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The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

• Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm
• Hiossen TS Implants 3.5mm, 4.0mm

The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with:

• Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm (K024111)
• Hiossen TS Implants 3.5mm, 4.0mm (K151858)

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.

The medical device under consideration is the CreoDent Solidex® Customized Abutment. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a standalone clinical study. Therefore, some of the requested information, such as sample sizes for test/training sets, number/qualifications of experts for ground truthing, adjudication methods, and MRMC studies, is not typically part of a 510(k) submission for this type of device and is not present in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CreoDent Solidex® Customized Abutment are implicitly derived from its substantial equivalence to predicate devices in material, indications for use, performance characteristics, and dimensions/angulations, backed by non-clinical testing. The performance is assessed against the established standards and the characteristics of the predicate devices.

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a non-clinical testing study focused on mechanical performance and compatibility.

• Study Type: Non-clinical testing, specifically static/fatigue testing, reverse engineering dimensional analysis, and sterilization validation.
• Standards Followed: ISO 14801:2007E (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants) and ISO 17665-1 (Sterilization validation).
• Purpose: To demonstrate that the CreoDent Solidex® Customized Abutment has sufficient mechanical strength for its intended clinical application and is compatible with the specified Astra Tech Osseospeed TX and Hiossen TS implant systems. This testing specifically addressed the differences identified when comparing to predicate devices (compatible implant bodies and angulation).

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

• Sample Size for Test Set: Not specified in the document. Non-clinical mechanical testing typically involves a sufficient number of samples to ensure statistical significance for the specific test (e.g., number of abutment-implant assemblies tested for fatigue) but this exact number is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As a non-clinical, in-vitro mechanical testing study, the data is generated in a laboratory setting.

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

• This is a mechanical testing study, not one requiring expert human interpretation of medical images or patient data to establish ground truth. Therefore, this information is not applicable and not provided. The "ground truth" here is the physical performance of the device under defined test conditions per international standards.

4. Adjudication Method for the Test Set

• Not applicable. As a mechanical testing study, adjudication of human interpretations is not involved.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating diagnostic or prognostic algorithms read by human experts, which is not relevant for this dental implant abutment.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

• Not applicable. This device is a physical medical device (an abutment for dental implants), not a software algorithm.

7. Type of Ground Truth Used

• The "ground truth" for this device's performance evaluation is established through physical measurements and adherence to international mechanical testing standards (ISO 14801:2007E). The benchmarks are defined by these standards, the performance of the legally marketed predicate devices, and the physical properties of the materials and design.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, and the validation process described is for its mechanical integrity and compatibility, not for an algorithm 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 a physical device like this.

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The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

• Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants .
• Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants .
• Zimmer Screw-Vent 3.7mm, 4.7mm ; Zimmer Tapered Screw-Vent , 3.7mm, 4.7mm and . 6.0mm diameter implants

The Solidex® Customized Abutment is made of CP TI Gr4 grade unalloyed titanium for surgical implants applications (meets ASTM Standard F67/Gr 04-06) and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with:

• . Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants (510K#023113)
• . Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants (510K#071370)
• Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants (510K#013227)

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist.

Here's an analysis of the provided text regarding the CreoDent Solidex® Customized Abutment, focusing on acceptance criteria and study details:

Preamble:
This document describes a 510(k) premarket notification for a medical device, the CreoDent Solidex® Customized Abutment. As such, the purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish novel clinical efficacy or safety standards through extensive clinical trials. The "acceptance criteria" here refer to demonstrating that the new device performs comparably to the predicate device, particularly in terms of mechanical strength and compatibility, and is therefore deemed safe and effective for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The core of the "acceptance criteria" and "reported device performance" for this 510(k) submission is the demonstration of similar mechanical properties to predicate devices and compatibility with specific implant systems. The study cited is non-clinical static/fatigue testing in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants.

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the test results demonstrate comparable or superior performance to the predicate under the defined standard. The text doesn't provide numerical acceptance thresholds or specific performance metrics from the predicate devices with which to compare. Instead, it makes a qualitative statement that the device has "sufficient mechanical strength."

Study Details

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: The document does not specify the exact number of units tested. ISO 14801 typically defines sample sizes (e.g., n=5 or n=10 per group). The phrase "worst case scenario for the Solidex® Customized Abutment connection platform" suggests that specific configurations were selected for testing. Without the full test report, the precise sample size is unknown.
   • Data Provenance: Not explicitly stated, but as a premarket notification to the US FDA, the testing was likely conducted in an accredited lab, potentially within the US or a country with recognized testing standards. This would be a prospective set of tests designed specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • This question is not applicable to the type of study performed. The study was a non-clinical mechanical engineering test (static/fatigue testing) following an international standard (ISO 14801:2007E). The "ground truth" is established by the standardized test methodology and objective measurements, not by expert consensus on clinical data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or subjective assessments. This was a non-clinical mechanical test with objective measurements guided by a standard.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental implant abutment, a physical component, and does not involve AI or human "readers" in its primary function or assessment for this submission.

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

   • No, this question is not applicable. This device is a physical medical device, not an algorithm or AI system.

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

   • The "ground truth" for this non-clinical study is defined by the ISO 14801:2007E standard itself, which provides a scientifically validated methodology for dynamic fatigue testing of dental implants. The "truth" is the objective measurement of load cycles to failure, maximum force, stiffness, etc., as determined by the specified test method. It's an engineering ground truth, not a biological or clinical one based on consensus or pathology.

7. The sample size for the training set:

   • This question is not applicable. There is no "training set" in the context of this non-clinical mechanical testing for demonstrating substantial equivalence. The device design and manufacturing processes are established based on engineering principles and materials science, not machine learning or AI training.

8. How the ground truth for the training set was established:

   • This question is not applicable as there is no training set.

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