(463 days)
The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is for delayed loading.
KJ Mini Implant System is a dental implant system made of Titanium 6AL 4V ELI Gt.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. 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 part has been treated with R.B.M. The KJ Mini Implant System offers the following implants with various sizes.
The document provided is a 510(k) premarket notification for the KJ Mini Implant System. It presents information to demonstrate substantial equivalence to predicate devices, rather than detailing a study focused on specific performance acceptance criteria for an AI or imaging device. Therefore, a direct answer to the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/imaging device performance cannot be fully provided from the given text.
The document discusses non-clinical testing for the dental implant system itself, which primarily focuses on manufacturing and material standards rather than diagnostic performance metrics.
Below is an attempt to structure an answer based on the available information, highlighting what is not present in the document.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) that would be typical for an AI-powered diagnostic device. Instead, it compares the new device (KJ Mini Implant System) to predicate devices based on design, materials, indications for use, and technological characteristics to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided document. The document describes non-clinical testing for sterilization and shelf-life, which are laboratory tests, not clinical studies with test sets of patient data.
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)
This information is not available in the provided document. As the device is a dental implant, not an AI/imaging diagnostic tool, the concept of "ground truth for a test set" established by experts in the context of diagnostic performance metrics does not apply to the information presented.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided document. Adjudication methods are relevant for clinical studies assessing diagnostic accuracy, which are not detailed 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
This information is not available in the provided document. The device is a dental implant, not an AI-assisted diagnostic tool, so MRMC studies or human-in-the-loop performance metrics are not applicable to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not available in the provided document. The device is a dental implant, and therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available in the provided document. The concept of ground truth in the context of diagnostic accuracy is not discussed. For a dental implant, "ground truth" would more likely refer to successful integration, absence of complications, or restoration of masticatory function, which would be assessed in clinical trials. However, the provided document focuses on premarket notification for substantial equivalence based on material and physical characteristics.
8. The sample size for the training set
This information is not available in the provided document. Training sets are applicable to machine learning algorithms, which are not part of this dental implant device.
9. How the ground truth for the training set was established
This information is not available in the provided document, for the same reasons as #8.
Summary of Non-Clinical Testing (from the document):
The provided document describes the following non-clinical tests for the KJ Mini Implant System to demonstrate safety and effectiveness for its intended use, focusing on material and physical properties, not diagnostic performance:
- Sterilization Validation Testing:
- According to ISO 11137-1 & ISO 11137-2 for implants (gamma sterilization).
- According to ISO 17665-1 & ISO 17665-2 for abutments.
- Three-year shelf-life testing: According to ASTM F1980.
- Chemical and SEM Analysis: (Details not provided in the summary).
The document concludes that based on the similarities in intended use, operating principle, basic design, material, and surface treatment to predicate devices, the KJ Mini Implant System is substantially equivalent. This implies that if the predicate devices meet performance and safety criteria, the new device, being substantially equivalent, would also meet them. However, specific acceptance criteria for these tests and their detailed results are not explicitly enumerated in this 510(k) summary.
§ 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.