Search Results

JTK One-Piece Integrated Implant System:

The JTK one-piece integrated dental implant system is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

JTK Two-Piece Implant System:

The JTK two-piece dental implant system is comprised of dental implant fixtures and prosthetic devices a two-piece implant system. The implants are intended for use in the mandla, in support of single unit or multiple unit cement or screw-receiving restorations and support of overdentures. The implants are intended for immediate placement and function for the support of single tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

The JTK Dental Implant System is offered in two different models consist of a one-piece integrated implant system where the implant and abutment are machined from the same piece of titanium, and a traditional two-piece implant system that consists of an implant and abutment that are made from different pieces titanium and held together by way of a supplied titanium healing cap is also supplied with the two-piece implants and abutments are supplied individually packaged and sterile to the end user via gamma radiation. The healing cap is packaged with the implant and the attachment screw is packaged with the abutment. All implant System are made by traditional CNC manufacturing methods. For both models of the implant body, the threaded portion receives a surface modification using sandblasting and acid etching (SLA).

For the one-piece implant system, the implants are offered in two thread diameters (3.0 and 3.3 mm) and in three thread lengths (10, 13 and 15 mm). The integral abutment portion of the implant is contoured and machined, is without a surface modification, and is offered in two platform heights (4 and 6 mm).

For the two-piece implant system, the implants are offered in five thread diameters (3.8, 4.0, 4.5, 5.0 and 5.5 mm) and in four thread lengths (8, 10, 13 and 15 mm). The neck of the implant is conical in shape, 2.5 mm in height and has been machined and is without a surface modification. The two-piece implant bodies are considered a tissue level implant. The abutments that are used with the two-piece system are offered in two different models (straight and angled (15° and 25°). The straight abutments are offered in a diameter of 4.4 mm and in lengths of 4.2, 5.2, 6.2 and 8.2 mm. The 15° angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 8.0 mm, while the 25° the angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 10.5 mm.

The titanium used to manufacture the one-piece implants conform with ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications while the titanium used to manufacture the abutments conform with ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

The provided text is an FDA 510(k) Premarket Notification summary for the JTK Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices through comparisons of device characteristics and non-clinical performance data.

Crucially, this document describes a dental implant system, a physical medical device, not a software or AI/ML-based device. Therefore, the concepts of acceptance criteria for algorithm performance (like sensitivity, specificity, AUC), ground truth experts, adjudication methods, MRMC studies, or training/test sets in the context of an AI/ML algorithm are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical performance testing required for medical devices to demonstrate safety and effectiveness and substantial equivalence to existing predicate devices.

Here's an interpretation based on the provided text, aligning with the type of device being discussed:

1. A table of acceptance criteria and the reported device performance:

The "acceptance criteria" here are generally international standards and FDA guidance documents that the device must conform to for safety and performance. The "reported device performance" indicates whether the device passed these tests.

2. Sample size used for the test set and the data provenance:

For this type of physical device, "sample size" refers to the number of physical units tested. The document does not specify exact numbers for each test (e.g., how many implants were tested for fatigue). The provenance is "Jiangyin Jintech Biotech Co., Ltd." in "Jiangyin City, Jiangsu Province, China," as they conducted the performance testing. These are non-clinical (laboratory) studies.

• Sample Size: Not explicitly stated for each test (e.g., number of implants for fatigue testing), but implied to be sufficient to meet the requirements of the standards.
• Data Provenance: Non-clinical (laboratory) testing conducted by Jiangyin Jintech Biotech Co., Ltd. in China.
• Retrospective or Prospective: These are laboratory tests specifically conducted for the submission, so they are prospective in nature to generate data to support the 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable here. Ground truth is typically established for diagnostic or AI/ML performance. For a dental implant, "ground truth" relates to its physical and biological performance as measured by objective tests (e.g., fatigue strength, biocompatibility, sterilization efficacy) against established international standards. The "experts" are the engineers, scientists, and technicians who design, conduct, and analyze these standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists interpreting images) to resolve disagreement. For physical device performance testing, the results are typically quantitative measurements against objective criteria, not subjective interpretations requiring adjudication.

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 concept is not applicable. An MRMC study is relevant for AI/ML-assisted diagnostic devices. This submission concerns a physical dental implant. There are no "human readers" or "AI assistance" in the context of this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This concept is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this medical device is the adherence to established international consensus standards (e.g., ISO, ASTM) and FDA guidance for the physical, chemical, and biological properties of dental implants. For instance, the "ground truth" for fatigue is whether the implant can withstand 5x10^6 cycles without failure as per ISO 14801. The "ground truth" for biocompatibility is whether it passes cytotoxicity and pyrogen tests per ISO 10993. These are objective, quantifiable standards, not subjective interpretations.

8. The sample size for the training set:

This concept is not applicable. There is no "training set" for a physical dental implant system in the AI/ML sense. The "training" for such a device occurs during its design and manufacturing processes, where iterations and refinements are made to meet engineering specifications and regulatory requirements.

9. How the ground truth for the training set was established:

This concept is not applicable. Since there is no "training set" in the AI/ML context, there's no ground truth established for it. The "ground truth" for the device's design and manufacturing quality relies on engineering principles, material science, and adherence to quality management systems (e.g., 21 CFR Part 820 Quality System Regulation).

Ask a specific question about this device

The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment and Screw are compatible with the following:

• Sweden & Martina Premium Implant System 3.3mm and 3.8mm

The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with:

• Sweden & Martina Premium Implant System 3.3mm and 3.8mm
  The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.

The CreoDent Solidex® Customized Abutment and Screw is a dental device intended for use with endosseous implants to support prosthetic devices. The information provided outlines the acceptance criteria and the study that proves the device meets these criteria as part of a 510(k) premarket notification.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "test set" in terms of a patient population size for clinical data. The testing described is primarily non-clinical:

• Non-clinical Testing Data: Static/Fatigue testing in accordance with ISO 14801:2007E. The sample sizes for these mechanical tests are not specified (e.g., number of abutments and screws tested).
• Dimensional Analysis: Conducted using OEM implant bodies, OEM abutments, and OEM abutment screws. The number of samples for this analysis is not specified.

The data provenance is from non-clinical laboratory testing and reverse engineering dimensional analysis, rather than patient-derived data from a specific country, and is therefore not retrospective or prospective in the clinical sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as the studies described are non-clinical (mechanical and dimensional testing) and do not involve human expert interpretation or ground truth establishment in the traditional sense of clinical imaging or diagnostic studies. The "ground truth" for these tests would be the established engineering standards (e.g., ISO 14801:2007E), and the manufacturing specifications for the device and compatible implants.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. There was no "test set" requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical and material equivalence of a dental abutment and screw to an existing predicate device using non-clinical testing. It does not involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical medical device (dental abutment and screw), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

• Industry Standards: ISO 14801:2007E for dynamic fatigue testing.
• Manufacturer Specifications: OEM implant bodies, OEM abutments, and OEM abutment screws for reverse engineering dimensional analysis.
• Regulatory Standards: ASTM F-136 for material composition (Ti-6A1-4V Eli titanium alloy).
• Previous Biocompatibility Data: Leveraged from their previous 510(k) (K150012).

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical dental implant component, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the reasons stated above.

Ask a specific question about this device