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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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