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VPS Impression Material(Light Body) is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique;
-One-step putty-wash impression technique;

• Two-step impression technique using dual viscosities ;
• Reline impressions ;
  -Fabricating full or partial dentures;

K203824:VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as atwo-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.

The provided text is a 510(k) summary for a dental impression material (VPS Impression Material) and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document.

The document describes the submission of a conventional medical device (dental impression material) and references standard performance testing (physical properties according to ISO 4823:2015) and biocompatibility testing (ISO 10993-5 and ISO 10993-10) to support its substantial equivalence to a predicate device. These tests are not related to AI/ML device performance metrics like sensitivity, specificity, or AUC, nor do they involve ground truth established by experts or multi-reader studies.

Therefore, I am unable to fulfill the request as it pertains to AI/ML device characteristics.

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