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The Hexim Implant - The HEXIM Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The HEXIM Implant System is for two stage surgical procedures. It is intended for delayed loading.

Samwon General Abutments - Couple Abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

The HEXIM Implant with Samwon General Abutments is a Root-form Endosseous Dental Implant and Endosseous Dental Abutment system designed for use in dental implant surgery. These devices have special controls as described by the document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments – Class II Special Controls Guidance for Industry and FDA Staff.

The HEXIM Implant is a threaded root-form endosseous dental implant with an internal hexagon connection. The HEXIM implants are surgically inserted into the upper and/or lower jawbone to provide a stable foundation for restorations. Geometrically, the implant is screw type. It has external self-tapping threads with chip pocket vertical flutes to facilitate implantation. The HEXIM implant also includes a cavity which extends through the bottom of the implant and connects to 5 channels running perpendicular to the implant body long axis to aid in intra bone fixation. The bottom cavity is not directly interconnected to the internal hex connection nor to the internal threading feature used to fix abutments to the implant.

The Samwon General Abutments are connected to the implant through the implant's internally threaded hole and an internal hex connection. Samwon General Abutments come in several types: Cover Screw, Healing Abutment, Hex type Couple Abutment, and Abutment Screw. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete. Healing abutments are used after osseointegration, once the cover screw is removed, to make a natural soft tissue shape before setting up prosthetics. The Hex-type Couple Abutment is designed to mate with the internal hex cavity of the endosseous implant and is fixed to the implant via an abutment screw. The Hex-type Couple Abutment is a transgingival component, which serves as the support for the artificial tooth or other prosthetic.

The provided FDA 510(k) clearance letter for the HEXIM Implant and Samwon General Abutments is for a medical device that includes physical implants and abutments, not an AI or software-based medical device. Therefore, the information typically associated with acceptance criteria and a study proving an AI device meets those criteria (such as sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, and training set details) is not applicable to this document.

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Intended Use and Indications for Use
• Technological Characteristics (material, design, dimensions, sterilization, surface treatment, connection type, principle of operation)
• Performance Testing (bench testing, biocompatibility, sterilization validation)

The "study" that proves the device meets acceptance criteria in this context is the non-clinical performance testing and the demonstration of substantial equivalence to legally marketed predicate devices, rather than a clinical trial or AI model validation study.

Here's a breakdown of the relevant information provided in the document concerning how the device meets its "acceptance criteria" (understood as demonstrating substantial equivalence and safety/effectiveness):

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in a tabulated form with specific numerical targets typical for AI model performance (e.g., AUC > X, Sensitivity > Y). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to relevant industry standards and guidance documents. The "reported device performance" is demonstrated through various tests and comparisons:

• Surface Treatment: SLA (Similar to predicate, same as reference; justified differences do not affect substantial equivalence).
• Sterilization: Gamma irradiation (Same as reference, predicate not specified).
• Connection Type: Internal Hex (Same as both predicate and reference).
• Fixture Body Diameter/Length: Differ slightly but fall within predicate/reference ranges or justified as not affecting safety/efficacy.
• Bottom Cavity: Presence/absence compared and justification provided. |
  | Technological Characteristics Equivalence (Samwon General Abutments) | - Material: Ti-6Al-4V ELI of ASTM F136 (Same as predicate/reference).
• Surface Treatment: None (Same as predicate; justified difference from reference).
• Sterilization: End User (Steam) (Same as predicate/reference where specified).
• Connection Type: Threaded/Internal Hex (Same or similar, justified).
• Dimensions (Diameter, Length, G/H, Post Height): Differ but fall within predicate/reference ranges or justified as not affecting safety/efficacy; mechanical testing confirms suitability. |
  | Biocompatibility | Tested in accordance with ISO 10993 series for various biological endpoints (cytotoxicity, irritation, sensitization, systemic toxicity, implantation effects, chemical characterization). Results implicitly met acceptance criteria as they support substantial equivalence. |
  | Sterilization Validation | For HEXIM Implants (sterile): ISO 11137 series.
  For Abutments (non-sterile, end-user steam): ANSI/AAMI ST79:2017 & ISO 17665 series. LAL bacterial endotoxin testing also performed. Results implicitly met acceptance criteria. |
  | Shelf-Life | Established via accelerated aging per ASTM F1980-2021 at 5 years for HEXIM Implants. |
  | Mechanical Performance (Bench Testing) | - Fatigue Testing: Performed per ISO 14801:2007 using worst-case geometries. Results met criteria.
• Implant-to-Abutment Compatibility: Determined through mechanical testing. Results implicitly met criteria.
• Surface Analysis (SLA): Chemical and visual analysis performed to ensure no blasting particles/chemicals remain. Results implicitly met criteria. |
  | MRI Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque. Justified as safe. |

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

This information is not applicable as this is a medical device clearance for physical implants and abutments, not an AI/software device. The "test set" here refers to physical samples used in bench testing.

• Sample Size: Not explicitly stated for each bench test (e.g., number of implants for fatigue testing). The tests were performed on "representative final manufactured samples."
• Data Provenance: Not applicable. Tests are conducted in a lab environment (e.g., ISO-certified labs for mechanical and biocompatibility testing).
• Retrospective or Prospective: Not applicable. Bench testing is a controlled, experimental process, not typically classified as retrospective or prospective clinical data.

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)

This information is not applicable. Ground truth establishment by experts pertains to diagnostic AI models. For physical implants, "ground truth" is established through physical and chemical measurements against engineering specifications and international standards, and results are interpreted by engineers and scientists.

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

This information is not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic studies for AI. For bench testing, results are objective measurements against defined standards.

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. MRMC studies are for evaluating diagnostic performance, particularly with AI assistance. This submission is for physical dental implants and abutments.

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

This information is not applicable. Standalone performance refers to AI algorithm performance. This is a physical device.

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

For this device, the "ground truth" for demonstrating safety and effectiveness includes:

• Engineering Specifications: Design drawings, material specifications (e.g., ASTM F67, ASTM F136).
• International Standards: ISO 14801 (fatigue), ISO 10993 series (biocompatibility), ISO 11137 / ANSI/AAMI ST79 / ISO 17665 series (sterilization).
• FDA Guidance Documents: "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
• Pre-market Review Precedents (Predicate Devices): The performance and safety profile of the legally marketed predicate devices (K111889, K190641, K221866, K222792) serve as the established "ground truth" for substantial equivalence.

8. The sample size for the training set

This information is not applicable. There is no "training set" for physical medical devices in the context of AI/machine learning.

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

This information is not applicable. There is no "training set" for physical medical devices that requires ground truth establishment in the AI sense. The design and manufacturing processes follow established engineering principles and quality systems (21 CFR Part 820), which ensure the product meets its intended specifications.

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