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DenFil™ is indicated for the following restorative applications;

1. Class: I, II, V restorations of posterior teeth
2. Class III, IV, V restorations of anterior teeth
3. Cervical cavities or defects involving root surfaces

DenFillM is light-cured restorative hybrid composite resin and accessories for use in both Posterior and Anterior restoration

This document is a 510(k) premarket notification for a dental composite material, DenFil™. It establishes substantial equivalence to existing predicate devices. However, it does not contain a study that proves the device meets specific acceptance criteria in the way modern AI/ML device submissions do.

Instead, the submission relies on the concept of substantial equivalence to predicate devices (Clearfil AP-X, Kuraray Medical Inc., K012740; Clearfil AP-X PLT, Kuraray Medical Inc., K023002; Multiple, Dentsply Intl., K863092). This means that the device is deemed safe and effective because it has the "same device characteristics as the predicate device" and its "material, design and use concept is similar."

Therefore, I cannot fill out the requested table and answer the study-specific questions as they do not apply to this type of submission.

Here's a breakdown of why and what information is available:

• Acceptance Criteria & Device Performance: Not applicable in the context of an AI/ML device and specific performance metrics. The implicit "acceptance criteria" is that it performs similarly enough to the predicate devices.
• Study That Proves the Device Meets Acceptance Criteria: No clinical study or performance study with defined acceptance criteria and statistical analysis is provided or required for this type of 510(k) submission. The document states:
  • "DenFil™ has been subjected to extensive safety, performance, and product validations prior to release."
  • "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations."
  • "An extensive review of literature pertaining to the safety and biocompatibility of DenFil™ has been conducted."
    These are general statements about pre-market activities, not a specific study detailing results against acceptance criteria.
• Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set: These concepts are relevant for AI/ML device submissions, which involve algorithms learning from data and then being tested. This 510(k) is for a physical medical device (dental composite) and therefore these questions do not apply.

In summary, this 510(k) submission for DenFil™ is based on establishing substantial equivalence to legally marketed predicate devices, not on a clinical or performance study that explicitly defines and measures quantifiable acceptance criteria for an AI/ML component.

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