Search Results

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:

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.

Ask a specific question about this device

Indications for Use for Zygoma-S GM Implant:

Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.

Indications for Use for GM Mini Conical Abutment 52° and 45°:

Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

Indications for Use for Coping for Removable Prosthesis:

The product, when used with non-zygomatic implants, is intended to be surgically placed in the bone of the upper or lower jaw, to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.

The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).

The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.

The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.

The provided document is a 510(k) premarket notification for a medical device (Neodent Implant System - GM Zygomatic Implant System). It focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily bench testing, sterilization validation, shelf life validation, and biocompatibility.

Crucially, this document does not contain information about an AI/ML algorithm or a study validating its performance, nor does it detail acceptance criteria for software or AI/ML components. The product being cleared is a set of dental implants and abutments. Therefore, I cannot extract the acceptance criteria and study details for an AI-powered device as requested.

The document discusses performance data in the context of the physical dental implants and abutments, which includes:

• Performance Testing – Bench: Dynamic fatigue testing (ISO 14801), insertion tests, torsion tests, and microscopic analysis of the implant body.
• Surface treatment: Discussion of the NeoPoros surface.
• MR Compatibility testing: Assessment of safety in MRI environments.
• Sterilization validation: Conformance to ISO standards for Gamma Irradiation (implants) and Ethylene Oxide (abutments).
• Shelf Life validation: Based on packaging integrity and physical stability.
• Biocompatibility: Testing per ISO 10993 standards.
• Clinical data: A review of published literature on zygomatic implants, including survival rates and observed complications (not a specific clinical study conducted for this device clearance).

If you are looking for information regarding acceptance criteria and study data for an AI/ML medical device, this document does not provide it, as it pertains to a different type of medical device.

Ask a specific question about this device