VENUS DIAMOND FLOW

• K Number: K091635
• Device Name: VENUS DIAMOND FLOW
• Manufacturer: HERAEUS KULZER, LLC
• Date Cleared: 2009-09-03 ( 91 days)
• Product Code: EBC , AND , EBF
• Regulation Number: 872.3765
• Type: Abbreviated
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

· Enlarged fissure sealing
· Cavity lining as the first layer for Class I and II cavities
· Class V fillings
· Minimally invasive Class I and II fillings in areas not subjected to masticatory forces
· Minimally invasive Class III fillings
· Small repairs of direct and indirect restorations combined with a suitable bonding agent
· Interlocking of loosened teeth

Device Description

Venus Diamond flow is a flowable, light-cured radiopaque nano-hybrid composite used for adhesive, tooth-coloured anterior and posteriors restorations.

AI/ML Overview

This document is a 510(k) premarket notification for the Venus Diamond Flow dental composite. It describes the device's intended use, biocompatibility, and physical properties. However, it does not contain any information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.

The document states that:

• "The physical data for the new Venus Diamond flow are in accordance with the functional specification for VENUS Diamond flow/NEFL and the requirements of DIN EN 4049."
• "The biocompatibility of the Venus Diamond flow was verified in accordance with the international standard. The biocompatibility of Venus Diamond flow was documented in a Biological Evaluation Report..."
• "Considering the evaluated data and technical results for Venus Diamond flow it is concluded that the product exhibits the claimed technical performance..."

Without a specific study that quantitatively measures the device's performance against defined acceptance criteria (e.g., a clinical trial comparing Venus Diamond Flow's restoration success rate to a benchmark), I cannot complete the requested tables and sections.

The provided text only details compliance with standards and general clinical effectiveness, not a specific study with quantitative performance metrics against acceptance criteria.

Therefore, I cannot provide the following information:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics (like accuracy, sensitivity, specificity) or corresponding acceptance criteria are provided in the document. The document refers to compliance with DIN EN 4049 and internal functional specifications for physical properties, but does not present these in a table format with specific, measurable values that could be considered "acceptance criteria."
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment method for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set is described.
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 material, not an AI diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no specific performance study with a test set and ground truth is described.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state concerning "acceptance criteria" and "performance":

The document primarily focuses on:

• Compliance with Standards:
  • Biocompatibility: Verified in accordance with EN ISO 10993-4. Documented in a "Biological Evaluation Report."
  • Physical Properties: In accordance with "functional specification for VENUS Diamond flow/NEFL" and "DIN EN 4049:2000."
  • Regulatory Compliance: Meets "relevant requirements for Polymer based filling restorative and luting materials in accordance with the Medical Device Directive 93/42/EEC and national European medical device legislation."
• Clinical Evaluation:
  • States that Venus Diamond flow "represents a well-known type of restoration material which has proven to exhibit the expected performance and clinical effectiveness."
  • "There is no hint for undesirable effects and potential risks when Venus Diamond flow is applied according to the instruction for use."
  • A "Clinical evaluation Report according to MEDDEV 2.7.1." was conducted, concluding a "positive risk versus benefits ratio."
• Risk Analysis: Performed according to EN ISO 14971, showing "an acceptable risk."

These statements imply that the device met certain regulatory and standard-based acceptance criteria, but they do not provide specific quantitative performance metrics from a dedicated study that would allow for the detailed breakdown requested in your prompt.

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.