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1.Bonding for all Classes of direct composite restoration 2.Bonding for indirect procedures involving metal, porcelain, and composite

DX. Bond V Dental Bonding Adhesive is a multi-purpose dental bonding adhesive for all classes of direct composite restoration as well as for indirect procedures involving metal, porcelain and composite. DX. Bond V is also used for amalgam, self- cure composite and orthodontic brackets bonding. DX. Bond V consists of methylmethacrylates and solvent. After applied to bonding area with thin layer, methylmethacrylates are initiated by free radical with blue light and then polymerized to form cross-linking polymer network resulting in solid and strong bonding membrane. The adhesive is dropped onto a mixing pad before application.

While the provided text describes the 510(k) submission for the DX. Bond V Dental Bonding Adhesive, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria for an AI/ML-enabled medical device.

The document details the substantial equivalence determination for a dental bonding adhesive, which is a material, not a software-driven or AI-enabled device. Therefore, the questions related to AI/ML device performance, such as:

• Table of acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, etc.)
• Sample size for test set and data provenance for an AI model
• Number of experts and their qualifications for AI ground truth
• Adjudication method for an AI test set
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI
• Standalone (algorithm-only) performance
• Type of ground truth (e.g., pathology, outcomes data for AI)
• Training set sample size and ground truth establishment for AI

cannot be answered from the provided text.

The document does mention performance data, but these refer to bench testing for a physical material, not an AI algorithm:

• Biocompatibility testing: Cytotoxicity, Sensitivity, Irritation, Acute Systemic toxicity, Genotoxicity (ISO standards)
• Non-clinical performance data (bench testing):
  • Film thickness: ISO 4049:2010
  • Shear bonding: ISO/TS 11405:2015; ISO29022:2013
  • Light sensitivity: ISO 4049:2010
  • Microleakage: ISO/TS 11405:2015

The text explicitly states:

• "Clinical performance data. This section is not applicable."
• "Software verification and validation testing. This section is not applicable."
• "Electrical safety and electromagnetic compatibility (EMC). This section is not applicable."
• "Mechanical and acoustic testing. This section is not applicable."

This further confirms that the device is not software-based or AI-enabled, and therefore, the requested information for AI/ML device evaluation is not present.

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