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1. Crown and Bridgework (with metal backing)
2. Metal free restorations: Jacket Crowns, Inlays, Onlays and Laminated Veneers
3. Implant superstructures
4. Reproduction of gum tissue for crown restorations

GRADIA PLUS is a dental composite consisting of cross-linked polymeric material reinforced by a dispersion of filler particles bonded to the resin matrix. The product contains a photo initiator to allow for curing/conversion. The end result is a conversion from a paste to a hard solid material. GRADIA PLUS is composed of 4 types of pastes, such as Opaque paste, Gum shade paste and Lustre paint. Opaque paste is used for masking the metal color. Body paste has two different consistencies. Paste HB and Paste LB. Both pastes can be used for creating several types of anterior or posterior restorations. There are several shades for dentin shade, Enamel shade and effect shade. The dentin layers have an enhanced brightness and masking ability that adjusts the opalescence of the composites. This gives a bright color tone in the oral cavity and eliminates unnatural translucency at the incisal edge. In addition, it has several red colors as a Gum shade paste with different transparency and color tone for reproducing of gingival tissue over crown. Lustre Paint is used for staining, characterizing and coating. The device is used for crown and bridgework with metal backing, jacket crowns, inlays, veneers, implant super structures and reproduction of gum tissue for crown restorations. In particular, Gradia Plus is intended to fabricate the tertiary element/exostructure of the implant superstructure, such as crown and bridges. GRADIA PLUS is filled in a syringe and is available in 73 shades.

Here's an analysis of the provided text regarding the acceptance criteria and study information for "GRADIA PLUS":

The document is a 510(k) premarket notification clearance letter from the FDA to GC America Inc. for their dental composite device, GRADIA PLUS. It primarily focuses on establishing substantial equivalence to predicate devices, rather than an independent clinical study demonstrating device performance against specific disease-related acceptance criteria.

Key Observation: This document describes a material science device (dental composite) and its bench testing to ensure it meets material property standards (ISO). It is not a diagnostic AI device, and therefore the typical questions about ground truth, expert readers, MRMC studies, or standalone algorithm performance are not applicable in this context. The "acceptance criteria" here refer to conformance with established material standards and the "study" is a series of bench tests.

Acceptance Criteria and Device Performance

Note: The document states, "It is confirmed that the device conforms to the required specifications of ISO 10477:2004 and company standard are suitable for its intended use." It also mentions "shows equivalence in flexural strength, water sorption and solubility" when comparing to predicate devices. Specific quantitative values for the reported device performance are not provided in this document, only a statement of conformance.

Study Details (as inferable from the document)

• 1. Sample size used for the test set and the data provenance:

  • Sample Size: Not explicitly stated. The testing would involve preparing multiple samples of the GRADIA PLUS material for each physical property test (e.g., multiple specimens for flexural strength, multiple for water sorption). The number of replicates for each test would typically follow ISO standard guidelines.
  • Data Provenance: The tests are "bench tests" performed by GC America Inc. ("company standard"). The country of origin of the data is implicitly the location where GC America Inc. conducted its R&D and testing (Alsip, Illinois, USA, as per their address). The data is prospective in the sense that it was generated for the purpose of validating the new device, but it is material property testing, not clinical trial data on human subjects.

• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not Applicable. This is not a study requiring human expert interpretation for "ground truth" as it is material science testing. The "ground truth" is derived from physical measurements against established ISO standards.

• 3. Adjudication method for the test set:

  • Not Applicable. No human adjudication process is described or implied for these material property tests.

• 4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • Not Applicable. This is a dental material, not an AI diagnostic device. No human-in-the-loop or MRMC study was conducted or is relevant.

• 5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

  • Not Applicable. This is a dental material, not an AI algorithm. No standalone algorithm performance was assessed.

• 6. The type of ground truth used:

  • The "ground truth" for the acceptance criteria is defined by established international standards (ISO 10477:2004) and internal company specifications for dental resin materials. This involves precise physical and chemical measurements rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus) relevant to diagnostic devices.

• 7. The sample size for the training set:

  • Not Applicable. This device is a dental composite material, not a machine learning model. There is no concept of a "training set" in this context.

• 8. How the ground truth for the training set was established:

  • Not Applicable. As there is no training set, this question is irrelevant.

Summary regarding the device type:

The GRADIA PLUS is a dental composite material used for restorations like crowns, bridges, inlays, onlays, and veneers, as well as gum tissue reproduction. The "study" referenced in the document is a series of performance bench tests designed to confirm that the material properties of the device conform to relevant ISO standards (ISO 10477:2004) and internal company specifications. The FDA's clearance is based on the determination of substantial equivalence to existing predicate devices, meaning it has similar indications for use, fundamental scientific technology, and performance characteristics (as demonstrated by these bench tests). The questions provided are primarily geared towards AI/ML diagnostic devices, which operate under a very different regulatory and validation framework than a material science product like this dental composite.

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