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510(k) Data Aggregation
(91 days)
Elos Accurate Hybrid Base
The Elos Accurate® Hybrid Base The intended for attaching to dental inplants in order to provide basis for dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:
Table 1.
Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm]
Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5
The zirconia superstructures for use with the Elos Accurate® Hybrid Base "" are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, ceramic material, milling machine and associated tooling and accessories.
Elos Accurate Customized Abutment
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutment is compatible with the implant systems listed in table 1: Table 1.
Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm]
Straumann BLX RB/WB | Ø3.4/Ø3.5/Ø4.5 | Ø3.5/Ø3.75/Ø4/Ø4.5/Ø5/Ø5.5/Ø6.5
Astra Tech 3.0 | Ø3. | Ø3
Astra Tech EV 3.0 | Ø3 | Ø3
All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ are both patient-specific components designed for attaching to dental implants, providing a basis for single or multiple tooth prosthetic restorations.
The Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ will be attached to the implant using the included Elos Prosthetic Screw.
The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the pre-manufactured prosthetic component, the Hybrid Base in Titanium alloy per ASTM F136, as the bottom-half, and the zirconia superstructure as the top-half, which the laboratory/clinic is designing by use of the 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455), which when assembled comprises the finished medical device. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) While the Elos Accurate® Customized Abutment is a one-piece abutment which consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The same applies to the Elos Accurate® Hybrid Base™ which fits directly to an endosseous dental implant. The customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility.
The Elos Accurate library files for both Elos Accurate® Customized Abutment and Elos Accurate® Hybrid Base™ have built-in design limitations, and the user isn't allowed to exceed these limitations as follows:
Customized Abutments: | Hybrid Base abutments (zirconia part):
Min. wall thickness 0.4 mm | Min. wall thickness 0.5 mm
Gingival height min. 0.5mm or max. 5 mm | Gingival height min. 0.5mm or max. 5 mm
Max. angulation 20° or 30°. | Max. angulation 20°.
Min. post height* 4 mm | Min. post height* 4 mm
*The post height is defined as the cementable height of the abutment.
The Elos Accurate® Customized Abutment and the Elos Accurate® Hybrid Base™ are both delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient.
The provided text describes the submission of a 510(k) premarket notification for the "Elos Accurate® Hybrid Base™" and "Elos Accurate® Customized Abutment" dental devices. The purpose of this submission is to demonstrate that these devices are substantially equivalent to previously marketed predicate devices. The document details the indications for use, product descriptions, a comparison of technological characteristics with predicate devices, and a summary of non-clinical testing.
Here's an analysis of the acceptance criteria and the study proving device conformity:
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria are not explicitly stated with numerical targets in the document. Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "reported device performance" is primarily presented as the devices meeting the same or similar functional and safety standards as the predicate devices, with specific validations for expanded compatibility and design workflows.
The "Element of Comparison" table acts as a de facto set of acceptance criteria, where the subject device's characteristics are compared against the predicate devices, and "Substantial equivalent" is the reported "performance."
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Support of a prosthesis to restore chewing function | Substantial equivalent (Same as predicate) |
| Abutment Designs: | |
| Elos Accurate® Customized Abutment: 1 piece - abutment mounted on implant, fixed with screw | Substantial equivalent (Same as predicate) |
| Elos Accurate® Hybrid Base™: 2 piece - zirconia bonded to hybrid base mounted on implant, fixed with screw | Substantial equivalent (Same as predicate) |
| Prosthesis Attachment: | |
| Customized Abutment: Abutment screw-retained to implant | Substantial equivalent (Same as predicate) |
| Hybrid Base: Abutment screw-retained to implant, superstructure cement-retained | Substantial equivalent (Same as predicate) |
| Restoration: | |
| Customized Abutment: Single-unit | Substantial equivalent (Same as predicate) |
| Hybrid Base: Single-unit, Multi-unit | Substantial equivalent (Same as predicate) |
| Abutment/Implant Platform Diameter (mm): | |
| Customized Abutment: 3.0 – 4.5 | Customized Abutment: Implant diameter for the subject device is down to 3.0mm, which is smaller than the primary predicate device (3.2 – 7.0 for the predicate). Mechanical performance of the 3mm diameter components for both AstraTech & AstraTech EV is demonstrated in fatigue testing. |
| Hybrid Base: 3.4 – 4.5 | Hybrid Base: Substantial equivalent as Implant diameter for the subject device is within the range of the Primary Predicate Device K230317 (3.2 – 7.0 for the predicate). |
| Abutment Angle: | |
| Customized Abutment: up to 20° (AstraTech), up to 30° (Straumann BLX) | Substantial equivalent, as the max angulation is within the value used for Reference Device K231307 (up to 30° for the predicate). |
| Hybrid Base: 20° maximum | Substantial equivalent (Same as predicate). |
| Gingival Height: Up to 5 mm | Substantial equivalent (Same as predicate). |
| Materials: | |
| Abutment: Ti-6Al-4V alloy | Substantial equivalent (Same as predicate). |
| Screw: Ti-6Al-4V alloy | Substantial equivalent (Same as predicate). |
| Zirconia superstructure: 3M Lava zirconia (for Hybrid Base) | Substantial equivalent (Same as predicate). |
| Surface: | |
| Customized Abutment: Abutment/Screw: Non-coated | The surface of the Subject Abutment & screw is substantial equivalent to Primary Predicate Device K230317. Mechanical performance is demonstrated in fatigue testing (Note: Predicate K231307 mentions "Medicarb coating" for the screw, while K230317 mentions "non-coated, Medicarb coated"). |
| Hybrid Base: Abutment: Anodized; Screw: Non-coated | The surface of the Subject Abutment & screw is substantial equivalent to Primary Predicate Device K230317. Mechanical performance is demonstrated in fatigue testing (Note: Predicate K230317 also mentions "non-coated, Medicarb coated" for the screw, which is partially different but deemed equivalent due to testing). |
| Design Workflow: 3Shape scanner, 3Shape Abutment Designer Software (K151455) | Substantial equivalent (Same as predicate). New digital libraries were validated as part of the subject submission, including: Scanner (3Shape >10um accuracy), Design library file (DME-file) with built-in limits, Design Software (3Shape Abutment Designer K151455). Testing of design limits conducted to show avoidance of designing outside specified limits. |
| Manufacturing Workflow: CORITEC milling unit (imes-icore) | Substantial equivalent (Same as predicate). |
| Adhesive material (for Hybrid Base): Multilink Hybrid Abutment Cement (K130436) or Panavia V5 (K150704) | Substantial equivalent (Same as predicate). |
| Sterilization: Full cycle pre-vacuum steam sterilization at 132 °C (270°F) for 4 mins, 20 mins dry time | Substantial equivalent (Same as predicate). Sterilization and Dry-time studies leveraged from K230317/K231317 (material, size, geometry are substantially equivalent). |
| Operating principle: Connect dental implant to prosthetic crown/bridge | Substantial equivalent (Same as predicate). |
2. Sample size used for the test set and data provenance
The document does not specify a "test set" in the context of an AI/human performance study. Instead, the testing described is primarily engineering and material characterization:
- Fatigue testing per ISO 14801: This testing involves multiple samples to assess mechanical durability. While the exact number of samples isn't given, standard ISO 14801 typically requires a significant number of samples tested to failure or for a specified number of cycles.
- Biocompatibility testing for cytotoxicity (ISO 10993-5): This testing would use biological samples or cell lines. The document states it's leveraged from previously cleared products (K230317/K231317) on "identically manufactured abutments and prosthetic screws manufactured from the same material."
- Sterilization validation (ISO 17665-1 & ISO 17665-2): Involves using Biological Indicators (BIs) or other validation methods, typically multiple cycles and samples. Leveraged from K230317/K231317.
- MRI Conditional Safety Evaluations (ASTM F2052, ASTM F2119, ASTM F2213, ASTM F2182): A "worst-case assembly" was tested, implying at least one, but possibly multiple, physical assemblies to cover various MRI conditions. Leveraged from K230317/K231317.
- Digital dentistry workflow validation: Conducted on "selected model of subject product lines," implying a representative set of designs.
Data Provenance: The data comes from non-clinical testing performed by the manufacturer (or leveraged from prior submissions by the same manufacturer, Elos Medtech Pinol A/S). The origin is Denmark (company location). The testing is prospective for the current submission but leverages retrospective data from previous clearances.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not applicable to this submission. The device is a physical dental abutment, not an AI/diagnostic device that generates an output requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its physical, mechanical, and biological properties, which are established through standardized engineering and laboratory tests, not expert consensus on diagnostic images.
4. Adjudication method for the test set
This is not applicable as there is no test set involving expert interpretation or a diagnostic outcome that would require 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 is not applicable as the device is a physical dental abutment, not an AI-assisted diagnostic tool or software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical dental abutment. The "digital dentistry workflow" involves software (3Shape Abutment Designer Software) but this is used for design and manufacturing, not for standalone diagnostic performance assessment.
7. The type of ground truth used
The "ground truth" for this engineering-focused submission is established through:
- Engineering and dimensional analysis: Measurements and specifications of various components (abutments, implants, screws).
- Mechanical testing: Fatigue testing per ISO 14801 to assess durability and strength under simulated physiological loading.
- Biocompatibility testing: Standardized testing (ISO 10993-5) to confirm non-cytotoxicity.
- Sterilization validation: Standardized testing (ISO 17665-1 & ISO 17665-2) to confirm sterility.
- MRI compatibility testing: Standardized testing (ASTM F2052, ASTM F2119, ASTM F2213, ASTM F2182) to confirm MR conditional status.
- Design software validation: Testing that the software (3Shape Abutment Designer) adheres to "built-in design limitations" and prevents users from exceeding them.
8. The sample size for the training set
This is not applicable. The submission is not for an AI/machine learning device that requires a training set. The descriptions of "design limitations" and "digital dentistry workflow validation" refer to the validation of software and manufacturing processes, not the training of an algorithm in the machine learning sense.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for the reasons outlined above. The "design limits" mentioned for the digital dentistry workflow are predefined by Elos Medtech based on engineering principles and safety considerations for dental prosthetics.
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(238 days)
The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
- · Replacing missing teeth in single or multiple unit applications in the mandible or 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 with other implant surface treatments may be less effective.
• Immediate and early loading for all indications, except in single tooth situations on implant shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain, and immediate loading may not be appropriate.
· The intended use for PrimeTaper EV Ø3.0 is limited to replacement of maxillary lateral incisors and mandibular incisors.
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.
MultiBase Abutments EV:
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.
The proposed (A) PrimeTaper EV Dental Implant Ø3.0 is a root form endosseous implant which is intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. It represents an additional extra small implant diameter implant) to reference device PrimeTaper EV Dental Implants (K210610).
The proposed (A) PrimeTaper EV Dental Implant Ø3.0 has the identical implant-abutment connection geometry as the predicate (A) Astra Tech EV Implant (K120414), and is therefore compatible with the reference device Astra Tech EV Abutments (K120414) with 3.0 mm diameter of the Astra Tech Implant System EV (K120414).
The proposed (B) DS Implant abutments with EV connection XS include the following abutments and accessories:
- TiDesign EV (XS) ●
- MultiBase Abutment EV (XS) ●
- . TempAbutment EV (XS)
- Healing Abutment EV (XS) ●
- HealDesign EV (XS) ●
- Cover Screw EV (XS)
- Abutment Screw EV (XS) ●
The proposed (B) DS Implants abutments with EV connection XS are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments compatible with the proposed (A) PrimeTaper EV Dental Implant Ø3.0 and represent an additional extra small abutment-implant diameter (XS, 3 mm diameter) to the Predicate (B) DS Implants abutments with EV Connection in sizes S (small), M (medium) and L (large) (K213449).
The proposed (B) abutments have the identical implant-abutment connection geometry as the reference device Astra Tech EV Abutments (K120414) and are therefore compatible with the predicate (A) Astra Tech EV Implants (K120414) with 3.0 mm diameter.
The proposed (A) PrimeTaper EV Dental Implant Ø3.0 and proposed (B) DS Implants abutments with EV connection XS are single-use devices and are provided sterile by electron-beam irradiation except for TiDesign EV (XS). TempAbutment EV (XS) and Abutment Screw (XS), which are provided non-sterile. Devices provided as non-sterilized by the end user via steam sterilization.
The document provided is a 510(k) summary for Dentsply Sirona's PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection (XS). It describes the devices, their intended use, and substantial equivalence to predicate and reference devices based on non-clinical performance data and published literature.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner with specific thresholds. Instead, it relies on demonstrating that the proposed devices (PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection XS) are substantially equivalent to legally marketed predicate devices. The performance is assessed by confirming that the proposed devices satisfactorily meet the requirements of non-clinical bench testing and aligning with published clinical data on similar devices.
However, based on the non-clinical testing performed, we can infer performance criteria against established standards:
| Acceptance Criteria (Inferred from testing standards) | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) of 10⁻⁶ (ISO 11137-1:2006, ISO 11137-2:2013) | Proposed sterile devices (implants and certain abutments) were validated to a SAL of 10⁻⁶ via Electron-Beam (E-beam) irradiation. No changes to sterilization method compared to reference/predicate. |
| Biocompatibility (ISO 10993-1:2018; ISO 10993-5:2009; ISO 10993-18:2020) | Devices confirmed to be biocompatible through cytotoxicity testing, gas chromatography (GC-MS), Fourier transformation infrared spectrometry (FT-IR), and pyrogenicity testing (monocyte activation testing). Materials, body contact, duration, packaging, and sterilization method are consistent with reference/predicate devices. |
| Dynamic Fatigue Performance (ISO 14801:2016) | Worst-case implant-abutment combinations were tested. Test results demonstrate that the proposed devices perform as intended and support substantial equivalence to the predicate devices. |
| Pyrogenicity (USP Bacteria Endotoxins Test) | During routine production, the method used (LAL test) confirms that the proposed sterile devices meet the established pyrogen limit. They will not be marketed as non-pyrogenic. |
| Packaging Integrity & Shelf Life (ISO 11607-1:2019) | Packaging and materials are the same as reference/predicate devices. A shelf life of five (5) years is applicable, supported by existing packaging validation. |
| MRI Safety (Conditional) (ASTM F2052-21, ASTM F2213-17, ASTM F2119-07(2013) and Computational modeling & simulation) | Testing confirmed: magnetically induced displacement force, magnetically induced torque, and image artifact. RF Induced Heating Simulation using Computational modeling and simulation (CM&S) was performed. Based on these results, proposed device labeling will indicate "MRI Conditional." (Specific performance values for MRI compatibility are not detailed in this summary, but the "MRI Conditional" designation indicates regulatory acceptance). |
| Clinical Performance (Inferred from literature) (High survival rates, well-maintained marginal bone) | Published literature on similar 3.0 mm dental implants (reference device, OsseoSpeed 3.0 mm. Astra Tech Implant System (K080396)) showed high survival rates (mean >98%) and well-maintained marginal bone around the implants, supporting reliability for limited alveolar space. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-clinical Testing (Bench Tests): The document refers to "worst-case implant-abutment combination" for fatigue testing but does not specify the exact number of samples tested for each non-clinical performance test (e.g., fatigue, biocompatibility, sterilization validation, MRI). It is implied that sufficient samples were tested to meet the requirements of the respective ISO and ASTM standards.
- Clinical Literature:
- Sample Size: 200 narrow diameter implants (OsseoSpeed 3.0 mm, Astra Tech Implant System (K080396)) were evaluated. These implants were placed in "over 160 patients."
- Data Provenance: The data is from "six peer-reviewed scientific publications" presenting "1 to 5 years of clinical follow-up data from four (4) different clinical trials." The country of origin is not specified but it relates to published peer-reviewed scientific literature. The studies were prospectively followed up.
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 section is not applicable to this submission. The "ground truth" in this context is established through compliance with recognized international standards (ISO, ASTM) for non-clinical testing and clinical outcomes reported in peer-reviewed literature, rather than expert adjudication of a test set in the way one might see for an AI algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/imaging device where expert adjudication for ground truth establishment is typically performed.
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 submission is for dental implants and abutments, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Non-clinical Testing: The "ground truth" for non-clinical performance (sterilization, biocompatibility, fatigue, MRI safety, pyrogenicity, packaging) is defined by established international standards (ISO, ASTM) and FDA guidance documents. The device's performance is measured against these technical standards.
- Clinical Performance (via literature): The "ground truth" is based on outcomes data (survival rates, marginal bone maintenance) reported in peer-reviewed clinical literature.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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(251 days)
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the AT TX 3.0 S, 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.XXXX) (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 in the document)
The Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K181520. The modified Sirona Dental CAD/CAM System with CEREC Chairside Software that is the subject of this premarket notification includes a line extension to the existing offerings. These additional TiBase variants facilitate compatibility with currently marketed dental implant systems.
The modified Sirona Dental CAD/CAM System with CEREC Chairside Software which is the subject of this premarket notification consists of:
- CEREC SW "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
- Additional Sirona TiBase titanium base components (line extension subject to this submission) compatible with Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 implants.
- inCoris ZI zirconium mesostructure blocks
As subject to this premarket notification, the Sirona Dental CAD/CAM System with CEREC Chairside Software 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 prefabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system.
As subject to this premarket notification, the subject Sirona Dental CAD/CAM System with CEREC Chairside Software is modified to include a line extension to the existing TiBase offerings by introducing TiBases which are compatible with the Dentsply Sirona Osseospeed TX 3.0, 3.5, 4.0, 4.5, and 5.0 dental implants.
The CEREC SW 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 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium/zirconia block materials.
The Sirona Dental CAD/CAM System with CEREC Chairside Software is intended for the design and fabrication of two-piece, CAD/CAM dental abutments.
Here's a breakdown of the acceptance criteria and the study information for the Sirona Dental CAD/CAM System with CEREC Chairside Software, based on the provided text:
Preamble: This 510(k) submission, K193408, is for a modification to an existing device (Sirona Dental CAD/CAM System, K181520), specifically a line extension for additional TiBase variants to facilitate compatibility with more dental implant systems. Therefore, the "study" described is primarily focused on demonstrating that the new variants perform comparably to the previously cleared predicate, rather than a de novo clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Geometric compatibility of implant to TiBase connection interface | Confirmed for new Sirona TiBase components via direct access to original manufacturer's implant geometry specifications for Dentsply Sirona, OsseoSpeed TX implant system. Designed through direct reference to original implant design specifications. |
| Dynamic fatigue testing per ISO 14801 (Dentistry - Implants) | Conducted using new TiBase variants in worst-case construct (maximum allowable abutment angulation and worst-case implant connection interface geometry). Results are not explicitly stated as passing a specific threshold in the provided text, but the conclusion states "The results of the performance testing support substantial equivalence." |
| Biocompatibility of new TiBase variants | Composed of identical materials and fabricated using the same methods as components cleared under K181520. No new biocompatibility data included, relying on previous clearance. |
| Steam sterilization parameters for new TiBase components | Identical to validated parameters recommended for TiBase components in K181520. Validation conducted according to ISO 17665-1 and ANSI/AAMI ST79. Reference to original validation supports substantial equivalence. |
| Software system integration testing for TiBase line extension | Conducted to validate system requirements for the introduction of the TiBase component line extension as selectable within CEREC Chairside CAD/CAM software. No modification to critical abutment design parameters. Results are not explicitly stated, but the conclusion states "The results of the performance testing support substantial equivalence." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a specific number for each test. The dynamic fatigue testing mentions "test sample constructs," implying multiple items were tested, but a precise number is not provided.
- Data Provenance: This is non-clinical performance data. The location of the testing is not specified, but it would have been generated by Dentsply Sirona or a contracted testing lab. It is inherently prospective data, generated specifically for this submission to demonstrate the performance of the new TiBase variants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This submission is for a medical device (dental CAD/CAM system components), not an AI/imaging diagnostic device that requires expert review for ground truth establishment. The "ground truth" here is based on engineering specifications, material properties, and standardized performance tests (e.g., ISO 14801).
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical performance testing of physical components and software functionality, there is no expert adjudication process involved in the same way as for diagnostic AI outcomes. The performance is assessed against established engineering standards and design specifications.
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
- No. An MRMC comparative effectiveness study was not performed. This device is a CAD/CAM system for fabricating dental abutments, not an AI diagnostic tool used by human readers to interpret medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, indirectly. The performance tests described (geometric compatibility, dynamic fatigue, biocompatibility, sterilization validation, software integration) evaluate the device's performance in a standalone manner, separate from its use by a human operator in a clinical setting for diagnosis. The software component, specifically, underwent system integration testing to validate its requirements and functionality for designing the mesostructure, which is a standalone algorithm function.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Results:
- Geometric compatibility: Original manufacturer's implant geometry specifications.
- Dynamic fatigue: Adherence to ISO 14801 standards for dental implants.
- Biocompatibility: Previous clearance (K181520) and established material properties.
- Sterilization: Adherence to ISO 17665-1 and ANSI/AAMI ST79 standards.
- Software integration: System requirements and design controls.
8. The Sample Size for the Training Set
- Not Applicable (or not provided in the document). This device is a CAD/CAM system modification, not an AI model that requires a training set in the typical machine learning sense. The software component is likely developed using traditional software engineering principles and validated through integration testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point #8.
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(207 days)
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in Table 1.
All digitally designed zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility.
The Elos Accurate Hybrid Base is a titanium base designed to interface with a dental implant and to support a patient-specific ceramic superstructure or a multi-unit direct restoration cemented to the base. The base and the superstructure form a patient-specific abutment that will support a definitive restoration, either a single crown or a multi-unit restoration. The Elos Accurate Hybrid Base Engaging is intended for single-unit restorations and Elos Accurate Hybrid Base Nonengaging is intended for multi-unit restorations. Alternatively, a definitive multi-unit restoration may be cemented directly to the Elos Accurate Hybrid Base.
Manufacture of the final finished device will be at an Elos Medtech-approved milling facility that is registered with FDA as a medical device manufacturer and is qualified as a contract manufacturer to Elos Medtech.
This submission includes a two-piece abutment (titanium base and zirconia superstructure) and abutment screws compatible with OEM implants from Dentsply Implants (Astra Tech TX, Astra Tech EV), Nobel Biocare (Nobel Active/Conical Connection and Nobel Replace) and Institut Straumann (Straumann Bone Level NC and RC).
Abutments compatible with Astra Tech implants are available in engaging (anti-rotational) designs, and all others are available in both engaging and non-engaging designs.
This document is a 510(k) Premarket Notification from the FDA regarding the "Elos Accurate® Hybrid Base" dental implant device. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study with acceptance criteria.
Therefore, the information required to directly answer some of your questions, particularly those related to the performance study design for an AI/ML-based medical device (e.g., sample size for test/training sets, expert consensus, MRMC studies, ground truth establishment for AI models), is not present in this document. This is because the device in question is a physical dental implant component, not an AI/ML algorithm.
However, I can extract the relevant information regarding the performance data provided for this physical device.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria and reported device performance in the way an AI/ML device submission would. Instead, it states that substantial equivalence is demonstrated through:
- Biocompatibility evaluation and confirmatory cytotoxicity testing: According to ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity).
- Dynamic compression-bending testing: According to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants).
- Engineering and dimensional analysis: To confirm compatibility with OEM implant bodies, OEM abutments, and OEM abutment fixation screws.
- Sterilization validation: In accordance with ISO 17665-1 and ISO 17665-2.
Reported Performance/Demonstration:
- "Substantial equivalence with regard to compatibility with OEM components is supported by engineering and dimensional analysis of OEM implant bodies, OEM abutments and OEM abutment fixation screws to confirm compatibility."
- "Substantial equivalence with regard to mechanical performance is supported by dynamic testing according to ISO 14801 Dentistry – Implants – Dynamic fatigue test for endosseous dental implants."
- "The coatings used on selected screws are identical to coatings on previously cleared devices."
- "Sterilization validation of the reprocessing instructions were conducted in accordance to ISO 17665-1 and ISO 17665-2."
- "Minor differences in the designs, dimensions, sizes, or compatible OEM implant lines... do not affect substantial equivalence. These minor differences... are related to the compatible OEM implant designs or are mitigated by the mechanical performance testing."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the non-clinical tests (biocompatibility, dynamic fatigue, engineering analysis, sterilization). The document indicates "No clinical data were included in this submission," further confirming that there wasn't a "test set" in the context of patient data for AI performance evaluation.
- Data Provenance: Not applicable as it's not clinical data. The tests are laboratory-based.
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)
- Not applicable. This device is a physical component, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As above, this is not a diagnostic study 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
- Not applicable. No clinical or human-in-the-loop study was conducted or required for this physical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The "performance data" refers to the physical and mechanical properties of the dental abutment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical performance data, the "ground truth" or reference standards are the ISO standards themselves (ISO 10993-5, ISO 14801, ISO 17665-1, ISO 17665-2), and the engineering specifications/dimensions of OEM implant components for compatibility analysis. This is a technical ground truth based on established material science and mechanical engineering principles, rather than medical expert consensus or patient outcomes.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/ML model for this physical device.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML model.
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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 maxillary lateral incisors and mandibular lateral and central incisors. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
This device is compatible with the Astra Tech OsseoSpeed 3.0 mm Implant.
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 restorations.
The Atlantis™ Abutments for Astra Tech OsseoSpeed 3.0 Implant System and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with Astra's 3.0 mm OsseoSpeed™ Implants.
This document is a 510(k) summary for the Atlantis™ Abutment for Astra Tech OsseoSpeed 3.0 Implant System and does not contain information about the acceptance criteria or a study proving that the device meets such criteria. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.
The document states:
- "The Atlantis™ Abutments for Astra OsseoSpeed 3.0 Implants are substantially equivalent in intended use, material, design and performance to the Atlantis Abutments tor Astra Implants cleared under K070833 and for the Astra Tech OsseoSpeed TM Narrow Implants cleared under K080396."
To answer the user's request, I would need a different type of document, such as a full study report or a design verification document, which is not provided here.
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