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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra 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. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra 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 of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with

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This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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The FRIALIT-2® Dental Implant System is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.

The FRIALIT-2® 3.4mm Dental Implant is an addition to the FRIALIT-2® Dental Implant System currently in commercial distribution. The FRIALIT-2® 3.4mm dental implant is available as a stepped cylinder coated with either FRIOS® TPS (titanium plasma sprayed) coating or FRIOS® HA (hydroxylapatite) coating, and a stepped screw-type implant line coated with the FRIOS® Deep Profile Surface. Surgical, prosthetic and laboratory components to facilitate the placement and restoration of the 3.4mm implant have also been designed.

This document describes the FRIALIT-2® 3.4mm Dental Implant and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and device performance. Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert qualifications, ground truth, or MRMC studies.

The document focuses on demonstrating that the new 3.4mm implant system is substantially equivalent to existing FRIALIT-2® systems and the Nobel BioCare Branemark 3.75mm dental implant based on design, materials, coatings, prosthetic options, functionality, mechanical strength, and intended use.

Here's what can be extracted:

Acceptance Criteria and Device Performance:

No specific "acceptance criteria" with numerical targets or "reported device performance" metrics are provided in the traditional sense of a clinical or analytical study. Instead, the "acceptance criteria" are implied by the substantial equivalence argument, meaning the device must be comparable to the predicate devices in the following aspects:

Missing Information:

The following information is not present in the provided text, as the document is a 510(k) summary focused on substantial equivalence rather than a detailed study report:

• Sample sizes used for the test set and data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment for a test set is mentioned.
• Adjudication method for the test set: No test set or adjudication process is described.
• Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a substantial equivalence claim for a physical device.
• Sample size for the training set: Not applicable, as this is not a machine learning study.
• How the ground truth for the training set was established: Not applicable.

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The Bicortical Screw is intended for surgical placement in edentulous anterior regions of the maxillary and/or mandibular arch to support crowns, bridges, or overdentures. In many cases the Bicortical Screw is inserted immediately after extraction.

The Bicortical Screw is a self-tapping, single-stage titanium implant that enjoys maximum primary support in the bone, i.e., bicortical support. The high degree of initial stabilization on insertion ensures undisturbed healing for this free-standing implant site is prepared with a small diameter pilot bur and the screw implant cuts its own thread configuration, leaving only a very small wound. The implant is intended for sale in the United States with a square head and round head in two thread diameters each (3.5 mm and 4.5 mm major diameter). The square head version is bendable at the head whereas the round head version is not bendable.

The provided document describes a 510(k) premarket notification for the Bicortical Screw dental implant, focusing on its substantial equivalence to previously marketed devices rather than a study against a specific set of acceptance criteria for algorithm performance.

Therefore, many of the requested sections about acceptance criteria, device performance, ground truth, and training an algorithm are not applicable to this submission.

However, I can extract information related to the device's performance and the clinical data used to support its safety and effectiveness in the context of the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" for a novel algorithm. Instead, the performance is demonstrated through comparison to predicate devices and clinical results highlighting safety and effectiveness.

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

• Clinical Study (Retrospective Analysis):
  • Total Patients: 276 (148 from Center A, 128 from Center B)
  • Total Implants: 559 (247 from Center A, 312 from Center B)
  • Data Provenance: Retrospective analysis of consecutive patients from two centers treated between 1984 and 1997. The country of origin is not explicitly stated but implied to be regions where these clinical centers operate, given Oraltronics' German origin.
• Animal Testing: A primate study was conducted, but the sample size (number of primates) is not specified.
• Human Explant Histopathology: Data from two patients (one implant removed due to trauma, six implants due to death).

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

This information is not provided in the document. The clinical studies used general criteria for success (lack of mobility for free-standing implants, freedom from pain, generalized radiolucency, uncontrolled bone loss), which would typically be assessed by treating clinicians/dentists. Histopathological evaluation would be done by pathologists, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable in the context of this 510(k) submission. The clinical data appears to be based on observed outcomes and clinical assessments by the treating teams at the respective centers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or mentioned, as this is a premarket notification for a physical medical device (dental implant), not an AI algorithm.

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

No, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Clinical Study:
  • Survival: Based on observed device presence and functionality over time, using Kaplan-Meier analysis.
  • Success criteria: Clinical assessment (lack of mobility, freedom from pain, absence of generalized radiolucency or uncontrolled bone loss).
• Animal and Human Explant Studies: Histopathological evidence of osseointegration (observing compact bone, absence of connective tissue, bone remodeling, no fibrous tissue layer).
• Mechanical Testing: Measured physical properties (static bending compression, fatigue limit) of the implants.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an algorithm, so there is no "training set" in the machine learning sense. The device design and materials are based on established engineering principles and prior knowledge of biocompatible materials.

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

Not applicable. As there's no algorithm being trained, there's no "ground truth for the training set." The design and material choices are based on existing standards (ASTM F67, ISO 11137, EN 552, CE Mark, ISO 9001, EN 46001) and known successful approaches in dental implantology, as well as comparative mechanical testing against predicate devices.

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ITI One Part octa implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.

ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

The All-in-O re implants are screw type dental implants made from CP titanium. Grade 4. They are available in various insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.

The provided document is a 510(k) summary for a dental implant system (ITI Dental Implant System®) seeking substantial equivalence to existing devices. It does not contain information on the acceptance criteria, study details, or performance of an AI/ML powered device. The document is primarily focused on the device description, intended use, and a comparison to predicate devices, which are all traditional medical devices and not AI-based.

Therefore, I cannot extract the requested information from the given text as it pertains to AI/ML device performance.

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