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The OneQ-SL Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is intended for delayed loading.

The OneQ-SL Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The OneQ-SL Implant system includes the i-Clean OneQ Fixtures which are Internal Octa-connected, non-submerged fixtures. The fixture is made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). The Fixtures are supplied sterile.

This document describes a 510(k) premarket notification for the OneQ-SL Implant System, a dental implant device. Therefore, the information typically requested in your prompt regarding acceptance criteria and study details for an AI/CADe device will not be present. This document does not describe a study that uses AI for diagnostic or screening purposes. Instead, it describes non-clinical testing performed to establish substantial equivalence to a predicate device.

Here's the breakdown of why I cannot answer your prompt with the given document:

• No AI/CADe device: The OneQ-SL Implant System is a physical dental implant, not an AI or CADe (Computer-Aided Detection) device. The document details its material, design, and intended use as a surgically placed implant.
• Substantial Equivalence Study: The document is a 510(k) summary, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is a common regulatory pathway for medical devices that are not high-risk and do not introduce novel technology.
• Non-Clinical Testing: The "study" mentioned here refers to non-clinical tests (packaging, sterilization, fatigue, cytotoxicity) to confirm the device meets certain standards and safety requirements, not to evaluate diagnostic accuracy or human reader performance.

Therefore, the following points from your request cannot be addressed by this document:

1. A table of acceptance criteria and the reported device performance.
2. Sample sized used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Summary of available information (related to non-clinical testing for substantial equivalence):

The document states that the OneQ-SL Implant System underwent the following non-clinical tests to evaluate its performance and demonstrate substantial equivalence to the predicate device (K120847, ET/SS Implant System manufactured by Osstem Implant Co., Ltd.):

• Packaging Test: Performed in accordance with ISO11607-1:2006 and ISO11607-2:2006.
• Sterilization Validation Test: Performed in accordance with ISO11137-1:2006 and ISO11137-2:2013.
• Fatigue Test: Performed in accordance with ISO14801:2007.
• Cytotoxicity Test: Performed according to ISO 10993-5:2009.

Acceptance Criteria and Reported Device Performance (Non-Clinical):

Ground Truth for Non-Clinical Tests: For these non-clinical tests, "ground truth" is established by the methods and requirements specified in the respective ISO standards. For example, for the fatigue test, the ground truth would be resistance to a certain number of cycles at a defined load without failure. For cytotoxicity, it would be the absence of toxic effects as per the ISO standard for biological evaluation of medical devices.

Clinical Testing: The document explicitly states: "No additional clinical testing was performed for this submission." This further confirms that this is not an AI/CADe study involving human readers or diagnostic accuracy.

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The Dentis Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures and not for immediate load. Also, this system is intended to be used in the molar region.

The Dentis Dental Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided text is a 510(k) summary for the Dentis Dental Implant System. It outlines the device information, indications for use, and a comparison to predicate devices, ultimately stating substantial equivalence. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, it is not possible to complete the requested table and study description based on the provided input.

The 510(k) summary focuses on demonstrating equivalence to previously cleared devices rather than providing detailed performance study data against specific acceptance criteria. This is typical for 510(k) submissions where clinical performance is often inferred from the predicate device through non-clinical testing (e.g., material properties, mechanical testing) and comparison of intended use.

To answer your questions, additional documentation beyond this 510(k) summary would be required, such as a detailed test report or clinical study report.

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The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

The I-FIX System is mini implant system, which serves temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. The I-FIX System is comprised in diameter of 2.0 - 3.0mm and range from 10 - 16 mm and is made of CP Titanium grade 4. The surface treatment of I-Fix System is of R.B.M (Resorbable Blasting Media).

This is a 510(k) premarket notification for a dental implant system, not a device that uses AI or goes through an acceptance criteria study as understood in modern AI/ML medical devices. The document focuses on demonstrating substantial equivalence to a predicate device through material and mechanical performance testing, rather than clinical performance or AI algorithm validation.

Therefore, most of the requested information regarding acceptance criteria, AI performance, ground truth, and training/test sets is not applicable to this submission.

Here's a breakdown of what can be extracted and why other points are not applicable:

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

   Acceptance Criteria	Reported Device Performance
   Mechanical strength equivalent to predicate devices, consistent with FDA guidance (Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004)	"mechanical testing of the implants demonstrated that the I-Fix System possess mechanical strength at least equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable. The "test set" here refers to the device itself undergoing mechanical testing, not a dataset for an AI model.

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)

   • Not applicable. Ground truth, in the context of this submission, relates to establishing the substantial equivalence of material and mechanical properties, not clinical or diagnostic accuracy requiring expert consensus.

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

   • Not applicable. This refers to adjudication of labels or outcomes in a clinical study, which is not described here.

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

   • No. This is a traditional medical device submission, not an AI-powered device.

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

   • No. This device does not involve an algorithm.

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

   • For the mechanical testing, the "ground truth" would be established by standardized mechanical testing methodologies and comparison data from the predicate device based on the FDA guidance document.

8. The sample size for the training set

   • Not applicable. There is no AI model requiring a training set.

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

   • Not applicable. There is no AI model requiring a training set.

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The Dentis Dental Implant system is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

The Dentis Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage for single and multiple unit prosthetics. The Dentis Dental Implant System consists of machined titanium, screw-form dental implant Ø 3.5mm. Ø 3.7mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm, Ø 5.5mm, 6.0mm in diameter. They are available in length of 7-14 mm. The implant's raw material is titanium and its alloys for surgical implant applications (as per ASTM-F-67, ASTM-F-136). Surfaces include as machined surfaces, grit blasted and surfaces treated with Resorbable Blast Media (RBM) roughened surface. The System includes surgical instruments such as twist drill, bone tap, Trephine

The provided text describes the Dentis Dental Implant System and its 510(k) submission, confirming its substantial equivalence to predicate devices. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets acceptance criteria, device performance metrics, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about MRMC or standalone studies.

The "Performance" section explicitly states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This indicates that performance testing was done, but the details of these tests, including the criteria and results, are not provided in this summary.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or answer the other specific questions about the study design, ground truth, or expert involvement based on the provided text alone. The document focuses on regulatory equivalence and device description rather than detailed clinical or performance study results.

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