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The CREOKORREKT Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

CREOKORREKT Aligners consist of a series of dentist-prescribed, thin, clear, thermoformed polyurethane and copolyester orthodontic appliances. The aligners provide gentle continuous force to move the patient's teeth in small increments from their original positions to planned positions. CREOKORREKT Aligners are intended as an alternative to conventional wire and bracket orthodontic technology and fixed appliances for the treatment of patients with tooth malocclusion.

A dentist determines a treatment plan based on the assessment of the patient's teeth and prescribes the CREOKORREKT. To obtain the dimensions and details of a patient's dentition, a dentist takes intraoral scanning or a physical impression (PVS Impression) and sends them with a prescription to CreoDent Prosthetics LTD.

With PVS impressions, physical models are fabricated and scanned. Scanned data are directly imported into dental design software for planning. CreoDent Prosthetics LTD designs the process of treatment by creating a series of the sequential model intended to gradually move the patient's teeth to the desired position in accordance with the dentist's prescription utilizing the dental design software. The doctor reviews and approves the treatment scheme. CreoDent Prosthetics LTD fabricates a series of models for thermoforming.

The provided document describes a 510(k) premarket notification for the CREOKORREKT Aligners. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with detailed acceptance criteria and performance metrics against a defined ground truth as would be common for novel high-risk devices.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available within this 510(k) summary.

Here's why and what information can be extracted:

• 510(k) Submissions: These primarily rely on non-clinical testing (e.g., material properties, biocompatibility) and comparison to predicate devices to demonstrate that the new device is as safe and effective as a device already on the market. They typically do not involve the kind of comparative effectiveness studies (e.g., MRMC studies with human readers and AI assistance) or standalone algorithm performance studies with detailed ground truth analysis that would be needed to answer your specific questions.
• "Acceptance Criteria" in this context: The "acceptance criteria" mentioned in the document relate to the manufacturing process validation test, which assesses if the manufactured aligner matches the software treatment design and achieves its intended use. This is a different type of acceptance criterion than, for example, a diagnostic device's sensitivity/specificity targets against a clinical ground truth.

Extracted Information (based on the document's content):

1. Table of Acceptance Criteria and Reported Device Performance:

   Test Type	Acceptance Criteria (as implied/stated)	Reported Device Performance
   Physical Properties Testing	Meets requirements of ASTM D6387, ASTM D790, ASTM D570, and ASTM D5420.	Demonstrated substantial equivalence (implicit passed).
   Biocompatibility Testing	Meets requirements of ISO 10993-3, 5, 10, and 11.	Demonstrated substantial equivalence (implicit passed).
   Manufacturing Process Validation Testing	"Evaluated the fit, form, and function of the final product by a trained physician as compared to software treatment design."	"Met the pre-established acceptance criteria." "Achieves its intended use, and it is substantially equivalent to the predicate devices."

2. Sample Size used for the test set and the data provenance:

   • The document does not specify the sample size for the manufacturing process validation test or any other "test set" in the context of clinical performance.
   • Data provenance for clinical outcomes is not mentioned, as this was not a clinical study to prove effectiveness.

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

   • The document mentions evaluation "by a trained physician" for the manufacturing process validation. It does not specify the number of physicians or their detailed qualifications beyond "trained."
   • No "ground truth" in a clinical sense (e.g., pathology, outcomes data) was established for an efficacy study. The ground truth for the manufacturing validation was the software treatment design.

4. Adjudication method for the test set:

   • Not applicable as a formal adjudication method for a clinical test set is not described. The document only mentions evaluation by a "trained physician" against the software design.

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:

   • No MRMC comparative effectiveness study was done. The device is a physical aligner, not an AI diagnostic or assistance tool for human readers.

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

   • Not applicable. This is a physical medical device. The "algorithm" here refers to the dental design software which guides the manufacturing, not a standalone AI for diagnosis or treatment decision.

7. The type of ground truth used:

   • For the manufacturing process validation, the "ground truth" was the software treatment design. For other non-clinical tests (material properties, biocompatibility), the ground truth generally refers to the standards/specifications that the material must meet.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" in the context of machine learning or AI algorithm development for clinical performance. The manufacturing process uses software for design, but it's not described as an AI system requiring a training set in the clinical performance sense.

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

   • Not applicable, as no training set (in the context of AI/ML) is mentioned or implied for clinical performance evaluation.

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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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