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• Direct anterior and posterior restorations
• Restoration of fractured (broken) teeth due to trauma
• Restoration of deciduous teeth
• Direct restorative for diastema closure

EsCom250 is the polymer-based dental restorative material. It can be light-cured intra orally for anterior and posterior restoration including occlusal surface. Filler size ranges from 16nm to 1.2 um. Various shades of A1, A2, A3, A3.5, A4, B1, B2, C2, D2, G1, AO2, AO3 and TW for esthetic restoration are provided. All shades of EsCom250 are radioopaque.

The provided text is a 510(k) summary for a dental device called EsCom250. This type of document is a submission to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The information you are requesting pertains to the performance evaluation of a device, particularly an AI/ML-based medical device. The provided document, however, describes a dental restorative material (a tooth shade resin material), not an AI/ML-based device.

Therefore, the concepts of acceptance criteria for AI performance (like accuracy, sensitivity, specificity), sample size for test/training sets, data provenance, expert ground truth adjudication for AI, MRMC studies, standalone AI performance, etc., are not applicable to this document.

This document focuses on the physical, chemical, and biological properties of the dental resin material as compared to a predicate device, using established standards for dental materials (e.g., ISO 4049, ISO 10993 for biocompatibility).

Key points from the document regarding "acceptance criteria" and "proof" for this specific device:

• Acceptance Criteria/Performance Evaluation: The primary method for proving the device meets acceptance criteria is through bench testing and biocompatibility testing.

  • Bench Testing: The device was tested according to ISO 4049:2019, Dentistry Polymer-based restorative materials. This standard specifies requirements and test methods for polymer-based dental restorative materials.
  • Biocompatibility Testing: The device was tested according to various parts of ISO 10993 (Biological evaluation of medical devices) and ISO 7405 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry). These standards assess the biological safety of medical devices.

• Reported Device Performance (Table): The table on page 6 of the document provides a direct comparison of several mechanical properties between the subject device (EsCom250) and the predicate device (Filtek Z250 Universal Restorative). These are the "reported device performance" metrics for this type of product.

  Metric	Acceptance Criteria (Predicate)	EsCom250 Performance
  Mechanical Properties
  Depth of cure (mm) - A3	2.80	2.27
  Depth of cure (mm) - AO3	(Not specified for predicate)	1.53
  Flexural strength (Mpa)	157.96	127.62
  Water sorption (µg/mm³)	16.00	11.52
  Solubility (µg/mm³)	0.0	0.0
  Radio-opacity (mmAl) - A3	2.9	3.6
  Radio-opacity (mmAl) - AO3	(Not specified for predicate)	3.1
  Knoop hardness (kgf/mm²)	77.9	55.4
  Compressive strength (MPa)	346	334
  Elastic modulus (GPa)	4.04	3.03
  Other Properties
  Standard Conformed	ISO 4049	≥ISO 4049
  Biocompatibility	Yes	Yes
  Sensitivity to light	Remained physically homogeneous	Remained physically homogeneous

  Note on "Acceptance Criteria" for this device type: For equivalence, the EsCom250 values generally need to be comparable to or better than the predicate, or at least meet the minimum requirements of the conformed standard (ISO 4049). The document explicitly states that "the performance results of the subject device and predicate device are not the same, but both products meet the requirements of ISO 4049." This implies that meeting the ISO 4049 standard itself is a key acceptance criterion for these properties, rather than strict numerical matching of the predicate.

Given the nature of the device (dental resin) and the provided document, the other requested points are not applicable:

• Sample size for test set and data provenance: Not applicable. These tests are laboratory/bench tests on material samples, not data sets from patients.
• Number of experts used to establish ground truth: Not applicable. Ground truth for these physical/chemical properties is established by standardized laboratory measurements, not human expert consensus.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. This is for AI/human reader performance.
• Standalone (algorithm only) performance: Not applicable. There is no algorithm.
• Type of ground truth used: For physical properties, it's objective measurements based on ISO standards. For biocompatibility, it's biological response testing per ISO standards.
• Sample size for training set: Not applicable. This material is not an AI/ML model.
• How ground truth for training set was established: Not applicable. There is no training set.

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