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For Strong SW HE Implants

S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

S.I.N. Dental Implant System implants with lengths of 18, 20, 22, or 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For Zygomatic Implants and Abutments

S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components to the S.I.N. Dental Implant System cleared in K170398, including a line of zygomatic dental implants and abutments.

The subject device Strong SW HE dental implants are nearly identical to the Strong SW HE dental implants cleared in K170398, with a cylindrical design that tapers slightly to the apex, a body/endosseous thread diameter of 3.75 mm, and a platform diameter of 4.1 mm. This submission adds overall lengths of 18, 20, 22, and 24 mm. The endosseous threads have a uniform trapezoidal design and have an acidetched surface. The implants have an external hexagon ("HE") abutment interface connection, internal threads, and an internal hexolobular feature for instrument attachment.

The subject device Zygomatic dental implants have a body diameter of 4.5 mm at the coronal end and a body diameter of 3.85 mm at the apical end with additional tapering to the apex. The abutment platform is 4.1 mm and is angled 45° to the long axis of the implant. The coronal end of the Zygomatic implants have a micro-channel surface feature starting at approximately the angled abutment platform extending over a length of approximately 2.9 mm; the micro-channel blends to a micro-thread and extends apically over a length of 2.15 mm. The micro-thread major diameter is 4.5 mm. All Zygomatic implants also are threaded over a length of 10.7 mm at the apical end with a major thread diameter of 3.85 mm. The endosseous threads at the apical aspect of the Zygomatic implants have the same uniform trapezoidal design and acid-etched surface as the Strong SW HE implants are provided in a range of lengths from 34 mm to 59 mm increments. The implant length is measured from the start of the micro-threads to the apex.

This submission includes an implant cover for the subject Zygomatic implants, with a coronal diameter of 4.1 mm that matches the implant platform, and is threaded to match the internal thread of the Zygomatic implants. This submission also includes Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical; these abutments are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard and Mini Abutment Zygomatic Conical are straight, multi-unit, non-indexed abutments for the external hex connection of the Zygomatic implants. Mini Abutment Zygomatic Standard are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.5 mm), and in gingival heights of 3 mm, and 5.5 mm. Mini Abutment Zygomatic Conical are provided in one platform diameter (4.1 mm), one prosthetic platform diameter (4.8 mm), and in gingival heights of 2 mm, 3 mm, and 4 mm. Each abutment requires a corresponding subject device abutment screw to match the gingival height of the abutment. The Mini Abutment Standard and Mini Abutment Conical are the only abutments that are compatible with the subject device Zygomatic implants. For the Mini Abutment Zygomatic Standard, this submission also includes an Abutment Protector and a castable Co-Cr Base. For the Mini Abutment Zygomatic Conical, this submission also includes an Abutment Protector, Temporary Titanium Cylinder, and a castable Co-Cr Base. A Coping Screw is also included for use with all zygomatic abutments.

The provided document is a 510(k) summary for a medical device (S.I.N. Dental Implant System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set size, ground truth for training set) is not typically included in such a submission.

However, the document does contain information about performance data used to support the substantial equivalence claim.

Here's a breakdown of the available information relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" are stated in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device. Instead, the performance data provided relates to the safety and mechanical integrity of the dental implants. The device performance is demonstrated through conformance to relevant standards and established methods for dental implants.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical performance. The "testing" refers to non-clinical tests (e.g., mechanical, sterilization).
  • For bacterial endotoxin testing: "samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis."
  • For shelf life testing: "samples after 4 years of real time aging."
  • For mechanical strength: "worst-case constructs comprising the subject device Zygomatic implants and compatible subject device Mini Abutment Zygomatic Standard."
• Data Provenance: The data is primarily non-clinical and internal to the manufacturer, leveraging past submissions (K170398) and conducted according to international standards (ISO, ASTM, ANSI/AAMI). No country of origin for the "test set" is applicable in the human data sense. It is all retrospective in the sense that previous testing for predicate devices and ongoing quality control testing is referenced.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this submission, as no human-expert-validated "ground truth" test set (clinical data) was used. The performance data is based on non-clinical engineering and biological safety tests.

4. Adjudication Method for the Test Set

This information is not applicable since no human expert review or adjudication of a clinical test set was involved.

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, as the device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic device. No AI component is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable, as the device is a physical dental implant system and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by engineering standards and biological safety standards. For example:

• Sterility: Defined by a Sterility Assurance Level (SAL) of 10⁻⁶.
• Bacterial Endotoxin: Defined by a quantifiable limit (< 20 EU/device) per standard.
• Mechanical Strength: Defined by performance criteria within the ISO 14801 standard.
• Biocompatibility: Defined by compliance with ISO 10993 standards (leveraged from predicate).

8. The Sample Size for the Training Set

This information is not applicable, as there is no mention of a "training set" for an algorithm. The device design and materials are based on established engineering principles and prior validated devices.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" and associated ground truth for an algorithm.

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