(242 days)
The Zuga-Dental-Implant-System-is-indicated-for-immediate-or-delayed-implant-placement-forsurgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading
The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, gum shapers, dental implant abutments and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one- or two-stage procedures.
Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is aluminum oxide (Al2O3) blasted then passivated. These are offered in diameters from 3.5 to 5.5mm in diameter with lengths ranging from 8mm to 17mm. Sizematched anterior and posterior abutments are offered having post heights from 4.0 to 7.0mm. These are fastened to the implant using a fixation screw. Sealing caps and gum shapers provide protection to the abutment connection threads during endosseous and gingival healing.
The implants are provided sterile, the remaining components must be sterilized prior to use.
The Zuga™ Dental Implant System is a dental implant device, therefore no AI or algorithm performance data is available.
Here's the information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Standard/Criterion | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ISO 14801 (Fatigue testing of dental implants) | Not explicitly stated in quantitative terms but implied to meet the standard. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: . Mechanical testing per ISO 14801." This typically means the device demonstrated acceptable fatigue strength and other mechanical properties as defined by the standard. |
| Cytotoxicity Testing | ISO 10993-5 (Biological evaluation of medical devices – Tests for in vitro cytotoxicity) | Not explicitly stated in quantitative terms but implied to meet the standard. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: Cytotoxicity testing per ISO 10993-5." This indicates the device materials were found to be non-cytotoxic under the tested conditions. |
| Surface Analysis | Not a specific standard, but techniques like FTIR & SEM-EDS were used. | Not explicitly stated in quantitative terms. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: Surface analysis by FTIR & SEM-EDS." This typically means the surface characteristics (e.g., elemental composition, surface topography, cleanliness) were analyzed and found to be consistent with the intended design and predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. For mechanical testing (ISO 14801), multiple samples of each implant size/design would typically be tested. For cytotoxicity, a specified number of samples or extracts would be tested.
- Data Provenance: The data is "pre-clinical testing" and was conducted by Zuga Medical Inc. There is no information regarding the country of origin of the specific lab that performed the tests. This is not human data, so terms like "retrospective" or "prospective" are not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable as the studies are pre-clinical (laboratory and bench testing) and do not involve human expert assessment of outcomes or images. The "ground truth" for these tests are the established parameters and passing criteria defined by the ISO standards and accepted engineering principles.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for discrepant interpretations in human reader studies, which were not conducted here.
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
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. The submission explicitly states: "No clinical data was used in support of this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
- The ground truth for the pre-clinical tests (mechanical, cytotoxicity, surface analysis) is defined by the established international standards (ISO 14801, ISO 10993-5) and generally accepted engineering and material science principles. These standards set the benchmarks and criteria for acceptable performance and material safety.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" as this is not an AI/ML device.
§ 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.