Search Results

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.

Ask a specific question about this device

The uLab Systems Dental Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

The uLab Systems Dental Aligner Kit is an orthodontic treatment system, that consists of doctorprescribed, clear, thin, plastic removable aligners. Patients are seen in a dental office where a dental professional (dentist/orthodontist) scans or takes a physical impression of the teeth, which is then used to fabricate the aligners. The aligners are designed and customized by dental professionals using uLab Systems technology. The aligners are made of aesthetic and medical grade materials. During the orthodontic treatment, each preformed plastic aligner is worn in sequence by the patient as prescribed by the dental practitioner, moving the patient's teeth gradually to the ideal position.

I am sorry, but the provided text (K211510 FDA 510(k) Summary for uLab Systems Dental Aligner Kit) describes an orthodontic treatment system (aligners) and not a device that would typically have the kind of acceptance criteria, test set, ground truth, and human-in-the-loop performance studies as outlined in your request.

The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of:

• Intended Use: "alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces."
• Technological Characteristics: clear plastic sequential aligners, principles of operation, aligner design process using dental software, materials (thermoplastic), and general features.

The "Performance Data" section (Page 6) briefly mentions that performance testing remains unchanged from the company's previous reference device submission (K192596) and includes:

• Biocompatibility (ISO 10993-10)
• Design verification and process validation testing
• User validation testing
• Packaging verification and shelf life testing
• Physical properties testing by the material manufacturer

This type of information is typical for a 510(k) submission for a physical medical device like an aligner, which is considered a Class II device (Orthodontic Plastic Bracket, Product Code NXC). It does not involve an AI algorithm or software that performs diagnostic or imaging analysis requiring the specific types of studies (e.g., MRMC, standalone AI performance, expert adjudication of ground truth for AI model testing) that your detailed request outlines.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document is about a physical dental aligner product, not an AI/software device that analyzes data or images.

Ask a specific question about this device