(83 days)
Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The ZAGA zygomatic implants are partially threaded root-form dental implants with an external hexagonal abutment interface angled 55° at the head of the implant, and are threaded internally for attachment of mating abutments. The ZAGA zygomatic implants are provided in two designs: the ZAGA Round zygomatic implant (previously named the ZAGA Regular), coronally and apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging of 30 mm and the ZAGA Flat zygomatic implant (previously named the ZAGA Advanced), apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging from 30 mm, with a flat cut into the buccal-facing side of the implant body. Only the length 30, 32.5, 57.5 and 60 mm ZAGA Round zygomatic implants and length 55, 57.5 and 60 mm ZAGA Flat zygomatic implants are a subject of this submission. All ZAGA zygomatic implants are manufactured from unalloyed titanium conforming to ASTM F67. The apically threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K192651. The subject device implants are manufactured in the same facilities using the same manufacturing processes as used for the Southern Implants predicate device previously cleared in K192651.
The provided text is a 510(k) Summary for the Southern Implants ZAGA Zygomatic System, a dental implant device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive independent clinical study data to meet specific numerical acceptance criteria for device performance.
Therefore, the document does not contain a table of acceptance criteria and reported device performance in the typical sense of directly measurable performance metrics (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is demonstrated through a comparison of technological characteristics, materials, and intended use with a predicate device, supplemented by non-clinical and limited clinical data to support similarities or address differences.
However, based on the information provided, here's a breakdown of the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, this document does not present acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, or specificity) that a diagnostic AI device would typically have. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device, specifically:
- Identical Indications for Use: The subject device must have the same indications for use as the predicate.
- Similar Technological Characteristics: The subject device must have comparable design principles, materials, and other characteristics to the predicate.
- Safety and Effectiveness: Demonstrated through non-clinical data (biocompatibility, sterilization, MR safety, mechanical testing) and limited clinical data, showing that any differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (as demonstrated in submission) |
|---|---|
| Indications for Use: Identical to Predicate K192651 | Identical to Predicate K192651 |
| Technological Characteristics: Similar to Predicate K192651 (Implant design, diameter, platform angle, prosthetic diameter, interface, material, endosseous surface, sterility method, usage) | Identical in most aspects (design, diameter, platform angle, prosthetic diameter, interface, material, endosseous surface, sterility, usage). Differences in implant lengths are addressed by clinical and non-clinical data. |
| Material: Unalloyed titanium (ASTM F67) Grade 4 | Manufactured from unalloyed titanium conforming to ASTM F67. |
| Sterilization Method: Gamma irradiation | Sterilized via Gamma irradiation. |
| Mechanical Performance: Meet ISO 14801 standards (for dynamic compression-bending fatigue) | Referenced from K192651 on worst-case constructs; additional lengths do not warrant new testing as per rationale. Existing data demonstrates performance exceeds indication. |
| Biocompatibility: Compliant | Referenced from K192651; materials are identical. |
| Sterile Barrier Shelf Life: Compliant | Referenced from K192651. |
| Bacterial Endotoxin: Compliant | Compliant with USP 39-NF34. |
| MR Safety: Compliant with FDA Guidance | MR Conditional labeling based on scientific rationale and published literature. |
| Clinical Performance: Support additional lengths | A clinical case report and two published articles support the use of longer zygomatic implants, including the new lengths. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not a traditional test set/training set scenario for an AI device. The submission relies on non-clinical testing and existing clinical literature.
- Non-clinical Data:
- Mechanical Testing (ISO 14801): Referenced from K192651. The sample sizes are not explicitly stated in this document but are implied to be sufficient for the prior clearance. It's a lab-based, engineering test.
- Biocompatibility, Sterilization Validation, Shelf Life, Bacterial Endotoxin, MR Safety: These are typically in-vitro or bench tests with specific sample sizes per standard, but the exact numbers are not detailed here. Much of this is "referenced from K192651," meaning the data was established for the predicate device.
- Clinical Data:
- Clinical Case Report: 1 patient for the 60mm length zygomatic implant. The country of origin and whether it's retrospective or prospective are not specified, but case reports are typically retrospective observations.
- Parel et al. (2001): 59 zygomatic implants (lengths 25-60mm). This is a published article; details on provenance (country, retrospective/prospective) are not provided in this summary but are usually available in the full publication.
- Fernández-Ruiz et al. (2021): 40 zygomatic cases (lengths 35-60mm). This is reported as a "prospective randomized clinical study." Details on country of origin are not included here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable to this type of 510(k) submission. This is not an AI diagnostic device where expert ground truth for interpretation is established. The "ground truth" for the device's function is its mechanical integrity, biocompatibility, and clinical performance as an implant, supported by engineering standards and clinical observations/studies.
4. Adjudication Method for the Test Set
Not applicable. As there is no "test set" requiring interpretation or classification by experts, no adjudication method (like 2+1, 3+1) was used.
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 not an AI-assisted diagnostic device, so MRMC studies comparing human readers with or without AI assistance are not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. It is a physical medical device (dental implant).
7. The Type of Ground Truth Used
The "ground truth" for this medical device submission is established through:
- Engineering Standards: Bench testing against established international standards like ISO 14801 for mechanical properties.
- Regulatory Standards: Compliance with biocompatibility, sterilization, and MR safety guidelines.
- Clinical Outcomes/Acceptance: Historical clinical use data (from published literature and case reports) demonstrating successful rehabilitation and patient satisfaction with similar zygomatic implants, particularly at the extended lengths.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.