Search Results

SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

SprintRay Crown HT is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer upon layer of the composite material. SprintRay Crown HT resin is offered in various shades such as Bleach. A1, A2, A3, and B1. Crown HT is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.

SprintRay Crown HT resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Crown HT resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Crown HT file created in an optical impression system, 3D printer, and curing light equipment.

Crown HT resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device instruction for use (IFU) document.

The provided text describes the 510(k) summary for SprintRay Inc.'s "Crown HT" dental resin. It includes acceptance criteria for the device based on performance testing but does not describe a study involving human readers, ground truth consensus, or AI assistance for diagnostic purposes. The device being discussed is a material for fabricating dental prosthetics, not a diagnostic imaging AI system.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of human reader improvement with AI, type of ground truth for AI, training set size for AI, ground truth establishment for AI training) are not applicable to this submission.

However, I can extract the relevant acceptance criteria and performance data for the material properties of the Crown HT resin, as well as information about the studies conducted to prove these properties.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the requirement to perform testing based on ISO standards and to show comparable or better performance than the predicate device.

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

• Sample Size for Testing: The specific sample sizes for each test (e.g., number of specimens for flexural strength) are not explicitly stated in the provided text. The text only mentions that "samples of the Crown HT resin that had been formed into dental appliances using a 3D printer" were used.
• Data Provenance: Not specified in terms of country of origin. The studies are described as "Biocompatibility testing" and "Additional following bench testing." It is implied that these were conducted by or on behalf of SprintRay Inc. as part of their 510(k) submission. No indication of retrospective or prospective human subject data, as this is a material property study.

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

• Not Applicable. This submission is for a dental material, not a diagnostic device requiring expert interpretation of medical images or clinical data for ground truth establishment. The "ground truth" for this device relates to its physical, chemical, and biological properties, which are measured using established laboratory methods and validated against ISO standards.

4. Adjudication method for the test set

• Not Applicable. As per point 3, this is not a study requiring adjudication of expert interpretations.

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 device is a dental material, not an AI-enabled diagnostic tool requiring MRMC studies.

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

• Partially Applicable (in a different context): The performance data presented (e.g., flexural strength, sorption) represents the standalone performance of the material itself when fabricated into a dental appliance. There is no algorithm being tested. The material's properties are measured independently of a human "in the loop" for diagnostic purposes.

7. The type of ground truth used

• Not Applicable (in the requested context of AI/diagnostics).
• For material testing: The "ground truth" is defined by the objective measurements obtained through standardized laboratory tests (e.g., ISO 10477, ISO 10993 series) for physical, chemical, and biological properties. These standards define the methods and acceptance limits that establish whether the material meets its intended performance requirements.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not Applicable. As per point 8, no training set was used.

Ask a specific question about this device