(72 days)
Restoration of Class I, II, III, IV, V cavities Restoration of root surface caries Restorations in deciduous teeth Filling tunnel shaped cavities Sealing hypersensitive areas Liner/base/filling in cavity undercuts Sealant Splinting mobile teeth Additions to composite restorations
MI Fil (GCUC-505) is a light-cured nano-filled radiopaque composite resin filled in a syringe topped with a needle tip. The device is a flowable composite resin of normal consistency. The material is available in 17 shades.
The provided text (K091388) is a 510(k) summary for a dental device called "MI Fil (GCUC-505)". This document is a regulatory submission for a Class II medical device, specifically a tooth shade resin material. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this type of regulatory document.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Not Provided: This document does not present specific quantitative acceptance criteria or detailed performance results from a study designed to meet such criteria. 510(k) submissions primarily focus on demonstrating substantial equivalence through comparison of technological characteristics and indications for use with predicate devices, often relying on non-clinical (e.g., bench) tests rather than clinical performance studies with acceptance criteria in the sense typically used for AI/diagnostic devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: The document does not describe a "test set" in the context of a clinical performance study. There's no information about sample size, data provenance, or study design.
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)
- Not Applicable/Not Provided: No experts were mentioned or used for establishing ground truth for a test set, as this is not a clinical performance study involving diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: There is no "test set" or adjudication method mentioned.
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/Not Provided: This device is a dental composite resin, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable/Not Provided: This device is a physical material, not an algorithm. Therefore, a standalone algorithm performance study was not conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided: No ground truth in this context was established, as this is not a diagnostic device.
8. The sample size for the training set
- Not Applicable/Not Provided: There is no "training set" for this device.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: There is no "training set" or ground truth for it.
Summary of Device and Substantial Equivalence (from the text):
- Device Name: MI Fil (GCUC-505)
- Description: A light-cured nano-filled radiopaque composite resin, flowable, available in 17 shades.
- Indications for Use: Restoration of Class I, II, III, IV, V cavities; restoration of root surface caries; restorations in deciduous teeth; filling tunnel shaped cavities; sealing hypersensitive areas; liner/base/filling in cavity undercuts; sealant; fixing loose teeth; additions to composite restorations.
- Predicate Devices:
- Substantial Equivalence Claim: The applicant device is substantially equivalent to the predicate devices in its intended use, as they are all composite resins used for restorations of teeth, filling material, and sealant.
Conclusion based on the provided document:
The provided 510(k) summary for MI Fil (GCUC-505) is a regulatory filing demonstrating substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the manner requested for a diagnostic or AI-driven device. The evaluation of this device would typically involve non-clinical testing (e.g., mechanical properties, biocompatibility) to show it performs similarly to predicate devices, but such details are not explicitly provided in this summary.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.