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The Novidia™ Bulk Fill Flow Composite is indicated for:

• 1. Base under Class I and II direct restorations
• 2. Liner under direct restorative materials
• 3. Pit and fissure sealant
• 4. Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
• 5. Class III and V restorations
• 6. Blocking out of undercuts
• 7. Repair of small enamel defects
• 8. Repair of small defects in esthetic indirect restorations
• 9. Repair of resin and acrylic temporary materials

10. As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown

Novidia™ Bulk Fill Flow Composite is a low viscosity, visible-light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications. The resin matrix of the Novidia™ Bulk Fill Flow Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Novidia™ Bulk Fill Flow Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (QASi), added to maintain the integrity of the restoration. The Novidia™ Bulk Fill Flow Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in two shades (A2 and A3).

The provided text describes a 510(k) premarket notification for a dental device, "Novidia™ Bulk Fill Flow Composite." The information focuses on demonstrating substantial equivalence to a predicate device ("Filtek™ Bulk Fill Flowable Restorative") primarily through non-clinical performance testing (bench testing and biocompatibility assessments).

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria will reflect this focus on non-clinical, in vitro performance, rather than clinical study data involving human readers or AI algorithms.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Novidia™ Bulk Fill Flow Composite are implicitly aligned with the performance characteristics of its predicate device, Filtek™ Bulk Fill Flowable Restorative, as well as the requirements of the ISO 4049:2009 standard for polymer-based restorative materials.

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

The document does not specify the exact sample sizes (e.g., number of specimens tested for flexural strength) for the non-clinical bench tests. However, it indicates that testing was conducted "per ISO 4049 and FDA guidance document 'Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions'." These standards and guidance documents typically specify minimum sample sizes for material properties testing.

The data provenance is from non-clinical laboratory testing performed to support the 510(k) submission. No specific country of origin for the testing lab is mentioned, but the submitter, Nobio Ltd., is based in Kadima, Israel. This is retrospective in the sense that the testing was completed prior to the submission for regulatory clearance.

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for the device's performance is established by objective, standardized laboratory measurements against established international standards (ISO 4049:2009) and FDA guidance, not by expert consensus or human interpretation of images/data for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable. This device is a material, and its performance is evaluated through physical and chemical property testing, not through human adjudication of diagnostic outcomes.

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 device is a dental restorative material, not an AI-assisted diagnostic or imaging device. No MRMC study was performed or is relevant. The document explicitly states: "Animal and clinical performance data was not included." and "Clinical studies demonstrating that the presence of QASi in this device improves clinical outcomes have not been conducted."

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective, standardized measurements of its physical, chemical, and biological properties as defined by:

• International standards (e.g., ISO 4049:2009 for polymer-based restorative materials, ISO 10993 for biocompatibility).
• FDA guidance documents for dental composite resin devices.
• Comparison to the established performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process.

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