(276 days)
JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations for functional and esthetic rehabilitation. JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.
JJ Implant System Mini implants may be used for denture stabilization using multiple implants in the anterior mandible and the anterior maxilla, and are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.
The JJ Implant System comprises three lines of endosseous root-form dental implants: two lines with an internal hexagonal prosthetic interface (Genesis Normo), mating abutments, abutments, abutment screws, and other associated components; and a line of one-piece, small diameter dental implants (Mini) for retention of overdentures.
This looks like a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to non-clinical performance and comparisons to predicate devices, rather than clinical efficacy studies with specific performance metrics like sensitivity/specificity often seen with AI/CADe devices.
Based on the provided document, here's a breakdown of the information:
1. Table of Acceptance Criteria and the Reported Device Performance:
Since this is a dental implant (a passive medical device), the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy). Instead, they relate to safety, performance against established standards, and equivalence to predicate devices. The device's "performance" is demonstrated through successful completion of these non-clinical tests and a comparison of its technological characteristics and indications for use with predicate devices.
| Acceptance Criterion (Type of Test/Standard) | Reported Device Performance / Compliance |
|---|---|
| Sterilization Validation (ISO 11137-1, -2, ISO 17665-1, ISO 14937) | Device complies with standards (submitted non-clinical data). |
| Bacterial Endotoxin Testing (USP 40-NF 35 ) | Device complies with standards (submitted non-clinical data). |
| Biocompatibility (ISO 10993-5, ISO 10993-12) | Confirmatory biocompatibility testing was performed and demonstrates compliance. |
| Accelerated Aging (ASTM F1980) | Device complies with standards (submitted non-clinical data). |
| Static Compression Fatigue Testing (ISO 14801) | Demonstrated sufficient strength for intended use for both Genesis Active and Genesis Normo implants (in combinations with a 15° angled abutment). |
| Surface Evaluation (SEM, EDS, Auger) | Used to evaluate residual materials; implied satisfactory results (no abnormal findings reported). |
| Equivalence in Indications for Use (IFUS) | Subject device IFUS for Genesis Active and Normo implants is substantially equivalent to predicate K142260 and reference K120414. Minor wording differences do not affect intended use. |
| Equivalence in IFUS (Mini implants) | Subject device IFUS for Mini implants is substantially equivalent to reference K100932. Minor wording differences do not affect intended use. |
| Equivalence in Design/Dimensions (Genesis Active) | Substantially equivalent to predicate K142260 and reference K120414 in thread form, prosthesis attachment, restorations, abutment-implant interface, material, and sterilization. Dimensions within corresponding ranges. |
| Equivalence in Design/Dimensions (Genesis Normo) | Substantially equivalent to reference K120414 in thread form, prosthesis attachment, restorations, abutment-implant interface, material, and sterilization. Dimensions within corresponding ranges. |
| Equivalence in Design/Dimensions (Abutments) | Substantially equivalent to reference K120414. Includes similar components, dimensions within ranges, and similar attachment/restoration types. |
| Equivalence in Design/Dimensions (Mini Implants) | Substantially equivalent to reference K100932 in thread form, prosthesis attachment, retention, material, and sterilization. Dimensions within corresponding ranges. |
| Materials Compliance | Implants, abutments, and abutment screws use Ti-6Al-4V alloy conforming to ASTM F136; materials are similar to predicates. |
| Sterilization Method (End-user) | Abutments and abutment screws to be moist heat (steam) sterilized by end-user, similar to predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device clearance is based on non-clinical performance data and substantial equivalence to predicate devices, not on a clinical "test set" with patient data in the context of AI/CADe. Therefore, there's no mention of a clinical test set sample size or its provenance in this document. The "test sets" would refer to the samples used in the mechanical and biocompatibility testing (e.g., number of implants tested for fatigue, number of samples for bacterial endotoxin, etc.), but specific numbers are not provided in this summary.
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. This is not a study requiring expert readers or ground truth establishment for diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical "test set" in the diagnostic sense was used or 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
Not applicable. This is not an AI/CADe device, and no MRMC comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (dental implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" is established by adherence to recognized consensus standards for material properties, mechanical strength, biocompatibility, and sterilization, as well as a demonstration of equivalence to legally marketed devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.