(267 days)
JDZygoma Dental implant is a JDentalCare implant system.
JDZygoma Dental implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxilla, in order to restore patient esthetics and chewing function.
The JDZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
JDZygoma dental implants are implantable devices produced in commercially pure titanium, intended to be integrated in the Zygomatic bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function.
The JDZygoma implant bodies are single use, gamma sterilized devices that shall be used by qualified medical personnel. The abutments are supplied non sterile and must be sterilized prior to use.
The JDZYGOMA DENTAL IMPLANTS includes 2 lines of devices with different body diameters of implants (3.9 mm and 4.3 mm) with different implant lengths:
- Diameter(mm) 3.9 Lengths (mm): 30 / 35 / 37.5 / 40 / 42.5 / 45 / 47.5 / 50 / 52.5 / 55 / 57.5 ●
- Diameter(mm) 4.3 Lengths (mm): 30 / 35 / 37.5 / 40 / 42.5 / 45 / 47.5 / 50 / 52.5 / 55 / 57.5 .
The surfaces JDZYGOMA DENTAL IMPLANTS, both 3.9 mm and 4.3 mm of diameter, is machined in the distal part of the fixture while the apical part, the threaded part, is characterized by a surface that is a SLA surface obtained through a sandblasting process followed by acid etching.
Machined surface has been analyzed form a morphological point of view using scanning electron microscope (SEM) with different level of magnification (100x, 500x, 1000x and 250x) and also performing a 3D analysis, that allow to define roughness profile with an average height of selected area (Sa) equal to 0.64 um, with a Root mean square gradient (Sdq) of 1.06 and a developed interfacial area ratio (Sdr) of 47.64%.
The abutments are made of titanium grade 5 and have the following angulations:
- . 45° 52.5° and 60°
The connection implant / abutment is done through an internal hexagon.
The conical abutments surface is completely treated with anodic oxidation resulting in perception of yellow color.
The anodization process is performed by immersing the anodization solution and by providing an electrical voltage for a time necessary to activate the process with the material (titanium grade 5) and then performing washing process and drying the devices.
The result of this process has been evaluated from a morphological point of view using scanning electron microscope (SEM), measuring the roughness parameters and performing qualitative analysis of the chemical composition of the abutments surface with X-Ray detector considering and comparing both a non anodized abutments and the same anodized abutments in their finished forms.
These evaluations show a relatively uniform surface with characteristic textures of typical machined titanium, clean and free from significant residues or contaminants, with a morphology of the surface before and after anodization that doesn't show appreciable differences also for roughness and X-ray analysis identify a presence of only of Ti, Al, V, O, as expected.
The provided text is a 510(k) summary for the JDZygoma dental implants, which is a medical device. This type of document is a submission to the FDA demonstrating that the device is as safe and effective as a legally marketed predicate device. The information required in the prompt (acceptance criteria, study details, etc.) is typically found in performance studies used to support substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for specific performance metrics with corresponding reported values in a pass/fail format. However, it describes several performance tests and their outcomes:
| Performance Test / Criterion Type | Reported Device Performance (Implied Acceptance) |
|---|---|
| Biocompatibility | Conducted according to ISO 10993-1:2018 and ISO 10993-5. (Implies compliance with these standards, meaning the device is biocompatible). |
| Washing Process | Demonstrated that no residual substances were present on implant or abutment surface. (Implies successful cleaning and absence of harmful residuals). |
| Packaging Shelf Life | Accelerated aging testing conducted according to ISO 11607-1. (Implies meeting the shelf-life requirements of this standard). |
| Mechanical Fatigue | Comparative mechanical fatigue testing was performed according to a method modified from ISO 14801. Results confirm that fatigue performances of the subject device are comparable to or better than both predicate and reference Devices. (Implies the device meets or exceeds the mechanical durability of predicate/reference devices). |
| Gamma Ray Sterilization | Validation in accordance with ISO 11137-1:2006 and ISO 11137-2: 2013. (Implies effective sterilization and compliance with these standards). |
| Endotoxin Tests | Performed on all batches to demonstrate that pyrogen limit specifications through LAL test according to the United States Pharmacopeial Convention is always respected. (Implies the device is non-pyrogenic). |
| Clinical Survival Rate | Survival rates of the 3.9mm and 4.3mm implants which met the criteria for successful implant osseointegration, were 100% for both studies. (Implied acceptance based on comparison with existing clinical expectations for dental implants. High survival rates are a key indicator of clinical success). |
| Clinical Complications | No differences were registered among clinical indices related to the different abutments inclinations (modified Plaque Index (mPLI), modified Bleeding Index (mBI), Mucosal Seal Efficacy Evaluation (MSEE) and Zygomatic Implants Classification Level (ZICL)). (Implies that different abutment angles do not lead to increased complications). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Clinical): 143 JDZygoma dental implants in a total of 66 patients.
- Data Provenance: The studies were retrospective studies. The country of origin of the data is not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical studies. It states that "Outcome measures were evaluated," but doesn't specify who performed these evaluations or their credentials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the clinical study outcomes.
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
This section is Not Applicable to the provided document. The JDZygoma dental implant is a physical medical device (dental implant and abutments), not an AI/software device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable for the same reasons as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical studies, the ground truth was outcomes data including:
- Implant/abutment success (defined by criteria for successful implant osseointegration)
- Prosthetic survival
- General postoperative complications
- Secondary outcomes: Modified Plaque Index (mPLI), modified Bleeding Index (mBI), Mucosal Seal Efficacy Evaluation (MSEE), and Zygomatic Implants Classification Level (ZICL).
8. The sample size for the training set
The document refers to retrospective studies and does not mention a separate "training set" in the context of device development or validation. The "143 JDZygoma dental implants in a total of 66 patients" represent the clinical data used for validation, not a separate training set as would be typical for AI/machine learning.
9. How the ground truth for the training set was established
As there is no described "training set" in the context of AI/machine learning, this point is Not Applicable. The clinical "ground truth" (outcomes data) for the retrospective studies was established by evaluating the performance of the implants in patients post-surgically, as described in point 7.
§ 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.