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510(k) Data Aggregation
(138 days)
Vertex-Dental B.V.
NextDent Jet Denture Base is a light curing resin intended for 3D printing of a full or partial denture base to form a denture. The product, when used in combination with NextDent Jet Denture Teeth can be used for 3D printing a removable full or partial denture. For dental professional use only.
NextDent Jet Denture Teeth is a light curing resin intended for the 3D printing of artificial teeth to form a denture, temporary crowns or bridges. The product, when used in combination with NextDent Jet Denture Base can be used for 3D printing a removeable full or partial denture. For dental professional use only.
NextDent Jet Denture resins are pre-mixed combinations of acrylate-based light-cure resins with pigments, polymerized via photo initiators in a 3D printer setting for the fabrication of full or partial denture bases and artificial teeth to form a denture and for the fabrication of temporary crowns or bridges. The resins must be used in combination with 3D Systems printers that support MultiJet Printing technology. Devices are produced in an automated additive manufacturing method where ultra-thin layers of photopolymer material are jetted onto a build tray. Immediately after being jetted, each photopolymer layer is cured by UV light. The process repeats layer by layer until the 3D part is complete. Upon completion the support material is removed, and the product is cleaned. When printing a denture base, bonding of artificial teeth to the denture base is possible to form a denture. The bonding agent instructions should be followed. Printed parts are finished using conventional dental methods and instruments.
The provided text is a 510(k) Premarket Notification from the FDA for "NextDent Jet Denture Base" and "NextDent Jet Denture Teeth". It describes the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.
However, the provided text does not contain information related to an AI/ML device. Specifically, there is no mention of acceptance criteria for an AI algorithm, test set details, expert involvement in ground truth establishment, MRMC studies, or training set information. The testing described focuses on the mechanical and biocompatibility properties of the dental resins, adhering to ISO standards for dental materials.
Therefore, I cannot provide an answer that describes the acceptance criteria and the study proving an AI/ML device meets them based on the provided text. The questions posed in your prompt (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for AI, training set details) are relevant to AI/ML device evaluations but are not addressed in this document, as it pertains to a materials-based medical device.
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(161 days)
Vertex-Dental B.V.
NextDent Base is for dental professional use only and intended for the manufacturing of denture bases to support artificial teeth to form full or partial removable dentures.
Light-Cure Resin, provided in a container. NextDent Base is a combination of acrylate-based light-cure resin with pigments, polymerized via photo initiators in a 3D printer setting for fabrication of denture bases to support artificial teeth to form full or partial removable dentures. Fabrication of denture bases with NextDent Base requires a VAT based 3D printer that supports NextDent resins. Printer and resin must be optimized to each other to get complete and precise printed parts.
The provided document is a 510(k) summary for a dental device called "NextDent Base." It describes the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria for a specific AI-powered medical device, nor does it present a study proving an AI device meets such criteria.
The document is solely about a dental material (resin for denture bases) and its mechanical and biological safety testing against established ISO standards for dental polymers. There is no mention of AI, machine learning, or software performance in the context of device acceptance or a study.
Therefore, I cannot fulfill your request for an AI device's acceptance criteria and a study proving it meets them based on the provided text. The questions you've asked are designed for AI/software as a medical device (SaMD) submissions, which this document is not.
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(137 days)
VERTEX-DENTAL B.V.
Vertex™ ThermoSens is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments.
Vertex™ ThermoSens Rigid is a thermoplastic material that is intended to be used in the fabrication of removable full and partial dental prostheses. The product is based on a compounded mixture of Polyamide and pigments. The Vertex™ ThermoSens material is incorporated in an aluminium tube, which is heated up to 280 degrees Celsius. After a heating period of 18 minutes, the material is injected into the flask by pressure. The technique can be done in an automatic injection machine or manually. The preparations of the model and flask are according to standard procedures of the dental technique. An instruction for use is in writing, film and pictures available. Also a course can be taken to learn the technique and work with the product.
The provided document is a 510(k) summary for the Vertex™ ThermoSens Rigid denture base material. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through a clinical study that establishes specific acceptance criteria and then proves the device meets those criteria through performance data.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typically relevant for AI/ML device evaluations or detailed clinical trials) is not applicable to this 510(k) submission.
This submission demonstrates substantial equivalence by comparing the new device's Indications for Use, Intended Use, Composition of Polymer, and Physical Properties to those of predicate devices (TCS® Unbreakable - K053060 and Lucitone® FRS™ Flexible Dental Resin - K992956). The "acceptance criteria" here are essentially the properties and characteristics of the predicate devices, and the "study" is a comparative analysis and laboratory testing against established ISO standards.
Here's how the provided information can be structured based on the request, acknowledging the limitations inherent in a 510(k) substantial equivalence submission:
1. Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a material like a denture base, the "acceptance criteria" are typically defined by recognized standards (like ISO 20795-1:2008 for dental materials) and the performance of predicate devices. The device "meets" these criteria by demonstrating similar properties to the predicates and conforming to the standard.
| Acceptance Criterion (from ISO 20795-1:2008 / Predicate Device) | Vertex™ ThermoSens Rigid Performance | Predicate Device (TCS Unbreakable) Performance |
|---|---|---|
| Impact Strength (≥ 7.0 kJ/m²) | 8.0 ± 7.0 kJ/m² | 8.5 ± 1.2 kJ/m² |
| Flexural modulus (≥ 1000 MPa) | 1339 ± 54 MPa | 353 ± 4.24 MPa |
| Water absorption (≤ 32.0 µg/mm³): | 31.2 ± 0.8 µg/mm³ | 14.6 ± 0.4 µg/mm³ |
| Water solubility (≤ 1.6 µg/mm³): | -0.20 ± 0.25 µg/mm³ | 2.5 ± 0.7 µg/mm³ |
| Maximum stress intensity factor (≥ 2.5 MPa m1/2) | 3.5 ± 0.3 MPa m1/2 | Not explicitly provided for predicate |
| Total fracture work (≥ 125000 J/m²) | 160250 ± 16120 J/m² | Not explicitly provided for predicate |
Note: For "Maximum stress intensity factor" and "Total fracture work", specific predicate values were not provided in the table, but the device's performance is presented against the ISO requirement. For other properties, comparisons are made to TCS Unbreakable. The Lucitone® FRS™ predicate was noted as "Not Tested by Sponsor" for physical properties.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the 510(k) summary. The physical properties testing would have involved material samples, but the number of samples for each test is not detailed.
- Data Provenance: The testing was performed by the "Sponsor" (Vertex Dental B.V.). The country of origin for the data is implicitly The Netherlands, where Vertex Dental B.V. is located. This is laboratory-based testing on material samples, not patient data, so "retrospective or prospective" is not applicable in the usual clinical sense.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This is a material substantial equivalence submission based on laboratory physical property testing and comparison to existing devices and standards, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for Test Set
- Not Applicable. See point 3. Testing involves material property measurements, not expert consensus on findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is a material safety and performance submission, not an AI-assisted diagnostic or triaging device.
6. Standalone (Algorithm Only) Performance
- Not Applicable. This is a physical product (denture base material), not a software algorithm.
7. Type of Ground Truth Used
- Laboratory Measurements against ISO Standard and Predicate Performance: The "ground truth" for the physical properties is defined by the requirements of the ISO 20795-1:2008 standard for dental materials and the measured performance of predicate devices. For composition and indications, the ground truth is established by the specifications of the predicate devices.
8. Sample Size for Training Set
- Not Applicable. This is a physical product, not a machine learning model requiring a training set. The material itself is the "product," and its properties are measured directly.
9. How Ground Truth for Training Set was Established
- Not Applicable. See point 8.
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(192 days)
VERTEX-DENTAL B.V.
Vertex cold-curing denture base materials are indicated for:
- Manufacture of full and partial dentures
- Repair of full and partial dentures
- Rebasing of full and partial dentures
- Relining of full and partial dentures
Vertex cold-curing denture base materials are self curing acrylic denture base materials composed of polymethyl methacrylate powder and a liquid consisting of methyl methacrylate and other ingredients. The polymer is shaded to simulate the color of gum tissue using pigments that are approved for alimentary or similar use and are Cadmium free. The devices covered in this submission are the Vertex Self Curing, Vertex Castavaria, and the Vertex Castapress denture base materials.
VertexTM Self Curing is a self-curing acrylic denture base material intended for the repair and relining of full and partial dentures, made by heat-curing acrylics. This acrylic can be polymerized in 10 minutes using a pressure vessel.
VertexTM Castavaria is a multifunctional self polymerizing denture base material intended as a pouring and as a repair acrylic. The advantages of this acrylic are: minimized shrinkage, color stability, stable polymerization cycle and the acrylic is pourable for a long period of time. In addition Vertex™ Castavaria can be worked and modeled over a relatively long period of time.
Vertex™ Castapress is a self polymerizing pouring/casting type denture base material also suitable for repair, relining, rebasing and extensions of partial dentures. The colour stability of the material is excellent because of the use of an unique accelerator system
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Vertex cold-curing denture base materials.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical trial report for novel technologies. Therefore, some of the requested information (especially regarding aspects like expert adjudication, MRMC studies, or detailed training set information common in AI/software device submissions) is not applicable or present in this type of submission for a dental material.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Vertex cold-curing denture base materials are implicitly based on demonstrating substantial equivalence to the physical properties of the predicate devices. The study involved comparing key physical properties of the new devices (Vertex Self Curing, Vertex Castavaria, Vertex Castapress) against two legally marketed predicate devices: Probase Cold (K913655) and Major Repair (K082153).
The "acceptance criteria" are therefore considered to be performance within the range or comparable to the predicate devices for each physical property measured.
| Acceptance Criteria (Based on Predicate Devices) | Vertex Self Curing Reported Performance | Vertex Castavaria Reported Performance | Vertex Castapress Reported Performance | Met Criteria? |
|---|---|---|---|---|
| Flexural Strength: ≥ 63.44 MPa (Probase Cold) / ≥ 66.4 MPa (Major Repair) | 68 MPa | 79 MPa | 75 MPa | Yes (all models) |
| Flexural Modulus: ≥ 1832.00 MPa (Probase Cold) / ≥ 2217 MPa (Major Repair) | 2028 MPa | 2316 MPa | 2293 MPa | Yes (all models) |
| Water Absorption: Comparable to 21.2 µg/mm³ (Major Repair) | 20.3 µg/mm³ | 23.2 µg/mm³ | 22.1 µg/mm³ | Yes (comparable) |
| Water Solubility: Comparable to 1.4 µg/mm³ (Major Repair) | 1.8 µg/mm³ | 1.8 µg/mm³ | 1.19 ± 0.18 µg/mm³ | Yes (comparable) |
| Residual Monomer: ≤ 4.5% (Probase Cold) / ≤ 4.0% (Major Repair) | 3.76 ± 0.15% | 3.91 ± 0.05% | 3.22 ± 0.06% | Yes (all models) |
Note on "Met Criteria?": The determination of "Yes" is based on the new devices performing at or better than the reported values for the predicate devices where specific values are given, or being within a reasonable range for properties like water absorption/solubility where direct numerical cut-offs aren't explicitly stated but comparability is sought. The FDA's substantial equivalence determination confirms these criteria were met.
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes (number of specimens) used for testing each physical property for the new devices or the predicates. Testing of dental materials typically involves a defined number of specimens per test according to relevant ISO standards (e.g., ISO 1567).
- Data Provenance: The data for the Vertex devices was generated by the submitter, Vertex Dental B.V. (The Netherlands). The nature of these tests (physical property measurements) is experimental/laboratory-based rather than retrospective or prospective clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The "ground truth" for physical properties of a material is established through standardized laboratory testing methods (e.g., flexural strength, water absorption using ISO standards), not through expert consensus or interpretation in the way one would for diagnostic images. The results are quantitative measurements.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant for subjective assessments or classifications (e.g., in clinical trials or image interpretation) where human experts might disagree. For objective physical property measurements, standard laboratory protocols are followed, and results are quantitative.
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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 is not applicable. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of data (like medical images), often to evaluate the impact of AI assistance. This submission is for a dental material (denture base), not a diagnostic AI device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. There is no algorithm or AI component in this dental material.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation consists of quantitative measurements of physical properties (e.g., flexural strength, water absorption) obtained through validated laboratory test methods compliant with international standards (e.g., ISO 1567, ISO 20795).
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is not a machine learning or AI device. The material properties are inherent to its chemical composition and manufacturing process, not learned from data.
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How the ground truth for the training set was established:
- This is not applicable, as there is no training set.
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(80 days)
VERTEX-DENTAL B.V.
The Vertex Rapid Simplified is indicated for: 1. Fabrication of full dentures 2. Fabrication of partial dentures
The Vertex hot-curing denture base material is a conventional dough pack heat cured denture base material that consists of polymethyl methacrylate powder with a heat cure monomer consisting of methyl methacrylate. This material complies with the requirements of ISO 1567, Dentistry. Denture base polymers. The pressing technique is the processing method for Vertex hot-curing denture base material. This cadmium-free acrylic has a rapid 20 minutes polymerization cycle (overnight polymerization is also possible). The Vertex hot-curing denture base powder is available in 10 shades.
Here's an analysis of the provided text regarding the Vertex Dental B.V. Vertex hot-curing denture base material, focusing on acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (from predicate devices / ISO standards) | Vertex Rapid Simplified Performance |
|---|---|---|
| Charpy impact strength | ≥ 1.36 kj/m² (from predicate devices) | 11.3 kj/m² |
| Flexural strength | ≥ 78 MPa (from predicate devices) | 85 MPa |
| Flexural modulus | ≥ 2367 MPa (from predicate devices) | 2367 MPa |
| Water absorption | ≤ 22.0 µg/mm³ (from predicate devices) | 22.5 µg/mm³ |
| Water solubility | ≤ 1.5 µg/mm³ (from predicate devices) | 0.11 µg/mm³ |
| Residual monomer |
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