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510(k) Data Aggregation
(263 days)
UF(II) Anatomic abutment
The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.
The UF(II) Anatomic abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The anatomic abutment has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. It consist of straight abutment and angled of 5°, 18°, and are made from titanium alloy conforming to ASTM F136. The anatomic abutments are pre-manufactured (stock) abutments is provided non-sterile, this should be user steam sterilized before use.
The provided text describes the 510(k) summary for the UF(II) Anatomic abutment, focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study design for device performance. Medical devices like this, classified as Class II, typically undergo performance testing to ensure safety and effectiveness.
Based on the information provided, here's a breakdown of the acceptance criteria and the studies conducted:
1. A table of acceptance criteria and the reported device performance
The document mentions several tests performed according to specific ISO standards and FDA guidance. The "acceptance criteria" are implied by adherence to these standards and demonstration of "substantial equivalence." The "reported device performance" is framed as successful completion of these tests, indicating the device meets the requirements of the standards.
| Acceptance Criteria (Implied) | Reported Device Performance (as described in document) |
|---|---|
| Sterilization Validation: Achieve a Sterility Assurance Level (SAL) of 10^-6 for steam sterilization, per ISO 17665-1 and ISO 17665-2, and FDA Guidance. | "Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Sterilization was conducted in accordance with FDA Guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'." |
| Fatigue Test: Meet the dynamic fatigue resistance requirements for endosseous dental implants, considering worst-case scenarios, as per ISO 14801:2007 and FDA Guidance. | "The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants. The worst case scenario was chosen based on the FDA guidance... The subject device was tested to evaluate its substantial equivalence..." |
| Biocompatibility: Demonstrate biocompatibility based on material composition and contact with the body, following ISO 10993-1 and FDA Guidance. | "The Biocompatibility Test are leveraged from previous submission (K122519). Biocompatibility test conducted in accordance with FDA Guidance Document Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'." "No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required." |
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 explicitly state the sample sizes used for the non-clinical tests (sterilization, fatigue). It refers to standard testing protocols outlined in the cited ISO standards and FDA guidance documents. These standards typically specify the number of samples required for robust testing.
- Sterilization Validation: Sample size not specified, but implied to be sufficient for achieving SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2.
- Fatigue Test: Sample size not specified, but implied to be sufficient for testing according to ISO 14801:2007, often involving multiple samples tested to failure or a specified number of cycles. The test was conducted on "the subject device."
- Biocompatibility: No new samples were tested for biocompatibility; it was leveraged from a previous submission (K122519).
Data Provenance: The document does not specify the country of origin of the data for the non-clinical tests, nor whether the studies were retrospective or prospective. These are lab-based tests, not clinical studies involving human patients. The submitter is DIO Corporation, located in the Republic of Korea, so the testing was likely conducted in that region or by a contract lab.
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 question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance tests like sterilization and fatigue are objective measurements against established engineering and biological standards (e.g., microbial kill rate, force sustained before failure). These tests do not typically involve human expert interpretation or consensus for establishing "ground truth" in the way a clinical diagnostic accuracy study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used in clinical studies where human interpretation or a "gold standard" reference is subject to variability or requires reconciliation among multiple experts. The non-clinical tests described are objective, laboratory-based physical and biological assessments.
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
This question is not applicable. The device described, the UF(II) Anatomic abutment, is a dental implant component (an abutment). It is a passive mechanical device and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as the device is mechanical and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed in point 3, the concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not directly applicable to the non-clinical performance tests mentioned in the document.
For:
- Sterilization Validation: The "ground truth" is an objective measurement of microbial reduction (e.g., spore log reduction) or sterility against a defined standard.
- Fatigue Test: The "ground truth" is the objective mechanical performance (e.g., cycles to failure, maximum load sustained) measured by engineering equipment against the requirements of ISO 14801.
- Biocompatibility: The "ground truth" is derived from established biological responses to materials as per ISO 10993-1 (e.g., cytotoxicity, sensitization, irritation).
8. The sample size for the training set
This question is not applicable, as this is a mechanical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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