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This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device. The document is an FDA 510(k) clearance letter for a dental alloy named "Continum™ V," confirming its substantial equivalence to a legally marketed predicate device. It addresses regulatory information, marketing authorization, and general compliance requirements, but it does not include performance studies or validation data.

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This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crown and bridge dental restorations.

This device is a non precious, nickel-chromium-molybdenum-beryllium based alloy.

I apologize, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Aalba Dent, Incorporated for their Continum™ dental alloy. It primarily confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details on sample sizes, data provenance, or retrospective/prospective study design.
3. Information on the number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
6. Data on standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The letter only states the device name (Continum™), its regulation name (Base Metal Alloy), regulatory class (Class II), and its intended use (a non-precious, nickel-chromium-molybdenum-beryllium based alloy for use in the construction of cast ceramic bonded crowns and bridges). It indicates that the FDA has determined the device to be substantially equivalent.

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This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872, the classification name for this device is Base Metal Alloy, a Class II device.

This device is a non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy.

I am sorry, but based on the provided document, the information you are requesting about acceptance criteria and a study proving device adherence to such criteria is not available. This document is a 510(k) K033356 clearance letter from the FDA for Verasoft ES, a dental alloy.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the device was cleared based on its substantial equivalence to an already legally marketed predicate device, as per the 510(k) pathway. This pathway typically relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and studies demonstrating that the device meets those criteria in the same way a Premarket Approval (PMA) application would.

Therefore, the document does not contain:

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 methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

The "Indications For Use" section simply defines the device as a "non precious, nickel-chromium-copper-tin based crown and bridge ("Type III") alloy for use in the construction of cast crown and bridge prosthetic devices." This describes the intended use but does not provide specific performance metrics or acceptance criteria as you've outlined.

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This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.

nonprecious, nickel-chromium-molybdenum based ceramic casting alloy

The provided document is an FDA 510(k) clearance letter for a dental alloy named "VeraBond 2." This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory clearance letter rather than a technical study report.

Therefore, I cannot provide the requested information from this document. The letter simply states that the FDA has reviewed the device and determined it to be "substantially equivalent" to predicate devices already on the market, thus allowing it to be marketed. It refers to the "indications for use" as stated in an enclosure, but the enclosure itself (which would detail the device's properties and intended use) is not present in the provided text.

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This device is a nonprecious, copper-aluminum (plus gold) based casting alloy for use in the construction of cast dental crown and bridge prosthetic devices, such as fullmetal-coverage (FMC) crowns and bridgework, inlays/onlays, posts and cores, and metal sub-structures for polymer crown and bridge resins.

nonprecious, copper-aluminum (plus gold) based casting alloy

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy device (NPG+2). It confirms the device's substantial equivalence to a legally marketed predicate device.

However, this document does NOT contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

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This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.

This device is a nonprecious, nickel-chromium-molybdenum based ceramic casting alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

This document is a 510(k) premarket notification letter from the FDA regarding a dental alloy, Verabond 2V. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The information requested in the prompt, specifically related to acceptance criteria and a study proving the device meets those criteria, is not present in the provided document.

This letter is a regulatory approval notice based on substantial equivalence, not a detailed report of a clinical or performance study with specific acceptance criteria.

Therefore, I cannot provide the requested table and study details.

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This device is a "white" colored, casting alloy for use in the construction of dental inlay and onlay prosthetic devices. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.

This device is a "white" colored, casting alloy for use in the construction of dental inlay and onlay prosthetic devices.

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy device (Platalloy). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain information about:

• Acceptance criteria and reported device performance in a table.
• Details about any study conducted to prove the device meets acceptance criteria.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, types of ground truth, or training set information.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input.

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This device is a "white" colored, soldering (welding) alloy for use in the construction and repair of crown and bridge dental prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, a Class II device.

"White" Colored, Soldering (Welding) Alloy

The provided text is a 510(k) cleared letter from the FDA for a dental soldering alloy. It does not contain information regarding an AI/ML medical device, clinical study, or acceptance criteria.

Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth.

The document pertains to the clearance of a physical material (dental alloy) and confirms its substantial equivalence to pre-amendment devices, under general controls provisions of the Act.

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This device is a "white" colored, casting alloy for use in full coverage and onlay prosthetic devices.

"white" colored, casting alloy

The provided FDA letter and associated documents for K972534, "White" Colored, Casting Alloy, do NOT contain the information necessary to describe acceptance criteria or a study proving device performance as requested.

This document is a 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device already on the market. It does not typically include detailed performance study results or acceptance criteria for a new device.

Therefore, I cannot provide the requested table or answer the specific questions regarding performance studies, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is not part of this specific FDA communication.

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VERA PDN, a cobalt-chromium based alloy in nugget form, is intended for use in the fabrication of custom-made removable denture appliances.

VERA PDN, a cobalt-chromium based alloy in nugget form

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental alloy named Vera PDN. This document primarily concerns the regulatory approval for marketing the device based on its substantial equivalence to previously marketed devices. It does not contain information about specific acceptance criteria or the details of a study proving the device meets such criteria.

Therefore, I cannot provide the requested information. The document is a regulatory approval letter, not a study report.

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