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1. Liner or base
2. Blocking out undercuts
3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel
4. Sealing hypersensitive areas
5. Fissure sealant
6. Direct restorative for Class I, II, III, IV, V cavities
7. Core build-up

NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades.

The provided text describes a 510(k) premarket notification for a dental device named NMF004A. This document asserts the device's substantial equivalence to previously cleared predicate devices by outlining its characteristics, indications for use, and performance bench tests against a recognized standard (ISO 4049:2009).

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document states that "The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials)." While specific measured values for NMF004A are not explicitly provided in the table, the text implies that NMF004A's performance meets these requirements. The table below presents the acceptance criteria from ISO 4049:2009 as listed in the document.

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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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everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.

everX Posterior is a light-cured, fiber-reinforced, universal type composite resin packaged in a unitip and available in one universal shade.

Here's an analysis of the provided text regarding the acceptance criteria and study for the everX Posterior dental device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that bench testing was performed in accordance with ISO 4049:2009 Dentistry - Polymer based restorative materials, and that the "testing results indicate that the device conforms to the required specifications."

Based on the information provided, the key performance criteria for everX Posterior are:

For biocompatibility, the criteria are defined by ISO 10993-1, with specific tests:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the bench tests.
The data provenance is not explicitly stated in terms of country of origin, but it is from non-clinical laboratory bench testing. The study is retrospective in the sense that the results are being presented as completed tests rather than a prospective study setup.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies described are non-clinical bench tests (physical and chemical properties, biocompatibility) of a material, not diagnostic or clinical interpretation studies requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Bench tests follow standardized procedures, and the results are typically measured objectively by instruments or established laboratory methods, not through expert adjudication.

5. 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

An MRMC comparative effectiveness study was not done. This device is a dental restorative material, not an AI-powered diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical dental material, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the physical and chemical properties (e.g., flexural strength, depth of cure, water sorption, solubility, color stability), the "ground truth" is established by the defined specifications and test methods outlined in ISO 4049:2009. The device's performance is measured against these objective standards.
For biocompatibility, the "ground truth" is established by the scientific consensus and methodologies defined in ISO 10993-1, ISO 10993-5, and ISO 10993-10 for evaluating biological responses to medical devices.

8. The Sample Size for the Training Set

This information is not applicable. The testing described is for a physical material's properties and biocompatibility, not for training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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