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510(k) Data Aggregation
(385 days)
The C&B NFH Hybrid is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The C&B NFH Hybrid material is used for fabricating temporary or permanent restorations such as crowns and bridges, inlays, onlays, veneers and full crown restoration of C&B NFH Hybrid requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
The C&B NFH Hybrid is a light-cured, methacrylate oligomer based polymerizable resin used by dentist or dental technician for the CAD/CAM manufacturing of indirect restorative for both anterior and posterior restorations, including occlusal surfaces, such as temporary or permanent crowns and bridges, inlays, onlays and veneers. Methacrylate based resin is known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physicalchemical, mechanical and biocompatible properties.
This document is a 510(k) Premarket Notification from the FDA for a dental resin material named "C&B NFH Hybrid." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria in a clinical study involving experts or human readers with AI assistance.
Therefore, many of the requested details about acceptance criteria and a study proving device meets them are not applicable in this context, as this document pertains to a material's physical and chemical properties and biocompatibility for substantial equivalence, rather than an AI-powered diagnostic device or a device requiring a multi-reader, multi-case study.
However, I can extract the acceptance criteria and reported performance for the physical properties of the dental resin, which are relevant to its substantial equivalence.
Acceptance Criteria and Reported Device Performance (Physical Properties of Dental Resin)
| Acceptance Criteria (Standard) | Reported Device Performance (C&B NFH Hybrid) |
|---|---|
| Flexural Strength (≥50 MPa; ISO 10477) | Avg. 114.32 MPa |
| Flexural Strength (≥100 MPa; ISO 4049) | Avg. 114.32 MPa |
| Water sorption (≤40 µg/mm³) | Avg. 31.32 µg/mm³ |
| Solubility (≤7.5 µg/mm³) | Avg. 5.59 µg/mm³ |
Study Information (Based on the document provided):
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Sample size used for the test set and the data provenance: Not explicitly stated with specific numbers of samples for each test (e.g., how many specimens were tested for flexural strength). The data provenance is from non-clinical performance testing conducted by the manufacturer, ARUM DENTISTRY Co., Ltd., likely in a laboratory setting. This is not patient-specific or clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical property testing of a material, "ground truth" is typically established by standardized testing methods and measurements, not by expert interpretation in the medical sense.
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Adjudication method for the test set: Not applicable. Standardized laboratory testing methods do not involve adjudication in the way clinical studies with human observers do.
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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 device is a dental material, not an AI-powered diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material, not an algorithm.
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The type of ground truth used: Standardized laboratory measurements according to ISO 10477:2020 and ISO 4049:2013 for physical properties (flexural strength, water sorption, solubility). For biocompatibility, compliance was shown with ISO 7405, ISO 10993-1, -5, -10, -11, -12, and -23.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires training data.
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How the ground truth for the training set was established: Not applicable.
Summary of the "Study" (Non-Clinical Performance Data) from the document:
The device did not undergo a "study" in the clinical sense with human readers or AI. Instead, the manufacturer provided Non-Clinical Performance Data to support the substantial equivalence determination for the "C&B NFH Hybrid" dental resin.
The data presented focuses on:
- Physical Property Testing: The device was tested for flexural strength, water sorption, and solubility. The reported values demonstrate that the device meets or exceeds the requirements set by the international standards ISO 10477:2020 ("Dentistry - Polymer-based crown and veneering materials") and ISO 4049:2013 ("Dentistry - Polymer-based restorative materials").
- Biocompatibility: The C&B NFH Hybrid material (Dimethacrylate based resins) was shown to be compliant with a series of ISO 10993 and ISO 7405 standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization, systemic toxicity).
- Shelf-Life: Accelerated aging tests in accordance with ASTM F1980 validated a 2-year shelf-life.
The purpose of these tests was to demonstrate that the C&B NFH Hybrid has similar safety and effectiveness characteristics to its predicate device (K202846, TERA HARZ by Graphy Inc.) and meets established performance standards for dental materials. The conclusion is that the subject device is substantially equivalent to the predicate device.
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(93 days)
The Ti-Base & Master Fix are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally-designed Ti-Base and Master Fix are intended to be sent to an ARUM DENTISTRY validated milling center for manufacture.
The Ti-Base & Master Fix consist of a two-piece abutment, where the titanium base is premanufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that compose the final abutment.
Device Components:
- Abutment
- Ti-Base
- Master Fix
- Abutment Screw
The Ti-Base and Master Fix are provided non-sterilized. Ti-Base is enclosed with Abutment Screw in a packing. Master Fix is enclosed with Master Fix Screw in a packing. These devices are intended for single use only. All digitally designed custom abutments for use with Ti-Base or Master Fix are to be sent to ARUM DENTISTRY validated milling center for manufacture. All superstructures are to be manufactured from zirconia (cleared K190112). Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension. The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
The provided document is a 510(k) premarket notification for the "Ti-Base & Master Fix" dental implant abutments. It includes a summary of technology characteristics and performance data but does not contain specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth, expert opinions, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device (DESS Dental Smart Solutions, K191986) primarily through material composition, intended use, and mechanical testing that mitigates minor design differences.
Therefore, many of the requested details cannot be extracted from this document.
However, based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum fracture strength, fatigue life thresholds) or report specific numerical performance outcomes against such criteria for the "Ti-Base & Master Fix" directly.
- It references mechanical performance testing as a method to mitigate differences in design and ensure safety and effectiveness, implying that such tests were conducted and their results were deemed acceptable, but the actual data/criteria are not provided in this summary.
- It also mentions biocompatibility testing according to ISO 10993-5 and ISO 10993-12, and moist heat sterilization validation according to ISO 17665 -1 and ISO 17665-2. These standards implicitly contain acceptance criteria, but the specific results or criteria are not detailed in this submission summary.
Table of Acceptance Criteria and Reported Device Performance (Based only on what's implicitly mentioned as having been met)
| Acceptance Criteria Category | Acceptance Criteria (Implicit from referenced standards/statements) | Reported Device Performance (Implicit from overall submission) |
|---|---|---|
| Mechanical Performance | Meets performance requirements to ensure safety and effectiveness despite design differences (e.g., fracture strength, fatigue resistance). | Testing was conducted, and differences were mitigated, implying acceptable performance. No specific values or thresholds provided. |
| Biocompatibility | Complies with ISO 10993-5 (cytotoxicity) and ISO 10993-12 (sample preparation). | Testing was performed according to these standards, implying compliance. |
| Sterilization | Validated for moist heat sterilization per ISO 17665-1 and ISO 17665-2. | Validation was performed, implying a sterile product post-processing by the end-user. |
| MRI Safety | Evaluation performed for magnetically induced displacement force and torque, per FDA guidance. | Review performed using scientific rationale and published literature, implying acceptable safety in MR environment. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not provide details on sample sizes for mechanical performance testing, biocompatibility, or sterilization validation.
- No information on the country of origin of the data or whether the studies were retrospective or prospective can be extracted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable and not provided. The submission is for a medical device (dental implant abutment), and the performance data primarily relates to physical and material properties, not diagnostic imaging or clinical interpretation requiring expert ground truth establishment in that typical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable and not provided. This typically applies to clinical or imaging studies where expert consensus is formed, which is not the type of study described here.
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
- Not applicable and not provided. This is a medical device (dental implant abutment) submission, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not provided. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For physical device testing, ground truth would typically refer to established engineering standards, material properties, and validated test methods (e.g., ISO standards for mechanical testing, biocompatibility).
8. The sample size for the training set
- Not applicable and not provided. There is no machine learning or AI component described that would require a training set.
9. How the ground truth for the training set was established
- Not applicable and not provided.
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