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The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

SS Abutment System is made of titanium alloy. SS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The medical device described in the document is the SS Abutment System from Osstem Implant Co., Ltd. This device is an endosseous dental implant abutment, classified as Class II under regulation 21 CFR 872.3630 with product code NHA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to predicate devices, focusing on design, function, indications for use, material, manufacturing process, and performance characteristics. The acceptance criteria are implicitly aligned with the performance characteristics of the predicate devices, particularly regarding mechanical properties, biocompatibility, sterilization, and MR compatibility.

For ComOcta Milling Abutment: Lengths (L 14, L 14.35) not in predicate range, but diameter range is same. Performance: "fatigue of the proposed device is considered to be equal to or greater than that of the predicate device." No additional fatigue testing. Modifiability is within safe limits (min post height 4mm, gingival height 1-3mm, no angulation).

For Port Abutment: Larger diameter (Ø6.06) compared to predicate (Ø4.8), same length range. Performance: "added diameter is bigger than reference device and the lengths 3.5~6.5mm is same as the range of reference device." "not received single load because this is used for making overdenture that means load is dispersed to the full denture. Therefore, we don't consider additional fatigue testing."

For O-ring Abutment: Larger diameter (Ø4.3) compared to predicate (Ø3.5), same gingiva height range. Performance: "added diameter is bigger than reference device and the gingiva height 0~4mm is same as the range of predicate device." "not received single load because this is used for making overdenture that means load is dispersed to the full denture. Therefore, we don't consider additional fatigue testing."

For Closing Screw: Longer dimensions than predicate. Performance: "does not affect safety and effectiveness because it is used to protect the exposed platform of the implant during healing period." No additional fatigue testing. |
| Biocompatibility | Compliance with FDA Guidance Document Use of International Standard ISO 10993-1. The material composition of the device should be safe for biological contact. | "The SS Abutment System has same materials, manufacturer, manufacturing process etc., as predicate devices. Therefore, we didn't conduct additional biocompatibility test." |
| Sterilization Validation | Demonstrated sterility and maintenance of sterility throughout the claimed shelf-life. The sterilization process should be validated and consistent with predicate devices or established methods. | "Validation of the gamma irradiation process was previously conducted for the predicated device. There has been no change to the manufacturing or sterilization processes since then and the subject devices do not present a new worst case for sterilization validation; therefore, additional validation is not required." |
| Shelf-life | Stability and integrity of the device over its claimed shelf-life. | "SS Abutment System are made with titanium and titanium alloy we don't consider about shelf life of material by itself because this metal is widely known that it generally has no adversely affect by aging. Therefore we certify that product such like metal has no shelf life." The predicate device likely had an 8-year shelf life for some components (e.g., Closing Screw), and this is maintained where applicable. |
| MR Compatibility | Safety in the Magnetic Resonance (MR) Environment, including assessment of magnetically induced displacement force and torque, 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 Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance." |

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

The document does not describe a traditional "test set" in the context of a clinical performance study. Instead, performance is established through non-clinical testing and comparison to predicate devices, often leveraging the fact that the subject device either has:

• Identical characteristics to a predicate.
• Dimensions that are considered to offer equivalent or superior performance (e.g., larger diameter on an implant component).
• A different intended use/loading condition (e.g., overdenture dispersing load) that mitigates concerns about increased stress from dimensional changes.

Therefore, there is no sample size for a "test set" from patients or images. The "samples" would be the configurations of the devices tested in laboratory settings (e.g., for fatigue), or the material samples for biocompatibility, or the specific device designs analyzed for MR compatibility. The document does not specify the number of units tested for any of these non-clinical evaluations, but refers to "worst-case scenarios" for mechanical testing, which implies selection of specific configurations deemed most challenging.

Data Provenance: Not applicable as no human or image data is used for performance testing. The "data" comes from laboratory physical testing, material standards, and scientific literature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is a non-clinical submission based on substantial equivalence to predicate devices and established standards (e.g., ISO, ASTM, FDA guidance), there is no "ground truth" derived from expert consensus on patient data. The "truth" is based on adherence to engineering and material science principles, and regulatory guidelines.

4. Adjudication method for the test set

Not applicable for the reasons outlined in point 3.

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 physical dental implant abutment, not an AI-powered diagnostic or assistive tool.

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 a software algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Standards and Guidance Documents: ISO 14801 for fatigue testing, ISO 10993-1 for biocompatibility, and FDA guidance documents for dental implants and MR compatibility.
• Material Science: Established properties of Titanium Alloy (ASTM F136), Titanium Gr 3 & 4 (ASTM F67), and POM (Polyoxymethylene).
• Existing Validations: Relying on previous biocompatibility, sterilization, and shelf-life validations performed for predicate devices with identical materials, manufacturing processes, or for which the subject device does not represent a new worst-case.
• Scientific Rationale: For MR compatibility, scientific literature and rationale are used.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable for the reasons outlined in point 8.

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