(101 days)
Klockner Abutments are intended for use in dental implants to provide a support structure so that the edentulous or partially edentulous patients will regain their masticatory and aesthetic functions.
All digitally designed abutments for use with Klockner TiBase Abutments are intended to be sent to a SOADCO S.L. validated milling center for manufacture.
The abutments consist of healing abutments, temporary abutments, straight abutments, and an overdenture attachment system that consists of abutments, denture housings, and retention inserts, and TiBase abutments with screws.
This is a medical device 510(k) premarket notification for Klockner Abutments which are endosseous dental implant abutments. The submission aims to demonstrate substantial equivalence to previously cleared devices.
Here's the breakdown of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance targets (e.g., "must achieve X% accuracy"). Instead, it lists various non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests in comparison to the predicate devices.
| Acceptance Criteria (Implied by tests performed) | Reported Device Performance (as stated in the document) |
|---|---|
| Sterilization validation (according to ISO 17665-1 and 17665-2) | Leveraged from previously cleared submissions K151194 and K170022. (Implies compliance with these ISO standards) |
| Biocompatibility (for TiBase, straight, healing, temporary, denture housing) | Leveraged from K170022 and K151194. (Implies compliance with biocompatibility standards for these components) |
| Biocompatibility for TiCN and ZrN coated abutments (according to ISO 10993-5, 10993-10, 10993-12) | Passed tests for in vitro cytotoxicity, skin sensitization for irritation and sensitization, and sample preparation/reference materials. (Implies compliance with these ISO standards for the coated abutments) |
| Mechanical testing (according to ISO 14801 Dentistry Implants Dynamic loading test) | Conducted. (Implies the device meets mechanical performance requirements for dynamic loading of endosseous dental implants) |
| Retention testing | Conducted to ensure retention is maintained throughout expected use. (Implies the device meets retention performance requirements) |
| Coating characterization (according to FDA Guidance Class II Special Controls Guidance Document) | Conducted using methods outlined in the FDA Guidance. (Implies the coating properties were characterized and meet relevant guidance) |
| MRI compatibility/safety | Non-clinical worst-case MRI review to evaluate metallic devices in the MRI environment using scientific rationale and published literature. Rationale addressed parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. (Implies MRI safety has been addressed) |
| Materials | Titanium alloy conforming to ASTM F136; Zirconia (for copings) conforming to ISO 13356. Same materials as previously cleared products. |
| Manufacturing Process | Identical manufacturing processes as used for SOADCO S.L. products cleared previously in K151194 and K170022. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state a "sample size" in terms of number of patients or clinical cases for a test set, nor does it specify data provenance (country of origin, retrospective/prospective).
The studies mentioned are primarily non-clinical bench testing (e.g., sterilization, biocompatibility, mechanical testing, retention testing, coating characterization, MRI review). For these types of tests, "sample size" would refer to the number of devices or components tested, which is not detailed in this summary.
The "leveraged" data refers to studies performed on previously cleared predicate devices (K151194, K170022) and is therefore retrospective in relation to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is typically relevant for studies involving human assessment or interpretation (e.g., imaging studies, clinical trials with expert review). Since the provided text describes primarily non-clinical bench testing, there is no mention of experts establishing ground truth in this context. The "truth" for these tests is based on objective measurements and compliance with recognized standards.
4. Adjudication Method for the Test Set
Again, this is applicable to studies with subjective assessments. As the studies are non-clinical bench tests, there is no adjudication method mentioned or applicable. Compliance is determined by objective measurements against established standards.
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
No MRMC study was mentioned. This submission focuses on the substantial equivalence of a physical dental device (abutments) through non-clinical performance testing against established standards and predicates, not on AI-assisted diagnostic or interpretive tasks.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No standalone algorithm performance study was mentioned. The device is a physical dental implant component, not a software algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by:
- Established standards: e.g., ISO 17665-1, ISO 17665-2, ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 14801, ASTM F136, ISO 13356.
- FDA Guidance: e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
- Performance of predicate devices: The subject device's performance is compared to that of previously cleared predicate devices (K151194, K170022, K222288, K191123, K220612) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
There is no mention of a training set as this is not an AI/machine learning device. The studies described are non-clinical laboratory tests.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this question is not applicable.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)