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BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.

BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.

This appears to be a 510(k) premarket notification document for a dental alloy, BegoPal+. This document does not contain information about software, or a device that would require the kind of performance study details (acceptance criteria, training/test sets, expert adjudication, MRMC studies) you've requested.

The document discusses:

• Device Description: BegoPal+ is a palladium-containing cobalt-chromium alloy for dental restorations.
• Processing: It's processed by selective laser melting (SLM).
• Indications for Use: Porcelain-fused-to-metal (PFM) noble alloy for crown and bridge restorations.
• Predicate Devices: Lists similar alloys (Wirobond C, Wirobond C+, Callisto CP+).
• Comparison to Predicate Devices: States substantial equivalence based on indications, technical parameters, and biocompatibility, despite differences in product shape, processing, and material composition.
• Testing: Mentions test results according to ISO 22674, ISO 9693-1, ISO 10271, and ISO 10993 which demonstrate safety and effectiveness.

Therefore, it is impossible to extract the information you requested from this document as it pertains to a physical material, not a software or AI-driven medical device.

If you are looking for an example of a 510(k) submission for a software or AI device, you would need a different document.

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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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"DREAMBOND" (Ceramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

"DREAMCAST CHROME" (Partial Denture Dental Casting Alloy) is for the use in dental laboratories, suitable for preparation of removable dental applications.

"DREAMCAST V" (Cramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

"DREAM FLEXICAST"" (Partial Denture Cobalt Base Alloy") is for the use in dental laboratories. suitable for preparation of removable dental applications.

"DREAM LITHECAST" (Ceramic dental casting Alloy Nickel & Beryllium Free) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.

General:- Dental Alloys
Specific :- "DREAMBOND""DREAMCAST CHROME" "DREAMCAST V" "DREAM FLEXICAST" "DREAM LITHECAST"

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Dream Bond, DreamCast V, DreamCast Chrome, Dream FlexiCast, and Dream LitheCast devices.

The document is a 510(k) premarket notification letter from the FDA to American Green Dental Manufacturing, Inc. It states that the referenced devices are substantially equivalent to legally marketed predicate devices. This means that the FDA has determined the new devices are as safe and effective as existing ones, but it does not detail specific acceptance criteria or performance studies of the devices themselves within this document.

The document focuses on:

• FDA's determination of substantial equivalence (K033045).
• Regulation numbers and product codes for the devices.
• General controls and additional controls that may apply.
• Contact information for various FDA offices.
• Indications for Use for each device.
• Classification as Prescription Use.

Therefore, I cannot provide the requested information based on the text provided.

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Wirobond C is a non-Precious dental casting alloy to make full crowns and copings for porcelain fused to metal dental restorations.

Wirobond C is a non-Precious dental casting alloy.

The provided document is a 510(k) clearance letter from the FDA for a dental alloy, Wirobond C. It does not contain any information about acceptance criteria, device performance studies, or AI/software algorithm assessments.

Therefore, I cannot provide a response to your request, as the necessary information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details is completely absent from the provided text.

This document is solely focused on the regulatory clearance of a physical medical device (dental alloy) and confirms its substantial equivalence to a predicate device.

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This device entitled: Nano-TiCrown ™ Titanium Metal Alloy Dental Device (aka: Nano-TiCrown ™ ) is a Titanium/Titanium Nitride based alloy intended for use as a base metal alloy in the making of single unit device porcelain-fused-to-metal (PFM) prosthetic dental materials and custom-made dental prosthetic devices, such as a porcelain-to-metal veneer for a tooth. The Nano-TiCrown ™ is intended to be used as a single unit coping device, i.e., a PFM dental restorative device is not intended for use on metal only or other non-ceramic porcelain restorations. Nano-TiCrown ™ is a Class II (non-exempt) medical device that is described within the Dental Products medical specialty panel of the U.S. Food and Drug Administration (FDA), under FDA Regulation Number 21 CFR 872.3710, and Product Code: EJH. The Nano-TiCrown ™ device is recommended for all anterior and posterior tooth dental crown restorations. This Titanium Nitride coping device (i.e., Nano-TiCrown ™) is to be used by dental laboratories in the fabrication of PFM dental crowns for dentists, This Nano-TiCrown ™ is intended to be marketed to medical professionals and for point-of-care use, and is not intended for sale over-the-counter in its current design. [Warning: This device should be used with caution where the patient has known metal allergies and specifically is not intended to be used where known patient allergies to Titanium exist].

The Nano-TiCrown ™ Titanium Nitride dental coping substructure for full fused porcelain to metal PFM devices, consists of a Titanium Nitride substructure. The Nano-TiCrown ™ device is intended to be used in single unit coping dental restorative devices with full porcelain to metal coverage for PFM devices.

Here's a summary of the acceptance criteria and study information for the Nano-TiCrown™ device, organized as requested:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify a distinct "test set" in the sense of a clinical or imaging study with a defined number of cases. Instead, the "test set" refers to samples of the Nano-TiCrown™ material that underwent various laboratory tests. The number of samples for each test (e.g., chemical composition, biocompatibility, mechanical properties) is not explicitly stated, but the testing was performed on the device material itself.
   • Data Provenance: The data originates from laboratory testing performed according to international and national standards (ISO, ASTM, ADA/ANSI). The country of origin for the testing itself is not specified but is implicitly associated with the material fabrication and relevant testing facilities. The study is retrospective in the sense that data was collected from manufactured material, not from a prospective clinical trial.

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

   • This is not applicable as the "ground truth" for material properties is established by adherence to recognized international and national consensus standards (e.g., ISO 9693:1999(E), ASTM B 265-02, ISO 10993:1997(E)). These standards define the methodologies and acceptable ranges for various material properties. The experts involved would be the certified laboratory personnel performing the tests and ensuring compliance with these standards, rather than clinical experts providing diagnostic ground truth.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" is compliance with the specified quantitative and qualitative parameters outlined in the referenced consensus standards. Test results either meet or do not meet these predefined criteria.

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 a dental material (base metal alloy), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant.

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

   • Not applicable, as it is not an algorithm or AI device.

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

   • Ground Truth: Adherence to established international and national consensus standards for dental materials and biocompatibility (e.g., ISO 9693:1999(E), ASTM B 265-02, ISO 10993-1:1997(E), ANSI/ADA Specification NO. 41). These standards define ideal material properties and acceptable performance ranges.
   • For chemical composition, the ground truth also references CRC publish composition data.

7. The sample size for the training set:

   • Not applicable. This is a material science and biocompatibility study, not a machine learning study requiring a training set. The "development" and "refinement" of the material would involve iterative testing of various compositions and manufacturing processes, but not in the context of a "training set" for an algorithm.

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

   • Not applicable, as there is no training set mentioned in the context of this device's evaluation.

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Non-Precious Dental Casting Alloy . Suitable for use in fabrication of removable dental appliances.

Not Found

The provided document is an FDA 510(k) clearance letter for a dental casting alloy, not a study evaluating an AI-enabled medical device. Therefore, it does not contain information related to acceptance criteria, study methodologies, or AI performance metrics as requested in the prompt.

Specifically, the document establishes the substantial equivalence of the "PD Casta-H" device to legally marketed predicate devices, allowing it to be marketed. This process does not involve the type of performance evaluation, ground truth establishment, or statistical analysis typically associated with AI device studies.

Therefore, I cannot provide the requested information based on the given document.

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Non-Precious Dental Casting Alloy. Suitable for use in the fabrication of Ceramic Fused to Metal (metallo-ceramic) dental restorations.

Not Found

The provided text describes a 510(k) premarket notification for a dental alloy, Ceracast-V. It does not contain information about acceptance criteria, device performance details, or any study involving AI assistance for medical image analysis. Therefore, I cannot generate the requested information based on the provided input.

The document is a clearance letter from the FDA, stating that Ceracast-V is substantially equivalent to legally marketed predicate devices for use as a non-precious dental casting alloy in ceramic fused to metal dental restorations. It does not involve any algorithm performance or clinical study data as typically seen with AI/ML-enabled medical devices.

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Superbond (Ceramic Dental Casting Alloy) is for the use in Dental Laboratories, suitable for use in fabrication of metal-ceramic dental restoration.

Not Found

This document is an FDA 510(k) clearance letter for a dental alloy named "Superbond". It's a regulatory approval, not a scientific study report describing acceptance criteria and device performance in the way you've outlined. Therefore, I cannot extract the requested information from the provided text.

The document primarily focuses on:

• Device identification: Superbond, a Ceramic Dental Casting Alloy.
• Regulatory classification: Class II, Product Code EJH.
• Substantial equivalence determination: The FDA found it substantially equivalent to legally marketed predicate devices.
• Intended use: For use in Dental Laboratories, suitable for use in the fabrication of metal-ceramic dental restoration.
• Regulatory compliance: Information about general controls provisions and other FDA regulations.

It does not contain any information about:

• Specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity).
• Results of a study proving the device meets acceptance criteria.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• MRMC studies or standalone algorithm performance.
• Ground truth types or training set details.

To address your request, a different type of document, such as a clinical study report, a technical performance study report, or the 510(k) summary (which sometimes includes more detail on performance data if applicable to the device type), would be needed.

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