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The KeyPrint® KeySplint Hard™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners and retainers.

KeyPrint® KeySplint Hard™ material is a UV-curable methacrylate-based resin, intended to be used by trained dental professionals for the 3D printing of various biocompatible dental devices such as mouthguards, splints, repositioners, and retainers. The printing of these devices is carried out using DLP printers utilizing pre-specified wavelengths. Each material is indicated for the fabrication of orthodontic and other dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the devices are 3D printed to create custom devices or appliances.

The provided text describes a 510(k) premarket notification for a dental device, KeyPrint® KeySplint Hard™. However, it does not contain information related to a study proving the device meets acceptance criteria for an AI/ML powered device, nor does it detail acceptance criteria for such a device. The document focuses on demonstrating substantial equivalence to predicate devices through physical property testing and biocompatibility for a UV-curable methacrylate-based resin used for 3D printing dental appliances.

Therefore, I cannot extract the information required by your prompt, as it pertains to AI/ML device testing criteria. The document discusses:

• Device Name: KeyPrint® KeySplint Hard™
• Intended Use: Fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers.
• Testing Performed: Physical property testing (flexibility, strength, durability, kinetic interaction with water) and biocompatibility testing.
• Comparison Method: Demonstrating similar performance to predicate devices (KeyPrint® KeySplint Soft™ and Whip Mix VeriSplint) and meeting ISO and ASTM standardized testing requirements.

The document does not provide information on:

• A table of acceptance criteria and reported device performance for an AI/ML powered device.
• Sample size used for a test set in an AI/ML context.
• Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
• Adjudication methods for an AI/ML AI/ML test set.
• MRMC comparative effectiveness study or related effect size for human readers.
• Standalone AI algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
• Sample size for training set in an AI/ML context.
• How ground truth for the training set was established for AI/ML.

The provided text discusses a traditional medical device (resin for 3D printing) and its approval process, not an AI/ML powered device.

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A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.

Seity 37% Phosphoric Acid Etchant Gel

This document is a 510(k) clearance letter from the FDA for a dental etchant gel. It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document describes a dental etchant gel, which is a chemical product, not a software device or an AI/ML-based medical device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth, and AI/ML performance are not applicable to the information provided in this document.

The letter focuses on regulatory approval based on substantial equivalence to existing products, rather than performance studies as would be required for novel medical devices or AI/ML systems. No information about a study proving the device meets acceptance criteria in the context of an AI/ML device is present.

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For fabrication of temporary prostheses, such as crowns or bridges

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The provided document is a 510(k) clearance letter from the FDA for a dental device called "Mizzy Express." This document is not a study report and therefore does not contain information about acceptance criteria or performance studies of the type requested.

The letter simply states that the FDA has reviewed the premarket notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This means that the manufacturer provided sufficient evidence to show that their device is as safe and effective as a device already on the market, without needing to conduct a full clinical trial or provide detailed performance data.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone algorithm performance.
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 serves as a regulatory clearance, not a scientific publication detailing performance studies.

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Mycone Dental's denture material, known as Diamond D, is intended to form new dentures or to repair fractured dentures. It is to be used only by professional dental practitioners who make or repair dentures for patients.

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This document is a 510(k) clearance letter from the FDA for a dental device called "Diamond D High Implant Denture Material." It indicates that the device has been found substantially equivalent to a predicate device. However, the letter does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily states:

• The device name, regulation number, regulation name, and product code.
• The FDA's determination of substantial equivalence.
• General controls and additional controls applicable to the device.
• Contact information for further inquiries.
• The "Indications For Use" for the device, which states it is "intended to form new dentures or to repair fractured dentures" and "to be used only by professional dental practitioners who make or repair dentures for patients."

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This type of detail would typically be found in the 510(k) submission document itself, not in the clearance letter.

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The denture materials manufactured by Keystone Industries are intended to be used to form new dentures or to repair fractured dentures. They are to be used only by professional dental practitioners who make or repair dentures for patients.

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I am sorry, but the provided text is a 510(k) clearance letter for a dental device (denture acrylic material) and does not contain information about acceptance criteria, device performance studies, or ground truth establishment. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not detail the technical studies typically performed for AI/ML-based medical devices as per your request.

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