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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.
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(739 days)
JTK One-Piece Integrated Implant System:
The JTK one-piece integrated dental implant system is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
JTK Two-Piece Implant System:
The JTK two-piece dental implant system is comprised of dental implant fixtures and prosthetic devices a two-piece implant system. The implants are intended for use in the mandla, in support of single unit or multiple unit cement or screw-receiving restorations and support of overdentures. The implants are intended for immediate placement and function for the support of single tooth restorations, recognizing bone stability and appropriate occlusal load requirements.
The JTK Dental Implant System is offered in two different models consist of a one-piece integrated implant system where the implant and abutment are machined from the same piece of titanium, and a traditional two-piece implant system that consists of an implant and abutment that are made from different pieces titanium and held together by way of a supplied titanium healing cap is also supplied with the two-piece implants and abutments are supplied individually packaged and sterile to the end user via gamma radiation. The healing cap is packaged with the implant and the attachment screw is packaged with the abutment. All implant System are made by traditional CNC manufacturing methods. For both models of the implant body, the threaded portion receives a surface modification using sandblasting and acid etching (SLA).
For the one-piece implant system, the implants are offered in two thread diameters (3.0 and 3.3 mm) and in three thread lengths (10, 13 and 15 mm). The integral abutment portion of the implant is contoured and machined, is without a surface modification, and is offered in two platform heights (4 and 6 mm).
For the two-piece implant system, the implants are offered in five thread diameters (3.8, 4.0, 4.5, 5.0 and 5.5 mm) and in four thread lengths (8, 10, 13 and 15 mm). The neck of the implant is conical in shape, 2.5 mm in height and has been machined and is without a surface modification. The two-piece implant bodies are considered a tissue level implant. The abutments that are used with the two-piece system are offered in two different models (straight and angled (15° and 25°). The straight abutments are offered in a diameter of 4.4 mm and in lengths of 4.2, 5.2, 6.2 and 8.2 mm. The 15° angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 8.0 mm, while the 25° the angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 10.5 mm.
The titanium used to manufacture the one-piece implants conform with ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications while the titanium used to manufacture the abutments conform with ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
The provided text is an FDA 510(k) Premarket Notification summary for the JTK Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices through comparisons of device characteristics and non-clinical performance data.
Crucially, this document describes a dental implant system, a physical medical device, not a software or AI/ML-based device. Therefore, the concepts of acceptance criteria for algorithm performance (like sensitivity, specificity, AUC), ground truth experts, adjudication methods, MRMC studies, or training/test sets in the context of an AI/ML algorithm are not applicable to this submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical performance testing required for medical devices to demonstrate safety and effectiveness and substantial equivalence to existing predicate devices.
Here's an interpretation based on the provided text, aligning with the type of device being discussed:
1. A table of acceptance criteria and the reported device performance:
The "acceptance criteria" here are generally international standards and FDA guidance documents that the device must conform to for safety and performance. The "reported device performance" indicates whether the device passed these tests.
| Acceptance Criterion (Standard/Guidance) | Reported Device Performance |
|---|---|
| Biocompatibility Testing per ISO 10993-1 (cytotoxicity, rabbit pyrogen test) | Passed all testing |
| Dynamic Fatigue Testing per ISO 14801 | Demonstrated 5x10^6 cycles without failure |
| Sterilization Validation per ISO 11137-1, -2, -3 | Demonstrated a SAL of 10^-6 via gamma radiation |
| Shelf-life Validation per ASTM F1980-07 | Stated shelf-life of 2 years |
| Packaging Validation per ISO 11607 | Stated (implicit in shelf-life validation) |
| Risk Analysis per ISO 14971 | Conforms to the ISO standard |
| LAL testing for pyrogenicity (FDA Guidance) | Addressed all recommendations |
2. Sample size used for the test set and the data provenance:
For this type of physical device, "sample size" refers to the number of physical units tested. The document does not specify exact numbers for each test (e.g., how many implants were tested for fatigue). The provenance is "Jiangyin Jintech Biotech Co., Ltd." in "Jiangyin City, Jiangsu Province, China," as they conducted the performance testing. These are non-clinical (laboratory) studies.
- Sample Size: Not explicitly stated for each test (e.g., number of implants for fatigue testing), but implied to be sufficient to meet the requirements of the standards.
- Data Provenance: Non-clinical (laboratory) testing conducted by Jiangyin Jintech Biotech Co., Ltd. in China.
- Retrospective or Prospective: These are laboratory tests specifically conducted for the submission, so they are prospective in nature to generate data to support the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable here. Ground truth is typically established for diagnostic or AI/ML performance. For a dental implant, "ground truth" relates to its physical and biological performance as measured by objective tests (e.g., fatigue strength, biocompatibility, sterilization efficacy) against established international standards. The "experts" are the engineers, scientists, and technicians who design, conduct, and analyze these standardized tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists interpreting images) to resolve disagreement. For physical device performance testing, the results are typically quantitative measurements against objective criteria, not subjective interpretations requiring adjudication.
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:
This concept is not applicable. An MRMC study is relevant for AI/ML-assisted diagnostic devices. This submission concerns a physical dental implant. There are no "human readers" or "AI assistance" in the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This concept is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this medical device is the adherence to established international consensus standards (e.g., ISO, ASTM) and FDA guidance for the physical, chemical, and biological properties of dental implants. For instance, the "ground truth" for fatigue is whether the implant can withstand 5x10^6 cycles without failure as per ISO 14801. The "ground truth" for biocompatibility is whether it passes cytotoxicity and pyrogen tests per ISO 10993. These are objective, quantifiable standards, not subjective interpretations.
8. The sample size for the training set:
This concept is not applicable. There is no "training set" for a physical dental implant system in the AI/ML sense. The "training" for such a device occurs during its design and manufacturing processes, where iterations and refinements are made to meet engineering specifications and regulatory requirements.
9. How the ground truth for the training set was established:
This concept is not applicable. Since there is no "training set" in the AI/ML context, there's no ground truth established for it. The "ground truth" for the device's design and manufacturing quality relies on engineering principles, material science, and adherence to quality management systems (e.g., 21 CFR Part 820 Quality System Regulation).
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(360 days)
The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile. Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.
The provided text is a 510(k) summary for the Implant-One™ System, a dental implant device. It demonstrates the device's substantial equivalence to existing legally marketed predicate devices through non-clinical performance data.
However, the document does not describe a study involving an algorithm, AI assistance, human readers, or any form of "acceptance criteria" related to diagnostic performance or accuracy as one would expect for an AI/ML medical device.
Instead, the "acceptance criteria" and "study" described in this document pertain to engineering and biocompatibility performance of a physical medical device (dental implants and abutments), not a software or AI-driven system.
Therefore, for each of the requested points, the answer is that the information is not applicable (N/A) in the context of this document, as it describes a physical dental implant system and not an AI/ML device that would have such performance criteria.
Here's how to address each point based on the provided text:
Acceptance Criteria and Device Performance (Based on Device Type - Dental Implants)
Since this is for a physical dental implant system, the "acceptance criteria" are related to mechanical integrity, biocompatibility, sterilization, and packaging/shelf-life, rather than diagnostic accuracy. The "device performance" indicates that the device met these criteria by demonstrating substantial equivalence to predicates.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Demonstrated Equivalence To) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ISO 14801 (for worst-case construct performance) | "Non-clinical mechanical testing of the worst case Implant-One™ System construct was performed according to ISO 14801 and demonstrated that the Implant-One™ system performs as well as or better than the predicate devices." |
| Biocompatibility | ISO 10993-5 | "Biocompatibility testing was performed according to ISO 10993-5 and demonstrated substantial equivalence." |
| Sterilization | ISO 11137 and ISO 17665 | "Sterilization validations were performed according to ISO 11137 and 17665 and demonstrated substantial equivalence." |
| Packaging & Shelf-life | ASTM D4169 (including ASTM F1886, ASTM F88, and ASTM F1929) | "Packaging and shelf-life validations were performed according to ASTM D4169 including ASTM F1886, ASTM F88 and ASTM F1929 and demonstrated substantial equivalence." |
| Endotoxin Limit |
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(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.
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(234 days)
The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively prith MyPlason and and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In castof oppriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be appriverad.
The MyPlant II implant system serves as a tooth root substitute and can be used in free jaw sections or edentulous jaws. The MyPlant II implant is made of pure titanium Grade 4 (3.7065). The implant surface is micro-structured. The surface structure is created by blasting with white corundum (> 99 % AlsO3 = aluminum oxide) and etching with acid. Prosthetic connection and thus force transmission is conveyed via an internal cone. A sterile cover screw of 1 mm height is enclosed with each implant to enable an immediate occlusion of the internal thread after successful insertion. The implants are supplied sterile and are intended for single use. MyPlant II Implant System includes various implant variations with different diameters and lengths.
Dental abutments are used to support prosthetic reconstruction. Prosthetic applications can include individual crowns, bridges, partial or full prostheses. Abutments can be used for the replacement of one or more teeth. Depending on the indication and the anatomical conditions, the user will use several components for the specific prosthetic purpose. All components are made of a material suitable for the purpose of the application. The abutments are made of pure titanium Grade 4 (3.7065), titanium alloy Grade 5-ELI (Grade 23/3.7165), or PEEK. Except for the PEEK healing caps, the abutment surface is anodized. Connection to the implant is assured via an internal tapered connection as well as a metric thread. In the case of Abutments 0° / 15° and Shoulder Abutments, the abutment screw is not anodized and undergoes laser welding to connect the threaded sleeves with the shaft. The subject abutments are listed in a table with article number, description, and specifications.
The document provided is a 510(k) Premarket Notification from the FDA for the MyPlant II Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a study with performance metrics.
Therefore, many of the requested details about acceptance criteria and study design are not explicitly available or applicable in the provided text. The document's purpose is to show that the new device is as safe and effective as a legally marketed one, not to independently prove its performance against a set of acceptance criteria in a quantitative sense with a large-scale clinical study that would yield metrics like sensitivity, specificity, or effect sizes for human readers.
However, I can extract information related to the non-clinical tests performed to demonstrate substantial equivalence, which can be seen as meeting certain underlying "acceptance criteria" for material, sterility, and mechanical performance.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of explicit acceptance criteria and corresponding reported device performance in the manner typically seen for diagnostic algorithms (e.g., sensitivity, specificity, F-score). Instead, it lists performance tests and validations conducted against established standards to demonstrate the safety and effectiveness of the dental implant system. The "performance" is reported as conformance to these standards.
| Acceptance Criteria (Standard Conformance) | Reported Device Performance (Conformance) |
|---|---|
| Gamma sterilization validation according to ISO 11137-1 and 11137-2 | Conducted on the subject device and met the standards. |
| Steam sterilization validation according to ISO 17665 and ST79 | Referenced from K132214 (predicate/reference device), implying the subject device meets these by equivalence. |
| Cleaning validation: LAL endotoxin test according to USP [85] and ANSI AAMI ST72 | Referenced from K132214, implying the subject device meets these by equivalence. |
| Sterile barrier system validation according to ISO 11607, ASTM F88/F88M-15 and ASTM F1929-15 | Conducted on the subject device and met the standards. |
| Biocompatibility assessment according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 | Proposed implants: referenced from K143539. Proposed abutments: conducted on the subject device. Both met the standards. |
| Fatigue testing according to ISO 14801 and FDA Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments | Conducted on the subject device and met the standards. Effect of design change (inner cone connection extension) evaluated by fatigue testing and FEM analysis. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable/not provided in the context of this 510(k) submission. The document reports on non-clinical (laboratory) tests and relies on equivalence to predicate devices, rather than a clinical study with a "test set" of patients or data in the way an AI/software device would. The "samples" referred to are physical device components for testing (e.g., for fatigue, sterilization).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable/not provided. The ground truth for the non-clinical tests (e.g., successful sterilization, lack of cytotoxicity, fatigue resistance) is established by adherence to recognized international and national standards and validated laboratory procedures, not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable/not provided. Adjudication methods are typically relevant for clinical studies that involve human interpretation or subjective assessment. The tests performed are objective, based on standardized protocols.
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
This is not applicable/not provided. The MyPlant II Implant System is a physical medical device (dental implants and abutments), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers (e.g., dentists, radiologists) and AI assistance is not relevant or described in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable/not provided. The device is a physical dental implant system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is established by technical standards and validated laboratory methods. For example:
- Sterilization: Demonstrated sterility to a specified sterility assurance level (SAL).
- Biocompatibility: Absence of toxic effects as per ISO 10993.
- Fatigue: Resistance to fracture or failure under specified cyclic loading as per ISO 14801.
8. The sample size for the training set
This is not applicable/not provided. This document pertains to a physical medical device. The concept of a "training set" is relevant for AI/machine learning models, which are not the subject of this 510(k) submission.
9. How the ground truth for the training set was established
This is not applicable/not provided for the same reasons as point 8.
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(172 days)
Implants:
The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- replacing single and multiple missing teeth in the mandible and maxilla, ●
- immediate placement in extraction sites and in situations with a partially or completely . healed alveolar ridge,
- especially indicated for use in soft bone applications where implants with other implant ● surface treatments may be less effective,
- immediate loading in all indications, except in single tooth situations on implants shorter . than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.
The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.
Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
Atlantis Abutments:
The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.
The purpose of this submission is to expand the OsseoSpeed™ Plus Implant System to include all the components of the previously cleared OsseoSpeed System. The OsseoSpeed Plus Implant System, cleared September 26, 2011 under K111287, has the same design as the OsseoSpeed system, except for addition of an anti-rotation feature to the implant/abutment interface.
The OsseoSpeed Plus System includes implants with diameters ranging from Ø3.0 mm to Ø5.4 mm and lengths ranging from 6 mm to 17 mm. Radiographic guides are available for all implant sizes. Abutments sizes range from Ø3.0 mm to Ø5.4 mm in straight and angled designs ranging from 15° to 30°. Abutment designs include coverscrews, healing abutments, temporary abutments, cast-to abutments, ball abutments, straight and angled abutments.
This 510(k) Premarket Notification for the OsseoSpeed™ Plus Dental Implant System primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. Therefore, the information provided does not detail specific acceptance criteria for a new clinical study and a study that proves the device meets those criteria, as one would typically find for a novel device.
The submission is for an expansion of an existing system (OsseoSpeed™ Plus) to include components from the previously cleared OsseoSpeed System (K111287). The core argument for substantial equivalence is based on the device having the "same intended use and design principles" and "same technological characteristics" as predicate devices, supported by non-clinical testing.
Here's an analysis of what is available in the document, acknowledging that typical clinical study acceptance criteria and results are not present:
1. Table of Acceptance Criteria and Reported Device Performance
As this submission relies on substantial equivalence and non-clinical testing, explicit acceptance criteria tied to a clinical performance study with defined metrics (e.g., success rates, complication rates) are not provided in the document.
The "acceptance criteria" here are implicitly linked to demonstrating that the OsseoSpeed™ Plus system is as safe and effective as the predicate devices. The non-clinical data presented aims to show that any differences in technological characteristics do not raise new issues of safety or efficacy.
| Acceptance Criteria Category | Specific Criteria (Implicit/Referenced) | Reported Device Performance (as demonstrated by submission) |
|---|---|---|
| Intended Use Equivalence | Device has the same intended use as predicate devices (replacing single/multiple missing teeth, immediate placement, soft bone applications, immediate loading within specified limits). | The OsseoSpeed™ Plus system has the same stated intended uses as its predicate devices, including replacement of single/multiple missing teeth, immediate placement, soft bone applications, and immediate loading within specified limitations (e.g., OsseoSpeed Plus 3.0S limited to maxillary lateral and mandibular incisors). |
| Technological Characteristics Equivalence | Device has the same or very similar design, operating principle, materials, physical dimensions (diameter/length of implants, diameter/height/angle of abutments), packaging, and sterilization methods as predicate devices. The only noted design difference (anti-rotation feature) does not introduce new safety/efficacy concerns. | The OsseoSpeed™ Plus system has the "same design as the OsseoSpeed system, except for addition of an anti-rotation feature". It incorporates the same basic design, operating principle, and materials, with a comparable range of physical dimensions for implants and abutments. Packaging and sterilization methods are also similar to predicate devices. The non-clinical testing supports that the anti-rotation feature does not compromise safety/efficacy. |
| Non-Clinical Performance Equivalence (Referenced) | Device performance in mechanical and physical tests (engineering analysis, dimensional analysis, surface area/bone-to-implant contact area analysis, static/dynamic compression-bending testing according to ISO 14801) is comparable to predicate devices and acceptable for intended use. The objective is to demonstrate that any differences in technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy. | "Non-clinical testing data provided or referenced to demonstrate substantial equivalence included detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801." The FDA's clearance (K120414) implies that these data satisfied the agency that substantial equivalence was demonstrated. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as there is no specific clinical test set described from a prospective study. The evaluation relies on non-clinical engineering and bench testing data, and the historical performance of the predicate devices. The document does not specify sample sizes for the non-clinical tests, other than referencing the types of tests performed (e.g., ISO 14801).
- Data Provenance: The referenced predicate devices would have been previously marketed (interstate commerce prior to May 28, 1976, or reclassified devices). The non-clinical testing data would typically be generated in a lab setting by the manufacturer (Astra Tech AB, Sweden, or its testing partners).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This question is not applicable for this submission. The ground truth, in the absence of a clinical study, is the established safety and efficacy of the predicate devices, supported by the non-clinical testing confirming that the new device variant performs similarly. Expert consensus on clinical outcomes for a novel test set is not described.
4. Adjudication Method for the Test Set
- Not applicable. There is no clinical test set requiring an adjudication method by experts for ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No. This type of study is not mentioned or implied in this 510(k) submission, as it focuses on dental implants, not image-based diagnostic aids or similar devices where MRMC studies are common.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The OsseoSpeed™ Plus is a physical dental implant system, not a software algorithm or AI-driven device.
7. The type of ground truth used
- The "ground truth" for this 510(k) clearance is primarily:
- The established safety and efficacy profile of the legally marketed predicate devices.
- Bench test results and engineering analyses (e.g., mechanical strength, dimensional accuracy, surface characteristics) demonstrating that the subject device performs comparably to the predicates and meets relevant standards (like ISO 14801).
- The regulatory precedent set by the predicate devices.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of a machine learning algorithm for this physical device. If referring to product development and testing, the sample size for non-clinical tests would be defined by engineering standards and internal validation protocols, but specific numbers are not provided in this summary.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI algorithm, this question doesn't apply. The "ground truth" for the overall submission is based on regulatory precedent and engineering validation against established standards and predicate devices.
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(126 days)
The Atlantis Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
This device is compatible with the following manufacturers' implant systems:
The titanium abutments are compatible with the Dentsply 3.5mm, 4.5mm, 5.5mm and 7.0mm Ankylos Implants:
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Dentsply Ankylos Implant and abutment screw are made from Titanium grade Ti-6A 1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.5mm, 5.5mm, and 7.0mm sizes. The titanium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Atlantis™ Abutment for Dentsply Ankylos Implant:
This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for a new device's efficacy. In this case, the device is an implant abutment, which is a component of a dental implant system. The "performance" discussed primarily relates to its compatibility and functional equivalence to existing, legally marketed components.
Based on the provided text, a formal study with quantitative acceptance criteria as one might expect for a diagnostic AI device is not presented. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for substantial equivalence for a physical medical device (dental abutment), the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnostic study. Instead, the acceptance criteria are met by demonstrating the device is:
- Substantially equivalent in intended use, material, design, and performance to the predicate devices.
- Able to perform the same functions as the predicate devices.
- Made of the same material as the predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Atlantis™ Abutment) |
|---|---|
| Material Equivalence: Made of the same material as predicate. | Titanium alloy (Ti-6Al-4V ELI, meets ASTM Standard F-136) - Meets. (Same as Dentsply Ankylos C/X Implant System) |
| Performance Characteristics Equivalence: Allows prosthesis to be cemented/screw-retained, abutment screw secures abutment to implant. | Allows prosthesis to be cemented or screw-retained to the abutment. Abutment screw secures the abutment to the endosseous implant. - Meets. (Same as Dentsply Ankylos C/X Implant System) |
| Specifically designed for the screw to fail before the implant, indicating a considered design decision. | |
| Intended Use Equivalence: Supports prosthetic device in partially/completely edentulous patients, single/multiple tooth prosthesis, mandible/maxilla. | Intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. Intended for use to support single or multiple tooth prosthesis, in mandible or maxilla. - Meets. (Same as Dentsply Ankylos C/X Implant System) |
| Safety Concerns Equivalence: No new safety or effectiveness concerns compared to predicate devices or the general class of devices. | The document discusses known safety and effectiveness problems for similar abutment systems but argues the device is substantially equivalent, implying it does not introduce new or unmitigated risks beyond those already recognized for the predicate devices. |
| Compatibility: Compatible with specified implant systems. | Compatible with Dentsply 3.5mm, 4.5mm, 5.5mm and 7.0mm Ankylos Implants. - Meets. |
2. Sample Size Used for the Test Set and Data Provenance
No specific "test set" in the context of an AI study is mentioned. The submission relies on a comparison of characteristics and intended use to existing, legally marketed predicate devices (Dentsply Ankylos C/X Dental Implant System K083805 and Astra Tech Inc. Atlantis™ Abutment K093780). There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document describes a physical medical device (dental abutment), not an AI or diagnostic device that would require expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no human-reviewed test set or adjudication method described.
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 a filing for a physical medical device, not an AI or diagnostic software subject to MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a filing for a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for a physical device like a dental abutment would be its physical properties, material composition, manufacturing tolerances, and functional performance (e.g., torque strength, fatigue resistance), typically evaluated through engineering tests, not a "ground truth" as understood in AI/diagnostic studies. The document mentions ASTM Standard F-136 for material, which provides a standard specification for titanium alloy for surgical implants, serving as a form of "ground truth" for material properties.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set or associated ground truth establishment process described.
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