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TECNO MED MINERAL, TECNO MED MINERAL DENTINE and TECNO MED MINERAL TISSUE are used to create reduced crowns and bridges (max. 2 pontics and min. 13 mm² connection cross-section), telescopic primary crowns, copings as well as frameworks for composite veneered bridges. The width of the bridge must not exceed two pontics for reasons of stability.

TECNO MED is designed for the manufacturing of frictional elements on telescopic restorations or attachments.

Tecno Med and the three Tecno Med Mineral devices are tooth-shade polymer discs based on polyether ether ketone (PEEK). These discs are available in a variety of shapes for different milling systems. For each device, there are two diameter variants, 95 mm and 98 mm. The discs with a diameter of 98 mm are additionally available with or without step. Moreover, each model is provided in different heights (8mm-30 mm). The users can choose according to their requirements and preferences among the different models. Tecno Med Mineral, Tecno Med Mineral Dentine as well as Tecno Med Mineral Tissue have the same indications for use, for the Tecno Med device there are other indications for use.

These polymer discs are used by specifically trained personnel using CAD/CAM techniques.

The provided text is a 510(k) summary for dental resin materials (Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue). It does not describe an AI/ML medical device. Therefore, I cannot extract information related to acceptance criteria, study methods, ground truth establishment, or sample sizes as they pertain to AI/ML device performance.

The document focuses on demonstrating substantial equivalence to a predicate device (breCAM.BioHPP) through non-clinical performance testing of physical properties such as water absorption, water solubility, density, modulus of elasticity, flexural strength, and biocompatibility, as well as similarities in chemical composition, indications for use, and intended user.

A table of acceptance criteria and reported device performance (for an AI/ML device) cannot be created from this document.

The document details the following for the dental resin materials:

• Non-clinical performance tests conducted: In-vitro cytotoxicity, Skin sensitization, Irritation, Mutagenicity (all for Biocompatibility), and tests according to ISO 10477:2004 and DIN EN ISO 20795-2:2013 for physical properties.
• Reported device performance (physical properties):
  • Melting Temperature: Approx. 340 °C (for Tecno Med Mineral, Tecno Med, and predicate)
  • Water absorption (µg/mm³):
    • Tecno Med Mineral: 7.3
    • Tecno Med Mineral Dentine: 6.5
    • Tecno Med Mineral Tissue: 7.2
    • Tecno Med: 4.73
    • Predicate (breCAM.BioHPP): 6.5
  • Water solubility (µg/mm³):
    • Tecno Med Mineral: 1.2
    • Tecno Med Mineral Dentine: 0.6
    • Tecno Med Mineral Tissue: 1.2
    • Tecno Med: 1.67
    • Predicate (breCAM.BioHPP): 0.1
  • Density (g/cm³):
    • Tecno Med Mineral: 1.49
    • Tecno Med Mineral Dentine: 1.52
    • Tecno Med Mineral Tissue: 1.36
    • Tecno Med: 1.31
    • Predicate (breCAM.BioHPP): 1.44
  • Modulus of elasticity (MPa):
    • Tecno Med Mineral: 4100
    • Tecno Med Mineral Dentine: 4400
    • Tecno Med Mineral Tissue: 5100
    • Tecno Med: ≥ 4300
    • Predicate (breCAM.BioHPP): 4585
  • Flexural strength (MPa):
    • Tecno Med Mineral: 201
    • Tecno Med Mineral Dentine: 198
    • Tecno Med Mineral Tissue: 189
    • Tecno Med: 174
    • Predicate (breCAM.BioHPP): 178
  • Biocompatibility: Established for all new devices and predicate.

None of the other requested information (sample size for test set/training set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for AI, how ground truth for training set was established) is relevant or present in this document as it pertains to AI/ML device evaluation.

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