6 Dental Implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.
Abutments: The Nucleoss Dental Abutments consist of the following designs: Standard Straight, Esthetic Straight, Esthetic Angled, Ball and Equator, Cover, Gingiva Former and Screw. Nucleoss Dental Abutments are cement-retained and screw-retained restorations and intended for placement on Nucleoss T6 implants with diameters of 3.5, 4.1 and 4.8 mm. The connection to the dental implant is achieved by an internal hexagon. These devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.
Covers and Gingiva Formers: The Nucleoss Cover and Gingiva Former are used during the healing and prosthesis period following surgical placement of the dental implant. All of these devices are constructed of titanium alloy (Ti6Al4V ELI) per ISO 5832-3.
Screws: The Nucleoss Dental Implant and Abutments devices also include screws for securing abutments to the implant to provide a secure coupling for the denture prosthetic attachment to the abutment.
The provided text is a 510(k) Summary for the Nucleoss T6 Dental Implant System. It details the device, its indications for use, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence.
However, the document does not contain any information about acceptance criteria or a study proving that an AI/Machine Learning device meets specific performance criteria. The entire document focuses on a dental implant system, which is a physical medical device, and the testing described (pull-out, fatigue, sterilization, accelerated aging, biocompatibility) are all standard engineering and material science tests for such a device. There is no mention of an algorithm, AI, machine learning, or any form of digital image analysis.
Therefore, I cannot extract the requested information regarding AI device acceptance criteria or performance from this document. The questions about sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets are relevant only for AI/ML device studies, which are not described in this submission.
Ask a specific question about this device
(122 days)
The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S. SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase. inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems follows).
The Sirona Dental CAD/CAM System which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of a new "chairside" CAD/CAM software version, CEREC SW version 4.6.1, in which additional functionality for the control of critical CAD/CAM abutment dimensions has been added. Additionally, the modified Sirona Dental CAD/CAM System that is the subject of this premarket notification includes a line extension to the existing offerings of the Sirona TiBase titanium base component offerings. These additional TiBase variants facilitate compatibility with additional implant systems. The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification consists of: CEREC SW version 4.6.1, "chairside" CAD/CAM software; CEREC AC digital acquisition unit; CEREC AC Connect digital acquisition unit; CEREC Omnicam 3D digital intraoral scanner; CEREC MCXL product family of CAM milling units; Sirona TiBase titanium base components; inCoris ZI zirconium mesostructure blocks. As subject to this premarket notification, the Sirona Dental CAD/CAM System is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system. The CEREC SW 4.6.1 CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW 4.6.1 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium block materials. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement in order to complete the finished, two-piece CAD/CAM dental abutment.
Here is the information about the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K111421) rather than explicitly detailing numeric acceptance criteria for each test. However, it lists the types of non-clinical performance data and states that the results support substantial equivalence. The implied acceptance criterion for all tests is "conformity" with the referenced standards or successful validation/analysis, and the reported performance is that these criteria were met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity with IEC 60601-1 (medical electrical equipment basic safety and essential performance) | Testing conducted, results reported to support substantial equivalence. |
| Conformity with IEC 60601-1-2 (electromagnetic compatibility) | Testing conducted, results reported to support substantial equivalence. |
| Conformity with IEC 62304 (medical device software lifecycle processes) | Software validation conducted, deliverables compiled, and included with reference to FDA guidance. |
| Dynamic fatigue testing of new TiBase variants (worst-case construct) according to ISO 14801 | Dynamic fatigue testing conducted, results reported to support substantial equivalence. |
| Compatibility analyses of new TiBase interface geometries with OEM implant connection geometries | Compatibility analysis conducted (reverse engineering on OEM implant body, abutment, screw, or by manufacturing agreement), results reported to support substantial equivalence. |
| System validation testing (design and fabrication workflow of CEREC SW 4.6.1) | System validation testing conducted to confirm design and fabrication workflow with defined scanning, acquisition, and milling equipment. |
| Software verification and validation for abutment design library (including design restrictions) | Software verification and validation conducted to demonstrate that restrictions prevent mesostructure design outside limitations and that established design limitations in the encrypted library are locked and cannot be modified. Screenshots under user verification testing were included to demonstrate this. |
| Validation of recommended steam sterilization parameters (EN ISO 17665-1, ANSVAAMI ST79:2010) | Recommended parameters for steam sterilization of TiBase components validated. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of abutments for fatigue testing, number of software test cases). It refers generally to "testing" and "analyses."
The data provenance is implied to be internal testing conducted by Dentsply Sirona, as the document details their testing efforts to support the 510(k) submission. No information about country of origin of the data is provided, nor whether it was retrospective or prospective, although typically such a submission would involve prospective testing designed to meet the specified standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The document describes compliance with recognized standards and internal validation processes but does not detail the involvement of external experts for establishing ground truth on a test set.
4. Adjudication Method for the Test Set:
This information is not provided. The non-clinical testing appears to rely on objective measurements against established engineering and regulatory standards rather than subjective expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done or reported. This device is a CAD/CAM system for designing and fabricating dental abutments, not an AI or imaging diagnostic tool that would typically involve human reader performance studies.
6. Standalone (Algorithm Only) Performance Study:
Yes, a standalone performance study in the form of non-clinical performance data and software verification and validation testing was performed. The document describes:
- Testing to verify conformity with various IEC and ISO standards for medical electrical equipment, electromagnetic compatibility, and dynamic loading.
- Compatibility analyses of new TiBase interface geometries.
- System validation testing for the CAD/CAM software's design and fabrication workflow.
- Software verification and validation testing specifically for the abutment design library to demonstrate design restrictions and locked specifications.
These tests focus on the technical performance and safety of the device components and software, independent of human clinical application for their evaluation.
7. Type of Ground Truth Used:
The ground truth used for non-clinical testing is based on:
- Engineering specifications and design requirements: For confirming the functionality and outputs of the CAD/CAM system and software.
- Recognized international standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 62304, and ISO 14801 which define performance benchmarks and safety criteria.
- Original manufacturer's implant connection geometries: For compatibility analyses of TiBase interfaces.
8. Sample Size for the Training Set:
This information is not applicable and therefore not provided. The Sirona Dental CAD/CAM System, as described, is not an AI/ML-based diagnostic device that typically requires a "training set" in the context of machine learning model development. It's a system for computer-aided design and manufacturing within predetermined parameters.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no mention or indication of a "training set" for an AI/ML model for this device. The software functions based on established CAD/CAM principles and predefined parameters rather than learning from a training dataset.
Ask a specific question about this device
Page 1 of 1