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R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid universal composite for anterior restorations. It is intended for professional use by below mentioned Indications for Use;

• · Restorations of deciduous teeth
• · Splinting of mobile teeth
• · Restoration in the posterior region (Classes I and II)
• · Anterior restorations (Classes III, IV)
• · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• · Extended fissure sealing in molars and premolars
• · Veneering of discoloured anterior teeth
• · Repair of composite and ceramic veneers

R&D Series Nova Compo N is a light-curing, radiopaque, nano hybrid composite for anterior and posterior restorations.

According to the applicable FDA recognized consensus standard: ISO 4049:2009 "Dentistry-Polymer Based Restorative Materials", this device is classified into the following:

• -Type 1: polymer-based filling and restorative materials;
  -Class 2: Materials whose setting is effected by light;

-Group 1: Materials whose use requires the energy to be applied intra-orally.

R&D Series Nova Compo N light cure nano hybrid composite is designed with the high reduced shrinkage resin. The higher molecular weight of the resin results in less shrinkage, reduced aging and a slightly softer resin matrix. Additionally these resins impart a greater hydrophobicity and are less water absorption. Prepolymerized fillers provide low stress, non-sticky, easy handling and shaping formulation. High loading Prepolymerized fillers provide better wear resistance than traditional less loaded Prepolymerized fillers in other marketing composites. The nanofillers provide high polish, high wear, surface hardness and making the material smooth.

R&D Series Nova Compo N light cure nano hybrid composite was tested for biocompability and found to be biocompatible as a result of testing.

The user is asking for specific details about the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) summary.

Here's an analysis of the provided text and the answers to your questions:

The provided document is an FDA 510(k) premarket notification for a dental composite material, R&D Series Nova Compo N. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through comparison to established standards (like ISO) and predicate device performance, along with bench testing.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, it presents the performance of the new device (R&D Series Nova Compo N) in comparison to the performance of its predicate devices, implying that performance similar to or better than the predicates, and adherence to relevant ISO standards, constitutes the "acceptance criteria."

The closest representation of this is Table 1 in the "Substantial Equivalence" section of the document, which compares the physical properties of the new device with its predicates. The "acceptance criteria" can be inferred as being at least equivalent to the predicate devices and meeting the requirements of the ISO 4049:2009 standard.

Inferred Acceptance Criteria and Reported Device Performance (from Table 1 and text):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the physical property bench tests. It states, "In-vitro bench tests were performed on the R&D Series Nova Compo N light cure nano hybrid composite according to the requirements in ISO 4049: 2009 (Dentistry - Polymer-based restorative)." ISO standards typically specify minimum sample sizes for various tests, but these specific numbers are not detailed in the summary.

• Sample Size for Test Set: Not explicitly stated for individual tests.
• Data Provenance: The studies are in-vitro bench tests and biocompatibility tests. No mention of human patient data (retrospective or prospective) for performance evaluation. The submitting company is IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. from Turkey, so it can be inferred the testing was conducted under their purview, likely in Turkey or by an accredited lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the studies are primarily in-vitro bench tests and biocompatibility tests. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology reports) is not required or established for this type of device and testing. The ground truth for these tests comes from the established physical and chemical properties as measured by standardized laboratory methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the in-vitro bench tests and biocompatibility studies described. Adjudication methods are typically employed in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies.

5. 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. The device is a dental composite material, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant nor were they conducted.

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

This is not applicable. The device is a dental composite material, not a software algorithm.

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

For the physical properties, the "ground truth" is established by standardized laboratory measurements according to ISO 4049:2009. For biocompatibility, the "ground truth" is established by laboratory tests according to ISO 10993-1 and ISO 7405, which determine the biological response (e.g., cytotoxicity, sensitization). There is no "expert consensus" or "pathology" in the medical diagnostic sense for these tests.

8. The sample size for the training set

This is not applicable. Since this device is a physical material (dental composite) and not an AI algorithm, there is no "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no "training set" for a physical dental composite device.

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