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510(k) Data Aggregation
(50 days)
Extended fissure sealing First-layer lining for class I and class II cavities Class I, II, III and V direct restorations Repair of direct and indirect restorations in combination with a suitable adhesive Splinting loosened teeth resulting from trauma or periodontal associated events
Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite. The uncured dental composite is introduced into the oral cavity to be applied and cured to the tooth structure or restoration pre-treated by the dentist, thus achieving the clinical benefit.
The provided text describes the regulatory submission for the Venus Bulk Flow ONE, a dental restorative material. It focuses on demonstrating substantial equivalence to a predicate device (Venus Diamond Flow, K091635) primarily through non-clinical bench testing. There is no information regarding AI/ML device acceptance criteria or performance.
Here's the breakdown of the information requested, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Parameter | Required Specification (Acceptance Criteria per ISO 4049:2019) | Reported Device Performance (Venus Bulk Flow ONE) |
|---|---|---|
| Sensitivity to dental OP light | > 60 s | Exceeded specification (results equal or better than predicate) |
| Depth of cure | > 1.5 mm | Achieved 4 mm (predicate device was 2 mm) |
| Flexural strength | > 80 MPa | Exceeded specification (results equal or better than predicate) |
| Water sorption | < 40 µg/mm³ | Exceeded specification (results equal or better than predicate) |
| Water solubility | < 7.5 µg/mm³ | Exceeded specification (results equal or better than predicate) |
| Color stability | No more than slight change in color | Exceeded specification (results equal or better than predicate) |
| Radio-opacity | > 100%-Al and SD < 50%, if claimed | Exceeded specification (results equal or better than predicate) |
2. Sample sized used for the test set and the data provenance:
The document describes non-clinical bench testing according to ISO 4049:2019. It does not specify sample sizes for these tests. The data provenance is from internal studies conducted by Kulzer, LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for this device is based on objective, quantifiable physical and chemical properties measured through laboratory bench testing according to international standards (ISO 4049:2019), not expert consensus.
4. Adjudication method for the test set:
Not applicable. The "test set" here refers to material samples undergoing laboratory characterization against predefined ISO standards.
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 a dental restorative material, not an AI/ML diagnostic or assistive device. There were no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental restorative material, not an AI/ML algorithm.
7. The type of ground truth used:
The ground truth used for demonstrating device performance is based on the specified requirements of international standard ISO 4049:2019 for polymer-based restorative materials. These are objective, measurable physical and chemical properties.
8. The sample size for the training set:
Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set. The "development" of the product involved modification of materials and composition, not training of an algorithm.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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