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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.

INTERNA 3.0 UnicCa® implants with a diameter of 3.3 mm are only intended 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.

INTERNA 3.0 UnicCa® implants with a diameter of 3.0 mm are only intended for replacement of maxillary lateral incisors and mandibular incisors, and are only intended for delayed loading.

INTERNA 3.0 UnicCa® implants with a diameter of 2.5 mm are only indicated for missing mandibular central and lateral incisors, and are only intended for delayed loading.

All digitally designed zirconia components for use with Aesthetic Post Abutments are to be sent to a BTI validated milling center for manufacture.

The purpose of this submission is to add components to the B.T.I. Biotechnology Institute, S.L. product line of endosseous dental implants, abutments, and prosthetic components. Specifically this submission seeks marketing clearance for dental implants with body diameters of 2.5 mm, 3.0 mm, various compatible conventional abutments, and two-piece abutments to be used with a zirconia superstructure fabricated using CAD-CAM technology.

The subject device Interna 3.0 implants have an internal hexolobular connection and a platform diameter of 3.0 mm. The implants are provided in body diameters of 2.5 mm, 3.0 mm. Each body diameter is provided in overall lengths of 8.5 mm, 10 mm, 11.5 mm. The subject implants are manufactured from unalloyed titanium (conforming to ASTM F67 and ISO 5832-2), and the endosseous surface has the UniCa" surface treatment that improves the hydrophilicity of the implant.

The subject device abutments are provided in various designs including Healing Abutments. Healing Screws, Temporary Titanium Abutments, Definitive Titanium Abutments, Square Abutments (Ti-Bases), Transeptihelial Abutments (Single-unit and Multi-unit, with corresponding screws), and Aesthetic Interfaces for Transepthelial Abutments. The Temporary Titanium Abutments and Definitive Titanium Abutments are provided straight (00) only and are not to be customized to create an angled abutment or to correct for angulation.

The subject Square Abutments are two-piece abutments consisting of titanium bases combined with ceramic superstructures, to be attached directly to the Interna 3.0 implants to support single-unit or multi-unit restorations. The Square Abutments are provided in gingival heights ranging from 0.5 mm to 3 mm, with a titanium base platform diameter ranging from 3.76 mm. The titanium base post height (length above the gingival height) either is 3.5 mm, or in versions with an angled screw access channel, 6.5 mm with a cut-down post height of 2.1 mm, 3 mm, or 3.5 mm. The post of all titanium base versions includes an anti-rotation design to prevent rotation of the superstructure or hybrid crown. The abutments are used with cemented and screw-retained restorations. The fabrication of the top-half of the abutment by conventional workflow was cleared in K211952, and a workflow using CAD-CAM technology to design and fabricate a superstructure or hybrid crown-abutment was cleared in K231827. The ceramic material to be used will be zirconia conforming to ISO 13356. All fabrication of the patient specific superstructures for use with the Square Abutments will be done at a BTI validated milling center. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Square Abutments are:

minimum wall thickness – 0.4 mm

minimum post height for single-unit restoration (post height is the length above the gingival height) – 4.0 mm maximum gingival height - 6 mm

minimum gingival height - 0.0 mm in the superstructure

(all Square Abutments have a minimum gingival height of 0.5 mm)

maximum angle - 0°, straight only.

Transepithelial Abutments are for supporting single-unit or multi-unit, temporary or definitive, restorations on the Interna 3.0 implants. Transepthelial Abutments are provided to fit implants with a body diameter of 2.5 mm, and to fit body diameters of either 3.0 mm. Transepithelial Abutments are provided in a variety of gingival heights ranging from 0.5 mm. Transepithelial Abutments are used with previously cleared BTI retention screws, temporary cylinders, aesthetic interfaces, and the subject device Interfaces for Transepithelial Abutments.

The subject Aesthetic Interfaces for Transepithelial Abutments are two-piece abutments on titanium bases combined with ceramic superstructures, used to support single or multi-unit definitive prosthetic restorations. Aesthetic Interfaces for Transepithelial Abutments are provided in gingival heights of 0.5 mm to 1.05 mm, titanium base diameters ranging from 3.5 mm, and titanium base post heights (length above the gingival height) ranging from 5.45 mm to 6.5 mm. Aesthetic Interfaces for Transepithelials are provided in two configurations, Straight and Expanded configurations have a larger titanium base platform diameter than the Straight configurations with the same platform diameter. The titanium base platform diameters range from 3.5 mm to 6.5 mm and all designs include anti-rotation indexes to prevent rotation of the superstructure or hybrid crown. The fabrication of the top-half of the abutment by conventional workflow was cleared in K211952 and a workflow using CAD-CAM technology to design and fabricate a superstructure or hybrid crown-abutment was cleared in K231827. The ceramic material to be used will be zirconia conforming to ISO 13356. All fabrication of the patient specific superstructures will be done at BTI validated milling center. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelial Abutments are:

minimum wall thickness - 0.4 mm

minimum post height for single-unit restoration (post height is the length above the gingival height) – 4 mm

maximum gingival height - 6 mm

minimum gingival height - 0.0 mm in the superstructure

(all Aesthetic Interfaces have a minimum gingival height of 0.5 mm)

maximum angle - 0°, straight only.

All subject device abutments are manufactured from unalloyed titanium conforming to ASTM F67 and ISO 5832-2, and zirconia confirming to ISO 13356. Selected abutments are provided with a Titanium Nitride (TiN) coating to enhance the aesthetic appearance of the device. Subject device abutments used with screws previously cleared in K211952 and K053355. The screws that are part of the Transepithelial Abutment assemblies are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3. The screws have a diamond-like carbon (DLC) coating that is identical to the DLC coating on screws cleared in K211952.

Subject device components provided sterile by gamma irradiation include the Interna 3.0 Implants, Healing Abutments, Healing Screws, and Transepithelial Abutments. Components provided non-sterile for end-user moist heat sterilization include the Temporary Titanium Abutments, Definitive Titanium Abutments, Square Abutments, Aesthetic Interfaces for Transepithelial Abutments, and retention screws.

This document, K240262, is a 510(k) premarket notification for a dental implant system. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) device. The non-clinical data submitted or referenced in this document are for a traditional dental implant system and include:

• Worst-case MRI review.
• Measurements of surface area comparisons with predicate implants.
• Moist heat sterilization validation.
• Gamma sterilization validation.
• Sterile barrier shelf life data.
• Biocompatibility data for device materials.

Therefore, I cannot extract the requested information in the format of acceptance criteria and a study proving the device meets the acceptance criteria for an AI/ML device from the provided text. The document explicitly states: "No clinical data were included in this submission." and the device is a dental implant system, not an AI/ML device used for diagnostic or screening purposes that would require such performance studies.

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The BTI Interna Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System.

All digitally designed zirconia components for use with Aesthetic post abutments are to be sent to a BTI validated milling center for manufacture.

The purpose of this 510(k) is to expand the BTI product offering and include a variety of abutments compatible with the already cleared BTI Dental Implants. Subject device abutments include 15° Angled abutments, Transepithelial abutments, Temporary titanium abutments, Healing caps, Aesthetic post abutments and Screws. Aesthetic post abutments include Square abutments and Aesthetic interfaces for Transepithelials, as the bottom part of a two-piece abutment. A zirconia superstructure fabricated through CAD-CAM technology is the upper part of the two-piece abutment.

The subject 15º Angled Titanium abutments are designed to a BTI Interna Narrow implant, to hold single and multiple cement-retained restorations. The compatible BTI implants have been previously cleared in K211952. The abutments are offered with a 15º angulation and gingival heights of 3.0, 4.0, and 5.0 mm. They are manufactured in commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance.

The subject Temporary abutments are designed for single-unit screw-retained restorations on Transepithelial abutments are offered in prosthetic diameters of 3.5, 5.0 and 5.5 mm, with no angulation. They are manufactured from commercially pure titanium.

The subject Transepithelial abutments are designed for single-unit and multi-unit screw-retained restorations on previously cleared BTI implants. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are available in an engaging and a non-enqaging connection. They are offered in a prosthetic platform diameter of 3.5, 5.0 and 5.5 mm, and gingival heights ranging from 0.5 to 5.0 mm, with 0°, 17° and 30° angulation. They are manufactured from commercially pure titanium, with a TiN coating on abutment surface. The retention screw is provided with the abutment and is manufactured from titanium alloy with a DLC coating.

The subject Healing caps are designed to be connected to a Transepithelial abutment implant during the healing period, between Transepithelial placement and final dental restoration placement. These abutments are provided in prosthetic diameters of 3.5 and 5.0 mm. They are manufactured from commercially pure titanium and anodized.

The subject Aesthetic interfaces are two-piece abutments composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Aesthetic interfaces are to be attached to a Transepithelial abutment to hold single or multi-unit restorations. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance.

The design parameters for this top-half abutment fabrication are as follows:

• Minimum wall thickness: 0.4 mm -
• Minimum post height for single-unit restorations: 4.0 mm -
• Minimum gingival height: 0 mm in the zirconia superstructure -
• -Maximum gingival height: 6.0 mm
• -Maximum angulation: 0°

The subject Square abutments are two-piece abutments, composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Square abutments are to be attached to a BTI implant to hold single or multi-unit restorations. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance. The subject Square abutments are straight abutments (0%, and are provided in a variety of gingival heights ranging from 0.5 mm to 3.0 mm.

The design parameters for this top-half abutment fabrication are as follows:

• Minimum wall thickness: 0.4 mm -
• -Minimum post height for single-unit restorations: 4.0 mm
• Minimum qingival height: 0 mm in the zirconia superstructure -
• Maximum gingival height: 6.0 mm -

The zirconia superstructures for use with the subject Square abutments and Aesthetic Interfaces will be made at a BTI validated milling center and the material will conform to ISO 13356. The bonding cement recommended for the zirconia superstructure is Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

The subject Screws are designed to attach Square abutments and Aesthetic Interfaces to the compatible BTI dental implant or Transepithelial abutment, respectively. The Screws are manufactured from titanium allov, with a DLC coating on screw thread. One subject Screw is also anodized for ease identification.

I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study proving the device meets them, as it is a 510(k) summary for dental prosthetic components. This type of document focuses on demonstrating substantial equivalence to previously cleared devices rather than on performance studies with specific statistical acceptance criteria for a device involving AI or software.

The document discusses:

• Device Name: BTI Interna Prosthetic Components
• Regulatory Information: Class II device, product code NHA, regulation number 21 CFR 872.3630 (Endosseous Dental Implant Abutment).
• Indications for Use: To function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System. It also mentions that digitally designed zirconia components are to be sent to a BTI validated milling center for manufacture.
• Predicate Devices: Lists several predicate and reference devices, primarily other BTI Interna components and systems, and components from other manufacturers like AccelX Abutments and Medentika GmbH.
• Device Description: Detailed descriptions of various abutment types (15° Angled, Transepithelial, Temporary titanium, Healing caps, Aesthetic post abutments, and Screws), their materials (commercially pure titanium, zirconia), coatings (TiN, DLC), and design parameters (e.g., wall thickness, post height, gingival height, angulation).
• Performance Data (Non-clinical):
  • Moist heat sterilization validation.
  • Biocompatibility testing (ISO 10993-5 and ISO 10993-12).
  • Mechanical testing (ISO 14801).
  • Coating characterization.
  • Non-clinical worst-case MRI analysis.
  • Crucially, it explicitly states: "No clinical data were included in this submission."
• Technological Characteristics and Substantial Equivalence Discussion: A comparative analysis of the subject device with predicate and reference devices regarding indications for use, materials, surface treatment, restoration types, fixation methods, compatible implant platforms, dimensions (gingival height, angulation, prosthetic diameter), sterilization status, and packaging.

Why the requested information cannot be found in the provided text:

The request is for information typically found in the clinical study section of a submission for a device, especially those involving AI or software, where performance against a ground truth is evaluated. The provided document is a 510(k) summary for implant prosthetic components, which are mechanical devices, not AI/software. Therefore, concepts like "acceptance criteria" related to AI performance metrics (e.g., sensitivity, specificity), test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are not applicable and not present in this document.

The "Performance Data" section in this document refers to non-clinical bench testing (sterilization, biocompatibility, mechanical strength, material characterization, and MRI compatibility) to demonstrate the physical and material properties of the dental components, and it explicitly states that no clinical data was included.

To answer your request, a different type of FDA submission document (e.g., one for an AI/ML-driven diagnostic or screening tool) would be required.

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The BTI Interna Dental Implant System UnicCa® - Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System implants.

All digitally designed zirconia components for use with Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials are to be sent to a BTI validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for the subject device abutments, Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials, as part of a two-piece abutment with a zirconia superstructure fabricated using CAD-CAM technology.

The subject Square Aesthetic abutments are stock manufactured abutments, to be attached directly to BTI dental implants with the Interna implant connection (Narrow, Universal Plus and Wide platforms), to hold single or multiple restorations. The Square Aesthetic abutments are compatible with BTI implants previously cleared in K211952, K202825, K173257, and K151391. The subject Square Aesthetic abutments are provided in a variety of gingival heights ranging from 0.5 mm, with a prosthetic platform diameter ranging from 4.0 mm to 5.9 mm, and a prosthetic post height of 3.5 mm. All versions include anti-rotation indexes to prevent crown or bridge rotation. Engaging and non-engaging designs are available for single and multiple restorations, respectively. The abutments are used with cemented and screw-retained restorations.

The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Square Aesthetic Abutments are:

minimum wall thickness - 0.45 mm minimum post height for single-unit restoration - 4.2 mm maximum gingival height - 6.0 mm minimum gingival height - 0 mm in the zirconia superstructure maximum angle - 0°, straight only.

The subject Aesthetic Interfaces for Transepithelials are stock manufactured abutments, used to support single or multi-unit definitive prosthetic restorations over BTI Transepthelial Abutments (Unit and Multi-im, respectively). The compatible Transepithelial Abutments were previously cleared in K213106 and the Transepithelial Abutments are compatible with the BTI Interna connection implants (Narrow, Universal, Universal Plus and Wide platforms), previously cleared in K211952, K202825, K173257, and K151391. The previously cleared Transepithelial Abutments have a minimum gingival height of 1.0 mm and the Aesthetic Interfaces for Transepithelials have a minimum gingival height of 0.3 mm; when used together (as required) the minimum gingival height is 1.3 mm. The Aesthetic Interfaces for Transepithelials are provided in a range of prosthetic diameters from 3.5 mm, with a range of post heights from 3.5 mm. The Aesthetic Interfaces for Transepithelials are provided in two configurations, Straight and Expanded configurations have a larger prosthetic platform diameter than the Straight configurations with the same platform diameter. Overall, the prosthetic platform diameters range from 3.5 mm to 6.5 mm.

The design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelials vary for the minimum wall thickness and prostheight depending on the design of the Aesthetic Interface and the corresponding Transepithelial Abutments. The overall design parameters for the CAD-CAM fabrication of the patient-specific superstructures for use with the Aesthetic Interfaces for Transepithelials are:

minimum wall thickness - 0.4 mm minimum post height for single-unit restoration - 4 mm maximum gingival height - 6.0 mm minimum gingival height - 0 mm in the zirconia superstructure maximum angle - 0°, straight only.

All zirconia superstructures for use with the subject device will be made at a B.T.I. Biotechnology Institute, S.L. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All superstructures will be bonded to the abutment using Multilink Hybrid Abutment Cement (Ivoclar AG, cleared in K130436).

All subject device components are manufactured from unalloyed titanium conforming to ASTM F67 and ISO 5832-2 and are provided with a Titanium Nitride (TiN) coating to enhance of the device. All subject device components are used with abutment and prosthetic screws previously cleared in K213106, and K053355.

The provided text is a 510(k) summary for the BTI Dental Implant System UnicCa® - Aesthetic Post Abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use, rather than presenting a performance study with acceptance criteria for an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment for a device performance study cannot be extracted from this document, as it describes a dental implant abutment, not a device whose performance is measured through such clinical or AI-centric metrics.

The document states: "No clinical data were included in this submission." This explicitly indicates that the type of study typically associated with performance criteria, and the establishment of ground truth for AI/ML models, was not part of this 510(k) submission.

The "Performance Data" section solely discusses non-clinical data related to:

• MRI review for components.
• Moist heat sterilization for non-sterile devices.
• Biocompatibility testing (cytotoxicity) for the final abutment.

These are standard engineering and material science performance tests for medical devices, not an evaluation of a diagnostic or therapeutic AI/ML device's accuracy or effectiveness in a clinical context.

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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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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.

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. to expand the product offering for the Wide and Universal Plus 5.5 mm and 6.0 mm diameter Interna® implants to extend implant length up to 15 mm.

This document is an FDA 510(k) summary for the BTI Dental Implant System UnicCa®, which is a dental implant system. The submission describes modifications to the existing device, specifically expanding the available dimensions (diameter and length) of certain implants. Importantly, this is a modification of an already cleared device (predicate K151391), and the document emphasizes substantial equivalence rather than presenting an entirely new device's performance data.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Strict acceptance criteria and performance data for the modified device itself are not explicitly presented as a pass/fail table in the document. Instead, the document relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K151391) and other reference predicates. The "performance data" provided relates to general device safety and effectiveness based on established standards and previous clearances, rather than a novel statistically powered study for the dimensional changes.

However, based on the provided text, we can infer the following:

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

The document does not describe specific sample sizes for a new test set for the modified dimensions. The overarching theme is that the modifications (dimensional changes) do not alter the fundamental design, materials, or intended use. Therefore, the data presented relies on previous testing for the predicate device.

• The biocompatibility testing, bench testing (fatigue, corrosion, hydrophilicity), shelf-life validation, and sterilization validation all refer back to studies performed for the predicate device K151391. No new samples or data provenance are explicitly stated for these tests regarding the new extended sizes.
• Human Factors Study: A Human Factors study was performed, but the sample size is not specified. The data provenance is implied to be prospective, specifically assessing the handling of the proposed single-barrier packaging.

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

This is not applicable as the document describes a dental implant system, not an AI/diagnostic device that typically requires expert-established ground truth for performance evaluation. The "ground truth" here is compliance with established engineering standards and safety/performance requirements for medical devices.

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

Not applicable for this type of medical device submission. Adjudication methods are typically used in clinical trial settings or for performance evaluation of diagnostic/AI devices where agreement among experts on a finding is critical.

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 a dental implant (hardware), not an AI-assisted diagnostic or imaging device.

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

Not applicable. This device is a physical dental implant.

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

The "ground truth" for this device's acceptance is primarily based on:

• Compliance with recognized international and national standards (e.g., ISO 10993 series for biocompatibility, EN ISO 14801 for fatigue, ISO 5832-2 and ASTM F67 for material, ANSI ST72, USP, USP for endotoxins).
• Demonstration of substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics, materials, and intended use.
• Previous performance data from the predicate device (K151391) being deemed applicable to the modified device due to the nature of the changes (dimensional expansion within a similar design).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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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. Comprises two types of connections: Externa® and Interna® with a range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm) for various platforms, we refer to Table 5-1. BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The provided text describes the acceptance criteria and the study conducted for the BTI Dental Implant System UnicCa®. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative table for the clinical study. However, the reported device performance is:

The study implicitly aims to demonstrate that these survival rates are comparable to or exceed commonly observed rates in the literature (90% to 98%).

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

• Sample Size (Test Set): 170 patients with 430 BTI UnicCa implants.
• Data Provenance: Retrospective observational study. The country of origin of the data is not specified in the document.

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

This information is not provided in the document. The study is described as an "observational retrospective study," which typically involves reviewing existing patient records or clinical outcomes, rather than having experts establish ground truth for a new test set. The criteria for "implant survival" are defined (stable prosthesis, no pain, infections, pathology, absence of radiopaque images around implant, no loss/fracture/significant bone loss/infection), implying a clinical assessment standard.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

There is no indication of a Multi Reader Multi Case (MRMC) comparative effectiveness study or any involvement of AI in this document. The device is a dental implant, not an AI-powered diagnostic tool.

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 dental implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on clinical outcomes and observations following implant insertion. This includes criteria such as:

• Stable prosthesis without pain, infections, or any pathology
• Absence of radiopaque images around the implant
• No implant loss or fracture
• Bone loss not exceeding 2-3mm
• No infection

8. The Sample Size for the Training Set

There is no mention of a training set as this study is a clinical evaluation of a physical medical device, not an AI model.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set mentioned.

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BTI Dental implants 5.5 - 6.5 mm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure. These implants are not indicated for immediate loading. These implants are not indicated to support removable resilient retained restorations or angled abutments.

The BTI Dental Implant 5.5-6.5 is a self tapping, threaded dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameters: 4.5, 5.0, 5.5, 6.0 and lengths: 5.5, 6.5

The provided text is a 510(k) summary for a dental implant device (K091387) and an FDA clearance letter. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding the testing and validation of the device.

The 510(k) summary primarily focuses on:

• Device Description: Self-tapping, threaded dental implant made of titanium for restoring missing teeth.
• Intended Use: Restore missing teeth in partially or fully edentulous patients, or for fixation of overdentures.
• Substantial Equivalence: Compares the device to previously cleared predicate devices (K022258, K053355, K063779).
• Technological Aspects: States that the device is substantially equivalent to predicates in terms of features and intended use.

The FDA letter confirms the clearance of the device based on substantial equivalence and outlines regulatory requirements.

Therefore, I cannot provide the requested table and study details because the necessary information is not present in the given text.

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BTI Dental Implant Tiny® 3.0 are intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.

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 Tiny® Ø3.0 is a self tapping, threaded, root- form dental implant intended for restoring missing teeth in partially or fully edentulous patients to restore the chewing capacity of patients. It is made of titanium and offers a variety of sizes including diameter: 3.0mm and lengths: 11.5, 13, 15mm

The provided text is a 510(k) summary for the BTI Dental Implant Tiny® Ø3.0. This document primarily focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way you've outlined for an AI/software device evaluation.

Dental implants, like the one described, are typically evaluated through:

• Mechanical Testing: To ensure strength, fatigue resistance, and fracture toughness. Standards like ISO 14801 (Fatigue Test for Endosseous Dental Implants) are common.
• Biocompatibility Testing: To ensure the material is safe for implantation. Based on ISO 10993.
• Animal Studies or Clinical Performance Data: Especially for new designs or materials, to demonstrate osseointegration and long-term success.

The 510(k) summary only mentions "Technological Aspects: A comparison of the device features, intended use and other information demonstrate that the BTI Dental Implant Tiny® Ø3.0 substantially equivalent to the predicate devices." This implies that the device's performance is assumed to be similar to its predicate devices, which have already gone through their own testing and regulatory approval processes.

Therefore, I cannot fill in the table or answer most of your questions as the requested information (acceptance criteria, specific performance studies, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, or standalone studies) is not present in the provided text.

The closest I can get is extracting the intended use and device description, but these are not "acceptance criteria" in the sense of a quantitative performance metric.

Here's what I can extract from the provided text, acknowledging that it doesn't align with your request for AI/software-specific evaluation:

1. Table of (Implied) Acceptance Criteria and Reported Device Performance:

The following questions cannot be answered from the provided text as they pertain to a different type of device evaluation (e.g., AI/software performance) than what is presented in a dental implant 510(k) summary based on substantial equivalence:

2. Sample size used for the test set and the data provenance: Not applicable/Not provided. The 510(k) relies on substantial equivalence to predicate devices, not a test set in the AI sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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/Not provided, as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided in the context of device performance testing for substantial equivalence. Clinical outcomes data for predicate devices would implicitly support their safety and effectiveness.
8. The sample size for the training set: Not applicable/Not provided.
9. How the ground truth for the training set was established: Not applicable/Not provided.

In summary, the provided document is a regulatory submission for a dental implant, detailing its intended use and features to demonstrate substantial equivalence to existing devices. It does not include the detailed performance study information with acceptance criteria, sample sizes, and ground truth establishment that would be found in submissions for AI/software-based medical devices.

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Endosseous dental implant angled abutments are premanufactured prosthetic components directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation. They can be used in singled and multi-unit restorations where angled correction is required.

BTI Endosseous dental implant angled abutments consist of 15 degree angled abutments. The artificial tooth abutments are designed to fit and function on the internal and external BTI conexion implants.

They can be used in singled and multi-unit restorations where angled correction is required.

The angled abutments differ from the BTI predicate abutments in that the abutments are angled. The angled abutments provide for more flexibility in the implant placement and restoration process.

The provided text is a 510(k) summary for a medical device (Endosseous dental implant angled abutments). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness are not applicable or not present in this type of submission.

Here's a breakdown of the information that can be extracted based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable.
This 510(k) summary for Endosseous dental implant angled abutments does not present specific quantitative acceptance criteria or performance metrics derived from a study designed to meet such criteria. Instead, it claims "substantial equivalence" in material, design, and function to existing predicate devices.

The basis for clearance is that the device is "as safe and effective as the predicate devices" based on this substantial equivalence claim, rather than a direct performance study against defined thresholds.

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

Not Applicable.
No specific test set or data from a performance study is described in this 510(k) summary. The submission relies on demonstrating substantial equivalence to already cleared devices.

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

Not Applicable.
Since no specific test set or performance evaluation is described, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

Not Applicable.
Since no specific test set or performance evaluation is described, there's no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No.
An MRMC comparative effectiveness study was not done. The submission is a 510(k) for substantial equivalence of a physical dental implant component, not an AI or diagnostic device that would typically involve a reader study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable.
This device is a physical dental implant component, not an algorithm or AI system. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

Not Applicable.
Since no specific performance study is discussed, there is no mention of a ground truth being established (e.g., pathology, expert consensus, outcomes data). The "truth" in this context is the comparison to the performance and safety profiles of the predicate devices.

8. The Sample Size for the Training Set

Not Applicable.
This submission pertains to a physical medical device (dental implant abutment), not a machine learning or AI model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable.
As there is no training set mentioned, the establishment of ground truth for it is not applicable.

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Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants. Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.

Dental bur are rotary cutting devices intended to cut hard structures in the mouth, such as teeth or bone. They are also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices. Endosseous dental implant abutments are premanufactured prosthetic component directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation.

The provided submission for K061383, "TRADITIONAL 510 (K) SUBMISSION BTI Dental Implant System Modification," does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.

The submission is a 510(k) for a modified dental implant system (sterile dental drills kit/abutments and caps). The primary focus of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish specific performance acceptance criteria for a novel device and then prove those criteria are met through a dedicated study.

Here's a breakdown of why this information is absent, based on the provided text:

• Substantial Equivalence Approach: The submission explicitly states, "The modified BTI Dental Implant System is claimed to be substantially equivalent in material, design, and function to BTI Dental Implant System cleared by FDA under 510(k) K022258 on Sep 11, 2003 and 510(k) 053355 on Mar 14, 2006." This indicates that the core approval strategy relies on comparing the new device to existing, already approved devices, rather than establishing de novo performance criteria.
• Lack of Performance Data: The document describes the device, its intended use, and its classification, but it does not present any specific performance metrics (e.g., bone cutting efficiency, abutment stability, wear resistance) that would typically have acceptance criteria. Consequently, there is no study described that would aim to "prove" such criteria were met.
• Focus on Design, Material, and Function: The "CONCLUSION" reiterates: "The modified BTT Dental Implant System is considered to be substantially equivalent in design, material and function to BTI Dental Implant System." This further emphasizes that the evaluation was a comparison of attributes rather than a measurement against new, independent performance benchmarks.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a proving study, as this information is not present in the provided 510(k) submission.

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided.
2. Sample size for test set and data provenance: Not applicable, as no specific performance test data is presented.
3. Number of experts and qualifications for ground truth: Not applicable, as no ground truth establishment for a performance study is described.
4. Adjudication method for test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported.
6. Standalone (algorithm only) performance study: Not applicable (this is a physical medical device, not an algorithm).
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

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