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Cortex CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) 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; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with Cortex Dental Implants with internal hex- connection mating platform and conical connection platform diameters.

All digitally designed abutments and/or copings for use with Cortex CAD/CAM Abutments are intended to be sent to a Cortex-validated milling center for manufacture. Cortex abutments designed using CAD/CAM techniques must fulfill the Cortex allowable range of design parameters.

Cortex CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) 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; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant.

This document is an FDA 510(k) clearance letter for Cortex CAD/CAM Abutments. This type of document typically shows that a device is substantially equivalent to a predicate device and provides information on its intended use. It does not contain information about specific acceptance criteria or detailed study results proving a device meets those criteria from an AI/ML perspective.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is a regulatory approval, not a technical performance report or a clinical study report for an AI/ML device.

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Cortex Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.

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I'm sorry, but the provided text is a standard FDA 510(k) clearance letter for the Cortex Dental Implant System. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document only states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input.

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The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading.

The procedure can be accomplished in a one-stage or two-stage surgical operation.

The SATURN Dental Implant employs a new strategy that of extended sub-crestal threads, expanded out in a wing-like effect to engage socket walls mid-crestally. The implants material composition is: TI 6AL 4V - ELI

The system consists of a variety of bone screw implants in three diameters ø 3.8, 4.2, 5.0 mm diameter. Each respective diameter is available in various lengths from 8 mm to 16mm. The bone screw (implant) is connected to the abutment via an internal connecting screw while the alignment of the abutment is determined.

SATURN Dental Implants are tapered internal hex implants, designed to enable easy insertion, while supporting initial stability. The variable thread (coil) design enables self-tapping, thus providing solution for a variety of bone conditions.The internal hexagon helps to minimize rotation. SATURN Dental Implant System offers a solution for immediate placement and immediate loading.

The SATURN Dental Implant System is cleared for marketing in Europe. The device was implanted in thousands of patients in Israel and Europe.

Materials:

The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.

Function:

The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading.

The procedure can be accomplished in a one-stage or two-stage surgical operation.

The medical device in question is the SATURN Dental Implant System by Cortex Dental Implants Industries Ltd.

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

1. Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" here are implied by the performance of the predicate devices and the outcome of the non-clinical and clinical tests demonstrating this equivalence.

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

• Sample Size for Non-Clinical Test (Fatigue): Not explicitly stated as a number of devices. The test was conducted on the "longest implant (16mm) in combination with the highest angled abutment (30°)." It implies testing of a sufficient number of samples of this specific configuration to meet ISO 14801 standards, but the exact count isn't given.
• Sample Size for Clinical Test (Case Reports): "Long-term results of several patients implanted with the SATURN Dental Implant System were presented." The exact number of patients is not provided.
• Data Provenance: The document states, "The device was implanted in thousands of patients in Israel and Europe." This implies the clinical experience referenced is retrospective from real-world usage in Israel and Europe.

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

• Non-Clinical Test: Ground truth is established by adherence to the ISO 14801:2007 standard and FDA guidelines for fatigue testing. No human experts are described as establishing ground truth in this context; rather, the standard dictates the methodology and acceptance criteria.
• Clinical Test (Case Reports): The summary refers to "Case Reports" and mentions the "biomechanical theory." While undoubtedly clinical experts (dentists/oral surgeons) were involved in collecting and reporting these cases, the document does not specify the number or qualifications of experts involved in establishing a formalized "ground truth" for the purpose of a study. The presentation of results seems to be based on the observed clinical outcomes in these patients.

4. Adjudication Method for the Test Set

• Non-Clinical Test: No adjudication method described; results are determined by whether the tested implants meet the criteria of ISO 14801.
• Clinical Test (Case Reports): No formal adjudication method is mentioned for the clinical case reports. The cases were "presented," suggesting a review of clinical outcomes, but not a blinded consensus or similar adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission relies on non-clinical testing and clinical case reports to demonstrate substantial equivalence, not a direct comparison of human readers with and without AI assistance. This device is an implant, not an AI-powered diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

Not applicable. The SATURN Dental Implant System is a physical dental implant, not an algorithm or AI system. Therefore, no standalone (algorithm only) performance study was conducted.

7. Type of Ground Truth Used

• Non-Clinical Test: The ground truth for mechanical performance is defined by the ISO 14801:2007 standard for dynamic fatigue testing.
• Clinical Test (Case Reports): The ground truth for clinical performance is effectively the observed clinical outcomes in the reported patient cases, specifically "no bone loss in the neck of the implanted SATURN." This is a form of outcomes data and expert observation, but not a formally established "ground truth" in the way it might be for a diagnostic device.

8. Sample Size for the Training Set

Not applicable. This device is a physical dental implant, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Cortex Dental Implant System is indicated for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.

The Cortex Dental Implant System includes an integral array of devices comprising mainly of dental implants, abutments, additional prosthetic and surgical components, post surgical components, and surgical instruments.

This submission (K090709) is for a dental implant system, not an AI device. As such, the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (like those involving test sets, expert ground truth, MRMC studies, or standalone algorithm performance) are not relevant here.

The "performance" section of the document instead focuses on mechanical strength testing and material processing validation for the physical implant device.

Here's a breakdown of the relevant information from the provided text, adapted to the nature of this device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in terms typically used for digital data (e.g., number of images, patient cases). For mechanical testing, this would refer to the number of physical implant units tested. The document mentions "The specimen tested represents the most vulnerable system configuration (worst case)," implying at least one (or a representative set) of this 'worst-case' configuration was tested.
• Data Provenance: Not applicable in the context of digital data. The testing was performed on physical devices.

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

• Not applicable as this is not an AI/ML device requiring expert-labeled ground truth for digital data. Mechanical and material properties are typically evaluated against established engineering standards by qualified engineers or lab personnel.

4. Adjudication method for the test set

• Not applicable. Evaluation of mechanical and material properties is typically objective, based on measurements and adherence to specifications, rather than expert adjudication of subjective assessments.

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 not an AI-assisted device.

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

• Not applicable. This is not an AI algorithm.

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

• For mechanical strength: The "ground truth" is defined by the acceptance criteria specified in the FDA's "Class II Special Controls Guidance Document" for root-form endosseous dental implants. This guidance sets the objective performance thresholds for strength and durability.
• For the Acid Treatment Process: The "ground truth" is adherence to ASTM B 600-91 guidelines and objective scientific evidence (SEM-EDS results) confirming surface morphology preservation and cleaning efficacy.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that uses a "training set."

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

• Not applicable.

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