(102 days)
The SFI-Bar® is intended to be used with the implant manufacturer's . (Table 1) implant to provide support for fixation of overdentures.
The SFI-Bar® provides the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI-Bar® consists of an implant adapter (abutment) and a stress-free bar for the fixation of removable overdentures. The implant adapter is screwed into the dental implant.
The provided text describes a 510(k) submission for the SFI-Bar® Abutment, a dental device. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific numerical acceptance criteria for each test. Instead, it states that "The acceptance criteria were met" and that the "SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®." The performance characteristics evaluated are generally described.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent performance characteristics to the predicate SFI-Bar® | "Testing has shown that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®." This equivalence is established through: |
| (Specific torque values for mechanical stability not explicitly stated) | Torque tests: Conducted to evaluate performance characteristics. The methods used were the same as in the predicate device. The device was found to be equivalent in performance. |
| (Specific functional criteria not explicitly stated) | Application testing: Conducted to evaluate performance characteristics. The methods used were the same as in the predicate device. The device was found to be equivalent in performance. |
| (Specific functional criteria not explicitly stated) | Functional testing: Conducted to evaluate performance characteristics. The methods used were the same as in the predicate device. The device was found to be equivalent in performance. Key functional characteristics mentioned (also shared with the predicate) include: primary splinting of implants, countering forces that would dislodge the denture, distribution of shear forces, resilience compensation, common cleaning procedures for patients, and common patient handling (cleaning and insertion of denture). |
| (Shelf life performance equivalent to predicate) | Shelf life: "95% after 10 years" (same as predicate device). |
| (Manufacturing processes and materials equivalent to predicate) | Packaging, materials and processes: "Produced on process orientated CNC machines. The last step is a validated cleaning process (same processes). Packaging: Dentalblister, non-sterile." The material is "Wrought Titanium-6Aluminium-4Vanadium ELI Alloy for Surgical Implant applications" conforming to ASTM F 136 (same as predicate). |
| (Compatibility with specified implant systems) | Compatibility: The SFI-Bar® Abutment is designed to connect with various dental implant systems from Thommen Medical, Neoss, and Institut Straumann (specifically listed in Table 1). The development and manufacturing were done "in close cooperation with the implant companies" with Quality Agreements in place (Design Control, Change Control, Complaint Handling, and Post Market Surveillance). This implies successful compatibility testing was conducted to ensure proper fit and function with these diverse implant systems, similar to the predicate device's compatibility. |
| (Safety for intended use) | "The summary of technological characteristics as well as the torque test, application and functional testing indicate that the device is safe and effective for its intended use and performs as well or better than the predicate devices." This is a general conclusion based on the non-clinical testing and comparison to the predicate, demonstrating that the device does not raise new questions of safety or effectiveness. This is the overarching "acceptance criterion" for a 510(k) submission seeking substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for the torque tests, application testing, or functional testing. It only states that these tests were conducted.
- Data Provenance: The data is non-clinical test data. The country of origin of the data is not explicitly stated, but the applicant (Cendres+Métaux SA) is located in Switzerland. The testing was conducted to support a 510(k) submission to the FDA (USA). The study is retrospective in the sense that it relies on existing testing methodologies and comparisons to a previously cleared predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) as the study described is a non-clinical, bench testing study comparing the performance of a new device to a predicate device. There is no "ground truth" derived from expert review of cases or outcomes in a clinical context. The "ground truth" for the testing would be established by validated test methods and engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not in bench testing of a dental implant abutment.
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 information is not applicable (N/A). The device described, the SFI-Bar® Abutment, is a physical dental implant component, not an AI or imaging diagnostic device. Therefore, an MRMC study and AI assistance effect size are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable (N/A). As mentioned in point 5, this is a physical dental device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of non-clinical device testing is engineering specifications, validated test methods, and the performance characteristics of the legally marketed predicate device. The goal is to demonstrate that the candidate device performs "as well or better than" the predicate device under the same test conditions. There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in the clinical sense for this specific evaluation. The "worst-case test samples" were identified through analysis of platforms, indicating an engineering-based approach to defining test parameters.
8. The Sample Size for the Training Set
This information is not applicable (N/A). There is no concept of a "training set" in the context of this non-clinical bench testing for a physical dental device. Training sets are relevant for machine learning algorithms or similar data-driven models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A), as there is no training set for this type of device submission.
§ 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.)