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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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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: These 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.

The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., 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 allow B.T.I. Biotechnology Institute, S.L. to expand the product offering for the Universal and Universal Plus Interna® implant platforms. Specifically, the currently cleared Universal Interna® implants with diameters ranging from 4.0 to 4.25 mm and the 6.0 mm diameter Universal Plus Interna® implants will be provided in shorter lengths of 5.5 and 6.5 mm. The implants subject of this premarket notification, collectively referred to as BTI Extra-Short Dental Implant System UnicCa®, are summarized in Table 5-1.

This document is a 510(k) Premarket Notification from the FDA, determining substantial equivalence for a dental implant system. As such, it does not contain information about a study that proves the device meets specific acceptance criteria in the manner of a clinical trial for a novel device or software. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical testing and comparison of characteristics.

Therefore, many of your requested points related to acceptance criteria for a study proving performance, sample sizes for test/training sets, expert adjudication, or MRMC studies, are not applicable here. This document leverages existing predicate devices and non-clinical testing to argue that the new, shorter versions of the implant are safe and effective.

Here's a breakdown of the information that is available or implicitly addressed, and what is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission doesn't present a table of acceptance criteria and performance results in the context of a "study proving the device meets criteria" as one might expect for a new AI or diagnostic device. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (K151391 as primary, K133049 and K170392 as reference devices) through a comparison of technological characteristics and non-clinical testing.

The "acceptance criteria" here are implicitly that the new device configuration (shorter lengths of existing implants) should be as safe and effective as the predicate devices, as demonstrated by:

• Identical Indications for Use
• Identical Operating Principle
• Identical Materials
• Identical Surface Treatment
• Identical Shelf Life
• Identical Packaging and Sterilization materials and processes
• Compliance with relevant ISO standards and FDA guidance for non-clinical testing.

The "reported device performance" is not expressed in measured outcomes against specific clinical performance thresholds, but rather in the statement of "substantial equivalence" based on the comparisons provided.

Relevant Data from Tables 5-3 and 5-4, representing the "performance" by demonstrating similarity to predicates:

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set with patient data. The "tests" are non-clinical (biocompatibility, corrosion, fatigue, comparative area analyses, sterilization, packaging, endotoxin). The sample sizes for these engineering bench tests are not specified in the summary document.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical data or patient data is mentioned or used for proving substantial equivalence of these specific design changes. The data provenance would be from the B.T.I. Biotechnology Institute, S.L. in Spain (the submitter) for the non-clinical testing performed.

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

• Not applicable. This submission relies on non-clinical engineering and biological testing, not on human expert review of clinical cases to establish ground truth for a test set. Substantial equivalence is determined by the FDA reviewing the provided engineering, material, and performance data against established predicate devices and standards.

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

• Not applicable. No expert adjudication of a test set occurred.

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. This is a dental implant (physical device), not an AI or diagnostic imaging device. Therefore, no MRMC 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 dental implant, not an algorithm.

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

• Not applicable in the sense of clinical ground truth. For a physical device like a dental implant seeking substantial equivalence for a dimension change, the "ground truth" for the non-clinical testing performed (biocompatibility, fatigue, etc.) is the adherence to material specifications (e.g., Titanium CP4), compliance with established international standards (ISO 10993-1, ISO 14801, ISO 11137-1/2, ISO 17665-1/2, ANSI/AAMI ST72), and the established safety and performance profile of the predicate device.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

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

• Not applicable. There is no "training set" in the context of this 510(k) submission for a physical device.

In summary, this FDA 510(k) clearance is based on demonstrating substantial equivalence of new, shorter versions of an existing dental implant system to established predicate devices through a comprehensive battery of non-clinical (bench) testing and comparison of physical and material characteristics, rather than through new clinical trials or performance studies against specific acceptance criteria for a novel device or software.

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