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510(k) Data Aggregation
(164 days)
JDEvolution Plus L and JDEvolution Plus LE implant system is intended for surgical placement in the upper jaw.
JDEvolution Plus L and JDEvolution Plus LE implant system provides a means for prosthetic attachment in partially or fully edentulous spans with multiple teeth utilizing delayed, or immediate loading, or as a terminal or intermediary abutment for fixed ore removable bridgework or to retain overdentures. JDEvolution Plus L and JDEvolution Plus LE is intended for immediate function multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
JDEvolution Plus L and JDEvolution Plus LE implants with lengths of 18, 20, 22, 24, 26 mm are only indicated for multiple unit restorations in splinted applications with at least two implants when placed in the maxilla.
JDEvolution Plus L and LE, are tissue level implantable devices produced in commercially pure titanium, intended for surgical placement in the upper jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function.
JDEvolution Plus L and LE are endosseous dental implants intended for surgical placement in the upper jaw. JDEvolution Plus L and LE implants includes dental implant fixtures only.
JDEvolution Plus L and LE provide a means for prosthetic attachment partially or fully edentulous spans with multiple teeth utilizing delayed or immediate loading when good primary stability is achieved in order to restore patient chewing function.
The subject implant bodies are compatible with abutments cleared in K143142 and K233896
Knowledgeable clinicians are in charge for the following of a delayed instead immediate loading, evaluating the stability of the implant sites after the surgical operation.
The device insertion occurs at the end of the surgical procedure which consists in an osteotomy of the upper jaw.
JDEvolution Plus L and LE implants are single use devices, supplied sterile and that cannot be re-cleaned or re-sterilised.
JDEvolution Plus L and LE Implant System is a two-piece implant made of commercially pure titanium.
The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.
The connection is done through an internal hexagon: abutments and other accessories are exclusively designed for JDEvolution Plus L and LE Implant System.
Endosseous dental implant and abutment will represent the support, for the dentist, for building the artificial replacement tooth.
The artificial replacement tooth component is not part of this submission.
The main features of JDEvolution Plus L and LE Implant System are summarized in the table below:
JDEvolution Plus:
Materials: Titanium grade 4 (diameter 4.0)
Design:
General Features: Endosseous implant with connection with internal hexagon
Shape:
Collar: Machined gingival collar of 1,5mm length for all the lengths
Body: Double thread with 0.6 mm lead: straight cylindrical of 4,0 mm diameter for a total length (including collar) of 20 / 22 / 24 / 26mm. Tapered apex with bone cutting flutes.
Double thread with 1.2 mm lead: tapered body of 4,0 mm for a total length (including collar) of 18 / 20 / 22 / 24 / 26mm
Thread: Double thread with 0.6 mm or 1.2 mm lead
Abutment: To be connected with the Conical abutment cleared under K143142, K233896
Ti gr.5: Straight– angled 15° - angled 17° - angled 25°- angled 30°
Surface:
Collar: Machined, without any surface treatment
Body: Treated through sandblasting followed by acid etching (SLA) for the full length of the endosseous portion for all variants (the surface treatment is the same of the JDentalCare Implant System JDIcon cleared under K 182081)
Thread:
Body: Double thread
outline: trapezoidal
Thread lead: 0.6 mm (for tapered body version)
Thread lead: 1.2 mm (for straight cylindrical body version)
Self-Threading Capacity: Self-threading capacity in both direction
Dimensions:
Mean Diameter: 4.0 mm
Total Length: 18mm (only for JD Evolution Plus LE Implant), 20mm, 22mm, 24mm and 26mm
Implanted Length: 16.5mm (only for JD Evolution Plus LE Implant), 18.5mm, 20.5mm, 22.5mm and 24.5mm
Connection:
Shape: Internal hexagonal connection (Hexagon dimension of 2.425 mm)
Packaging:
Type of package: Blister with internal vial and protective cap for implants
External carton box as commercial packaging
Blister material: Tyvek
Polyester PET MO65
Vial material: Polystyrene Empera 116 vial closed with Eralyte PET cap
N/A
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(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.
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(249 days)
JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.
.DentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare Dental Implant System is intended for immediate function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a one-stage surgical approach is applied, the immediately loaded when good primary stability is achieved and the functional load is appropriate.
Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
JDental Care implant system JDIcon 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single stage or two stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations
JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery.
In order to grant Dentists with a wide range of prosthesis solution, the JDentalCare® Dental Implant System are proposed with different trade name within families lines JDEvolution® plus, JDIcon®, JDIcon® plus, characterized mainly by same mechanical and surface treatment solution and different measure of the hexagon in the connection system. All families have the internal hexagon connection.
JDentalCare® Dental Implant System is a two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.
The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System.
The provided text is a 510(k) Premarket Notification for a dental implant system. It details the device's description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about an AI/ML-enabled medical device.
Therefore, I cannot extract information related to acceptance criteria and the study proving the device meets those criteria for an AI/ML device, as the document describes a physical dental implant system and not an AI/ML product.
The sections regarding acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training sets are all relevant to the evaluation of AI/ML models. Since this document is about a physical medical device (dental implants), these concepts are not applicable in this context.
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