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EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.

EzDent-i is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.

EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616) but the EzDent-i itself does not view, transfer or process 3D radiographs.

EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor images by interfacing with X-ray capture software.

EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;

• · Easy and convenient data search function for patient information and clinical images
• · Various image viewing format for 2D dental images
• · Various image processing functions including adjustment of brightness and contrast for images
• · Measurement function of length and angle for 2D images
• · Dental implant simulation for treatment planning and effective patient consultation
• · Crown simulation for more effective patient consultation
• · Print function supporting various viewing output format

The provided text is a 510(k) summary for the EzDent-i / E2 / Prora View dental imaging software. While it states that "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria," it does not include specific acceptance criteria or details about the study that proves the device meets those criteria.

Therefore, I cannot provide the requested information from the given document. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on common intended use, technical characteristics, and functionalities, with the understanding that new features are for user convenience and do not raise new questions of safety or effectiveness.

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The JR 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The JR Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

The JR Implant system is made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the implant has been treated with R.B.M (Resorbable Blast Media). The fixtures are offered in the following length and diameter. There are five different types of abutments offered and they are provided straight only.

The provided text describes a 510(k) summary for the JR Implant System, a dental implant device. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance based on a study of AI performance. The document focuses on demonstrating substantial equivalence to a predicate device through material and biocompatibility testing, rather than a clinical or AI-driven performance study with acceptance criteria.

Therefore, for aspects related to AI performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies, the provided text does not offer the necessary details.

Here's a breakdown of what can and cannot be extracted from the document based on your request:

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

The document does not specify "acceptance criteria" in the context of a performance study for AI or clinical efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" mentioned refers to mechanical and biological properties like biocompatibility and sterilization validation, not clinical outcomes or AI accuracy metrics.

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

Not applicable. No "test set" in the context of an AI study or clinical trial is described. The performance testing mentioned (biocompatibility, sterilization validation, surface treatment analysis) is laboratory-based, not involving human patient data sets.

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 expert consensus on a test set is not mentioned, as no such study is described. The testing is related to material properties and biological compatibility.

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

Not applicable. No test set adjudication method is mentioned.

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 MRMC study is mentioned. This document is for a dental implant, not an AI diagnostic or assistance tool.

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

Not applicable. This is not an AI algorithm.

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

The document describes material and biocompatibility testing. The "ground truth" for these tests would be established by validated laboratory testing procedures and scientific standards (e.g., ISO standards for cytotoxicity). It does not involve expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not applicable. No "training set" for an AI model is involved.

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

Not applicable.

Summary of available information related to performance testing:

The device's performance is established through manufacturing and material testing, not through a clinical performance study with AI.

Study Description:

The document refers to performance testing as a means to demonstrate the safety and effectiveness of the device, particularly focusing on the differences in titanium grade and surface treatment compared to the predicate device. The studies were laboratory-based tests for biocompatibility, sterilization validation, and surface treatment analysis. These tests were conducted to prove that the material differences between the subject device (JR Implant System) and the predicate device (NobelReplace Tapered Conical Connection) do not raise issues in safety and performance.

The data provenance for these laboratory tests would typically be internal to the manufacturer or conducted by certified testing laboratories, likely in South Korea (country of origin of the manufacturer). The studies are not clinical trials and therefore do not have a retrospective or prospective patient data element.

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The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.

The Kerator is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. There are one fixture model and three abutment models in the Kerator. Among three abutment model is compatible with the Kerator fixture, and the other two abutment models are compatible with the fixtures made by other manufacturers. The implant may be used to replace one or more missing teeth. The 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 surface of the fixture has been treated with R.B.M (Resorbable Blast Media) and the head part of the abutment has TiN coating over it. The Kerator abutment is placed into the dental implant to provide support for a prosthetic restoration.

The Kerator system is a dental implant system. The provided text describes the device and its equivalence to predicate devices, but it does not contain any information about a study with acceptance criteria and reported device performance in relation to AI or any advanced analytical methods.

Therefore, I cannot provide the requested information in the format of the table or other points, as the document focuses on regulatory approval based on substantial equivalence to existing devices, primarily through material and design comparisons and standard non-clinical testing (sterilization, shelf life, chemical analysis). It does not involve AI or algorithms, nor does it present clinical performance data against specific acceptance criteria in the manner described in your prompt.

The document indicates "Non-Clinical Testing" for sterilization, shelf life, and chemical/SEM analysis, which are standard safety and manufacturing validations, not performance against clinical or analytical acceptance criteria.

If the prompt were referring to a different type of device or study that typically involves such criteria, the answer would differ. However, based solely on the provided text, there is no such study or acceptance criteria information to extract.

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