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The SFI-Bar® Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.

Device Description

The SFI Bar® Implant Abutments provide the connection between compatible dental implant systems for the fixation of removable overdentures. The SFI Bar® Implant Abutments consist of an abutment, which is attached to a stress free bar for the fixation of removable overdentures. The implant abutment is screwed into the dental abutment.

The implant abutments fit Straumann Bone Level RP, Straumann Bone Level NP, Ankylos, Nobel 5mm Trilobe, Nobel Conical RP, Nobel Conical NP, Astra 4.5/5.0, Astra 3.5/4.0, Zimmer TSV 5.7mm.

There are nine (9) different platforms and each platform is compatible with one or more implant types. The platforms of the abutments are [BD], [BE], [AE], [AN], [AY], [AY], [AJ], [AK], [BF]. Table 1 indicates which implants are compatible with these platforms. The difference between each platform is the internal connection with the specific implant.

The devices are supplied non-sterile, therefore there is no shelf life.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the SFI Bar® Implant Abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials with specific acceptance criteria and detailed performance metrics.

Therefore, many of the requested categories for device performance, ground truth, and comprehensive study details are not applicable or available in this type of regulatory submission. The document primarily describes non-clinical testing to support the claim of equivalence.

Here's a breakdown based on the available information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Material Conformance: Material of implant abutments conforms to ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy.	The material of the implant abutments conform to ASTM F136, Wrought Titanium 6 Aluminum-4 Vanadium ELI Alloy.
Performance Equivalence: Device performs equivalently to predicate SFI Bar® Implant Abutments.	Testing has shown that the SFI-Bar® Implant Abutments included in this application are equivalent in performance characteristics to the predicate SFI Bar®. The acceptance criteria were met. (Specific numerical performance criteria are not detailed in the document.)
Design and Manufacturing: Designed and developed, and manufactured according to manufacturer's specifications and controlled procedures. Validation protocol done in accordance with Design Control requirements per FDA CFR820.30.	The implant abutments were designed and developed, and manufactured according to manufacturer's specifications and controlled procedures. A validation protocol was done in accordance with Design Control requirements per FDA CFR820.30.
Non-clinical Test Methods: Application and functional testing done using the same test methods as in predicate devices.	The test methods used were the same as in predicate devices.
Worst-Case Sample Identification: Tolerance analysis of platforms performed to identify worst-case test samples.	Tolerance analysis of platforms -to-identify-worst-case-test-samples was performed.
Fatigue Testing: (Not applicable as noted in the document)	Fatigue testing .was-not-done as the basic design is the same as the predicate devices.
Torque Tests, Application and Functional Tests: Performed as part of non-clinical testing.	Torque tests, application and functional tests have been carried out.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as numerical counts of products tested. The document mentions "tolerance analysis of platforms -to-identify-worst-case-test-samples" which implies selected samples were tested, but the exact number isn't provided.
Data Provenance: Not specified. Given it's a US-based company submitting to the FDA, it's highly probable the testing was conducted in the US, but this is not explicitly stated. The testing is described as non-clinical, likely laboratory-based.
Retrospective or Prospective: Not applicable, as this refers to clinical studies, and only non-clinical testing was performed.

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)

Number of Experts & Qualifications: Not applicable. Non-clinical testing for equivalence does not typically involve expert consensus to establish a "ground truth" in the way clinical studies do. The "ground truth" for material specifications and performance would be established by engineering standards and internal company specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This concept is relevant to clinical studies involving human interpretation or subjective assessments. Performance testing of abutments involves objective measurements against engineering specifications.

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

MRMC Comparative Effectiveness Study: No, this type of study was not done. The device is a dental implant abutment, not an AI-powered diagnostic tool.
Effect Size: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. The device is a mechanical component (dental abutment), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the non-clinical testing, the "ground truth" would be engineering specifications, material standards (like ASTM F136), and validated test methodologies to assess physical properties and fit. There is no biological "ground truth" in the context of this 510(k) submission.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. The device is a manufactured medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable.

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