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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 - 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and interna®), in a variety of platforms and range of diameters (3.0 – 6.0 mm) and lengths (5.5 – 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The purpose of this 510(k) is to expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included.

This document describes the BTI Interna Narrow/Plus Dental Implant System UnicCa®, which is a dental implant system. The information provided is for a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for outcomes. Instead, it demonstrates substantial equivalence to predicate devices through various non-clinical tests and comparisons. The "performance" is largely reported as demonstrating "substantial equivalence" or being "identical" or "similar" to the predicate devices.

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

• Sample Size for Test Set: The document mentions "Comparative area analyses for full external area and for bone resorption of up to 3 mm have been performed for subject implants and reference device." However, specific numerical sample sizes for this or other non-clinical tests (e.g., fatigue testing, biocompatibility) are not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether it is retrospective or prospective. It refers to manufacturing in Spain (B.T.I. Biotechnology Institute, SL Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN). The tests are non-clinical, implying laboratory or bench testing, not human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided as the submission relies on non-clinical, bench testing for substantial equivalence, not clinical study data requiring expert-established ground truth.

4. Adjudication method for the test set:

This information is not applicable and not provided as the submission relies on non-clinical, bench 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. The device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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 implant system, not a software algorithm.

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

The "ground truth" for this submission is based on established engineering and biological performance standards (e.g., ISO, ASTM standards, FDA guidance documents) and comparative data to already cleared predicate physical devices. For example:

• Biocompatibility: Conformance with ISO 10993-1.
• Fatigue Testing: Conformance with ISO 14801 and FDA guidance.
• Sterilization Validation: Conformance with ISO 11137 series.
• Physical measurements and material specifications are compared to those of the predicate devices.

8. The sample size for the training set:

This information is not applicable as there is no mention of a "training set" in the context of this physical device submission, which does not involve machine learning or AI models.

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

This information is not applicable for the reasons stated in point 8.

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ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.

ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured and bonded into the ET Link Abutment by Hiossen only with design input using CAD software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics.

This document is a 510(k) summary for the ET Hybrid Abutment by HIOSSEN Inc., intended for use with HIOSSEN ET dental implants to support prosthetic restorations. The submission relies on the substantial equivalence to a primary predicate device, ET Hybrid Abutment (K162390), and two reference predicates: Straumann Variobase Abutments (K132219) and ET SmartFit Abutment (K123627). No clinical studies were submitted. Therefore, the information provided below will be based on the non-clinical testing and comparison to predicate devices, rather than a clinical study establishing the device's meeting of acceptance criteria from human data.

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

The document does not explicitly state "acceptance criteria" in a quantitative format for the entire device. Instead, it relies on demonstrating substantial equivalence to predicate devices through material similarity, manufacturing processes, intended use, and non-clinical testing (biocompatibility and fatigue). The performance is demonstrated by conformance to relevant ISO standards for dental implants.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Specific sample sizes for the fatigue tests (ISO 14801) are not explicitly stated in this 510(k) summary. ISO standards typically specify minimum sample sizes for such tests.
• Data Provenance: The origin of the testing data is not explicitly stated in terms of country, but it would have been conducted by or for HIOSSEN Inc., which is based in Fairless Hills, Pennsylvania, USA. The testing is prospective as it was conducted to support the
  510(k) submission.

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 is a medical device (dental abutment) undergoing non-clinical mechanical and biological testing for substantial equivalence, not an AI or diagnostic device requiring expert consensus for a ground truth in image interpretation or patient diagnosis.

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

Not applicable. As this is not a diagnostic device or a study involving human interpretation of data, there is no adjudication method used. The testing relies on objective, standardized physical and material property measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI-related effectiveness study was conducted.

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

Not applicable. This is a physical medical device (dental abutment), not an algorithm or software.

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

The "ground truth" in this context refers to the established standards and specifications for material properties, mechanical performance, and biocompatibility of dental implant abutments. These are based on:

• International Standards: Primarily ISO 14801 for fatigue testing, and ISO 17665-1, ISO/TS 17665-2 for sterilization validation.
• Predicate Device Data: The performance and safety profile of the legally marketed predicate devices (K162390, K132219, K123627) serve as the benchmark for demonstrating substantial equivalence.
• Material Specifications: Established specifications for Titanium Alloy Ti-6AL 4V and Zirconia Oxide.

8. The sample size for the training set

Not applicable. There is no training set as this is not a machine learning or AI device.

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

Not applicable. No training set was used.

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Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

Straumann® Variobase® abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures.

The Straumann Variobase Abutments for Bars & Bridges are non-engaging abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.

The provided text is a 510(k) Summary for the Straumann® Variobase® Abutment for Bridges/Bars. It outlines the characteristics of the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a diagnostic or clinical performance study.

Instead, the "study" referred to is a bench study focused on mechanical performance and material characteristics to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or effectiveness.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

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

The document doesn't present explicit "acceptance criteria" in a quantitative, pass/fail table for clinical performance. Instead, it discusses "equivalence" based on various features and a dynamic fatigue test.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on bench testing for dynamic fatigue. It doesn't specify a sample size for this testing other than "data have been referenced." No information is provided about data provenance ( країни of origin or retrospective/prospective nature) as it's not a clinical data study.

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 information is not applicable here because the "test set" refers to physical samples for mechanical testing (dynamic fatigue), not a dataset for a diagnostic algorithm where expert ground truth would be established.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical bench 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. The device is an endosseous dental implant abutment, a physical component, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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 medical device, not a software algorithm.

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

The "ground truth" in this context is the mechanical performance standards (e.g., ISO 14801 for dynamic fatigue) and the material properties of the device, which are evaluated through bench testing. There is no biological or diagnostic "ground truth" from human subjects involved in this 510(k) submission for mechanical equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

This is not applicable for the same reason as point 8.

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