(77 days)
BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.
The applicant device is a Brushable Dental Composite, classified as a Tooth Shade Resin Material. It is a low viscosity microfilled composite with a filler percentage of 36%. It is supplied as preloaded, plastic syringes. The material is extruded onto a suitable pad or well and applied to the instrument.
This document is a 510(k) summary for a dental composite, not a study report for a medical device with acceptance criteria and performance data in the typical sense of AI/ML or diagnostic devices.
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 the provided text.
Here is an analysis based on the provided text, addressing the applicable points:
This document describes a 510(k) submission for a dental material (Brushable Composite) seeking substantial equivalence to a predicate device. It is not a clinical study report for a diagnostic or AI-powered medical device where performance metrics like sensitivity, specificity, or inter-reader agreement are typically established against predefined acceptance criteria.
Applicable Information from the Provided Text:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The primary "acceptance criterion" for a 510(k) dental material is demonstrating substantial equivalence to a legally marketed predicate device. This is primarily assessed through comparison of intended use, composition, physical/mechanical aspects, and how the product is supplied and used. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
- Reported Device Performance (Comparative Information): The provided table compares the applicant device (Cosmedent BRUSHABLE COMPOSITE) to the predicate device (Bisco SCULPTING RESIN). This table serves as the basis for demonstrating substantial equivalence rather than reporting explicit performance metrics against numerical acceptance criteria.
| Feature / Aspect | Acceptance Criterion (Implicit for Substantial Equivalence) | Cosmedent BRUSHABLE COMPOSITE (Applicant Device) | Bisco SCULPTING RESIN (Predicate Device) |
|---|---|---|---|
| Intended Use | Intended Use is substantially similar | Used to manipulate and sculpt esthetic dental restorative materials | Used to manipulate and sculpt esthetic dental restorative materials |
| Composition | Substantially same chemical composition | Light-cure, silica filled, difunctional acrylic composites | Light-cure, silica filled, difunctional acrylic composites |
| Physical/Mechanical Aspects | Similar physical and mechanical properties | Low viscosity microfilled composites | Low viscosity microfilled composites |
| How Supplied & Used | Similar packaging and application method | Supplied as preloaded, plastic syringes; extruded onto pad/well | Supplied as preloaded, plastic syringes; extruded onto pad/well |
| Filler Percentage | (Difference noted, but still considered substantially equivalent) | 36% | 30% |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This document describes a comparison to a predicate device based on material characteristics, not a clinical study with a "test set" of patient data.
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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. There is no "ground truth" derived from expert review of a test set in this 510(k) submission. The ground for equivalence relies on material science comparisons.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication process is described.
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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 a dental material, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a dental material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the traditional sense. For this 510(k), the "truth" is established by comparing the physical, chemical, and functional properties of the new device to those of the predicate device, typically using standardized material testing methods relevant to dental composites (which are not detailed in this summary). The FDA's determination of "substantial equivalence" is the regulatory ground truth.
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The sample size for the training set:
- Not Applicable. No "training set" is involved as this is not an AI/ML device.
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How the ground truth for the training set was established:
- Not Applicable. No "training set" or corresponding ground truth establishment is applicable here.
§ 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.