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This product is indicated for the manufacturing of bases of partial or full removable dentures, occlusal splints and night guards through heating and pneumatic injection of the material, following the Instructions of Use that come with the product.

FLEX FIT is a polyamide resin for non-clasp dentures. It is suitable for deep undercut cases, which need strength. The resin material has an inherent flexibility allowing for a strong yet flexible denture to be created. FLEX FIT (known as Bio Tone in attached test summaries) is a denture resin that is primarily based on polyamide. It is sold as a clear or pink colored, fine granular resin that is 1~2 mm3 in diameter. The resin is packaged in a re-sealable plastic containers. Using an injection-molding method, FLEX FIT polyamide resin can be effectively used to make various types of dentures that retain the highly flexible, yet durable characteristics. It is a highly effective material for making non-clasp dentures, partial prosthetic dentures, dental plates, denture bases, bite plates, personal trays, night guards, splints, etc. It uses thermal polymerization as its mode of polymerization. The FLEX FIT offers two colors: clear and pink.

The provided document is a 510(k) Pre-Market Notification for a dental resin called "FLEX FIT." It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving the device meets those criteria.

Here's why and what's missing:

• Acceptance Criteria and Reported Performance: The document states that "Physical testing meets standard for dental base polymers ISO 20795 - yes" and "Biocompatibility ISO 10993 complied." These are high-level statements that the device meets certain standards, but they do not provide a table of specific numerical acceptance criteria (e.g., minimum flexural strength, maximum water sorption) and the reported device performance against those specific criteria.
• Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document mentions "Performance Tests in accordance with ISO 20795-1" and "Biocompatibility Tests in accordance with ISO 10993" with specific tests listed (Cell Toxicity, Sensitization, Oral Mucosal Stimulation, Acute Toxicity). However, these are general descriptions of types of tests. The document does not provide details about:
  • The sample size used for these tests.
  • The provenance of any data (e.g., if human subjects were involved, which they typically are not for material property testing).
  • The involvement of experts or an adjudication method, which are relevant for diagnostic devices that rely on interpretation, not for material property testing.
  • Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done (this is for diagnostic AI devices, not material property).
  • Whether a standalone (algorithm-only) performance was done (again, for AI/diagnostic devices).
  • The specific type of "ground truth" used beyond stating compliance with standards (e.g., "patrology" or "outcomes data" are not relevant here; the ground truth would be the defined specifications of the ISO standards).
  • The sample size for any training set or how ground truth was established for it (irrelevant for a dental resin where properties are measured directly against standards, not learned by an AI).

In summary, the provided document is a regulatory submission for a dental material (resin). It confirms that the material meets relevant ISO standards for physical properties and biocompatibility. The questions you've asked are typically relevant for diagnostic software algorithms or AI-driven medical devices that analyze images or patient data and require validation against a 'ground truth' established by experts. This document does not describe such a device or study.

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Nobilplast Denture Resin is intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night quards.

Nobilplast Denture Resin is a polyamide (nylon) resin available in pink and white colors. The resin granules are packaged in injectable aluminum cartridges or sold in a bulk container where users can fill empty aluminum cartridges that are sold separately.

The FDA 510(k) summary for Nobilplast Denture Resin is a submission for substantial equivalence based on comparison to legally marketed predicate devices. The document does not describe a clinical study in the typical sense (e.g., a multi-reader, multi-case study with human-in-the-loop performance or standalone algorithm performance). Instead, it relies on bench testing and a comparison of material properties and indications for use to existing predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, and expert involvement are not applicable in this context. The document focuses on demonstrating that the new device is as safe and effective as the predicate devices based on material characteristics and standard tests.

Here is an attempt to address the prompts based on the provided document, noting where information is not applicable (N/A) for this type of submission:

Acceptance Criteria and Device Performance for Nobilplast Denture Resin

The acceptance criteria for Nobilplast Denture Resin are implicitly based on demonstrating that its material properties and performance characteristics are substantially equivalent to its primary predicate device, FLEXSTAR V, and other reference devices (TCS Unbreakable, DENTSOLL Rezen NF, and Valplast). This is achieved through a series of bench tests and a comparison of intended use and material composition.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on direct comparison rather than a device with specific quantifiable "performance" in a diagnostic or assistive capacity, the acceptance criteria are framed as "similarity" or "comparability" to established predicate devices. The "reported device performance" is how Nobilplast Denture Resin's measured properties compare to those of the predicate.

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

• Sample Size for Test Set: The document does not specify a "sample size" in terms of cases or images for testing an AI device. Instead, it refers to the number of samples used for various bench tests of the material properties. These are standard material science tests, and the sample sizes would be defined by the specific ASTM/ISO standards referenced (e.g., a certain number of specimens for tensile strength, impact, etc.). The document does not provide these detailed sample counts.
• Data Provenance: The data provenance is from laboratory bench testing of the Nobilplast Denture Resin material, as well as biological testing. This is not clinical data derived from patients or images. It is prospective testing performed on the manufactured material. The country of origin for the data is not explicitly stated, but the company is based in the USA.

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

N/A. This is a material testing submission, not an AI or diagnostic device submission requiring expert human interpretation of data for ground truth. The "ground truth" here is the measured physical and chemical properties of the material, verified through standardized testing protocols (ASTM, ISO).

4. Adjudication Method for the Test Set

N/A. No human adjudication is involved for material properties testing.

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

N/A. This type of study is for diagnostic or assistive devices involving human readers interpreting cases. Nobilplast Denture Resin is a material for fabricating dentures.

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

N/A. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Standardized Bench Testing: Direct measurement of material properties (e.g., density, melting point, hardness, tensile strength, flexural properties, impact strength, sorption & solubility) according to internationally recognized ASTM and ISO standards.
• Biocompatibility Testing: Evaluation of biological response as suggested by FDA Guidance (Cytotoxicity, Irritation, Sensitization tests).
• Comparison to Predicate Devices: The established and legally marketed performance and safety profiles of the predicate devices (FLEXSTAR V, TCS Unbreakable, DENTSOLL Rezen NF, Valplast) serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

N/A. There is no training set as this is not a machine learning or AI device.

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

N/A. Not applicable.

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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.

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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This product is indicated for the manufacturing of bases of partial or full removable dentures, r nis products thatoated for the marketing and pneumatic injection of the material, following the Indications of Use that come with the product.

Deflex Acrilato is a pigmented polimethyl-methacrilate (PMMA) resin that belongs to the group of thermoplastic polymers which is used for the manufacturing of partial, complete and combined dentures. The product is presented in pellets, packed in an aluminum canister (as a primary packaging), and then in a vacuum sealed aluminized plastic bag (as a secondary packaging). the PMMA granules are pigmented so as to achieve aesthetic effects on the manufactured denture.

The provided text describes a 510(k) summary for a dental device (DEFLEX ACRILATO, a PMMA resin for denture bases). This summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of material properties, rather than an AI-powered diagnostic device. Therefore, many of the requested categories related to AI performance, expert ground truth, and clinical study designs are not applicable.

Here's the analysis based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission compares the new device to predicate devices, stating that its properties are "similar" or "more resistant" or "much lower." It does not provide specific quantitative acceptance criteria or detailed numerical performance data for these comparisons within the provided text. Instead, it relies on a qualitative comparison to establish substantial equivalence.

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

The document does not specify general "test sets" in the way a diagnostic AI study would. The testing was laboratory-based on material properties.

• Sample Size: Not specified for each test.
• Data Provenance: The device submitter is NUXEN S.R.L. based in Buenos Aires, Argentina. The testing was conducted by an "Internal laboratory" or against recognized standards (EN 20795-1:2009, ANSI+ADA+12-2002+(R2008)). The data is prospective in the sense that the manufacturer conducted these tests specifically for this submission.

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

Not applicable. This is a material science study, not a diagnostic study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a material science study, not a diagnostic study requiring adjudication.

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

No, an MRMC study was not done. This is a material science study for a dental resin, not an AI-powered diagnostic device.

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

Not applicable. This is not an algorithm or AI device. The device itself is the product being tested (the PMMA resin). The "performance" is its inherent physical and chemical properties.

7. The Type of Ground Truth Used

The "ground truth" here is established by the specified standardized testing methods (EN 20795-1:2009, ANSI+ADA+12-2002+(R2008)) for material properties relevant to dental resins. The data generated from these calibrated tests represents the factual properties of the material.

8. The Sample Size for the Training Set

Not applicable. This is a material science product, not an AI model that requires a training set.

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

Not applicable.

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