Search Results

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.

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:

*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.

Ask a specific question about this device

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."

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.

Ask a specific question about this device

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 Abutments are compatible with the implant systems listed in Table 1.

The Elos Accurate® Customized Abutment is a patient specific abutment 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 the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent 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 customized shape of the abutument 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® Customized Abutment is 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 Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided document, K231307 for Elos Accurate® Customized Abutment, is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial or a performance study for an AI/ML powered medical device would.

The "acceptance criteria" discussed in this document pertain to the device meeting the requirements for FDA 510(k) clearance by demonstrating substantial equivalence to predicate devices, primarily through engineering, dimensional, and non-clinical testing. There is no mention of a human-in-the-loop study, a multi-reader multi-case (MRMC) study, or an AI/ML algorithm-only standalone performance study.

Therefore, many of the requested fields regarding expert adjudication, MRMC studies, and ground truth establishment for AI/ML models are not applicable to the information contained within this 510(k) submission.

Here's an interpretation of the document's contents in relation to your request, with a focus on non-clinical testing and substantial equivalence:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicates and meeting established material and dental implant abutment standards. The document doesn't present a table with numerical acceptance criteria and performance for a diagnostic AI algorithm. Instead, it lists various non-clinical tests and their successful outcomes as evidence of substantial equivalence and safety/effectiveness.

2. Sample sizes used for the test set and the data provenance

• Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of abutments or implants tested for each reported non-clinical test. The tests are general performance validations (e.g., fatigue, cytotoxicity, sterilization efficacy) and dimensional analyses that demonstrate compliance with relevant standards or a worst-case scenario. For example, fatigue testing often involves a small number of samples (e.g., 6 minimum per ISO 14801, though more are often used for statistical power) under specific loading conditions. Similarly, biocompatibility is performed on representative samples.
• Data Provenance: The data comes from the manufacturer's (Elos Medtech Pinol A/S) internal testing and leverages data from previously cleared devices where material, size, and geometry are substantially equivalent. The provenance is therefore the manufacturer's testing facilities and associated regulatory submissions. There is no indication of different countries of origin for the data concerning these non-clinical tests. The tests are prospective in nature, as they are part of the premarket submission process.

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. The "ground truth" for this medical device (dental abutment) is established by engineering specifications, material properties, performance standards (e.g., ISO, ASTM), and clinical safety and effectiveness data from the predicates. There is no AI/ML component described that would require expert human review or "ground truth" establishment in the context of diagnostic interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable as there is no human interpretation or diagnostic "test set" 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 question is not applicable. The device is a physical dental abutment and its associated digital design workflow, not an AI-powered diagnostic tool requiring human reader studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is not a standalone AI algorithm. The digital dentistry workflow involves CAD software and CAM software, but these are tools for designing and manufacturing the physical abutment, not for automated diagnostic interpretation or decision-making in the clinical sense of an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance, as demonstrated in the submission, is based on:

• Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665 for sterilization).
• Engineering and dimensional analysis against established dental implant system specifications.
• Physical testing results (e.g., torque, heating, displacement) for MR compatibility.
• Validation of the digital workflow ensuring design constraints and manufacturing accuracy.
• The fundamental demonstration is substantial equivalence to existing legally marketed predicate devices, implying that their established safety and effectiveness forms the basis of the "ground truth" for this device's intended use.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML device that requires a training set for model development. The design software has built-in constraints ("design limitations" and "design limits in the library file"), which are more akin to pre-programmed rules and geometric parameters rather than a learned model from data.

9. How the ground truth for the training set was established

This question is not applicable. No AI/ML training set is mentioned or implied. The "ground truth" for the design limitations within the software (e.g., minimum material thickness) would be established by engineering principles, biomechanical studies (often in labs, not clinical trials), and clinical experience with dental prosthetics, which define safe and effective design parameters.

Ask a specific question about this device

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] |
|--------------------------------|---------------------------|--------------------------------|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 |

The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an 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™ 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 bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.

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:

• 1. Minimum wall thickness 0.5 mm
• 2. Minimum post height 4.0 mm (for single unit restorations)
• 3. Maximum gingival height 5.0 mm (min. GH of 0.5mm)
• 4. 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 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.

The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860.

Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection.

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 Elos Accurate® Hybrid Base™ is a dental device intended for attaching to dental implants to provide a basis for single or multiple tooth prosthetic restorations. It acts as an interface between a dental implant and a zirconia superstructure.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:

   • Fatigue Testing: "fatigue testing was performed on the subject devices per ISO 14801." The exact number of samples tested per device type is not specified but implied to be sufficient for ISO 14801 compliance.
   • Engineering and Dimensional Analysis: Performed on "original manufactures' components (abutments, implants & abutment screws)." The number of components is not specified.
   • Digital Dentistry Workflow Validation/Design Limitation Test: "The digital dentistry workflow validation was completed on selected models of subject product line" and "A design limitation test is performed...". Number of models/tests not specified.
   • Biocompatibility (Cytotoxicity): A cytotoxicity test was performed on "a complete restoration produced via the described validated workflow." Exact number of samples not specified.
   • Data Provenance: Not explicitly stated, but the testing appears to be conducted by or for the manufacturer (Elos Medtech Pinol A/S). No information is given about the country of origin of the data or if it was retrospective or prospective in the context of clinical studies (as this is a non-clinical submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • This submission focuses on non-clinical testing and substantial equivalence to predicate devices based on engineering and performance standards. There is no mention of "experts" establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for the engineering and material properties would be established by validated test methods and established standards (e.g., ISO 14801, ISO 10993).

4. Adjudication Method for the Test Set:

   • Not applicable. This is a non-clinical submission based on engineering tests and standards, not a clinical study requiring adjudication of diagnostic results.

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 MRMC study was mentioned or performed. This device is a dental implant component, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. 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" in this context refers to established engineering standards, material properties, and performance requirements for dental implant abutments. This includes:
     • ISO 14801: "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" for fatigue testing.
     • ISO 17665-1 & ISO 17665-2: For sterilization validation.
     • ISO 10993-1 & ISO 10993-5: For biocompatibility (cytotoxicity).
     • Engineering and dimensional analysis: Based on specifications of original manufacturers' components.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning product and does not have a "training set." The closest analogy could be the design and manufacturing parameters used to create the device, which are based on established engineering principles and prior device knowledge.

9. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of medical device. The design and manufacturing are based on established engineering principles and validation against performance standards.

Ask a specific question about this device

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 a patient specific abutment 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 the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent 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 customized shape of the abutment is intended to be manufactured according to a digital dentistry workflow. The Elos Accurate® Customized Abutment is 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 Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided text describes the regulatory clearance of a dental abutment, not an AI/ML medical device. Therefore, it does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the Elos Accurate® Customized Abutment to previously cleared predicate devices. The non-clinical testing described is for the physical dental device itself (e.g., fatigue testing, biocompatibility, sterilization validation) and validation of the digital dentistry workflow for designing and manufacturing the abutment.

There is no mention of:

• Acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A test set, training set, or data provenance for an AI/ML algorithm.
• Experts establishing ground truth for AI/ML performance.
• Adjudication methods for AI/ML.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Ground truth types related to AI/ML (e.g., pathology for image classification).

The "digital dentistry workflow validation" mentioned refers to the software (3Shape Abutment Designer Software) that provides design limits for the abutment, not an AI/ML algorithm that performs a diagnostic or predictive task. It essentially ensures the software's constraints prevent users from designing abutments outside safe parameters.

Therefore, I cannot extract the requested information about AI/ML device acceptance criteria and study details from the provided document. The document is for a traditional medical device (dental abutment) and its manufacturing workflow, not an AI/ML enabled device.

Ask a specific question about this device

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:

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:

1. Minimum wall thickness 0.5 mm
2. Minimum post height 4.0 mm (for single unit restorations)
3. Maximum gingival height 5.0 mm
4. 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:

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 Abutments are compatible with the implant systems listed in table 1:

Table 1.

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment 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 the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment 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 customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile 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 Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided document, a 510(k) Premarket Notification summary for the Elos Accurate® Customized Abutment, outlines the device's indications for use, technological characteristics, and non-clinical testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain information typically found in an acceptance criteria and performance study for a medical device that uses an algorithm or AI. This document is for a physical dental abutment, not a device that relies on an algorithm or AI for its function.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device meets acceptance criteria related to an AI/algorithm-based device. The original document does not offer data points for:

• A table of acceptance criteria and reported device performance (in the context of algorithm performance)
• Sample size for a test set or data provenance
• Number of experts or their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth (e.g., pathology, outcomes data)
• Sample size for a training set
• How ground truth for a training set was established

The "testing" mentioned in the document (fatigue testing, biocompatibility testing, dimensional analysis) is for the physical material and design of the abutment, not for an algorithm's performance.

Ask a specific question about this device

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 Abutments are compatible with the implant systems listed in table 1:

Table 1.

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment 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 the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment 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 customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile 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 Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided text describes a medical device, the Elos Accurate® Customized Abutment, and its 510(k) submission to the FDA. However, the document does not contain information regarding objective acceptance criteria (e.g., performance metrics with defined thresholds), nor does it detail a study that proves the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K190299) based on similar intended use, operating principle, design, materials, and sterilization processes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, or ground truth details, as these are not present in the provided text.

The information that is available regarding testing is non-clinical and aims to show similarity and safety compared to the predicate device, rather than meeting specific performance thresholds against a defined clinical outcome.

Here's a summary of the non-clinical testing performed, which serves as the evidence for substantial equivalence:

Non-Clinical Testing Information (as provided):

• Type of Testing:
  • Engineering and dimensional analysis of original manufacturers' components (abutments, implants & abutment screws) for determination of compatibility.
  • Fatigue testing per ISO 14801 according to FDA guidance for Industry and FDA Staff "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" dated May 12, 2004.
  • Biocompatibility testing for cytotoxicity according to ISO 10993-5.
• Tests Included for Biocompatibility:
  • Non-coated prosthetic screw (representative for subject device, tested on primary predicate device K190299).
  • Medicarb coated prosthetic screw (representative for subject device, tested on reference predicate device K171799).
  • Elos Accurate® Customized Abutment (representative for subject devices, tested on reference predicate device K171799).
• Sterilization: The primary predicate device was tested according to ISO 17665-1 & ISO 17665-2, demonstrating a Sterility Assurance Level (SAL) of $10^{-6}$. No additional testing was deemed necessary for the subject device.

Missing Information (Not provided in the document):

• Specific quantitative acceptance criteria for performance metrics.
• A clinical study designed to demonstrate performance against such criteria.
• Sample size used for a test set (as no such test set for performance evaluation is described).
• Data provenance for a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Effect size of human reader improvement with AI vs. without AI assistance.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The document's purpose is to establish substantial equivalence for regulatory clearance, not to report on a clinical performance study with predefined acceptance criteria.

Ask a specific question about this device

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 Abutments are compatible with the implant systems listed in table 1:

Table 1.
| Elos Accurate Customized
Abutment - Model Type | Platform compatibility | Platform diameter
[mm] | Implant Body diameter
[mm] |
|---------------------------------------------------|-------------------------|---------------------------|-------------------------------|
| AB-NBR35 | Nobel Replace NP | 3.5 | 3.5 |
| AB-NBA30 | Nobel CC 3.0 | 3 | 3 |
| AB-NBA43 | Nobel CC RP | 3.9 | 4.3 & 5 |
| AB-NBA60 | Nobel CC WP | 5.1 | 5.5 |
| AB-SBO33 | Straumann Bone Level NC | 3.3 | 3.3 |
| AB-SBO41 | Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |

All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.

The Elos Accurate® Customized Abutment is a patient specific abutment 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 the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment 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 customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile 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 Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided text describes the Elos Accurate® Customized Abutment, a dental device, and its FDA 510(k) clearance. This document is a regulatory submission, not a study report detailing AI/ML model performance. Therefore, many of the requested criteria related to AI/ML model evaluation are not applicable or cannot be extracted directly from this type of regulatory submission.

However, I can provide information based on the device's performance against engineering and material acceptance criteria, as well as the non-clinical testing performed to demonstrate substantial equivalence to its predicate device. This is primarily focused on mechanical and biological compatibility, not AI/driven diagnostic accuracy.

Here's the information derived from the provided text, adapted to the closest relevant categories:

1. A table of acceptance criteria and the reported device performance

For a device like the Elos Accurate® Customized Abutment, acceptance criteria primarily relate to mechanical properties, biocompatibility, and compatibility with implant systems. The "reported device performance" here refers to the aspects that were tested and deemed acceptable through non-clinical testing to establish substantial equivalence.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of an AI/ML model. The evaluation here is based on non-clinical testing (mechanical, dimensional, and biocompatibility).

• Sample Size: The document does not provide specific numerical sample sizes for the engineering tests (e.g., how many abutments were subjected to fatigue testing). This level of detail is typically found in the full test reports, not the 510(k) summary.
• Data Provenance: The data comes from non-clinical laboratory testing and engineering analyses performed by or for Elos Medtech Pinol A/S. The country of origin of the data is not explicitly stated, but the company is located in Denmark. The data is prospective in the sense that these tests were conducted specifically for this submission to demonstrate substantial equivalence.

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. The device is a physical dental abutment, not an AI/ML diagnostic tool requiring expert interpretation for "ground truth." Ground truth, in this context, would be established by validated measurement techniques, material science principles, and biological testing standards (e.g., ISO standards for mechanical testing and biocompatibility).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. "Adjudication method" refers to the process of resolving disagreements among human readers or experts for establishing ground truth in a diagnostic study. For this device, acceptance is based on meeting predefined engineering and biological performance standards through validated 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

This is not applicable. No MRMC study was performed as this is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an AI algorithm. Its design uses CAD/CAM technology, but the clearance is for the physical abutment itself, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" or basis for acceptance relies on:

• Established engineering standards: e.g., ISO 14801 for fatigue testing of dental implants.
• Biocompatibility standards: e.g., ISO 10993-5 for cytotoxicity.
• Dimensional analysis: Verifying compatibility with specified implant systems.
• Material specifications: Conformance to Titanium Alloy 6Al-4V ELI (medical grade 5).

There is no "expert consensus" in the diagnostic sense or pathology/outcomes data used for device clearance as described in the summary.

8. The sample size for the training set

This is not applicable because there is no AI/ML model for which a "training set" would be used.

9. How the ground truth for the training set was established

This is not applicable because there is no AI/ML model for which training set ground truth would be established.

Ask a specific question about this device