(267 days)
Zit-z dental implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. They are indicated for single or multiple unit restorations in splinted or non-splinted applications. The zit-z dental implants are restored with fixed/cemented crowns and bridges. Not for immediate loading.
The 3.5mm implant is contraindicated for restorations of the posterior teeth in the upper or lower jaw and for single-tooth restoration of canines and central incisors in the upper jaw.
Zit-z Dental Implant System is a root-form dental implant system with a one-piece cylindrical screw implant design. They have a pentagonal geometry anti-rotation feature which also provides ease of insertion. They are made from HIP zirconium dioxide ceramics (3Y-TZP) which meets (SO 13356.
The provided text describes a 510(k) submission for the Zit-z Dental Implant System, focusing on its substantial equivalence to previously cleared devices. The "study" mentioned is primarily a conformity assessment based on existing standards and predicate devices, rather than a prospective clinical trial designed to prove device performance against specific acceptance criteria in a robust statistical manner as one might expect for novel technology.
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense with corresponding reported device performance metrics that are typically seen in studies for AI/software devices (e.g., sensitivity, specificity, AUC). Instead, the submission focuses on demonstrating substantial equivalence based on material properties, design, and existing standards.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Mechanical Integrity/Durability: Satisfactory fatigue resistance in accordance with ISO 14801. | "Fatigue testing according to ISO 14801 was completed satisfactorily." |
| Clinical Efficacy/Safety: Ability to function as intended for support of prosthetic devices, restoring esthetics and chewing function, with no significant safety issues. | "Canine data was submitted." |
| "Successful clinical case study data was provided along with some cases of human histology." | |
| "The nonclinical and clinical data show the implants can be used successfully and will withstand the fatigue forces necessary for their use." | |
| "The predicate device Z-Look3 has been used successfully clinically for several years and has not been found to have fatigue issues either." (This points to the assumption of equivalence based on predicate's performance.) | |
| Biocompatibility/Material Equivalence: Material (Y-TZP) is equivalent to legally marketed predicate devices. | Material is "Y-TZP" and "of the same material (zirconia)...as Nobel Biocare's ceramic implant and the Z-Look3." A difference in Y-TZP preparation method (coating vs. co-precipitation) is noted, but implied to be equivalent. |
| Design Equivalence: Similar design (one-piece screw implant) and dimensions (diameter, length) to predicate devices. | "one-piece screw implant." Diameters and lengths are "within the range cleared for Z-Look3." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data): The document mentions "Canine data was submitted" and "Successful clinical case study data was provided along with some cases of human histology." Specific sample sizes are not provided.
- Data Provenance: The document states "Canine data" (animal study) and "clinical case study data" with "human histology."
- The term "clinical case study data" suggests retrospective data or a small, possibly observational, prospective series rather than a large, controlled clinical trial. The origin country is not specified for these clinical cases, but the manufacturer is based in Germany.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. The submission does not describe a process for establishing ground truth via expert consensus in the way one would for diagnostic or AI algorithm studies. The "clinical case study data" and "human histology" would have been evaluated by treating clinicians and pathologists, but their specific number, role in establishing a 'ground truth' for a test set, or qualifications are not described. The evaluation seems to be focused on the successful outcome of the implant procedure itself, rather than assessing an interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. No formal adjudication method (like 2+1, 3+1) is mentioned, as the "study" described is not an interpretation task but rather a conformity and performance assessment of a medical device (dental implant).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for evaluating human interpretation performance, often with and without AI assistance. This submission describes an implantable device, not a diagnostic imaging or AI interpretation tool. Therefore, such a study was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is not an algorithm or AI device. The "device" is a physical dental implant. Standalone performance, in this context, refers to the implant's mechanical and biological performance independently, which is partially addressed by the ISO 14801 fatigue testing.
7. The Type of Ground Truth Used
- Clinical Outcomes/Histology/Mechanical Testing:
- For the "clinical case study data," the 'ground truth' would be the successful long-term integration and function of the implant in patients, observed through clinical follow-up.
- "Human histology" would provide a 'ground truth' on the tissue-implant interface and bone integration.
- For fatigue testing, the 'ground truth' is compliance with the ISO 14801 standard, where the implant either passes or fails the specified load cycles.
8. The Sample Size for the Training Set
- Not Applicable. This document does not describe an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML algorithm or "training set," this question is not relevant to the provided text.
§ 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.