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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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GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth. GRADIA CORE is intended to be used for restoration, core build-up and post cementation.

GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite resin filled in double syringe to provide auto-mixing system. GRADIA CORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter regarding a 510(k) premarket notification for a dental device called "GRADIA CORE," confirming its substantial equivalence to legally marketed predicate devices. It discusses regulatory compliance and general information but does not include any performance study data or acceptance criteria.

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GRADIA FORTE is intended to be used for the indirect restoration of crown & bridge, inlays, veneers and implant superstructures.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment for the GRADIA FORTE device. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to a legally marketed predicate device for its indicated uses. It does not contain the kind of detailed study breakdown you've requested.

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This product is a light-cured micro-filled composite resin for use in the following recommended indications: Direct restorative for Class I and II cavities.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Gradia Direct X." This document is a regulatory approval, not a scientific study report. It states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the approval is based on a comparison to existing devices, not a new study demonstrating performance against specific acceptance criteria in the manner requested.

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This product is a light-cured fluoride releasing microfilled hybrid composite restorative resin. Recommended Indications: 1. Restoration of Class I, II, III, IV, V cavities (particularly for small Class I cavities/ shallow Class V cavities/ other small cavities). 2. Restoration of root surface caries. 3. Restorations in deciduous teeth. 4. Filling tunnel shaped cavities. 5. Sealing hypersensitive areas. 6. Liner/base/filling in cavity undercuts. 7. Sealant. 8. Fixation of mobile teeth. 9. Additions to composite restorations.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental restorative material, not a study report detailing acceptance criteria and performance data for a device involving AI or complex statistical analysis.

Therefore, the requested information elements (1 through 9) related to a study proving device meeting acceptance criteria, especially those pertinent to AI/software performance, are not present in this document.

Specifically, there is no information regarding:

1. A table of acceptance criteria and the reported device performance: This letter indicates substantial equivalence to a predicate device, not a performance study against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a dental material, not an AI-assisted diagnostic device.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document serves as an FDA clearance for a dental material (Gradia® Direct LoFlo) based on its substantial equivalence to previously marketed predicate devices, not on a new clinical performance study with detailed acceptance criteria and statistical analysis as would be relevant for devices with diagnostic or AI components.

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GRADIA GUM is a light-cured composite resin specifically used for the reproduction of the gum on crown and bridge prostheses.

GRADIA GUM is a light-cured composite resin.

This document is a 510(k) clearance letter from the FDA for a dental device called GRADIA GUM. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document.

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GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below:

GRADIA DIRECT ANTERIOR:

1. Direct restorative for Class III, IV and V cavities.
2. Direct restorative for wedge-shaped defects and root surface cavities.
3. Direct restorative for veneers and diastema closure.

GRADIA DIRECT POSTERIOR:

1. Direct restorations for Class I and II cavities.

visible light-cured micro-filled hybrid resin

The provided text is a 510(k) summary from the FDA for a dental restorative material named "Gradia Direct." This document is a clearance letter, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, the document does not contain any information regarding:

• Acceptance criteria and reported device performance (in a quantifiable, study-driven manner)
• Sample sizes used for test sets or their data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used (expert consensus, pathology, outcomes data) for performance evaluation
• Sample size for training sets
• How ground truth for training sets was established

This document is solely an FDA clearance letter indicating that the device can be legally marketed based on its substantial equivalence to pre-existing devices, rather than comprehensive performance data from a specific study.

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Ask a specific question about this device