(194 days)
Jplant is intended for use in partially or fully edentulous maxilla, in support of single of multiple-unit restorations including cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Jplant is for single stage surgical procedures. This system is intended for delayed loading.
Jplant is intended for use in partially or fully edentulous mandibles and maxilla, 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. Jplant is for single stage and two stage surgical procedures. This system is intended for delayed loading.
The Jplant is dental implant which is made of titanium alloy 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, and to restore the patients chewing function. The fixture has the following sizes.
This document, a 510(k) summary for the Jplant endosseous dental implant, does not describe a study that proves the device meets specific acceptance criteria related to its performance in a clinical setting or against an AI-driven benchmark.
The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on proving device performance against detailed acceptance criteria in the manner of an AI/ML device study.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as they pertain to clinical or AI performance studies that were not conducted or described here.
Here's a breakdown of what can be extracted based on the provided text, indicating "Not Applicable (N/A)" for information that isn't present or relevant to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify performance-based acceptance criteria for a device, nor does it provide performance metrics in the way an AI/ML device would (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use.
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated as Numerical AC) | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|---|
| Intended Use | Same as predicate device | Jplant is intended for use in partially or fully edentulous mandibles and maxilla, 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. Jplant is for single stage and two stage surgical procedures. This system is intended for delayed loading. (Matches predicate) |
| Technological Characteristics | Similar to predicate devices (e.g., threaded, root form implants, titanium, SLA roughened surfaces, bone-level, similar body shape) | Internal Hexagon connection, self-tapping cutting edge threads; Made of Titanium (ASTM F67); SLA Surface treatment; Radiation Sterile. (Demonstrated to be similar to predicates) |
| Safety - Biocompatibility | Meets ISO 10993 standards and other relevant standards specified in predicate K160536. | Biocompatibility information leveraged from K160536, including tests for Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Reactivity, Pyrogen, Local Lymph Node Assay (LLNA), and Bone Implantation. Endotoxin testing will be conducted. |
| Safety - Sterilization | In accordance with ISO 11137. | Sterilization validating testing performed in accordance with ISO 11137. |
| Safety - Shelf Life | 5-year shelf life validated per specified ASTM/ISO standards. | Five-year shelf life validated through accelerating testing in accordance with ASTM F1980-07, ASTM F88, ISO 11607, and ISO 11737-2. |
| Material Characterization | Surface characteristics evaluated. | XPS and SEM performed to evaluate fixture surface characteristics after SLA treatment. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. The document does not describe a clinical test set or a dataset for performance evaluation. The "tests" mentioned are non-clinical (e.g., sterilization, shelf life, biocompatibility) and do not involve patient data in a "test set" context for device performance.
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)
- N/A. This information is not relevant to the type of non-clinical testing and substantial equivalence demonstration presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or expert adjudication process is described.
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
- N/A. This device is an endosseous dental implant, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. As above, this is not an AI/ML algorithm-driven device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A. For the non-clinical tests, "ground truth" would be the standard scientific methods and established procedures for evaluating materials, sterilization, and biocompatibility, as defined by the referenced ISO and ASTM standards. There is no "ground truth" related to clinical outcomes or expert consensus on findings as would be seen in an AI performance study.
8. The sample size for the training set
- N/A. There is no training set mentioned or implied for this mechanical implant device.
9. How the ground truth for the training set was established
- N/A. There is no training set for this device.
§ 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.