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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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NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Nobel Active TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only.

NobelReplace CC TiUltra

NobelReplace CC Tilltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function.

The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelParallel CC TiUltra

NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with

The TiUltra implants and Xeal abutments are endosseous dental implants and abutments with an internal conical connection (CC) with hex interface. The TiUltra implants are comprised of three implant lines with various body shapes, range of diameters (3.0 - 5.5mm), and lengths (6.5 -18mm). The Xeal abutments are comprised of specific abutment types (i.e., straight, angled, and base). Both the TiUltra implants and Xeal abutments are made of titanium and feature a surface treatment that preserves the hydrophilicity of the device.

Here's a breakdown of the acceptance criteria and the studies performed for the Nobel Biocare AB TiUltra Implants and Xeal Abutments, as described in the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore section 2, 3, 4, 5, 6, 8, 9 are not applicable in this case.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for dental implants and abutments, the acceptance criteria are primarily focused on demonstrating substantial equivalence to predicate devices through various performance tests and material characterizations. Direct numerical "acceptance criteria" for specific clinical outcomes (like sensitivity/specificity for diagnostic AI) are not explicitly stated in this format. Instead, the "acceptance criteria" are implied to be meeting established performance specifications and not raising new questions of safety or effectiveness compared to the predicate devices. The reported performance is the result of demonstrating these equivalences through testing.

Implied Acceptance Criteria for Substantial Equivalence and Reported Device Performance:

Studies Proving Acceptance Criteria are Met:

The submission relies on a combination of non-clinical (bench, material characterization, animal) and real-world evidence (clinical) studies to demonstrate substantial equivalence.

Non-Clinical Testing:

• Sterilization Validation: Conducted according to ISO 11137-1:2006 and ISO 11137-2:2013 to establish and validate a SAL of $10^{-6}$ for Gamma Radiation.
• Endotoxin Testing: Performed per USP 42-NF37:2019 and ANSI/AAMI ST72:2011/(R)2016.
• Packaging Performance Testing: Conducted according to ISO 11607-1:2019.
• Biocompatibility Testing: Comprehensive assessment following ISO 10993-1:2018 for permanent implant devices with tissue/bone contact. This included:
  • Expert toxicity assessment.
  • Dissolution kinetics of the soluble salt (protective) layer.
  • Chemical characterization of leachables (ISO 10993-18:2009).
  • Cytotoxicity assessment (ISO 10993-5:2009).
  • Sensitization testing (ISO 10993-10:2010).
  • Irritation testing (ISO 10993-10:2010).
  • Material mediated pyrogenicity testing (ISO 10993-11:2017).
  • Acute systemic toxicity testing (ISO 10993-11:2017).
  • Local effects after implantation testing (ISO 10993-6:2016).
• Mechanical Testing: Performed according to ISO 14801:2016 ("Dentistry - Implants — Dynamic loading test for endosseous dental implants") and the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004). An assessment of implant-to-abutment connection wear was also conducted.
• Surface Treatment Characterization: Modified surface treatment was characterized per the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutment" (May 12, 2004). Additionally, specific tests for hydrophilic surface properties (contact angle measurements and conductivity/salt amount testing) were done.
• Animal Study: A comparative study in a Yucatan mini-pig model, assessing clinical observations, clinical pathology, macroscopic observations, micro-CT for osseointegration, histomorphometry for osseointegration and soft tissue attachment, and histopathology for inflammatory response at 3, 6, and 13 weeks.

Clinical Testing (Real-World Evidence):

• Sponsor-Investigator Study: A prospective, single-arm study.
• Real World Evidence: Interim 18-month post-market surveillance data from CE mark recognizing countries and five case studies with 3-5 month follow-ups were also provided.

2. Sample Size for the Test Set and Data Provenance

• Sponsor-Investigator Study (Clinical Test Set):
  • Sample Size: 61 patients.
  • Data Provenance: Prospective, single-arm, sponsor-investigator study conducted in Italy.
• Animal Study (Pre-clinical Test Set):
  • Sample Size: Not explicitly stated as a number of animals, but refers to a "Yucatan mini-pig model" and "its predicates," indicating multiple animals used for comparison.
  • Data Provenance: Not specified, but likely a controlled laboratory setting.

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

• Not Applicable (N/A): This is a 510(k) submission for a medical device (dental implants/abutments), not an AI/ML diagnostic tool. Therefore, "ground truth" as established by human experts for an AI test set is not relevant in this context. The "truth" for device performance is established through physical, chemical, and biological testing, and clinical observation against established medical criteria. For the animal study, veterinarians and pathologists would have established observations. For the human clinical study, dentists/oral surgeons and clinical researchers would have established the outcomes. The qualifications of these individuals are not specified in the 510(k) summary provided.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): This device is not an AI/ML diagnostic device requiring adjudication of expert readings. Clinical outcomes in the human study would be based on direct observation and measurement by investigators, and the animal study observations would be made by scientific personnel.

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

• No: An MRMC comparative effectiveness study, typically used for evaluating the impact of AI on human reader performance for diagnostic tasks, was not conducted. This is not applicable to a device like a dental implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable (N/A): This is a medical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

• For Non-Clinical Testing:
  • Measurement Standards: Adherence to international standards (e.g., ISO, ASTM), physical and chemical characterization (e.g., surface roughness, material composition), and biological endpoints (e.g., cell viability, immune response).
  • Pre-clinical (Animal Study): Histology/Histomorphometry, Micro-CT findings, clinical observations, and pathology assessments.
• For Clinical Testing (Real-World Evidence):
  • Clinical Outcomes: Implant survival, soft tissue parameters, occurrence of adverse events, and demonstration of stable bone levels via radiography. These are direct patient outcomes and clinical assessments made by medical professionals.

8. The Sample Size for the Training Set

• Not Applicable (N/A): This device does not involve a "training set" in the context of AI/ML or statistical modeling. Its design and manufacturing are based on established engineering principles, material science, and prior predicate device designs for which extensive clinical experience exists.

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

• Not Applicable (N/A): As there is no "training set" in the AI/ML sense, "ground truth establishment" for a training set is not applicable. The design and validation are based on scientific principles, regulatory standards, and comparative data to predicate devices.

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