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510(k) Data Aggregation
(69 days)
XIVE TG ABUTMENTS
The XiVE® TG Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.
The XiVE® TG Abutment is part of the XiVE® TG Transgingival Dental Implant System. The XIVE® TG Abutment is intended for the fabrication of screwretained or cementable crowns and bridges. The XiVE® TG Abutment is constructed of CP-2 titanium and is available in a 3.4 - 4.5mm diameter to correspond to the XiVE® transgingival implant bodies. The XiVE® TG Abutment is available with a straight or angled configuration.
The provided text describes a 510(k) premarket notification for a dental device, the XiVE® TG Abutment. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance data.
Therefore, the requested information elements related to specific acceptance criteria, detailed study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not explicitly available in the provided text.
Based on the information given, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific, quantifiable acceptance criteria. Instead, it states that "Performance evaluations of the XiVE® TG abutment show that the device performs as intended." The primary "acceptance criteria" for a 510(k) submission are based on demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance (Inferred from 510(k)) |
|---|---|
| Substantial equivalence in design | "similar in design" to predicate device |
| Substantial equivalence in functionality | "equivalent to the predicate device in functionality" |
| Substantial equivalence in materials | "equivalent to the predicate device in materials" |
| Substantial equivalence in mechanical strength | "equivalent to the predicate device in mechanical strength" |
| Performs as intended | "device performs as intended" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not mentioned. The document refers to "Performance evaluations," but no details about the studies or sample sizes are provided.
- Data provenance: Not mentioned. It's likely the evaluations were conducted by FRIADENT GmbH in Germany, given the company's location, but this is not explicitly stated for the "performance evaluations."
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)
Not applicable and not mentioned. This type of detail is typically for diagnostic AI/CAD devices where expert interpretation forms the ground truth. For a dental abutment, performance is based on mechanical properties and clinical use, often tested physically or in animal/cadaver models, or by comparison to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not mentioned.
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. This is not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would likely be established through:
- Mechanical testing: Demonstrating structural integrity, fatigue resistance, and fit according to established standards.
- Material compatibility: Verification of biocompatibility.
- Clinical performance: Although not detailed in this summary, clinical experience with predicate devices and possibly limited in-house testing would inform the "performs as intended" conclusion. However, no specific "ground truth" data of these types are presented.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires training data in the traditional sense.
9. How the ground truth for the training set was established
Not applicable.
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