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K Number
K980965
Device Name
SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL
Manufacturer
CAVEX HOLLAND B.V.
Date Cleared
1998-05-01

(46 days)

Product Code
ELW,DAT
Regulation Number
872.3660
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SPECTRA FORM™ Chromatic Alginate Impression Material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.

Device Description

SPECTRA FORM™ Chromatic Alginate Impression Material is a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to off-white indicating the end of the setting time in the mouth.

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding an alginate impression material. It does not contain information about acceptance criteria or a study proving device performance in the context of AI or software. The letter is a regulatory document confirming substantial equivalence to a predicate device for a physical dental impression material.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance using the provided text. The document does not discuss:

  1. Acceptance criteria and reported device performance
  2. Sample size and data provenance for a test set
  3. Number and qualifications of experts for ground truth
  4. Adjudication method
  5. MRMC comparative effectiveness study or human reader improvement with AI
  6. Standalone (algorithm-only) performance
  7. Type of ground truth used (e.g., pathology, outcomes data)
  8. Sample size for the training set
  9. How ground truth for the training set was established

The provided text is a regulatory clearance for a dental material and does not involve AI/software performance studies.

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).