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510(k) Data Aggregation
(152 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 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] |
|---|---|---|
| Astra Tech EV 3.0 | Ø3 | Ø3 |
| Astra Tech EV 3.6 | Ø3.6 | Ø3.6 |
| Astra Tech EV 4.2 | Ø4.2 | Ø3.6 & Ø4.2 |
| Astra Tech EV 4.8 | Ø4.8 | Ø4.2 & Ø4.8 |
| Astra Tech EV 5.4 | Ø5.4 | Ø5.4 |
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. CAM software, ceramic material, milling machine and associated tooling and accessories,
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™ functions as an interface between a dental implant and a zirconia superstructure. It attaches to the implant using the included prosthetic screw and connects to the zirconia superstructure through cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.
The Elos Accurate® Hybrid Base™ is available for two types: Engaging and Non-Engaging.
- The Hybrid Base™ Engaging which is intended for single tooth dental restorations and having an indexing feature. which avoid the Hybrid Base from rotating in the implant.
- -The Hybrid Base™ Non-Engaging is intended for multiple tooth dental restorations and has no indexing feature, which allows the Hybrid Base to rotate in the implant.
The Elos Accurate® Hybrid Base™ is available with 4 different collar heights and is provided with a 7,5mm chimney which can be cut down to several heights by the user, to minimum 3,5 mm.
The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:
| Hybrid Base abutments (zirconia part): |
|---|
| Min. wall thickness 0.5 mm |
| Gingival height min. 0.5mm or max. 5 mm |
| Max. angulation 20°. |
| Min. post height* 4 mm |
*The post height is defined as the cementable height of the abutment.
The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.
The Prosthetic Screw, also made of Titanium Alloy (ASTM F136), provided for the Elos Accurate® Hybrid Base™ is used to secure the final prosthetic restoration to the implant in the patient's mouth. The Prosthetic Screws have a hexalobular driver connection interface. The intended driver to be used with the Elos Accurate® Hexalobular Prosthetic Screws is the Elos Accurate® Prosthetic Screwdriver 18mm, 26mm or 34mm (Ref. No. PS-AH18-1, PS-AH26-1 or PS-AH34-1). These screwdrivers are Class I Exempt devices per FDA product code NDP.
The Elos Accurate® Hybrid Base has a gold anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K230317.
The subject prosthetic screws are provided anodized identical to reference device K120414.
The Elos Accurate® Hybrid Base™ and the Prosthetic screw is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient. The recommended sterilization procedure is full cycle pre-vacuum steam sterilization at a temperature of 132 °C (270°F) for 4 minutes. Dry time: 20 minutes.
The Elos Accurate® Hybrid Base™ is sold in 1 pc. packaging and the Elos Accurate® Prosthetic screw is sold in 1 pc. packaging.
The provided text does not describe an AI medical device. It is a 510(k) summary for a dental implant component, the Elos Accurate® Hybrid Base™. Therefore, it is impossible to extract the requested information about acceptance criteria and a study proving an AI device meets those criteria.
The document focuses on demonstrating the substantial equivalence of the Elos Accurate® Hybrid Base™ to a predicate device, primarily through:
- Similar Indications for Use and Intended Use: The device serves the same purpose as existing products.
- Comparable Design and Materials: It uses similar components (titanium alloy, zirconia) and design principles.
- Non-Clinical Testing: Fatigue testing (meeting ISO 14801), engineering and dimensional analysis, sterilization validation, digital dentistry workflow validation, and biocompatibility testing were performed. The fatigue testing is the closest parallel to performance testing, but it's for mechanical durability rather than diagnostic or analytical accuracy.
There is no mention of an algorithm, AI, machine learning, or any form of software that provides diagnostic or analytical outputs. Consequently, none of the specific questions about AI device performance metrics, training sets, ground truth establishment, or multi-reader studies can be answered from this document.
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(228 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 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:
| Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] |
|---|---|---|
| Nobel Replace NP | 3.5 | 3.5 |
| Nobel Replace RP | 4.3 | 4.3 |
| Nobel Replace WP | 5 | 5 |
| Nobel Replace 6.0 | 6 | 6 |
| Nobel OC 3.0 | 3 | 3 |
| Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Nobel OC RP | 3.9 | 4.3 & 5 |
| Nobel CC WP | 5.1 | 5.5 |
| Straumann Bone Level NC | 3.3 | 3.3 |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
| Astra Tech 3.0 | 3 | 3 |
| Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 |
| Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 |
| Astra Tech EV 3.0 | 3 | 3 |
| Astra Tech EV 3.6 | 3.6 | 3.6 |
| Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 |
| Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 |
| Astra Tech EV 5.4 | 5.4 | 5.4 |
| Brånemark NP | 3.5 | 3.3 |
| Brånemark RP | 4.1 | 3.75, 4 & 5 |
| Brånemark WP | 5.1 | 5 & 6 |
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended 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, ceramic material, milling machine and associated tooling and accessories.
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 a two-piece abutment composed of the Hybrid Base as the bottom-half and the zirconia superstructure as the top-half.
The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (i.e. 3Shape Abutment Designer Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:
- Minimum wall thickness 0.5 mm
- Minimum post height 4.0 mm (for single unit restorations)
- Maximum gingival height 5.0 mm
- Maximum angulation 20°
The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436) and the final prosthetic restoration is attached to the implant using a Prosthetic screw. The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
The provided text describes the regulatory clearance of a dental device, the "Elos Accurate® Hybrid Base™", through a 510(k) premarket notification. This process is based on demonstrating substantial equivalence to previously marketed predicate devices, rather than proving safety and effectiveness through clinical trials with acceptance criteria traditionally associated with new drug or high-risk device approvals.
Therefore, the document does not contain information on acceptance criteria for device performance in the classical sense (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device), nor does it describe a study to prove the device meets these types of acceptance criteria.
Instead, the "acceptance criteria" here refer to the regulatory requirements for demonstrating substantial equivalence. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing and analyses performed to support this substantial equivalence claim.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent or different from a typical AI/diagnostic device performance study:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't define quantitative performance acceptance criteria like sensitivity/specificity for a diagnostic. The "acceptance criteria" for this 510(k) submission are met by demonstrating:
| Acceptance Criterion (Regulatory) | Reported "Performance" / Evidence Presented |
|---|---|
| Intended Use Equivalence | Subject device has the same intended use as predicate: "attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations." |
| Operating Principle Equivalence | Uses the same operating principle as predicate. |
| Basic Design Equivalence | Incorporates the same basic design (two-piece abutment, titanium alloy base, zirconia superstructure). |
| Material Equivalence | Incorporates same or very similar materials (Ti-6Al-4V alloy for Hybrid Base and screw, 3M Lava Plus Zirconia for superstructure, specific cement). |
| Sterilization Process Equivalence | To be sterilized using the same processes (non-sterile delivery, final restoration sterilized at dental clinic). |
| Dimensional and Compatibility Equivalence | Engineering and dimensional analyses of original manufacturers' components (abutments, implants & abutment screws) were made to determine nominal dimensions and tolerances and ensure compatibility with listed implant systems. |
| Fatigue Resistance (Mechanical Performance) | Fatigue testing per ISO 14801 was performed according to FDA guidance. |
| Biocompatibility | Biocompatibility testing for cytotoxicity according to ISO 10993-5 was performed. Previous 510(k) cleared products sharing identical manufacturing processes and materials also showed non-cytotoxicity. |
| Digital Workflow Validation | Validation of the digital dentistry workflow (scanner, design software, milling unit) with the subject product line, ensuring design limits are enforced by the software. |
2. Sample Sized Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., a set of medical images). The "testing" refers to mechanical and biocompatibility tests of the device components.
- For fatigue testing (ISO 14801): The sample size for this mechanical test is not explicitly stated in the provided text.
- For biocompatibility (cytotoxicity ISO 10993-5): "a complete restoration produced via the described validated workflow was performed." The exact number of samples tested is not specified.
- For engineering and dimensional analysis: The number of components analyzed is not specified.
- Data Provenance: The document does not mention human subject data or data provenance like country of origin or retrospective/prospective studies. The testing is described as non-clinical (mechanical, material, software validation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable as the document describes non-clinical testing of a dental implant component, not a diagnostic or AI device requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set
- This question is not applicable for the same reasons as point 3.
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 question is not applicable as the device is not an AI software intended to assist human readers. It is a physical dental implant component.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical component, not an algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests:
- Mechanical Integrity (Fatigue): Ground truth is defined by the performance standards of ISO 14801, which sets limits for mechanical failure under specific loading conditions.
- Biocompatibility (Cytotoxicity): Ground truth is defined by the standards of ISO 10993-5, determining if the material elicits a cytotoxic response.
- Dimensional Accuracy/Compatibility: Ground truth is defined by engineering specifications and measurements of existing implant systems and the device itself.
8. The Sample Size for the Training Set
- This question is not applicable as there is no "training set" of data in the context of machine learning for this physical device.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reasons as point 8.
In summary, the provided text details a regulatory submission for a physical dental device, focusing on demonstrating substantial equivalence through non-clinical testing (mechanical, material, digital workflow validation) rather than complex diagnostic performance studies common for AI or imaging devices.
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(50 days)
· Single crowns
· Bridges with a maximum of one pontic between two crowns
· Inlays, onlays, and veneers
XP202 zirconia blanks are used for the fabrication of esthetic zirconia restorations. The blanks are available in various heights and shades based on the Vita™ Classical shade guide. After sintering, restorations display a gradient shading and inherent fluorescence. The restorations are designed using dental CAD software and the data is converted into milling paths by CAM software. The blanks can be processed in milling units suitable for pre-sintered zirconia. Milled restorations must be final sintered in a furnace suitable for zirconia per the cycle designated for XP202.
The provided text pertains to the 510(k) premarket notification for the device XP202, a porcelain powder for clinical use (zirconia blanks for dental restorations). The document focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study with human readers or a specific acceptance criteria table for performance metrics like sensitivity/specificity.
Therefore, much of the requested information regarding clinical study design, human reader performance, and detailed statistical analysis of AI performance is not available in the provided text. The evaluation is primarily based on in vitro testing and comparison to recognized standards and predicate devices' properties.
Here's the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document states that in vitro testing was conducted to show that XP202 fulfills the requirements of FDA recognized standard ISO 6872: "Dentistry Ceramic materials" and compares its performance (flexural strength, chemical solubility, linear thermal expansion) to predicate devices. It concludes that "The results of XP202 are similar to Katana STML. The difference between XP202 and Lava Plus are their flexural strength and is addressed by limiting the indications to three unit bridges according ISO 6872."
Since a specific table of acceptance criteria with numerical values is not explicitly presented in the document, here's a conceptual representation based on the text:
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Standards Compliance | Fulfills requirements of ISO 6872: Dentistry Ceramic materials | Fulfilled |
| Flexural Strength | Similar to predicate device Katana STML; Meets requirements for indicated uses per ISO 6872 | Similar to Katana STML; Differences from Lava Plus addressed by limiting indications to 3-unit bridges per ISO 6872 |
| Chemical Solubility | Similar to predicate device Katana STML | Similar to Katana STML |
| Linear Thermal Expansion | Similar to predicate device Katana STML | Similar to Katana STML |
| Biocompatibility | Meets recommendations from FDA guidance and international standards (ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 7405) | Assessed by board-certified toxicologist; concluded safe for intended use |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for the in vitro tests. The document mentions "in vitro testing", but not the number of samples or items tested.
- Data Provenance: The tests are "in vitro testing", meaning conducted in a laboratory setting. The origin of the raw materials (zirconia blanks) would be from 3M Deutschland GmbH, Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the 'ground truth' for this device is established through in vitro measurements against recognized material standards (ISO 6872), not through expert interpretation of clinical images or data with human-in-the-loop.
- For biocompatibility, a "board-certified toxicologist" assessed the product, implicitly establishing "ground truth" for safety from a toxicological perspective.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this refers to adjudication of discrepancies in expert readings, which is not part of the described in vitro material testing.
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 done. This device is a material (porcelain powder/zirconia blank) used for dental restorations, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not relevant. The device is a material, not an algorithm. Its performance is evaluated through material properties in a laboratory setting, not through an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance testing, the ground truth is established by physical and chemical measurements of material properties (flexural strength, chemical solubility, linear thermal expansion) as defined by the ISO 6872 standard for dentistry ceramic materials.
- For biocompatibility, the ground truth is established by compliance with ISO 10993 series standards and FDA guidance on biological evaluation of medical devices, assessed by a board-certified toxicologist.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
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(215 days)
The Lava™ system is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.
Lava™ Frame and Lava™ Frame Shade are intended for the manufacturing of abutments.
The titanium connection for the abutment must meet the following dimensions:
- Overall cementation surface > 30 mm²
- Height of the head of the titanium interface from the shoulder > 2.8 mm
The following systems fulfill the above described specifications:
Co. Alitec Dental GmbH: Camlog Titanium base for Ceramic abutment. Abutment ø ≥ 4.3 mm
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Co. Alltec Dental GmbH: Camlog Titanium-base for Ceramic-abutment - Abutment a ≥ 4.3 mm
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Co. Dentsply Friadent GmbH: Friadent Cera Base
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Co. Neoss GmbH: Neo Link Neoss Mono Abutment Titanium; Neo Link Neoss Multi Abutment Titanium; Neo Link Neoss Mono Aesthetic Abutment Titanium; Neo Link Neoss Multi Aesthetic Abutment Titanium; Matrix Abutment Hex - Regular Mono Titan; Matrix Abutment Hex - Regular Multi Titan; Matrix Abutment Hex - Narrow Mono Titan; Matrix Abutment Hex - Narrow Multi Titan; Matrix Abutment C-Lect - Regular Mono Titan; Matrix Abutment, C-Lect - Regular Multi Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment ST - Mono Titan; Matrix Abutment ST - Mono Titan
Lava™ abutment made from Lava™ Frame zirconia mill blanks and dyed with Lava™ Frame Shade is classified as cndosseous dental implant abutment (21 C.F.R. § 872.3630) because it is a prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Lava™ Frame and Lava™ Frame Shade are parts of the Lava™ system (K011394). Lava™ Frame Zirconia mill blanks are used for the fabrication of frameworks for allceramic restorations. The frameworks for onlays, inlays, veneers, crowns and bridges are designed and manufactured by CAD/CAM technology, whereas the CAM fabricated Lava™ Abutments made from Lava™ Frame Zirconia mill blanks will be designed by means of a traditional wax up technique. The wax up will be scanned (Lava™ Scan, K062493) and milled without any further design step in the CNC milling unit Lava™ Form. After milling, the abutments are dyed with one of the 7 Lavat 10 Frame Shade dyeing liquids as required to achieve the desired tooth color, then sintered. The dyed abutments are sintered using the specialized program of the Lava™ Therm sintering furnace.
The wax up designed abutment will be cemented to a titanium interface which will be subsequently screwed into the respective implant (e.g. Camlog, Altatec Biotechnologies).
The provided text is a 510(k) Summary and FDA clearance letter for a dental device called "Lava™ Frame, Lava™ Frame Shade." This document describes the device and its intended use, but it does NOT include any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.
Therefore, I cannot fulfill your request for that specific information based on the text provided. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a device's performance against specific acceptance criteria.
The 510(k) summary only states: "In summary, it can be concluded that safety and effectiveness requirements for Laya™ Frame and Lava™ Frame Shade for the fabrication of abutments are completely met." This is a general statement of compliance, not a report on specific performance metrics or studies.
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