(126 days)
Southern Implants Zygomatic System Standard implants, Zygan (narrow apex) implants, and Oncology implants are intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
This submission includes fully threaded and partially threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon abutment interface angled 55° at the head of the implants are provided in three designs: Standard implant, fully threaded, diameter 4.3 mm (coronal) tapering to 3.8 mm (apical), in lengths of 30 mm and 57.5 mm; Zygan implant, partially threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in lengths from 30 mm to 57.5 mm; and Oncology implant, partially threaded diameter 4.3 mm (coronal) tapering to 3.8 mm (apical), in lengths from 30 mm to 47. 5 mm.
This submission includes additional designs of Compact Conical Abutments (gingival heights 2, 3, 4, and 5.5 mm) for use with any of the implants. This submission also includes a Titanium Cylinder Abutment, for use with the Compact Conical Abutments, with a collar (gingival) height of 5 mm, and a prosthetic platform diameter of 3.4 mm. All subject device abutments are for support of screw-retained overdenture prosthetic restorations.
All subject device implants are manufactured from unalloyed titanium conforming to ASTM F67. The threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K093562. The subject device Compact Conical Abutments are manufactured from titanium alloy conforming to ASTM F136. The subject device Titanium Cylinder Abutment is manufactured from unalloyed titanium conforming to ASTM F67. All of the subject device components are manufactured in the same facilities using the same manufacturing processes as used for the previously cleared predicate devices in K093562 and K070841.
Based on the provided text, the document is a 510(k) Premarket Notification for the Southern Implants Zygomatic Implant System. This document does not describe a study involving an AI/Machine Learning device. Instead, it proves the substantial equivalence of a dental implant system to previously cleared predicate devices through non-clinical performance data and comparison of technological characteristics.
Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to this document.
However, I can extract information related to the acceptance criteria and the study (referred to as performance data) that proves the dental implant device meets those criteria.
Here's a breakdown of the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of acceptance criteria with corresponding performance numbers in the way an AI/ML study would. Instead, substantial equivalence is demonstrated through:
- Identical intended use: The Zygomatic Implant System is intended to support fixed or removable dental prostheses in patients with partially or fully edentulous maxillae, identical to the predicate device.
- Similar technological characteristics: Comparisons are made regarding design, dimensions (platform diameter, implant diameter, implant lengths, threaded lengths, connection angle), abutment design, interface, gingival height, abutment angle, prosthesis attachment, and materials.
- Equivalent non-clinical performance: Biocompatibility, engineering analysis, dimensional analysis, sterilization validation, and dynamic compression-bending testing are the "performance data" used to demonstrate equivalence.
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | Reported Device Performance / Evidence |
|---|---|
| Intended Use Equivalence | The Indications for Use Statement for the subject device is similar to the primary predicate device (K093562). The subject device's statement includes additional Zygan and Oncology implants, but "the slight differences in wording... do not affect the intended use as dental implants placed into the zygoma for rehabilitation of the edentulous maxilla." |
| Design Equivalence (Implants) | Standard Implant: Identical design to K093562, with additional lengths. |
| Zygan Implant: Substantially equivalent design to K093562 (differences: non-threaded region, tapering diameter to 3.4 mm at apex, range of lengths). These differences were accounted for by additional labeling instructions without impacting safety/effectiveness. | |
| Oncology Implant: Substantially equivalent design to K093562 (differences: non-threaded region, range of lengths). Reference to K151909 for substantial equivalence of Oncology implant design and range of implant lengths. | |
| Overall: Fully and partially threaded root-form implants for placement into the zygomatic bone. Platform Ø 4.05 mm (identical to predicate). Implant connection angle 55° (identical to predicate). | |
| Design Equivalence (Abutments) | Compact Conical Abutments: Identical design to K070841, with only difference being additional sizes of gingival height (2.0 mm - 5.5 mm vs 1 mm for predicate). Reference to K070841. |
| Titanium Cylinder Abutment: Identical design to K053478, with only difference being a change in gingival height (5 mm vs unspecified for predicate). Reference to K053478. | |
| Overall: One-piece, compact conical design. External hex; 55° angulation at head of implant. 0° (straight) abutment angle. Screw-retained, multi-unit prosthesis attachment. | |
| Materials Equivalence | Implants: Unalloyed titanium, ASTM F67 (identical to predicate). |
| Abutments: Unalloyed titanium, ASTM F67; Titanium alloy, ASTM F136 (identical to predicate). | |
| Surface Treatment: Identical aluminum oxide grit-blasted surface as implants cleared in K093562. | |
| Biocompatibility: Supported by materials being identical in formulation, processing, component interactions, and storage conditions to predicate devices (K093562 and K070841). | |
| LAL Test: Conducted according to USP 39-NF 34 Bacterial Endotoxin Test, using kinetic chromogenic method. | |
| Sterilization & Packaging Equivalence | Provided sterile for single-patient, single-use, identical to predicate devices. Subject device and predicate devices are packaged in similar materials and sterilized using similar methods. The subject device packaging is mostly the same as K093562, with a minor difference in additional packaging of the implant and mount within a rigid plastic cylinder inside the PET tray. This change was addressed with specific labeling precautions for handling and removal to maintain sterility. |
| Mechanical Performance Equivalence | Dynamic compression-bending testing was performed according to ISO 14801 ("Dentistry - Implants - Dynamic fatigue test for endosseous dental implants") on worst-case subject device constructs. |
| Result: "The results from the testing demonstrated fatigue performance substantially equivalent to that of the reference device K141777." The reference device K141777 is also cited for substantial equivalence of the range of implant lengths and mechanical performance. | |
| Clinical Performance (Retrospective Data) | A retrospective study was referenced to support the oncology implant design. |
| Sample Size: 40 implants in 20 subjects. | |
| Performance: Demonstrated 100% implant success and no soft tissue complications up to 96 months. | |
| Source: Boyes-Varley JG, et al., Int J Prosthodont 2007; 20:521-531. |
2. Sample sizes used for the test set and the data provenance
- Non-clinical testing: No specific "test set" sample sizes are given for the engineering, dimensional, biocompatibility tests (these often rely on established standards and in-vitro methods).
- Clinical Data (referenced for Oncology implant):
- Sample Size: 40 implants in 20 subjects.
- Data Provenance: Retrospective (from a published study: Boyes-Varley JG, et al., 2007). The country of origin is not explicitly stated in this document but the journal International Journal of Prosthodontics is international, and one of the authors for the referenced paper (Boyes-Varley) appears to be associated with South Africa (which is also the manufacturer's location).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a dental implant device approval based on substantial equivalence to existing devices, primarily through non-clinical testing and referencing a retrospective clinical study. "Ground truth" in the AI/ML sense (e.g., expert labels on images) is not relevant here. The "ground truth" for the retrospective clinical study would be observed patient outcomes.
4. Adjudication method for the test set
Not applicable. There's no expert adjudication process mentioned for this type of device.
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 is for a physical medical device (dental implant), not an AI/ML 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 device, not an algorithm.
7. The type of ground truth used
For the retrospective clinical data referenced for the Oncology implant:
- Type of Ground Truth: Clinical outcomes data (implant success, soft tissue complications).
For the non-clinical performance data (biocompatibility, mechanical testing, etc.):
- Type of Ground Truth: Compliance with established international standards (e.g., ISO 14801, ISO 17665-1, ISO TS 17665-2, USP 39-NF 34 ) and comparison to the performance of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.