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

AGC Speziallegierung is a gold-platinum ceramic alloy with a high content of noble metals (97,5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and single crowns up to long span bridges with two or more pontics and pontics for AGC bridges. In addition, it can be used for manufacturing removable partials. It is free of copper and suitable for telescopic and milling work. AGC Speziallegierung 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. AGC Speziallegierung 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.

The provided text describes a dental alloy (AGC Speziallegierung) submission for 510(k) premarket notification to the FDA. The information focuses on the device description, its intended use, and its substantial equivalence to a predicate device. It does not contain any information regarding acceptance criteria, a study proving the device meets acceptance criteria, or any details about AI/algorithm performance.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, expert opinions, or AI performance, as this information is not present in the provided text.

The document primarily states:

• Device Name: AGC® Speziallegierung
• Device Type: Gold-platinum ceramic alloy for dental restorations.
• Intended Use: Fabrication of inlays/onlays, single crowns, short span bridges, long span bridges, pontics for AGC bridges, removable partials, and for telescopic and milling work. It can be veneered with dental ceramics and composites.
• Compliance: Complies with international standard ISO 9693 and European directive 93/42/ECC.
• Substantial Equivalence: Deemed substantially equivalent to the legally marketed device BioPorta G (K012826).

To fulfill your request, specific performance data, acceptance criteria, and study details would need to be provided.

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Auropal 1 is a gold-silver casting 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

Auropal 1 is an extra-hard gold-silver casting alloy (67% noble metals), 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 to removable partials. In addition, it is suitable for telescopic and milling work. Auropal 1 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided text is a Premarket Notification 510(k) for a dental alloy named "Auropal 1." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects requested in the prompt related to device performance evaluation (e.g., sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance, training sets).

The 510(k) submission for this type of device (a dental alloy) primarily focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. It typically relies on existing standards (like ISO 8891 mentioned) and material properties rather than clinical performance studies with specific acceptance criteria in the way medical imaging AI or diagnostic devices would.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and performance studies because that information is not present in the provided document.

To summarize, for this specific document:

1. Table of acceptance criteria and reported device performance: Not available.
2. Sample sized used for the test set and the data provenance: Not applicable/available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available.
4. Adjudication method: Not applicable/available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable/available.
6. Standalone (algorithm only) performance: Not applicable/available.
7. Type of ground truth used: Not applicable/available.
8. Sample size for the training set: Not applicable/available.
9. How the ground truth for the training set was established: Not applicable/available.

The document indicates that Auropal 1 "fully complies to the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." This compliance with standards would be the primary "proof" of its characteristics for this type of device, rather than a clinical performance study with the metrics you've asked about.

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Duo Pal 6 is a palladium-gold ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Duo Pal 6 can be veneered with suitable dental ceramics as well as with dental composites.

Duo Pal 6 is a dental alloy with high contents of noble metals (81,5%) intended for dental technicians to fabricate dental restorations. it has an indication which ranges from crowns up to long span bridges with two or more pontics and to removable partials. It is free of copper and therefore suitable for telescopic and milling work. Duo Pal 6 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. Duo Pal 6 can be veneered with suitable dental ceramics and with dental composites.

The provided text is a 510(k) summary for a dental alloy named "Duo Pal 6". It does not describe a study involving acceptance criteria and device performance in the way typically expected for an AI/software as a medical device (SaMD). Instead, it focuses on the material's properties and equivalence to a predicate device.

Here's an analysis based on the information provided, highlighting the aspects relevant to your request while acknowledging the device's nature:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that Duo Pal 6 "fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." ISO 9693 is a standard for dental ceramic-to-metal bonding alloys.

While specific acceptance criteria values (e.g., tensile strength, corrosion resistance thresholds) and measured performance values for Duo Pal 6 are not explicitly listed in a comparative table within the provided text, the statement of compliance implies that these criteria were met.

If we were to infer, the acceptance criteria would be derived from ISO 9693 and the essential requirements of Directive 93/42/ECC. The reported performance is that the device "fully complies" with these standards.

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

This document does not describe a study with a "test set" in the context of data for an AI/SaMD. The evaluation for Duo Pal 6 likely involved laboratory testing of material samples to demonstrate compliance with ISO 9693 and biocompatibility. The sample size for such material testing is not specified in this summary, nor is the provenance of "data" (e.g., country of origin, retrospective/prospective) as it would apply to clinical data. The product is manufactured by Wieland Edelmetalle GmbH & Co. in Pforzheim, Germany.

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

This information is not applicable to this type of device submission. Ground truth, in the context of material science and compliance with a standard like ISO 9693, would be established through defined test methodologies and measurements, not expert consensus on data interpretation.

4. Adjudication Method for the Test Set

Not applicable. This device is a material, not a diagnostic or AI-driven decision support system requiring adjudication of interpretations.

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 not an AI/SaMD device.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an AI/SaMD device.

7. The Type of Ground Truth Used

The "ground truth" for this device would be the objective measurements obtained through standardized laboratory tests (e.g., mechanical properties, corrosion tests, cytotoxicity tests) as defined by ISO 9693 and other relevant material standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/SaMD device. There is no concept of a "training set" for a dental alloy in this context.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document (a 510(k) summary) does not detail a specific "study" with experimental results, but rather states the conclusion of testing conducted to demonstrate compliance.

The study that proves Duo Pal 6 meets acceptance criteria is inferred to be a series of laboratory tests and analyses performed on the material. These tests were conducted according to the methodologies prescribed by international standard ISO 9693 (for dental ceramic-to-metal bonding alloys) and other tests necessary to fulfill the essential requirements of the European directive 93/42/ECC concerning medical devices.

The specific results of these tests and the details of their methodology (e.g., number of specimens tested for each property) are not included in this summary but would have been part of the full 510(k) submission. The FDA's substantial equivalence determination (K012841) indicates that they reviewed this data and found it sufficient to support the claims of compliance and safety. The statement that "Duo Pal 6 is highly corrosion resistant and has an excellent biocompatibility" are outcomes of these implicit tests.

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Portadur P 2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/ Onlays . - Crowns . - Short span bridges . - Long span bridges . - Removable partials . and can be used for - Telescopic and milling work .

Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work. Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided 510(k) summary for the Portadur P 2 device does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/medical device performance evaluation. The summary is for a dental casting alloy and focuses on its material properties, biocompatibility, and intended use as a medical device, rather than an AI or image-based diagnostic tool.

Therefore, many of the requested categories in your prompt are not applicable to the provided document. I can, however, extract relevant information about the device itself from the text.

Here's an analysis based on the provided text, indicating where information is present or absent for your specific questions:

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

This information is not provided in the 510(k) summary. The document states that the device "fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not specify the numerical acceptance criteria for various physical or chemical properties defined by ISO 1562, nor does it present a table of the device's performance against such criteria. It generally describes the device as being "extra-hard" and "highly corrosion resistant."

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. This is not an AI/diagnostic device, and no test set in that context is discussed.

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. This is not an AI/diagnostic device, and no ground truth establishment by experts is discussed.

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

Not applicable.

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.

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

Not applicable.

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

Not applicable. The "ground truth" for a dental alloy would relate to its physical and chemical properties as measured by standardized tests, not diagnostic accuracy. The text refers to compliance with ISO 1562.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of Device Information from the Provided Text:

• Trade Name: Portadur P 2
• Manufacturer: Wieland Edelmetalle GmbH & Co. (Germany)
• Device Type: Extra-hard gold casting alloy
• Composition: High noble metal content (75.1%)
• Intended Use: For dental technicians to fabricate dental restorations.
• Specific Indications: Inlays/Onlays, Crowns, Short span bridges, Long span bridges, Removable partials, Telescopic and milling work.
• Key Properties: Highly corrosion resistant, excellent biocompatibility.
• Standards Met: ISO 1562, European directive 93/42/ECC concerning medical devices.
• Predicate Device: Aurofluid 3 (K911539)
• Regulatory Class: II (under 21 CFR 872.3060, Alloy, Gold Based, For Clinical Use)

The document is a 510(k) summary demonstrating substantial equivalence to a predicate device, which primarily involves comparing material specifications, intended use, and general performance claims (like biocompatibility and corrosion resistance) to established standards and the predicate device. It does not involve a clinical study or performance evaluation as would be typical for an AI-based diagnostic device.

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Porta Aurium is a universal gold-based dental 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 Aurium can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.

Porta Aurium is an extra-hard universal alloy with high contents of noble metals (80,5%), 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 to removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Aurium 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 Aurium can be veneered with low-fusing dental ceramics with high expansion and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.

The provided text is related to a 510(k) premarket notification for a dental alloy named Porta Aurium. It describes the device, its intended use, and its classification, and states that it has been deemed substantially equivalent to a predicate device.

However, the document does not contain information about acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone AI performance).

Therefore, I cannot provide the requested information from the given text. The text is a regulatory submission for a medical device (a dental alloy), not a scientific study reporting on the performance of a diagnostic or AI-based device.

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Porta SMK 82 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work. Porta SMK 82 can be veneered with suitable dental ceramics as well as with dental composites.

Porta SMK 82 is a gold-palladium ceramic alloy with high contents of noble metals (90.5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single 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 SMK 82 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 SMK 82 can be veneered with suitable dental ceramics and with dental composites.

This 510(k) premarket notification for Porta SMK 82, a gold-palladium ceramic alloy, does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Deva Plus K K921419) and outlining the device description, indications for use, and general regulatory information.

Specifically, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: This document states that the device "fully complies to the international standard ISO 9693" and "fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not provide a table outlining specific acceptance criteria from these standards (e.g., tensile strength, corrosion resistance thresholds) or the measured performance of Porta SMK 82 against those criteria.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 device is a dental alloy, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As this is a dental alloy, not a software algorithm, this is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned. For a material like this, "ground truth" would likely relate to material property testing (e.g., mechanical testing, corrosion testing) against established standards.
8. The sample size for the training set: Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

In summary, the provided document acts as a 510(k) submission showing that the Porta SMK 82 dental alloy is substantially equivalent to a predicate device and meets relevant international standards. However, it does not include the detailed study design, acceptance criteria, and performance data typically found in submissions for devices requiring such evidence, particularly for AI/ML or diagnostic tools.

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BioPortadur is a gold casting 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.

BioPortadur is an extra-hard gold casting alloy (96% noble metals), 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 to removable partials. In addition, it is suitable for telescopic and milling work. BioPortadur is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

The provided text focuses on regulatory approval for a dental alloy, BioPortadur, and does not contain information about acceptance criteria or a study demonstrating device performance. The text is a 510(k) summary and approval letter, which describes the device, its intended use, and its substantial equivalence to a predicate device, rather than detailed performance data from a specific study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

The document states that BioPortadur "fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not provide the specific acceptance criteria within ISO 1562 or details of a study that directly verifies and reports performance against those criteria. It only asserts compliance.

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Porta Geo Ti is a gold-platinum ceramic 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 Geo Ti can be veneered with suitable dental ceramics as well as with dentalcomposites.

Porta Geo Ti is an extra-hard gold-platinum ceramic alloy with a high content of noble metals (95,4%), intended for dental technicians to fabricate dental restorations. lt 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 Geo Ti 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 Geo Ti 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.

The provided text describes a 510(k) premarket notification for a dental alloy named "Porta Geo Ti". It focuses on the device description, its intended use, and its equivalence to a predicate device. However, it does not contain any information about a study proving device performance against acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text. The document refers to compliance with ISO 9693 and the European directive 93/42/ECC, which implies that certain performance criteria are met, but it does not detail a specific study or present performance data.

Here's what I can extract from the provided text about the device:

Device Description and Claims (Not Acceptance Criteria or Performance Data):

• Device Name: Porta Geo Ti
• Device Type: Extra-hard gold-platinum ceramic alloy
• Intended Use: For dental technicians to fabricate dental restorations.
• Indications: Inlays/Onlays, Crowns, Short span bridges, Long span bridges, Removable partials, Telescopic and milling work.
• Composition: High content of noble metals (95.4%), free of copper.
• Properties Claimed: Highly corrosion resistant, excellent biocompatibility.
• Compliance: Fully complies with international standard ISO 9693 and fulfills essential requirements of European directive 93/42/ECC.
• Aesthetic Benefit: Golden yellow color provides an excellent basis for aesthetically pleasing dental restorations when veneered with suitable dental ceramics or composites.

Missing Information:

The provided text does not include:

• A table of acceptance criteria.
• Reported device performance data.
• Details of any study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Argedent 77PF, K935507) based on device characteristics, indications for use, and compliance with general standards, rather than presenting a detailed performance study against specific acceptance criteria.

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Porta Maximum is a universal gold-based dental 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 Maximum can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.

Porta Maximum is an extra-hard universal alloy with high contents of noble metals (83%), intended for dental technicians to fabricate dental restorations. lt 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 Maximum 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 Maximum can be veneered with low-fusing dental ceramics with high expansion and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.

The provided text is a 510(k) Premarket Notification for a dental alloy named "Porta Maximum." This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to existing, legally marketed devices. It does not describe a study involving device performance against acceptance criteria in the manner typically seen for complex medical devices or AI algorithms.

Instead, the submission for "Porta Maximum" focuses on its physical and chemical properties and its intended use, asserting its compliance with international standards (ISO 9693) and European directives. The "acceptance criteria" here are essentially the requirements for substantial equivalence to a predicate device and adherence to established material standards, rather than performance metrics from a clinical study.

Therefore, the requested information elements related to a study (sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable to this type of regulatory submission because an efficacy study of this nature was not performed or required for this type of device.

Below is a table summarizing the "acceptance criteria" as implicitly understood for a dental alloy of this nature, and the reported characteristics of the Porta Maximum, drawing from the provided text.

Acceptance Criteria and Reported Device Performance

Study Details (Not applicable for this type of device submission)

1. Sample size used for the test set and the data provenance: Not applicable. This submission is for a dental alloy, not a device requiring a clinical test set in the traditional sense. The "testing" referred to would be material characterization tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties are established through laboratory testing and compliance with standards, not expert consensus on clinical cases.
3. Adjudication method for the test set: Not applicable.
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 device is not an AI or diagnostic tool that involves human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device type would be established by material science standards, lab-based physical and chemical tests (e.g., tensile strength, corrosion resistance, composition analysis), and biocompatibility assessments, rather than clinical outcomes or expert consensus on patient data.
7. The sample size for the training set: Not applicable. This device is not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

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BioPorta G is a gold-platinum ceramic 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. BioPorta G can be veneered with suitable dental ceramics as well as with dentalcomposites.

BioPorta G is an extra-hard dental alloy with high contents of gold and platinum (97 %) 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 to removable partials. It is free of copper and therefore suitable for telescopic and milling work. BioPorta G 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. BioPorta G 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.

The provided text is a 510(k) Premarket Notification for a dental alloy named BioPorta G. This type of notification is for medical devices that are substantially equivalent to a legally marketed predicate device, and it typically does not involve studies demonstrating performance against acceptance criteria in the same way a novel device might.

Instead, the submission focuses on demonstrating that the new device (BioPorta G) is substantially equivalent to a previously cleared device (V-Gnathos Plus, K952122) in terms of its materials, intended use, and general performance characteristics. The primary "study" supporting this type of submission is often material characterization and comparison to recognized standards, rather than clinical trials with patient outcomes.

Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific 510(k) submission for a dental alloy.

Here's an analysis based on the information provided, highlighting the relevant sections and explaining why others are not present:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental alloy), "acceptance criteria" are typically defined by compliance with international standards and material properties expected for such alloys. The document states compliance with ISO 9693.

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

This information is not provided in the document. For material characterization studies for dental alloys, testing is performed on material samples rather than "test sets" of patient data. The document does not specify the number of material samples tested.

The data provenance would be related to the manufacturer's internal testing and compliance with the mentioned standards (ISO 9693), which would typically be conducted in a laboratory setting. There is no indication of country of origin for specific "test data" beyond the manufacturer's location (Germany).

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

This information is not applicable to this type of device and submission. Ground truth in this context would be defined by established material science principles and international standards, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in clinical assessments or interpretations, which are not part of this 510(k) submission for a dental alloy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or reported. These studies are typically conducted for diagnostic imaging devices or other technologies where human interpretation plays a role and AI assistance might improve performance. This device is a material, not a diagnostic tool.

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

No, a standalone study was not done or reported. This concept applies to AI algorithms, which are not relevant to a dental alloy.

7. The Type of Ground Truth Used

The "ground truth" used for this device's acceptance is based on:

• Material Science Principles and Specifications: The inherent properties of the alloy (composition, physical properties).
• International Standards: Compliance with ISO 9693.
• Biocompatibility Standards: Evidence of excellent biocompatibility, likely demonstrated through standard in vitro and/or in vivo material testing (though details are not provided in this summary).
• Predicate Device Equivalence: The attributes of BioPorta G are compared to the known and accepted properties of the predicate device, V-Gnathos Plus.

8. The Sample Size for the Training Set

This information is not applicable. This device is a material, not an AI algorithm, so there is no "training set."

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

This information is not applicable for the same reason as point 8.

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