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FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.

The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients.

Acceptance Criteria and Device Performance for FP3D

This document analyzes the provided FDA 510(k) Clearance Letter (K250489) for the FP3D device to detail its acceptance criteria and the studies that prove its compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details non-clinical performance testing against specific ISO and ASTM standards. The acceptance criteria are implicitly defined by these standards, and the "reported device performance" is the conclusion that the device "meets the requirements" or "was completed per" these standards. Specific numerical values for the performance are not provided in this summary.

Note: The FDA 510(k) summary typically summarizes the results rather than providing raw data or specific passing/failing values for each test. The statement "completed per" or "meets the requirements" implies that the device satisfied the acceptance criteria of the respective standards.

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

• Sample Size for Test Set: The document does not specify the sample sizes used for the physical and biocompatibility tests. It only states that "Nonclinical performance testing was conducted."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were conducted retrospectively or prospectively. Given the nature of these tests (material properties and biocompatibility), they are typically conducted prospectively in a laboratory setting.

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

This information is not applicable to the provided extract. The tests described (physical properties and biocompatibility) are objective, laboratory-based evaluations against established international standards (ISO, ASTM). They do not involve interpretation by human clinicians or the establishment of "ground truth" by experts in the same way clinical diagnostic studies do. The standards themselves define the "ground truth" for performance.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Laboratory tests against standards do not typically involve adjudication methods like 2+1 or 3+1, which are characteristic of expert review for clinical judgments.

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

An MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: Not Applicable." The device is a material for fabricating dentures, not a diagnostic imaging or AI-assisted diagnostic tool that would typically involve a multi-reader study.

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

This information is not applicable. The FP3D is a material (resin) for 3D printing, not an algorithm or software device. Therefore, a standalone performance study for an algorithm is not relevant here.

7. Type of Ground Truth Used

The ground truth for the non-clinical performance tests was established by international standards and regulations:

• For physical properties: ISO 20795-1:2013 (Dentistry - Base polymers - Part 1: Denture base polymers), ASTM D348 (tensile properties), and ASTM D790 (flexural modulus).
• For biocompatibility: ISO 10993.

These standards define the acceptable range or criteria for the properties being tested.

8. Sample Size for the Training Set

This information is not applicable. The FP3D is a material (resin), not a machine learning model or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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KeyPrint KeyDenture Base is a photopolymer resin indicated for the 3D fabrication of denture bases, including full and partial removable dentures, in dental laboratories. Fabrication requires a computer-aided design and manufacturing (CAD/CAM) system and 3D printer.

KeyPrint KeyDenture Base is designed for additive manufacturing in vat polymerization 3D printers utilizing wavelengths between 385nm-405nm. KeyDenture Base is indicated for the fabrication of oral denture appliances for fully and partially edentulous patients. KeyDenture Base is intended to be used within a computer-aided and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, and post-cure unit. For any components that are used in conjunction with the KeyDenture Base resin, the user should review all applicable product labeling including Instructions for Use, user manuals, and other associated labeling. Strict adherence to all labeling is critical in assuring a safe and effective printed appliance.

The provided document is a 510(k) Summary for the KeyPrint KeyDenture Base. It details the device's characteristics and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. There is no information about an AI/ML device in this document. Thus, I cannot fulfill the request as it relies on information about AI/ML device performance which is not present.

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

Not Found

This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The letter primarily focuses on:

• Confirming that the device (KeyPrint KeySplint Soft) is substantially equivalent to legally marketed predicate devices.
• Outlining regulatory requirements and general controls that the manufacturer must adhere to.
• Stating the intended indications for use of the device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from the provided text.

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Mycone Dental's High-Impact Denture Acrylic CAD/CAM Milling Disc material, known as Keymill, is intended to be used to form new dentures. It is intended to be used only by professional dental practitioners who make dentures for patients.

Keymill High-Impact Denture Acrylic CAD/CAM Milling Disc

The provided text is an FDA 510(k) clearance letter for a dental device called "Keymill High-Impact Denture Acrylic CAD/CAM Milling Disc." This document is a regulatory approval notice and does not contain any information about acceptance criteria or specific studies that prove the device meets those criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements for marketing the device. It also includes the intended use statement.

Therefore, I cannot provide the requested information based on the input text. The text does not describe:

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 methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

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Fabrication of removable dental prosthetic devices, such as full and partial dentures, occlusal splints and night guards.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the "ClearMet" device, which is a denture relining, repairing, or rebasing resin.

This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The letter primarily confirms that the FDA has reviewed the 510(k) submission for ClearMet and determined it to be substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and contact information for the applicant.

Therefore, I cannot provide the requested information based on this document.

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