(117 days)
The SFI-Bar® is intended to be used with the implant manufacturer's implant (TABLE a) to provide support for fixation of overentures.
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.
Here's an analysis of the provided text to extract information about acceptance criteria and the study proving compliance for the SFI-Bar® device:
The provided document describes the 510(k) premarket notification for the SFI-Bar® device, a dental implant abutment. It seeks to establish substantial equivalence to predicate devices, rather than proving performance against novel acceptance criteria in a comprehensive clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar® and that acceptance criteria were met. However, the document does not explicitly list specific numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating equivalence to the predicate device.
The "Performance Data" section mentions:
- Validation of Sterilization for metallic components.
- Evaluation of the intended manual disinfection procedure with SFI-Bar® Retention inserts G.
- Application and functional testing based on literature research.
The key acceptance criterion seems to be: "The SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization validated for metallic components. | Validation of Sterilization has been conducted. |
| Intended manual disinfection procedure evaluated. | Evaluation of the intended manual disinfection procedure with SFI-Bar® Retention inserts G. has been conducted. |
| Application and functional testing consistent with predicate. | Application and functional testing based on literature research have been conducted. The test methods used were the same as in the predicate device. |
| Overall performance equivalent to the predicate SFI-Bar®. | Testing has shown that the SFI-Bar® is equivalent in performance characteristics to the predicate SFI-Bar®. |
| Device is safe and effective for its intended use. | The summary of technological characteristics indicates that the device is safe and effective for its intended use and performs as well or better than the predicate devices. |
| Ability to provide support for fixation of overdentures with compatible implant systems. | The SFI-Bar® is intended to be used with the implant manufacturer's (TABLE A) implant to provide support for fixation of overdentures. (Supported by technical compatibility and material equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Non-clinical test data was used to support the substantially equivalence claim. Clinical testing was not necessary."
This indicates that a "test set" in the sense of a patient cohort or a large sample for a clinical trial was not used for this submission. The testing performed was non-clinical.
- Sample Size for Test Set: Not applicable in the context of clinical or large-scale performance testing. The "test samples" mentioned in the context of "analysis of platforms to identify worst-case test samples" would likely refer to physical samples or configurations chosen for non-clinical engineering tests (e.g., sterilization, disinfection). The specific number of these non-clinical worst-case samples is not provided.
- Data Provenance: The submission is from Cendres+Metaux SA, Biel/Bienne, Switzerland. The non-clinical testing was conducted by the manufacturer, but the location where the tests were performed is not specified. The data is retrospective in the sense that it's based on existing designs and literature, and performed prior to this submission for regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As clinical testing was not performed and the submission relies on demonstrating substantial equivalence through non-clinical data and comparison to predicate devices, there was no "ground truth" to be established by experts in a clinical context for a test set. The validation and evaluation mentioned primarily concern manufacturing processes and materials.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used.
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 device is a dental implant abutment, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or software.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given the nature of the device and the submission, the "ground truth" relied upon is primarily:
- Engineering and material standards (e.g., ASTM F 136 for Titanium alloy).
- Performance characteristics of legally marketed predicate devices (K073628, K083876, K102382) as established through their prior regulatory clearances.
- Scientific literature research supporting application and functional principles.
- Validation of manufacturing processes (sterilization, cleaning).
There isn't "ground truth" in the sense of clinical outcomes or expert consensus on diagnostic interpretations.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
In summary: The submission for the SFI-Bar® focuses on demonstrating substantial equivalence to existing predicate devices, leveraging non-clinical testing, material standards, and literature review. It does not involve new clinical trials, expert consensus, or AI performance metrics.
§ 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.)