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510(k) Data Aggregation
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The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths. The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.
This document is a 510(k) premarket notification for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study that proves the device meets specific performance acceptance criteria for a new and innovative AI/software functionality.
Therefore, many of the requested items (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for AI, effect size of human reader improvement with AI) are not applicable or extractable from this document as it pertains to a medical device (dental implant system), not an AI/Software as a Medical Device (SaMD).
However, I can extract information related to the non-clinical testing performed to establish substantial equivalence for this physical device.
Summary of Acceptance Criteria and Proving the Device Meets Them (Based on the Provided Document which is for a Physical Medical Device - Dental Implant System)
This 510(k) submission establishes substantial equivalence for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System to legally marketed predicate devices. The "acceptance criteria" here are not about software performance metrics but rather about demonstrating that the new device shares fundamental scientific technology, materials, design, and performance characteristics with existing devices, and that any differences do not raise new questions of safety or effectiveness. The "study" largely refers to non-clinical testing and comparison to predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Demonstrated) | Reported Device Performance / Assessment |
|---|---|---|
| Intended Use | The device is used in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework, for single and two-stage surgical procedures, intended for delayed loading. | Demonstrated Equivalence: The subject device (LOTA SLA/HA Dental Implant System) has the same indications for use as the primary predicate device (KJ Submerged System, K103810). |
| Fundamental Scientific Technology | The device should employ similar principles and mechanisms as legally marketed devices. | Demonstrated Equivalence: The subject device and the predicate device (KJ Submerged System, K103810) have the same fundamental scientific technology. |
| Materials | Biocompatibility and mechanical properties of materials (Titanium 6AL 4V ELI alloy, ASTM F136). | Demonstrated Equivalence: The subject and predicate devices employ the same materials (Titanium 6AL 4V ELI alloy, ASTM F136). |
| Design | Similar design elements (Implant Type: Bone Level, Connection Type: Internal Locking Taper, Neck Design: Straight walled neck, Body Design: Tapered) and dimensional ranges (diameters, lengths). | Demonstrated Similarity/Mitigation: The subject and predicate devices have very similar in design. Differences identified (fixture thread design, fixture size, abutment design) were addressed by identifying reference devices with similar features and size ranges (Bicon Implants K092035, J2a/J2c Dental Implant System K150060, MegaGen AnyRidge® Implant System K170044) to demonstrate these changes do not raise new concerns. |
| Surface Treatment | The SLA treatment should not introduce new safety concerns (e.g., biocompatibility, residual contaminants). | Mitigation/Equivalence: The SLA treatment is a difference from the primary predicate's RBM Treatment/HA Coating. This was addressed by identifying a reference device made by the same company (J2A SLA Dental Implant System, K161923) that goes through the same manufacturing processes and has the same material/surface treatment. Additionally, SEM analysis was performed to validate no residual contaminants remained on the implants. |
| Sterilization & Shelf Life | The device must be adequately sterilized and maintain sterility and integrity over its shelf life. | Testing Performed: Sterilization validation testing was conducted in accordance with ISO 11137-1 and 11137-2 (Gamma sterilization). Shelf life validation tests were performed in accordance with ASTM F1980-7, ASTM F88, ISO 11607, and ISO 11737-2. The results support substantial equivalence. |
| Endotoxins | Endotoxin levels must be within acceptable limits for lot release. | Testing Performed: Endotoxin testing for lot release was evaluated in accordance with USP 39 , confirming the endotoxin limit is 0.5 EU/mL. |
| Risk Management | Risks associated with modifications must be identified and mitigated. | Risk Analysis Conducted: Risk analysis was conducted according to ISO 14971 to evaluate the effect of the modifications. The activities/tests listed above (identification of reference devices, sterilization/shelf-life validation, endotoxin testing, SEM analysis) were performed based on this analysis to mitigate identified potential risks. |
Regarding AI/Software specific criteria (not applicable for this document):
The provided document is a 510(k) premarket notification for a physical medical device (dental implants). It is not for a software or AI device. Therefore, the specific questions related to AI/Software performance, test sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not detailed or relevant in this context.
If this were an AI/Software as a Medical Device (SaMD) submission, these sections would be crucial. Since it's for a physical implant, the "acceptance criteria" are based on material properties, design, manufacturing processes, intended use equivalence to predicates, and standard biological and physical testing.
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