(378 days)
MIS Conical Connection Implants are 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.
When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate.
The conical connection dental implants are self tapping, root-form, two piece screw type dental implants, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The conical connection dental implants are provided in 3.75, 4.2 and 5.0 mm diameters and with the following lengths:
0 3.75mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
0 4.2mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
o 5.0mm diameter: 8mm, 10mm, 11.5mm, 13mm and 16mm
The implants surface is sand blasted and acid etched.
The conical connection dental implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.
The conical connection dental implants are made of Ti6AL4V ELI complying with standard ASTM F 136-08- Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant. The conical connection dental implants were modified to integrate a new type of connection, internal conical connection of 6 degrees with an anti-rotation index of six positions, ensuring a more definite seal and a more stable connection.
This looks like information from a 510(k) premarket notification for a medical device, specifically dental implants. This type of submission is for demonstrating "substantial equivalence" to a predicate device, rather than proving safety and efficacy through clinical trials that would typically involve acceptance criteria and detailed performance studies like those common for PMAs or de novo submissions.
Therefore, many of the requested categories (like "acceptance criteria," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for training set") are not applicable in the context of this 510(k) submission.
The document focuses on comparing the new device to a legally marketed predicate device based on technological characteristics and non-clinical performance (like fatigue testing), with a brief mention of a preliminary clinical evaluation for stability.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance
Not applicable in the typical sense for a 510(k) submission. The "acceptance criteria" here is "substantial equivalence" to the predicate device. The performance is demonstrated through a comparison of technological characteristics and non-clinical testing.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Conical Connection Implants) |
|---|---|
| Material of Construction | Titanium Alloy - Ti6Al4V ELI (Same as predicate) |
| Sterility | Yes (Same as predicate) |
| Re-use Status | No (Same as predicate) |
| Shape | Screw type (Same as predicate) |
| Thread Diameter | 3.75, 4.2 and 5.0 mm (Same as predicate) |
| Length | 8, 10, 11.5, 13 and 16 mm (Same as predicate) |
| Indications for Use | Expanded slightly from predicate to include immediate loading under good primary stability and appropriate occlusal load, but still within the scope of dental implants. |
| Fatigue Performance | Fatigue test was performed on MIS conical connection implants and its results were found comparable to those of their predicate devices (MIS Implants Technologies Ltd. dental implants Seven, Biocom and Lance, cleared under 510(k) K040807). This is the key performance acceptance. |
| Clinical Stability | A preliminary clinical evaluation based on case studies with six months follow up showed good stability of the conical connection implant. (This is more of an observation than a quantified acceptance criterion in this context, but serves to support the overall claim of safety and effectiveness.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- Non-clinical (Fatigue Test): Not explicitly stated. Typically, fatigue tests follow ISO or ASTM standards, which specify sample sizes (e.g., 5-10 samples per group).
- Clinical Evaluation: "case studies" - the specific number of cases is not stated, but "case studies" typically implies a small number.
- Data Provenance: Not specified for the non-clinical or preliminary clinical evaluation. Israel, where the company is located, is the likely origin for the internal testing.
- Retrospective or Prospective:
- Non-clinical: Likely prospective (tests conducted specifically for this submission).
- Clinical Evaluation: "preliminary clinical evaluation, based on case studies with six months follow up" suggests prospective observation of a small number of patients post-implantation.
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. For a device like this, the "ground truth" for the non-clinical fatigue test is measured physical parameters, not expert consensus on images. The preliminary clinical evaluation likely involved clinical observations made by the treating clinicians, not multiple independent experts establishing a "ground truth" for a test set in the same way as, for example, a diagnostic AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described for either the non-clinical or preliminary clinical evaluation.
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 device is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an AI diagnostic device/algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Non-clinical Fatigue Test: The ground truth is the physical measurement of fatigue properties (e.g., cycles to failure, maximum load) according to established engineering standards.
- Preliminary Clinical Evaluation: The "good stability" observation would be based on clinical outcomes and examinations by the treating clinician over the six-month follow-up period.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
§ 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.