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SIMDA Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

It is compatible with the following systems:

Compatible System Implant Body Diameter(mm) Implant Platform
Osstem TS (K121995) 3.5, 3.75 Mini
Osstem TS (K121995) 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.9, 5.05, 5.08, 5.1 Regular
Straumann Bone Level (only the Roxolid® implants from K140878) 3.3 NC
Straumann Bone Level (only the Roxolid® implants from K140878) 4.1, 4.8 RC
All digitally designed abutments for use with SIMDA Abutments are intended to be sent to a SIMDA validated milling center for manufacture.

Device Description

SIMDA Abutment is made of titanium alloy (Ti-6A1-4V ELI. ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.

Pre-Milled Blank Design Limitation for Patient-specific abutment:

Design parameter (Patient-specific abutment) Subject System Design Limit
Minimum and Maximum Gingival (Cuff) Height 0.55mm
Minimum and Maximum diameter at abutment/implant interface ⌀4.0⌀8.0
Minimum and Maximum length of abutment 4.513mm
Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) 48mm
Minimum wall thickness at abutment/implant interface 0.4mm
Minimum and Maximum abutment angle 0~25°

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Pre-Milled Blank and Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure.

Raw material blanks

InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. ●
Cement
. RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.

Design Limitation for Zirconia superstructure:

Design Limits for Zirconia top-half (Min. ~ Max.)

Post Angle (°): 0~15
Cuff Height (mm): 0.55.0
-Post Length (mm): 4.06.0
-Diameter (Ø, mm): 5.0~8.0
-Thickness (mm): 0.4

AI/ML Overview

This FDA 510(k) summary (K223663) concerns a dental implant abutment, not an AI/ML medical device. Therefore, the information required to populate the fields related to AI/ML model performance, such as test set sample size, expert ground truth establishment, MRMC studies, and training set information, is not available in the provided document.

The document discusses the substantial equivalence of the SIMDA Abutment to existing predicate devices based on non-clinical testing for mechanical properties (fatigue), sterilization, and biocompatibility.

Here's an attempt to answer the relevant sections based on the provided text, and noting where information is not applicable or unavailable for an AI/ML device:

Acceptance Criteria and Device Performance for SIMDA Abutment

Since this is a non-AI/ML device (a dental abutment), the "acceptance criteria" are related to mechanical and biological performance rather than AI/ML algorithm metrics. The study described is a non-clinical study to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Parameter (Acceptance Criteria)	Reported Device Performance / Evaluation
Mechanical Performance	Fatigue testing (ISO 14801, FDA Special Controls Guidance) for worst-case scenarios of assembled implant/abutment systems.	"The results of the above tests have demonstrated the substantial equivalence with the primary predicate." (Implies meeting or exceeding predicate performance/safety).
Material Composition	Ti-6Al-4V ELI (ASTM F136) for Pre-Milled Blank and Ti-Base abutment.	"SIMDA Abutment is made of titanium alloy (Ti-6A1-4V ELI. ASTM F136)..." and "Material: Ti-6Al-4V ELI (ASTM F136) Zirconia"
Sterilization	End User Steam Sterilization Test (ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010).	"The results of the above tests have demonstrated the substantial equivalence with the primary predicate." (Implies effective and compliant sterilization). "Pre-Milled Blank and Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure." and "Sterile: steam sterilized before use"
Biocompatibility	Biocompatibility tests (ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010).	"The results of the above tests have demonstrated the substantial equivalence with the primary predicate." (Implies biocompatibility).
Dimensional Compatibility	Dimensional analysis and reverse engineering of critical features and tolerances of the implant-to-abutment connection platform (OEM implant body, abutment, screw). Cross-sectional images.	"Cross sectional images wre provided to demonstrate substantially equivalent compatibility." and "The testing aided implant to abutment compatibility and has established substantial equivalency of the proposed device with the predicate devices."
MR Environment Compatibility	Evaluation of metallic components in MR environment using scientific rationale and published literature per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."	"Non-clinical worst-case MRI review was performed to evaluate the metallic SIMDA abutment in the MRI environment using scientific rationale and published literature..."
Design Limits	Specific ranges for gingival cuff height, diameter at interface, length of abutment, post length, wall thickness, and abutment angle must fall within established safe/effective ranges relative to predicates.	The document provides design limits for "Patient-specific abutment" and "Zirconia superstructure" and compares them to predicate devices, discussing minor differences and concluding that performance testing demonstrated substantial equivalence. (e.g., "Even though there are some minor differences in dimensions, performance testing demonstrated that the subject device has substantially equivalent fatigue performance.")

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly stated in the document. Non-clinical mechanical fatigue testing typically uses a small number of samples (e.g., 5-10 per test condition) to demonstrate compliance with standards.
Data Provenance: The tests are non-clinical (laboratory) studies. The manufacturer is SIMDA Co., Ltd. from REPUBLIC OF KOREA. The studies are prospective in the sense that they were designed and conducted to evaluate the device for this submission.

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):

Not applicable for this type of device/study. This section typically applies to AI/ML devices where human expert consensus is used to label medical images for ground truth. For a dental abutment, "ground truth" is established by engineering and material science standards, measurements, and physical testing.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in human expert labeling of data, which is not part of the non-clinical testing for a dental 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:

No, this was not done. An MRMC study is performed for AI/ML devices to assess the impact of AI assistance on human reader performance. This is not applicable to a physical dental abutment. The document explicitly states: "Clinical testing was not necessary to establish substantial equivalency of the device."

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

Not applicable. This pertains to AI/ML algorithm performance in isolation. The product is a physical dental abutment.

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

Engineering and material science standards, physical measurements, and established performance criteria. Ground truth is implicitly defined by the referenced ISO standards (e.g., ISO 14801 for fatigue testing, ISO 17665-1 for sterilization) and the performance characteristics of the predicate devices. The "worst-case scenarios" were tested to ensure safety and effectiveness.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set."

Summary of what the study did prove:
The study proved that the SIMDA Abutment is substantially equivalent to a legally marketed predicate device (TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment K220562, and others) by demonstrating comparable:

Intended Use
Material composition
Mechanical properties (through fatigue testing)
Sterilization efficacy
Biocompatibility
Dimensional compatibility with specified implant systems
Safety in an MR environment

The conclusion is based on non-clinical testing, which was deemed sufficient by the FDA to demonstrate substantial equivalence without the need for clinical studies.

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