Search Results

Reconstruction of porcelain-to-metal dental restorations.

Apex 93, Apex87, Apex85, Apex77, e-Sarang 88 and e-Sarang 82 are dental gold alloys for the fabrication of Porcelain-Fused-to-Metal Crowns, Bridges, and implant-supported prosthesis substructures.

The provided text describes a 510(k) submission for dental gold alloys (Apex93, Apex87, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82) and aims to demonstrate their substantial equivalence to a predicate device, Bioherador SG, Herador S.

However, the provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria through empirical measurements or AI model evaluations. Instead, it focuses on the regulatory submission process for a medical device.

The document states:

• "Apex93, Apex87, Apex84, Apex85, Apex77, e-Sarang 88, e-Sarang 82 have the same device characteristics as the predicate device. Material, design and use concept is similar."
• "Apex93, Apex87, Apex84, Apex77, e-Sarang 88, e-Sarang 82 have been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations."
• "An extensive review of literature pertaining to the safety and biocompatibility of dental gold alloy has been conducted."

These statements indicate that the submission relies on the established safety and performance of the predicate device, general industry standards, and a literature review, rather than a specific, new study with defined acceptance criteria and performance metrics for the submitted devices. The "validations prior to release" are mentioned but no specifics about these validations, their acceptance criteria, or their results are provided in the text.

Therefore, many of the requested items related to a study proving acceptance criteria cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., tensile strength, biocompatibility thresholds) with numerical targets, nor does it present a table of measured performance data for the submitted devices against such criteria. It generally states that the devices have "the same device characteristics as the predicate device" and have passed "safety tests."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document does not detail any specific "test set" in the context of a performance study with a sample size. The safety and performance assessments are described broadly as "extensive safety, performance, and product validations" and "safety tests" without specifying sample sizes or data provenance.

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 / Cannot be provided. This question is relevant to studies involving expert review for establishing ground truth, typically for AI/imaging devices. As this is a materials submission for dental alloys, such a concept of "experts establishing ground truth for a test set" is not detailed or relevant in the provided text.

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

• Not applicable / Cannot be provided. Similar to point 3, this is relevant to expert review processes, which are not described in the context of a performance study for these dental alloys.

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 / Cannot be provided. MRMC studies are specifically for evaluating diagnostic performance, often with AI assistance for human readers. This submission is for dental materials, not a diagnostic or AI-powered device, so an MRMC study is not relevant and not mentioned.

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

• Not applicable / Cannot be provided. This refers to standalone AI algorithm performance, which is not relevant to a dental alloy submission.

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

• Not applicable / Cannot be provided. Ground truth is a concept for evaluating the accuracy of a diagnostic or predictive system. For dental alloys, the "truth" would be adherence to material specifications and biocompatibility standards, and these are stated as having been met through "validations" and "safety tests," but specific methodologies for defining "truth" for evaluation are not detailed.

8. The sample size for the training set

• Not applicable / Cannot be provided. A "training set" is used for machine learning algorithms. This submission is for dental materials, not an AI device.

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

• Not applicable / Cannot be provided. As above, this is relevant to AI/machine learning, not dental materials.

In summary, the provided document is a regulatory submission for dental alloys, demonstrating substantial equivalence to a predicate device based on similar characteristics, broad safety/performance validations, and a literature review. It does not include the details of a specific study with acceptance criteria and performance data as requested.

Ask a specific question about this device

This is a dental amalgam for the filling of tooth cavities of Black's Classes I and II.

Bestaloy is used as a filling material for restoring function to teeth that have lost portions to caries.

The provided text describes a 510(k) premarket notification for a dental amalgam called "Bestaloy." It states that Bestaloy has undergone safety, performance, and product validations and that it has the same device characteristics as its predicate device (LUXALLOY™, DEGUSSA AG K902249). However, it does not provide specific details about acceptance criteria or a study proving that the device meets those criteria with quantitative performance metrics.

Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed quantitative results.

Here's what can be inferred from the provided text, but it falls short of your specific requirements:

1. Table of Acceptance Criteria and Reported Device Performance: Not available in the provided text. The submission states, "Bestaloy has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US requiations." However, it does not list specific criteria or quantitative performance results.

2. Sample Size Used for the Test Set and Data Provenance: Not mentioned in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications: Not mentioned in the provided text.

4. Adjudication Method for the Test Set: Not mentioned in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size: Not mentioned in the provided text. This type of study is generally not typical for a dental amalgam 510(k) submission, which focuses on material equivalence.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a dental material, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.): Not mentioned in the provided text. The submission relies on "device characteristics" being the same as the predicate.

8. The Sample Size for the Training Set: Not mentioned in the provided text. (Training sets are typically for AI/ML models, which this device is not).

9. How the Ground Truth for the Training Set was Established: Not applicable as this is a dental material.

Summary of what is available from the text:

• Device Name: Bestaloy
• Predicate Device: LUXALLOY™, DEGUSSA AG K902249 (K902249)
• Basis for Equivalence: "Bestaloy has the same device characteristics as the predicate device. Material, design and use concept is similar."
• Testing Conducted: "extensive safety, performance, and product validations" and "Safety tests have been performed to ensure the devices comply to applicable industry and US requiations."
• Conclusion: The manufacturer concludes that Bestaloy is "safe and effective and substantially equivalent to predicate devices."

The document is a 510(k) clearance letter, which confirms that the FDA found the device substantially equivalent to a predicate. It does not contain the detailed performance study results that would be part of a submission to demonstrate performance against specific acceptance criteria.

Ask a specific question about this device

Reconstruction of dental restorations.

e-Sarang 86: Inlays for non stress-bearing areas.

DM-78: full crowns, 3/4 crowns, and short-span fixed partial dentures.

DM-55: full crowns, long-span fixed partial dentures, and removable partial dentures

e-Sarang 86, DM-78 and DM-55 are dental casting gold alloy for the fabrication of inlay/onlays, crowns, short span bridges, long span bridges and removable partials.

The provided text describes a 510(k) premarket notification for dental casting alloys and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting performance data from a clinical or analytical study with defined acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided document.

Ask a specific question about this device

Reconstruction of porcelain-to-metal dental restorations/reconstruction of dental restorations.

Apex90 is a dental gold alloy for the fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and implant-supported prosthesis substructures, which is composed of 98% of gold and platinum bearing gold color

The provided document is a 510(k) submission for a dental alloy named Apex90, not an AI device. As such, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI medical devices, is not applicable to this submission.

The Apex90 submission focuses on demonstrating substantial equivalence to a predicate device (Bio Herador SG) based on material composition, design, and intended use, rather than performance metrics of an AI algorithm. The document states: "Apex 90 has the same device characteristics as the predicate device. Material, design and use concept is similar." and "Apex 90 has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations." However, specific details of these "safety, performance, and product validations" are not provided in this summary.

Therefore, I cannot provide the requested information for an AI device.

Ask a specific question about this device