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Nova Resin dual cure, self adhesive resin cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, bridges, posts and veneers. *

Additional indications include core-buildup material, pit and fissure sealant, and cementation of crowns restorations to implants.

• Adhesive application on the prep is required for veneer cementation using Nova Resin dual cure, self adhesive resin cement.

Resin Cement dual cure, self adhesive resin cement for the cementation of indirect restorations made of high strength all ceramic, composite, metal-ceramic and metal.

When Resin Cement dual cure, self adhesive resin cement is used, additional bonding agents are not required. The automix double syringe enables saving time direct application of the luting cement into restoration.

This document, an FDA 510(k) summary for the "NOVA RESIN dual cure, self adhesive resin cement," describes the device and its equivalence to a predicate device, but it does not describe an AI/ML device or its associated acceptance criteria and study data.

The document focuses on the physical and chemical properties of a dental cement. The "acceptance criteria" and "reported device performance" provided in the table are for these physical properties (e.g., film thickness, flexural strength), not metrics related to AI/ML performance like sensitivity, specificity, or AUC.

Therefore, I cannot extract the information requested regarding a study proving an AI/ML device meets acceptance criteria, as this document does not pertain to an AI/ML device.

Here's why the requested information cannot be found in the provided text:

• No mention of AI/ML device or algorithm: The entire document describes a dental cement and its physical properties. There is no mention of algorithms, machine learning, artificial intelligence, or any form of software that processes data for diagnostic or predictive purposes.
• Acceptance criteria are for physical properties: The table provided lists metrics such as Film Thickness, Working Time, Flexural Strength, etc. These are standard engineering and material science metrics for dental cements, not performance metrics for an AI system.
• No "test set," "training set," "ground truth," or "experts" in the AI context: These terms are specific to the validation of AI/ML models. The document refers to "non-clinical performance testing" which are bench tests, not clinical studies involving human experts or patient data for AI validation.
• No MRMC study: A Multi-Reader Multi-Case study is a type of clinical trial specifically designed to evaluate the impact of AI on human reader performance in medical imaging. The provided document does not mention any clinical studies of this nature.
• No "standalone performance": "Standalone" performance refers to the algorithm's performance without human intervention. This is irrelevant for a dental cement.

In summary, this document is a regulatory submission for a dental material, not an AI/ML medical device.

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Nova Glass L:
-Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges
-Cementation of orthodontic bands
-Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns
-Base/liner
Nova Glass F:
-Class III, V and limited class I cavities
-Restoration of primary teeth
-Core Build Up
Nova Glass LC:
-Class III and V restorations
-Restoration of Cervical erosions and root surface caries
-Core build up
-Base/liner
Nova Glass BF:
-Class I & II cavities
-Decidious teeth: final restorative for Class I, II and V
-Long term restorative in non-load bearing areas of Class I, II and V
-Intermediate restorative & sandwich material for heavy stress bearing
-Core build up material
Nova Glass L Plus:
-Metal-based restorations
-Ceramic inlays
-Reinforced ceramic crowns and bridges
-All kinds of acrylic/resin crowns, inlays, onlays and bridges

• Nova Glass Cements are devices intended to serve as a temporary tooth filling or as a base ● cement to affix a temporary tooth filling.
• . Nova Glass Cements are based on the reaction of silicate glass powder and polyalkeonic acid. (acid-base reaction)
• . Nova Glass Cements are formulated to provide a powder and a liquid portion. In use the two are combined and a chemical reaction takes place to provide set cement.

The provided text is a 510(k) Premarket Notification for dental cements (Nova Glass Cements). This document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through comparison of indications for use, functional characteristics, composition, and physical properties, along with biocompatibility testing results.

Crucially, this document does not describe a study involving an AI/software device that requires human expert review for ground truth or MRMC studies. The device in question is a material-based dental cement. Therefore, many of the requested elements related to AI algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical and biological properties testing conducted on the dental cements themselves, to show they perform comparably to their predicate devices and meet established standards for safety and effectiveness.

Here's a breakdown of the relevant information provided in the document:

Acceptance Criteria and Device Performance (for a Dental Cement)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against which a study directly proves the device meets them in the way one might for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it demonstrates substantial equivalence by comparing the physical properties of the new device to its predicate devices and showing biocompatibility testing results against general safety standards.

Here's how the information can be presented for the dental cements, drawing from Section "PHYSICAL PROPERTIES" on page 7 and "NON-CLINICAL PERFORMANCE TESTING" on page 8.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is primarily non-clinical performance testing, consisting of:

• Physical Testing: In-vitro bench tests performed on all Nova Glass Cements according to the requirements of ISO 9917-1:2007 (Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements).
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 (Biological Assessment Medical Devices - Part 1: Evaluation and Testing) standard, specifically for Nova Glass F as a representative. For other products (Nova Glass LC, Nova Glass BF, Nova Glass L Plus), equivalence is asserted based on existing components in legally marketed devices.

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

• Sample Size: The document does not specify exact sample sizes for the physical or biocompatibility tests. For physical properties, it states "In-vitro bench tests were performed." For biocompatibility, it lists test names and "Report Numbers" but not the sample sizes used in those reports.
• Data Provenance: The tests were conducted to support a submission from a Turkish company (IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.). The testing itself would likely have been done in a laboratory environment, but the origin of the "data" itself isn't described as retrospective or prospective patient data, as this is a material-based device.

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

• Not Applicable: This criterion is for AI/software devices requiring human expert review to establish ground truth. For dental cements, ground truth is established by standardized laboratory testing procedures and the results are objective measurements (e.g., setting time, strength, toxicity).

4. Adjudication Method for the Test Set

• Not Applicable: This is an AI/software specific criterion for resolving discrepancies among human annotators.

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

• Not Applicable: This is an AI/software specific criterion. No human readers or AI assistance are involved in the function or testing of these dental cements.

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

• Not Applicable: This is an AI/software specific criterion. There is no algorithm.

7. The Type of Ground Truth Used

• Objective Laboratory Measurements/Standards:
  • Physical Properties: The ground truth for physical properties (e.g., film thickness, setting time, compressive strength) is based on the methods and limits defined in the international standard ISO 9917-1:2007 for water-based cements. The device demonstrates compliance with these established empirical standards and similarity to the predicate devices.
  • Biocompatibility: The ground truth for biocompatibility is based on the negative/positive control findings and criteria for safe biological response defined by ISO 10993-1 and specific test methodologies (e.g., OECD guidelines for genotoxicity).

8. The Sample Size for the Training Set

• Not Applicable: This is an AI/machine learning specific criterion. Dental cements do not have a "training set."

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

• Not Applicable: As above, no training set exists for this device.

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• 1. Direct restorations using light-cured composite resin
• 2. Cavity sealing as a pretreatment for indirect restorations
• 3. Treatment of exposed root surfaces
• 4. Treatment of hypersensitive teeth
• 5. Intraoral repairs of fractured restorations
• 6. Post cementation and core build-ups
• 7. Cementation of inlays, onlays, crowns, bridges and veneers

R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive. It can be used reliably in total-etch or selective-etch mode for both direct and indirect restorations. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching procedures. The product is intended to be used for both direct and indirect restorations. The 4-MET RDX multi-functional carboxylate methacrylate polymer creates a 3-dimensional, high-strength bond with calcium. MDP (Methacryloyloxydecyl Dihydrogen Phosphate) monomer binds to Ca+2 ions on all surfaces of the tooth. The R&D Series Nova Compo- B Plus forms a micro-mechanical bond between the dentine channels to form the resin tags. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures.

The provided text describes a 510(k) premarket notification for a dental bonding agent, R&D Series Nova Compo-B Plus. It assesses the device's substantial equivalence to predicate and reference devices based on indications for use, composition, and physical properties. However, this document does not contain information about an AI/ML-based medical device study that would involve the typical acceptance criteria and study design elements requested in the prompt (e.g., test set sample size, expert ground truth, MRMC studies, standalone performance).

The information provided is for a traditional medical device (a dental adhesive), comparing its physical properties like bond strength, appearance, and curing time to existing, legally marketed dental adhesives. It's a standard regulatory submission for a Class II medical device, focusing on bench testing and biocompatibility.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving an AI/ML device meets those criteria, as the provided text relates to a non-AI/ML dental bonding agent.

Specifically, the document states:

• Trade/Device Name: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
• Regulation Name: Resin Tooth Bonding Agent
• Device Description: "R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive."

This clearly indicates a chemical and physical product, not an AI/ML software device.

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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):

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