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3Delta UNlimited is a light-curing dental resin for restoring or improving chewing function by prosthetically

• reconstructing damaged or missing teeth using additively fabricated
• permanent full crowns, veneers, inlays, onlays
• temporary crowns & bridges (max. two consecutive pontics)
• monolithic full and partial dentures
• artificial denture teeth

3Delta UNlimited is a light-curing dental resin.

The provided text is a 510(k) clearance letter from the FDA for a dental resin device named "3Delta UNlimited." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is an administrative notification of clearance rather than a technical report detailing performance testing.

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Repair of removable partial and full dentures

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The provided text is an FDA 510(k) clearance letter for a dental device called "Acrifix" (K230341). This document does not contain any information about acceptance criteria or a study proving the device meets the acceptance criteria for an AI/ML medical device.

The letter is a standard clearance for a Class II medical device based on substantial equivalence to predicate devices, specifically "Denture Relining, Repairing, Or Rebasing Resin." It discusses regulatory aspects like general controls, registration, labeling, and good manufacturing practices. There is no mention of AI/ML, clinical study results, performance metrics, ground truth, or expert review processes typically associated with the evaluation of AI/ML-driven medical devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number and qualification of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth.
8. Training set sample size.
9. Method for establishing training set ground truth.

This information is simply not present in the provided document, as it pertains to a different type of medical device review.

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• Production of dentures.
• 3Delta Denture Base: Light curing resin for additive manufacturing of denture bases
• 3Delta Denture Bond: Light curing bonding agent for denture teeth and denture bases
• 3Delta Denture Fix: Dual curing cementation composite for denture teeth and denture bases

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

• The FDA's decision: The device (3Delta Denture Base, 3Delta Denture Bond, 3Delta Denture Fix) is substantially equivalent to legally marketed predicate devices.
• Regulatory information: Details about general controls, special controls, regulations, and reporting requirements for medical devices.
• Indications for Use: What the devices are intended for (production of dentures, light curing resin for additive manufacturing of denture bases, bonding agent for denture teeth and denture bases, dual curing cementation composite for denture teeth and denture bases).

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) from the provided text. This type of information would typically be found in the 510(k) submission itself, which is not included here.

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Additive production of permanent anterior and posterior restorations, e.g. - Single-tooth crowns - Veneers, inlays, onlays

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I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any details about device performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document is an FDA 510(k) clearance letter for a device called "3Delta Crown," manufactured by DeltaMed GmbH. It informs the company that their device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. The "Indications for Use" section lists the intended applications of the 3Delta Crown (additive production of permanent anterior and posterior restorations, such as single-tooth crowns, veneers, inlays, and onlays).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device

Additive production of temporary anterior and posterior restorations, e.g.

• Single tooth crowns.
• Bridges (max. six units, max. two consecutive pontics).
• Veneers, Inlays, Onlays.

P pro Crown & Bridge is a flowable, light-curing, acrylate-based composite material for the additive production of temporary anterior and posterior restorations.
It consists of multifunctional acrylic resins and fillers made of inorganic fillers ranging in size from 0.04 - 0.2 um. The raw materials used in the preparation have been used for many years in dental products.
Exposition: The temporary crown and bridge resin has an intended gingival, enamel/dentine contact for more than 30 days.

The provided text is a 510(k) Summary for a dental device called "P pro Crown & Bridge." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices. It focuses on the chemical, physical, and biocompatibility properties of the material rather than a "device" in the sense of an AI or diagnostic tool that would typically involve a multi-reader, multi-case study or extensive clinical performance data with ground truth experts.

Therefore, many of the requested elements for an AI/diagnostic device study (like MRMC, human reader improvement, number of experts for ground truth, adjudication methods) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning its physical, mechanical, and biocompatibility properties.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for "P pro Crown & Bridge" are primarily based on established ISO standards for dental materials (ISO 4049 and ISO 10477) and an internal DeltaMed standard for compressive strength. The device performance is then compared directly against these criteria and its predicate devices.

1. A table of acceptance criteria and the reported device performance:

Biocompatibility (ISO 10993-1, -5, -10):

Study Details (as inferable from the document):

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

• Sample size: Not explicitly stated in terms of the number of individual specimens tested for each property (e.g., how many samples for flexural strength). However, the results (e.g., "146 MPa") imply a quantitative measurement from a test set.
• Data provenance:
  • Country of origin: The manufacturer, DeltaMed GmbH, is based in Friedberg, Germany. The testing would presumably be conducted in Germany or by certified labs adhering to international standards.
  • Retrospective or Prospective: These are laboratory tests on material samples, not clinical studies involving patient data. Therefore, "retrospective" or "prospective" as typically applied to clinical data collection does not directly apply. The tests are conducted on manufactured material samples to demonstrate performance against specifications.

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

• Not Applicable. For a material device, "ground truth" is established by adherence to physical, chemical, and biological testing standards (e.g., ISO 4049, ISO 10477, ISO 10993 series). The "truth" is the measured property value compared to the standard's requirement, not an expert's interpretation of an image or clinical finding. These tests are performed by qualified laboratory technicians/scientists following validated protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods are relevant for subjective assessments (e.g., consensus among radiologists). For objective material properties testing, results are quantitative and directly measured. Statistical analysis of multiple measurements would be performed to ensure reliability, but not "adjudication."

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 is a material device, not a diagnostic imaging device or AI software. There are no "human readers" or "AI assistance" in this context.

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

• Not Applicable. This is a material device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Objective Laboratory Measurements against International Standards: The "ground truth" is derived from standardized laboratory testing procedures (e.g., measuring flexural strength, water absorption, cytotoxicity) as defined by ISO standards (ISO 4049, ISO 10477, ISO 10993). The "truth" is whether the measured physical/chemical property falls within the acceptable range specified by these standards.

8. The sample size for the training set:

• Not Applicable. This device is a material, not an AI/machine learning algorithm that requires a "training set." The characteristics of the material are inherent to its composition and manufacturing process, not learned from data. Extensive R&D and formulation development would have occurred, but not in the sense of "training data."

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

• Not Applicable. No "training set" as defined for AI/ML. The properties of the material (composition, etc.) are determined during the material science and engineering development process.

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e-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.

e-DENT TEMPORARY RESIN is a radiopaque, filled, resin-based temporary dental restorative composite. In general terms, the device is a typical, high quality, esthetic dental composite, composed of difunctional acrylic monomers and silaceous fillers. The product will polymerize on exposure to high-intensity incandescent illumination, yielding a hard, esthetic, temporary restoration that mimics natural tooth structure.

e-DENT TEMPORARY RESIN is intended to be fabricated in a laboratory-based, additive, Computer-Aided Manufacturing (CAM) and curing system, such as the EXTRA-ORAL CURING SYSTEM disclosed in this submission. The curing system consists of two pieces of equipment used to manufacture photocurable dental resin devices in a dental laboratory, using accompanying software to form and cure the devices.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) premarket notification for a dental resin and curing system, primarily focusing on demonstrating substantial equivalence to a predicate device.

It describes the device, its intended use, and states that its technological characteristics are "essentially identical" to the predicate device, VITA CAD TEMP, except for the manufacturing method (additive vs. subtractive). The document primarily outlines the regulatory approval process and confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested table or details about a study proving acceptance criteria as this information is not present in the given text.

The following information is not available in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about the study design.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set or how ground truth for the training set was established.

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