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510(k) Data Aggregation
(350 days)
DENRACLE DENTAL ABUTMENT
Denracle Dental Abutment for Osstem GS Implant is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. This device is compatible with the following implant system: OSSTEM GS Fixture System Ø 4.0 mm, Ø 4.5 mm and Ø 5.0 mm.
Denracle Dental Abutment for Osstem GS Implant are titanium abutments designed to be used in conjunction with specific dental implants utilizing the Dental Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. Denracle Dental Abutment for Osstem GS Implant is compatible with the following implant systems: OSSTEM GS Fixture System 04.0 mm, Ø4,5 and Ø5,0mm.
This looks like a 510(k) summary for a dental abutment, which is a medical device, not a software device. Therefore, the questions about AI performance, multi-reader multi-case studies, and ground truth establishment for software training and testing sets are not applicable.
However, I can extract the information relevant to the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
The provided document describes a "Denracle Dental Abutment for Osstem GS Implant" and focuses on demonstrating its substantial equivalence to a legally marketed predicate device (TDS Abutment for Friadent Xive - K103339). The acceptance criteria are primarily related to mechanical strength and compatibility for its intended use, rather than performance metrics for a diagnostic or AI-driven device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Strength | ISO 14801 Dentistry - Fatigue test for endosseous dental implants (worst-case scenario) | "sufficient mechanical strength for their intended clinical application" (acceptable results) |
| Material Biocompatibility | Biocompatibility testing | "acceptable results" |
| Sterilization | Sterilization process testing | "acceptable results" |
| Compatibility/Fit | Dimensions, tolerances, and rotation parameters with corresponding dental implants and screws | "compatible with the implant system for which they are indicated for use" (evaluated and found appropriate) |
| Substantial Equivalence | Same intended use, operating principle, basic design, materials, and production processes as predicate device (TDS Abutment for Friadent Xive) | Device deemed "substantially equivalent" to predicate device by FDA for indications and design principles. |
2. Sample Size and Data Provenance for Test Set:
- Sample Size for Test Set: Not explicitly stated. The document mentions "testing was conducted on a worst-case scenario" for mechanical testing, implying specific test articles were used, but the quantity isn't provided.
- Data Provenance: The testing was conducted internally by Green DenTech Co., Ltd. (the manufacturer) as part of their 510(k) submission. No information about country of origin of data or retrospective/prospective nature is applicable in the context of device mechanical and material testing.
3. Number of Experts and Qualifications for Ground Truth:
- This concept is not applicable for this type of medical device submission. Ground truth, in the context of AI, refers to expert-validated labels or diagnoses. For a dental abutment, the "ground truth" is established through engineering standards (e.g., ISO 14801) and material science principles, which are verified through objective laboratory testing.
4. Adjudication Method:
- This is not applicable. The testing involves objective measurements against established engineering standards, not subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of this device.
6. Standalone Performance Study:
- Yes, a form of "standalone" performance was effectively done in the form of the non-clinical mechanical, biocompatibility, and sterilization testing. These tests evaluate the device's inherent properties and performance against predetermined standards, independent of human interaction beyond operating the testing equipment.
7. Type of Ground Truth Used:
- The "ground truth" for this device's evaluation is based on established engineering standards (e.g., ISO 14801), material science principles, and predefined specifications for compatibility and fit. These are objective benchmarks against which the device's test results are compared.
8. Sample Size for Training Set:
- This concept is not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm that undergoes machine learning training.
9. How Ground Truth for Training Set was Established:
- This concept is not applicable for the same reason as above.
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