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Full veneering of crowns and bridges

Complete crowns

Inlays/onlays

Fiber reinforced crowns and bridges

Direct bonded bridges

Telescopic and conical crowns

Attachments and implant works

Veneers

Long term temporary restorations and their characterization

Customization of acrylic and ceramic artificial teeth

Extraoral repairs

SINFONY is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to be used for full and partial coverage of crowns and bridges and as a material for the fabrication of inlays and onlays to restore carious lesions or structural defects in teeth.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" with specific thresholds (e.g., "flexural strength must be > X MPa"). Instead, it outlines a strategy to demonstrate substantial equivalence by comparing SINFONY®'s performance to predicate devices. The "reported device performance" is implicitly that SINFONY® performed "as effectively" as the predicate devices.

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

• Sample Size: Not specified in the provided text. The document only states "performance test data are provided."
• Data Provenance: Not explicitly stated. However, given that ESPE Dental AG is based in Germany, it's highly probable the testing was conducted in Germany or Europe. The study is retrospective in the sense that it evaluates the device's performance against established predicate devices.

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

This information is not provided. The study focuses on material performance testing, not diagnostic accuracy based on expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication is typically relevant for studies involving human interpretation or subjective assessments.

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

This information is not applicable and not provided. The device described, SINFONY®, is a dental material, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The device described is a dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device (dental material) would be derived from physical, mechanical, and chemical property testing according to established standards, as well as clinical performance data from the predicate devices. The document implies a comparison of SINFONY's performance test data against the known performance of predicate devices. Specific types of data would likely include:

• Mechanical properties (e.g., flexural strength, wear resistance)
• Physical properties (e.g., water absorption, solubility)
• Biocompatibility data (although the document states a new toxicological assessment wasn't required due to similarity to existing materials)

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no mention of a "training set" as this is a material science study, not a machine learning model.

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

This information is not applicable and not provided since there is no "training set." The performance of the SINFONY® material was likely measured via lab-based testing and compared to the established performance characteristics and clinical history of the predicate devices.

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The Sinfony® system is indicated for use as a light-curing composite veneer material for:

• full and partial coverage of:
  • fixed crown and bridgework .
  • telescopic and conical crowns .
  • precision attachments
  • implant superstructures .
  • adhesive bridgework .
  • laminate veneers .
  • o individualizing denture teeth
  • individualizing long-term temporary restorations .

light-curing composite veneer material

The provided text describes a 510(k) premarket notification for a dental material (Sinfony®), focusing on its substantial equivalence to previously cleared devices. It outlines the intended use and states that physical and technical characteristics were compared using specific ISO and DIN standards. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving device performance as typically understood for AI/ML device evaluations.

Specifically, the document discusses a dental material and its mechanical properties, not an AI/ML device, and thus the concepts of "device performance," "sample size for test set," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set," and "ground truth for training set" are not applicable in the context of this traditional medical device submission.

Therefore, I will only be able to provide information relevant to the material described in the input text.

Here's what can be extracted and inferred from the text provided:

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

Note: The document states "To support substantial equivalence... characteristics of Sinfony® have been compared to those of Visio-Gem® using tests undertaken pursuant to ISO 10477 and DIN 53456." It does not provide the specific numerical acceptance thresholds or the detailed quantitative results for each characteristic, only that they were compared to establish substantial equivalence.

Regarding the other points, the provided text does not contain the information requested, as it pertains to a different type of medical device (a dental material) than what your questions imply (an AI/ML device). Therefore, the following points cannot be answered from the provided input:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a material test.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a material test.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a material test.
• 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 as this is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For material testing, "ground truth" is typically established by standardized physical/chemical measurements rather than expert consensus on diagnostic images or pathology. The "ground truth" here is the performance of the predicate device and the standards ISO 10477 and DIN 53456.
• 8. The sample size for the training set: Not applicable as this is not an AI device.
• 9. How the ground truth for the training set was established: Not applicable as this is not an AI device.

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