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HIGH NOBLE DENTAL ALLOY FOR THE FABRICATION OF SINGLE CROWNS, BRIDGES, INLAYS AND ONLAYS.

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The provided text is a 510(k) clearance letter from the FDA for a dental alloy named "PROMETAL HN86." This document grants market clearance based on substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical effectiveness studies (like MRMC or standalone performance).

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the given text. The document is primarily a regulatory clearance notification.

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BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.

Gold cylinder for using UCLA Abutment

This K041378 submission for the BIO 60 device, a gold cylinder for UCLA Abutment, relies on a comparison to a legally marketed predicate device, the Southern Implants Cylinder, using established industry standards rather than a clinical study with acceptance criteria in the traditional sense. Therefore, many of the requested fields are not applicable (N/A) as this is a material comparison and not an AI/software device.

Here's an analysis of the provided information based on the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission is for a material comparison based on established test methods (ANSI/ADA 5 and ISO 9693) for dental alloys, not a clinical study on a "test set" in the context of image analysis or AI. The performance data presented are for the material itself.
• Data Provenance: The data provenance is derived from laboratory testing of the material's properties according to the specified standards. The country of origin of the data is not explicitly stated but would presumably be from the manufacturer's testing facilities or a contracted lab. This is retrospective data, as it reflects the properties of the manufactured material.

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

• Not applicable. "Ground truth" in this context would refer to the accurate measurement of material properties, which are established through standardized laboratory tests, not by expert consensus or interpretation of images. The 'truth' is the measured physical and chemical properties.

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

• Not applicable. Adjudication methods are typically employed in studies where expert interpretation or consensus is required (e.g., medical imaging reads). This submission relies on objective, repeatable laboratory measurements of material properties.

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 submission is for a dental material (gold cylinder), not an AI or software device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

• Not applicable. This submission is for a dental material, not an algorithm or AI device.

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

• The "ground truth" for the material comparison is the measured physical and chemical properties of the alloy, determined according to recognized industry standards (ANSI/ADA 5 and ISO 9693). This is objective, quantitative data from laboratory testing.

8. The sample size for the training set

• Not applicable. This submission is for a material comparison, not an AI or machine learning device that requires a training set.

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

• Not applicable. As there is no training set for an AI device, this question is not relevant.

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Porta Reflex is a gold-platinum alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays, Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Porta Reflex can be veneered with suitable dental ceramics as well as with dental-composites.

Porta Reflex is an extra-hard gold-platinum ceramic alloy with high contents of noble metals (97,7%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns, up to long span bridges with two or more pontics and removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Reflex is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Porta Reflex can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.

Here's an analysis of the provided 510(k) summary for the Porta Reflex device, focusing on the acceptance criteria and study information:

This document, K040672 for "Porta Reflex," is a 510(k) Premarket Notification. For this type of device (a dental alloy), 510(k)s typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria that one might see for AI/ML-based diagnostic devices.

Therefore, the structure of the request for acceptance criteria and study data needs to be interpreted in the context of this specific device and filing type. The "study" here is primarily a demonstration of compliance with established standards and comparison to a predicate, not a clinical effectiveness trial in the way that an AI diagnostic would have.

Acceptance Criteria and Reported Device Performance

Given that this is a dental alloy and a 510(k) submission, the "acceptance criteria" are typically compliance with recognized standards and demonstration of properties comparable to a predicate device, rather than specific sensitivity/specificity targets.

Study Information

For this type of device, the "study" is more akin to engineering and materials testing, and a comparison to an existing predicate, rather than a clinical trial with human subjects testing AI performance.

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

   • The document does not specify sample sizes or data provenance for any specific mechanical or material property tests. This information would typically be detailed in the full submission, which is not provided, but often isn't explicitly summarized in the 510(k) summary itself for materials devices. The "tests" here are standard material characterization tests, likely conducted in a lab setting, not on patient data.

2. 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 as this is not a diagnostic device involving expert interpretation of medical images or patient data. The "ground truth" would be material properties established via standardized lab measurements.

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

   • Not applicable. This is not a clinical study requiring adjudication of diagnoses.

4. 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 not an AI/ML device, nor a diagnostic device that would involve human readers.

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

   • Not applicable. This is not an algorithm/AI device.

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

   • The "ground truth" for this device would be established through laboratory material characterization tests conforming to ISO 9693 and other relevant engineering standards. These tests measure properties like tensile strength, corrosion resistance, biocompatibility, etc.

7. The sample size for the training set

   • Not applicable. There is no AI/ML model for which to define a training set. If interpreted in a broader sense of "development data," it would refer to the materials used in R&D and optimization, but this is not specified.

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

   • Not applicable. There is no AI/ML model for which to define a training set. The "ground truth" for development would be the target material properties and performance characteristics defined by engineering specifications and industry standards.

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Porta Solder 1090 W is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions

Porta Solder 1090 W is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a white alloy with high contents of precious metals (Gold, Palladium, Iridium and Silver: 95,5%). Porta Solder 1090 W is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions, especially Euro 50, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta Solder 1090 W is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided text describes a 510(k) premarket notification for a dental brazing alloy called "Porta Solder 1090 W." The submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies typically associated with AI/software-as-a-medical-device (SaMD) clearances.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for an AI/SaMD device are not applicable to this document. The document describes a traditional medical device (a dental alloy).

Here's an analysis based on the information provided, highlighting the sections that are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable as this is a dental alloy, not an AI/SaMD device that would typically have a "test set" in the context of algorithm performance. The "study" referenced in the document is the process of comparing the Porta Solder 1090 W to its predicate device, Argesol-WSF (K 942505), to establish substantial equivalence based on material properties and intended use. There is no mention of a "test set" of patients or data in the way an AI study would define it.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable. The "ground truth" for a dental alloy typically refers to its physical, chemical, and mechanical properties, as measured by standardized tests, and its compliance with industry standards (like ISO 9333) and regulatory requirements. It is not established by expert consensus on clinical findings in the same vein as an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "test set" of clinical cases requiring adjudication by experts.

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

This information is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human readers for diagnostic tasks. This device is a dental alloy for fabrication, not a diagnostic tool where human readers interact with AI.

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

This information is not applicable. This device is a physical dental alloy, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on:

• Material Science and Engineering Properties: Chemical composition, melting range, corrosion resistance, and mechanical properties determined through laboratory testing according to established international standards (e.g., ISO 9333).
• Regulatory Compliance: Meeting the essential requirements of the European directive 93/42/ECC and demonstrating substantial equivalence to a legally marketed predicate device (Argesol-WSF).

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" for a physical dental alloy in the context of an algorithmic device. The term "training set" is generally used for machine learning models.

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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¾ and single crowns, inlays, veneer crowns and short span bridges.

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This document is a 510(k) clearance letter from the FDA for a dental device called "NDX-40." It does not contain information about acceptance criteria, study design, or performance data beyond the device's indications for use. Therefore, I cannot generate the requested table and study details.

The document indicates:

• Device Name: NDX-40
• Indications For Use: "¾ and single crowns, inlays, veneer crowns and short span bridges."
• Regulation Number: 21 CFR 872.3060 and 21 CFR 872.5000 (Gold Based Alloys and Precious Metal Alloys for Clinical Use)
• Regulatory Class: II
• Product Code: EJT

To provide the information you requested, I would need a different document, such as the actual 510(k) summary or a clinical study report that details the performance testing of the NDX-40.

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

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I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer GmbH & Company KG, confirming that their dental alloys are substantially equivalent to legally marketed predicate devices for the indicated uses. It outlines regulatory requirements and allows the company to market their devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or details about the training set.

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BegoStar is a precious dental casting alloy to make metal fused to ceramic dental restorations
Pontorex G is a precious dental casting alloy to make crown and bridge dental restorations
Platinlloyd KF is a precious dental casting alloy to make metal fused to ceramic dental restorations
Bio Platinilloyd is a precious dental casung alloy to make metal fused to ceramic dental restorations
Begopal S is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begorex 45 is a precious dental casting alloy to make metal fused to ccramic dental restorations
PontoStar Ti is a precious dental casting alloy to make metal fused to ceramic dental restorations
Pontolloyd G is a precious dental casting alloy to make metal fused to ceramic dental restorations
Bio Pontostar XL is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begolloyd 60 is a precious dental casting alloy to make crown and bridge dental restorations
Begolloyd PF is a precious dental casting alloy to make crown and bridge dental restorations
PontoStar G is a precious dental casting alloy to make metal fused to ceramic dental restorations
Gold EWL H is a precious dental casting alloy to make crown and bridge dental restorations
Platinlloyd M is a precious dental casting alloy to make crown and bridge dental restorations
Begopal 300 is a precious dental casting alloy to make metal fused to ceramic dental restorations
Begostar LFC is a precious dental casting alloy to make metal fused to ceramic dental restorations

Gold Dental Casting Alloys

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document appears to be a series of FDA 510(k) forms for various dental casting alloys, primarily indicating their names and intended uses. It confirms that these devices have been found substantially equivalent to predicate devices. There is no mention of any clinical trials, performance metrics, or study designs in the given text.

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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.

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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.

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APOLLO 3 ALLOY is indicated as a dental alloy for fabricating inlays, crowns and small span bridges.

APOLLO 3 ALLOY is a yellow, high noble, gold-based dental alloy.

The provided document is a 510(k) summary for a dental alloy, APOLLO 3 ALLOY. It does not describe an AI/ML powered device, nor does it present any studies involving human readers, ground truth establishment, or performance metrics typically associated with AI/ML devices. Therefore, I cannot extract the requested information related to AI/ML device acceptance criteria and study details from this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Degulor M Alloy K951779) based on its material composition, historical use, and biocompatibility testing. It states that APOLLO 3 ALLOY was found to be non-cytotoxic and non-mutagenic, and that other components have been used in legally marketed devices.

If you have a document pertaining to an AI/ML powered device, please provide that for analysis.

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