(462 days)
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.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Biocompatibility | - ISO Cytotoxicity: Completed, results show non-toxic. |
| - ISO Sensitization: Completed, results show non-sensitizing. | |
| - ISO Intracutaneous reactivity: Completed, results show non-reactive. | |
| Sterilization | - Sterilization validation: Completed (Method: Gamma). |
| Surface Treatment | - Surface treatment analysis: Completed (Surface: R.B.M (Resorbable Blast Media) for fixtures, Anodizing for abutments, cover screws, healing abutments, temporary abutments). |
| Material Composition | - Fixture: Titanium 6AL 4V ELI alloy, ASTM F136. |
| - Abutment, Cover screw, Healing Abutment, Temporary Abutment: Ti 6Al 4V ELI, ASTM F136. |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.