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The CORE 3D abutment system for digital prosthetic solutions are dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include:

• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abulment;
• Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques;
• Abutment Screws to permanently fix the abutments to the Implant.
  Core 3D abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.
  Core 3D abutments designed using CAD/CAM techniques must fulfill the Core 3D allowable range of design specifications and be provided as straight abutments only.
  Core 3D abutments and are compatible for use with the following dental implants:
• Nobel Biocare Branemark System (K022562, K934825)
• Zimmer Tapered Screwvent (K013227, K061410, K072589)

The proposed devices are dental implant abutments intended to be placed into dental implants and to provide support for dental prosthetic restorations.
The system is composed of the following principal components:

• Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment;
• Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques
• Abutment Screws: to fix abutments to the underlying dental implant.
  The final form of the device including superstructures to titanium bases and patientspecific designs for abutment blanks may be designed using CAD CAM techniques under Core3D design specifications and limitations using the following system:
• CAD/CAM Software: 3Shape Dental System including 3Shape Dental Designer
• Scanner: 3Shape D810 model
• Milling machine: SAUER HSC-20 DMG.
  Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.
  The proposed Titanium Bases and Titanium Abutment Blanks are available with either an internal conical connection or external connection, depending on the underlying dental implant. The internal conical types are available in diameters of 3.4, 4.5, and 5.7mm for bases and in diameters of 3.5, 4.5 and 5.7mm for blanks. The external connection types are available in diameters of 3.5, 4.1 and 5.1mm.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CORE 3D Abutment System for Digital Prosthetic Solutions:

Important Note: The provided document is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing entirely new safety and efficacy data through clinical trials. As such, the information you've requested regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies might not be explicitly present in the way it would be for a novel device. The document primarily highlights bench testing results proving compatibility and mechanical performance.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria alongside reported device performance in the format of a clinical study. Instead, it states that bench testing was performed to determine conformance to performance specifications and requirements.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify the sample size used for the bench tests (e.g., number of abutments tested for mechanical properties).
• Data Provenance: The study was non-clinical bench testing. The document does not specify the country of origin for the data itself, but the submitter is based in Spain. It is retrospective in the sense that the testing was completed before the submission.

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

• Number of Experts: This information is not provided in the document. For non-clinical bench testing, "ground truth" is typically established by engineering specifications and standards, not by human experts adjudicating clinical outcomes.
• Qualifications of Experts: Not applicable in the context of this type of non-clinical testing.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for non-clinical bench testing. The results are typically compared directly against engineering specifications and industry standards.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted.
• Effect Size: Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.

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

• Standalone Performance Study: The document does not describe a standalone performance study in the way it might for an AI algorithm. However, standalone bench testing of the physical abutments and an evaluation of the CAD/CAM software (which operates without human intervention in determining design limits once programmed) effectively represent the "algorithm only" performance for the relevant aspects of this device. The software validation aimed to ensure the software's inherent design limitations correctly prevent non-compliant abutment milling.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the mechanical and dimensional aspects of the abutments and their mating, the ground truth was based on engineering specifications, industry standards, and perhaps predicate device performance data. For the CAD/CAM software, the ground truth for software validation was the Core3D design specifications and limitations.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided and is generally not applicable in a traditional sense for a physical medical device. The CAD/CAM software is likely developed based on engineering rules and algorithms, not "trained" on a data set in the machine learning sense.

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

• How Ground Truth for Training Set was Established: Not applicable in the context of this device. The "ground truth" for the software's design rules would have been established by engineering design principles, material properties, and regulatory requirements specific to dental abutments.

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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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