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SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.

The Stern Vantage Varnish LC material is a single-component, acrylate-based, light-curing surface coating material for dental applications.

The provided PMA (Premarket Approval) documentation for SternVantage Varnish LC explicitly states that no performance or safety data was included in the premarket notification. Therefore, this device did not undergo a study to demonstrate it met acceptance criteria in the traditional sense of a clinical trial or performance validation study.

Instead, the device's approval was based solely on its substantial equivalence to a predicate device (Palaseal material marketed by Kulzer, Inc.) concerning its design and performance characteristics.

Given this, I cannot provide the requested information in the format for a device that underwent performance testing against acceptance criteria. However, I can explain why I cannot and what information is available based on the provided text.

Here's the breakdown of why the requested information cannot be fully provided:

• No Acceptance Criteria or Reported Device Performance: The document clearly states, "Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification." This means there were no defined acceptance criteria for a new study, and no performance metrics from a new study to report. The acceptance was based on the assumption that if the new device has similar characteristics to an already-approved predicate device, it meets an equivalent standard.

Therefore, many parts of your request for information about a study proving acceptance criteria cannot be fulfilled directly from this document.

However, I can extract the relevant information from the document to explain the approval context:

• Reason for Approval: Substantial Equivalence to a Predicate Device
• Predicate Device: Palaseal material marketed by Kulzer, Inc. (cleared for marketing by FDA in K892452).

Since no new study demonstrating performance against acceptance criteria was conducted for SternVantage Varnish LC as part of this 510(k) submission, the following information is not available in the provided documents:

• A table of acceptance criteria and the reported device performance: Not applicable, as no performance study was conducted.
• Sample sized used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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 dental varnish, not an AI diagnostic device).
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the Sterngold ImplaMed SternVantage Varnish LC was cleared for marketing based on its "substantial equivalence" to an existing, legally marketed predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

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SternOmega Temporary Cement Automix NE is indicated for use as a temporary cement for attaching all types of temporaries, e.g. temporary crowns, bridges, and inlays.

The SternOmega Temporary Cement Automix NE is an auto-mixing, non-eugenol cement indicated for the temporary bonding of crowns, bridges and inlays.

The Sterngold ImplaMed Abbreviated 510(k) Premarket Notification for the SternOmega Temporary Cement Automix NE does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

The document explicitly states:

"Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Temporary Cement Automix NE are equivalent to those of the predicate device."

Therefore, I cannot provide a response to your numbered points as the requested information is absent from the provided text. The submission relies solely on demonstrating substantial equivalence to a predicate device (TempoCem NE) based on design and material characteristics, rather than presenting new performance or safety study data.

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The Sterngold Implant can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures.

Device consists of titanium screws, and titanium alloy prosthetics, brass and stainless steel restorative components, and stainless steel and titanium alloy surgical instruments.

I apologize, but the provided text is a 510(k) summary for a dental implant device and does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on:

• Device Description: What the device is made of and its components.
• Intended Use: How the device is meant to be used for oral rehabilitation.
• Technological Characteristics: How it compares to existing devices from the same company.
• Comparative Products: How it compares to similar products on the market.
• FDA Clearance Letter: Official communication from the FDA clearing the device for market based on substantial equivalence to predicate devices.
• Indications for Use: The specific medical conditions for which the device is intended.

Therefore, I cannot provide the requested table and information, as it is not present in the given text. This type of 510(k) summary, especially from 1998, typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics.

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The SternOmega Dental Composite System is indicated for dental filling of cavities.

The SternOmega Composite LC is indicated for filling of all classes of cavities.

The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth.

The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.

The SternOmega Bonding Agent is a light-curing, one-component bonding agent for compomer and composite, which is applied to dentin and enamel. The bonding agent is self-conditioning, having the primer and bonding adhesive in one bottle.

The SternOmega Composite LC is a single-paste, light-curing, radiopaque universal hybrid composite dental filling material indicated for filling all classes of cavities. It is used in conjunction with the SternOmega Bonding Agent.

The SternOmega Compomer LC is a single-paste, light-curing, radiopaque dental filling material indicated for permanent filling of Class III and V cavities, and for temporary filing of Class I and II cavities. It is used in conjunction with the SternOmega Bonding Agent.

The provided text is a 510(k) Summary for a dental composite system. It does not contain information about specific acceptance criteria, device performance metrics, or a study that proves the device meets those criteria.

Instead, it states that the submission is a "Special 510(k): Abbreviated 510(k)" and that Sterngold ImplaMed has provided information to demonstrate conformity with FDA's guidance document entitled Guidance for the Preparation of a Premarket Notification (510(k)) for Direct Filling Dental Composites, January 1996.

This means that the manufacturer is asserting substantial equivalence to predicate devices based on meeting the general requirements outlined in that FDA guidance document, rather than conducting a new, detailed performance study with explicit acceptance criteria for this specific device. The approval letter further confirms this by stating the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot fill out the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document. The 510(k) summary focuses on demonstrating equivalence to existing products rather than presenting new performance data against novel acceptance criteria.

To answer your request thoroughly, a different type of document (e.g., a detailed clinical or performance study report) would be needed.

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SternOmega Compomer Cement Automix is indicated for use in permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.

The SternOmega Dental Compomer Cement is an auto-mixing, chemical cure, radiopaque cement indicated for the permanent luting of crowns, bridges, inlays and onlays. The cement contains fluoride which is released over time to provide the benefits associated with a fluoride-releasing material.

The provided document is a 510(k) Premarket Notification for the SternOmega Dental Compomer Cement Automix. It explicitly states that "Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification."

Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them from this document. The manufacturer did not submit performance data.

The document indicates that the device's equivalence was based on a comparison to several predicate devices. This means that the FDA determined the new device was substantially equivalent to existing, legally marketed devices based on its intended use, technological characteristics, and design, without requiring a specific performance study from the applicant.

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The Sterngold ImplaMed Implant System can be used in dental implant applications for oral rehabilitation of endentulous and partially dentate patients in the maxillae and mandible. Implant retained restoration may consist of single crowns or bridges as well as complete or partial dentures.

Sterngold Impla Med Hex Screw Implant, TPS and HA Coated.

I apologize, but the provided text from the FDA 510(k) communication for the Sterngold ImplaMed Hex Screw Implant does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance as outlined in your nine numbered points.

The document is a letter from the FDA confirming substantial equivalence for the device. It focuses on regulatory approval rather than a detailed report of performance testing or clinical studies.

Therefore, I cannot extract:

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 details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information would typically be found in the 510(k) submission itself (which is not provided) or in a separate study report, not in the FDA's clearance letter.

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Ask a specific question about this device