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510(k) Data Aggregation
(142 days)
Nexcomp
Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class I, III, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs.
Nexcomp is a light-cured, esthetic, resin-based dental restorative designed for direct placement in both anterior and posterior restorations. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra-fine filler and 40 nm silica particles. Nexcomp will be marketed in 19 shades which corresponded with the Vita Shade Guide.
The provided text describes the 510(k) premarket notification for a dental restorative material called Nexcomp. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI/device meets specific acceptance criteria for diagnostic performance.
Therefore, I cannot extract the detailed information requested regarding AI/device performance, reader studies, ground truth establishment, or sample sizes for training/test sets as these concepts are not applicable to the provided document. The document concerns a physical dental material, not an AI or diagnostic device.
However, I can extract the acceptance criteria and performance data for the physical properties of the Nexcomp dental material and present it in a table, as well as information about the testing performed.
Acceptance Criteria and Device Performance (for Physical Properties of Dental Material)
The document primarily focuses on demonstrating that the new Nexcomp device has similar physical properties to its predicate device, and that these properties meet relevant ISO standards for dental materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (ISO Standards/Predicate Similarity) | Reported Device Performance (Subject Device) | Reported Predicate Device Performance |
|---|---|---|---|
| Material Properties | |||
| Compressive strength | Should be more than 5MPa. | Average 232.76 MPa | Average 288.68 MPa |
| Flexural strength | > 80 MPa | Average 87 MPa | 91.82 MPa |
| Depth of cure | > 1.0 mm | 2.88 mm | 4.96 mm |
| Surface hardness (Vickers hardness) | Based on ISO 6507-1:2005 (no specific numerical criterion stated in table, but performance is compared) | Average 56 KHN | Average 39.36 KHN |
| Radio-opacity | > 1mm | More than 1mm | More than 1mm |
| Water sorption |
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(62 days)
NEXCOMP AND META ETCHANT
Meta Etchant is intended for use in dentin/enamel etching to prepare the tooth surface for application of a bonding agent.
Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class I, II, IV, and V restorations, core-buildup to replace missing tooth structure, for splinting and for diastema closure, direct veneers, composite and porcelain repairs.
Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide. Nexcomp bonds micromechanically and chemically to prepared tooth surfaces, dental primers and bonding resin adhesives through copolymerization of its air-inhibited layer. It's color can be matched with various shades of standard color quides. It is available in tubes which are designed to be fitted into a screw-syringe with a body cap seal.
Meta Etchant is a thickened, colored, phosphoric acid semi-gel designed to prepare tooth surfaces (dentin and enamel) for application of a bonding agent, cementation, or restorative materials.
The provided text describes two devices, Nexcomp and Meta Etchant, and their 510(k) summaries. However, it does not contain any information regarding specific acceptance criteria, study designs, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC studies for either device.
The primary method used for clearance for both devices is "Substantial Equivalence" to legally marketed predicate devices, as outlined in the "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3.
For Nexcomp:
- Acceptance Criteria: Nexcomp complies with ISO 4049:2000(E), Polymer-based filling, restorative, and luting materials. It also followed "Guidance for Industry and FDA Staff; Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions". The document does not provide specific numerical acceptance criteria for performance metrics.
- Reported Device Performance: The document states that Nexcomp "complies with" ISO 4049:2000(E) and the FDA guidance. However, no specific performance data or results are reported within the provided text beyond this general statement of compliance.
For Meta Etchant:
- Acceptance Criteria: "There appear to be no applicable standards for etching gels, however, we followed "Guidance for Industry and FDA Staff; Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions". Similar to Nexcomp, no specific numerical acceptance criteria for performance are mentioned.
- Reported Device Performance: The document indicates that the device followed the FDA guidance, but no specific performance data or results are reported.
Therefore, it is impossible to complete the requested table and answer questions 2-9 based on the provided text, as this information is not present. The documents are 510(k) summaries, which focus on demonstrating substantial equivalence to existing devices rather than detailing the results of performance studies against specific acceptance criteria.
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