(126 days)
Inversa Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Inversa Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
Inversa implants are fully threaded, tapered, root-form dental implants with a design feature known as body shift, where the body design of the implant has a narrow, straight coronal portion with an increased maximum diameter midway down the length of the implant tapering toward the apex. The body of the implant includes two thread types (square and V-shaped) that transition in the middle of the implant body. Inversa implants have a platform that is inclined 12° to the long axis of the implants are made of unalloyed titanium and provided in two connection types (External Hex and Deep Conical).
External Hex Inversa implants are provided in three sizes: coronal diameter 3.5 mm with maximum apical diameter 4.5 mm; coronal diameter 3.5 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.2 mm with maximum apical diameter 5.0 mm. Each size of the External Hex Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).
Deep Conical Inversa implants are provided in three sizes: coronal diameter 3.6 mm with maximum apical diameter 4.5 mm; coronal diameter 3.6 mm with maximum apical diameter 5.0 mm; and coronal diameter 4.0 mm with maximum apical diameter 5.0 mm. Each size of the Deep Conical Inversa implant is provided in four lengths (11.5, 13, 15, and 18 mm).
Inversa implants are made from unalloyed titanium conforming to ASTM F67.
This document is a 510(k) summary for the "Inversa Implants" dental implant system, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific performance acceptance criteria for a new AI/software device.
Therefore, many of the requested elements (e.g., acceptance criteria for device performance, sample sizes for test sets, expert involvement, MRMC study results, training set details) are not applicable or not found in this type of regulatory submission for a physical medical device like a dental implant.
The "Performance Data" section of this document refers to non-clinical tests for physical characteristics and safety, not for performance of a software/AI device.
Here's an attempt to extract relevant information and explain why other information is absent:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria and reported device performance in the way one would for a software or AI device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and intended use.
The "Performance Data" section mentions the following non-clinical tests performed or referenced:
| Test/Characteristic | Acceptance Criteria (Implicit) | Reported Performance (Implicit) |
|---|---|---|
| Sterilization Validation (according to ISO 11137-1 and ISO 11137-2) | Meets ISO standards (referenced from K163634 and K163060) | Deemed acceptable by reference to predicate data. |
| Biocompatibility Evaluation (according to ISO 10993-1) | Meets ISO standards (referenced from K163634 and K163060) | Deemed acceptable by reference to predicate data. |
| Bacterial Endotoxin Testing (in accordance with USP 40-NF 35) | Meets USP standards | Deemed acceptable. Specific results not in this summary. |
| Sterile Barrier Shelf Life | Meets requirements (referenced from K163634) | Deemed acceptable by reference to predicate data. |
| Dynamic Compression-Bending (to ISO 14801) | Implied to meet ISO 14801 standards, comparable to predicates. | Results not explicitly detailed in summary. |
| Insertion Torque Testing | Implied to be acceptable, comparable to predicates. | Results not explicitly detailed in summary. |
No clinical data were included in this submission. This means no human study was performed to "prove the device meets acceptance criteria" in a clinical setting.
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for this type of submission. The "test set" for a physical device like this refers to the samples of the device used for non-clinical bench testing (e.g., for mechanical strength, sterilization). The specific number of units tested for each non-clinical test (e.g., how many implants were tested for dynamic compression-bending) is not provided in this summary.
- Data Provenance: Not applicable. The data is primarily derived from bench testing (non-clinical) of prototype/production units and references to previously cleared predicate devices (K163634, K163060, K030463, K053478, K070841, K093562). The manufacturer is Southern Implants (Pty) Ltd., based in Irene, Gauteng, South Africa.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a submission for a diagnostic AI/software device that requires ground truth established by medical experts. The "ground truth" for a dental implant's performance would be engineering specifications and physical test results, not expert consensus on images.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert readings/assessments.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This type of study is typically done for diagnostic imaging devices/software to evaluate human reader performance with and without AI assistance. This submission is for a physical dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" would be the physical and chemical properties of the materials and the mechanical performance consistent with engineering standards (e.g., ISO 14801 for dynamic compression-bending). For the regulatory submission, the primary "ground truth" is the demonstration of substantial equivalence to existing, legally marketed predicate devices based on design, materials, and intended use.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model.
§ 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.