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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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