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For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.

• Provisional anterior and posterior crowns & bridges
• Implant and abutment supported prosthetics.
• Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)

The Subject device are discs made of poly methyl methacrylate (PMMA), a known material used in the dental field due their physical-chemical and biocompatibility properties. These discs are intended use with dental CAD/CAM equipment to produce a variety of provisional prosthetic restorations or devices. The discs are available in a variety of disc configurations to accommodate different commercial dental CAD/CAM machines fixture requirements. In addition, the CAD/CAM discs are available in a wide variety of heights and colors to facilitate matching of patient tooth or tissue shades.

The given text is a 510(k) Summary for a dental device (Portux CAD/CAM Disc). It details the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

However, this document does not describe acceptance criteria for an AI/software device, nor does it provide information about a study proving an AI device meets acceptance criteria. Instead, it focuses on the physical and chemical properties of a dental disc material and its equivalence to another dental disc.

Therefore, most of the requested information regarding AI device performance, sample sizes for AI model testing, expert involvement in ground truth establishment, MRMC studies, and training set details cannot be extracted from this document.

The only "acceptance criteria" and "performance data" mentioned in the document relate to the physical properties of the PMMA material, not the performance of an AI or software algorithm.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted:

• Acceptance Criteria (for the dental material, not AI): The document lists performance testing standards (ISO 10477 and ISO 20795) and specific physical property requirements for the dental disc material. These are akin to "acceptance criteria" for the material itself.
• Reported Device Performance (for the dental material, not AI): The document provides the device's measured physical properties alongside the ISO standard requirements.

What cannot be extracted (as it pertains to AI/software device studies, which are not described in this document):

• A table of acceptance criteria and reported device performance for an AI/software device.
• Sample sizes used for the test set for an AI/software device.
• Data provenance for an AI/software device test set.
• Number of experts used to establish ground truth for an AI/software device.
• Qualifications of experts for an AI/software device.
• Adjudication method for an AI/software device test set.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done for an AI/software device.
• Effect size of human readers improving with AI vs. without AI assistance.
• If a standalone (algorithm only) performance study was done for an AI/software device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
• The sample size for the training set for an AI/software device.
• How the ground truth for the training set was established for an AI/software device.

Based on the provided text, here is the information that can be extracted, framed within the context of the physical dental disc material:

1. A table of acceptance criteria and the reported device performance (for the dental material):

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New Stetic NU Alloy DP 40, NU Alloy DP, NU Alloy DP Active and Micronic Dental Amalgam Alloys are commonly used as a filling material for restoring the morphology and function of posterior teeth (cavities class I and II in molars and premolars), when these have lost their structure due to injuries such as cavities or fractures.

New Stetic Dental Amalgam Alloys for dental amalgam used as a filling material for oral cavities. They are made of silver, tin and copper and free of zinc. The products are packaged in different forms: pre-dosed capsules, tablets and powder.

The provided 510(k) summary for K140125 describes the New Stetic Dental Amalgam Alloys and compares them to predicate devices to establish substantial equivalence. The "study" here refers to the performance testing conducted to meet regulatory standards and demonstrate equivalence rather than a clinical trial on human subjects improved with the AI.

Here's an analysis based on the provided document:

Acceptance Criteria and Study Details for K140125: New Stetic Dental Amalgam Alloys

1. Table of Acceptance Criteria and Reported Device Performance:

The device's performance is assessed against the specifications outlined in ISO 24234:2004 for dental amalgam. The tables below compile the acceptance criteria from this ISO standard and the reported performance of the New Stetic Dental Amalgam Alloys (NU ALLOY DP 40, NU ALLOY DP, NU ALLOY DP ACTIVE, and MICRONIC).

Acceptance Criteria and Device Performance (NU ALLOY DP 40)

Acceptance Criteria and Device Performance (NU ALLOY DP)

Acceptance Criteria and Device Performance (NU ALLOY DP ACTIVE)

Acceptance Criteria and Device Performance (MICRONIC)

For all products, the report states: "Although the results are not exactly the same, our tests are carried out according to ISO 24234-2004 and all products are within specifications, which ensure the suitable performance of restoration."

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

The document refers to "Performance /Non-Clinical Testing" which was "completed in accordance to ISO 24234:2004". The results for each alloy type are provided with "Lot N°", indicating that samples from specific production lots were tested. However, the exact sample size (number of specimens per test) used for each physical property measurement is not explicitly stated in this document. The provenance of the data is from New Stetic S.A., located in Guarne - Antioquia, Colombia, who are the submitters of the 510(k). The testing is retrospective, as it was performed on finished product lots.

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

This document does not describe the establishment of a "ground truth" by experts in the context of diagnostic interpretation. Instead, the "ground truth" refers to objective physical and chemical properties measured against an international standard (ISO 24234:2004). There is no mention of human experts being involved in establishing the ground truth for these physical and chemical performance tests.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The performance is based on objective measurements against a standard.

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

Not applicable. This is a submission for a dental material (amalgam alloy), not an AI-assisted diagnostic device. Therefore, a study comparing human reader performance with and without AI assistance is not relevant and was not conducted.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a physical material, not an algorithm or software. Its performance is evaluated through material science testing.

7. Type of Ground Truth Used:

The ground truth used is the objective physical and chemical specifications defined by the international standard ISO 24234:2004. This standard sets the minimum or maximum acceptable values for properties like compressive strength, creep, and dimensional change.

8. Sample Size for the Training Set:

Not applicable. This is a physical dental material, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

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A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.

The provided text details the 510(k) summary for the New Stetic Artificial Teeth, which is a preformed plastic denture tooth. The submission asserts substantial equivalence to a predicate device (King Dental Corp - King-Hue, Royal Coral, Super-C Artificial Teeth, K931162).

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The device, New Stetic Artificial Teeth, is a Class II device (Preformed Plastic Denture Tooth) with product code ELM. The performance testing was conducted according to ISO 22112 First edition 2005-11-01, Dentistry -- Artificial teeth for dental prostheses.

The text does not explicitly list specific numerical acceptance criteria (e.g., minimum flexural strength, maximum water absorption) or reported device performance values in a table format. Instead, it states that "Performance testing was completed to ISO 22112 First edition 2005-11-01." This implies that the device met all the requirements outlined in this international standard for artificial dental prostheses.

Without specific performance values from the standard or the study, a "reported device performance" column cannot be fully populated with numerical data. However, based on the FDA's clearance, it is understood that the device did meet all applicable criteria within ISO 22112.

*Note: The 510(k) summary does not reproduce the detailed specifications of ISO 22112. These would typically include tests for properties like bond strength, color stability, water sorption, solubility, hardness, and mechanical strength relevant to dental prostheses.

Study Information

1. Sample sizes used for the test set and the data provenance:
   The document does not specify the sample size used for the test set during performance testing. It also does not mention the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted to an international standard (ISO 22112), which dictates testing methodologies but not necessarily data provenance in this context.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the 510(k) summary. Given that the testing was based on a laboratory standard (ISO 22112) for physical and material properties, the "ground truth" would be established through calibrated laboratory instruments and adherence to testing protocols, rather than expert human interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable or provided. Laboratory-based performance testing following an ISO standard typically relies on objective measurements rather than human adjudication of results in the way clinical studies might.

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:
   No MRMC study was done. This device is a preformed plastic denture tooth, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. The assessment focuses on the material and physical properties of the teeth.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device is a physical product (artificial teeth), not an algorithm or software. Its performance is inherent in its material properties and manufacturing.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth for this type of device is established by objective measurements of material properties and performance characteristics defined by the international standard ISO 22112. This standard specifies tests for things like flexural strength, water absorption, color stability, and bond strength as relevant to artificial teeth. There is no "pathology" or "outcomes data" in the clinical sense for this type of premarket submission, as it relates to the physical product itself.

7. The sample size for the training set:
   Not applicable. This device is a physical product, not a machine learning algorithm, so there is no "training set."

8. How the ground truth for the training set was established:
   Not applicable. As there is no training set for a physical product, this question is not relevant.

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The indication for use of the New Stetic® Acrtylics is for the repair or fabrication of the denture base.

The product is a denture system consisting of monomer and polymer powder and liquid components.

The provided 510(k) summary (K102874) details the substantial equivalence of New Stetic Acrylics to a predicate device, Myerson's Economy Denture Base Material (K970522). The "study" that proves the device meets acceptance criteria is a series of non-clinical performance tests conducted by New Stetic, aligning with specific international standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the New Stetic Acrylics are based on ANSI/ADA Specification No. 12:2002/ISO 1567:1999 (and 2008 for heat-polymerized acrylics) for Denture Base Polymers. The reported performance for both heat-polymerized and self-polymerized acrylics (which include New Stetic Acrylics) shows that they meet or exceed these requirements.

Heat-Polymerized Acrylics (e.g., Opti-cryl, Veracil, Novacryl, Poti-cryl Pour and EZ-cryl)

Self-Polymerized Acrylics (e.g., Duracryl, O-cryl and Fidelity)

Qualitative Properties:

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of specimens tested) for each physical property. It only mentions that "All testing that is required has been performed" and presents the experimental results.
• Data Provenance: The testing was conducted in New Stetic's Quality Control Laboratory. New Stetic is located in Guarne, Antioquia, Colombia. Therefore, the data provenance is Colombia and the data is retrospective as it was collected for the purpose of the 510(k) submission based on existing testing protocols.

3. Number of Experts and Qualifications for Ground Truth

This submission pertains to the physical and chemical properties of a dental material, not a diagnostic device requiring expert interpretation of images or other subjective data. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense (e.g., radiologists, pathologists) is not applicable. The "ground truth" here is defined by the technical specifications of the ANSI/ADA and ISO standards, and the measurements are performed using calibrated laboratory equipment.

4. Adjudication Method

Not applicable. As described above, this is a non-clinical performance evaluation against established objective standards using laboratory equipment, not a subjective assessment requiring human adjudication.

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

No. A MRMC comparative effectiveness study is typically conducted for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission describes the testing of a dental material's physical properties.

6. Standalone Performance

Yes, in a sense. The reported performance data represents the standalone (algorithm-only, if considering the testing methodology as an "algorithm") performance of the New Stetic Acrylics samples as measured by laboratory equipment against predefined standards. There is no human-in-the-loop component in determining these physical properties.

7. Type of Ground Truth

The type of ground truth used is expert consensus/established standards. Specifically, the ground truth is defined by the requirements outlined in ANSI/ADA Specification No. 12:2002/ISO 1567:1999 (and 2008) for Denture Base Polymers. These standards are developed by industry experts and regulatory bodies to ensure the safety and effectiveness of dental materials.

8. Sample Size for the Training Set

Not applicable. This submission describes the performance testing of a physical material, not an AI or machine learning model that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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