(331 days)
MIS dental 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.
MIS short implants are to be used only with straight abutments.
The MIS short 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 MIS short implants are provided in 6.0mm length and 4.2mm, 5.0 mm, and 6.0mm diameters, as follows:
Seven internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Biocom internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
Lance internal hexagon 6.0mm length: diameter 4.20mm, 5.0 mm and 6.0mm
The implants surface is sand blasted and acid etched.
The MIS short implants are two piece devices whereas the implant is to be used in combination with cover screws, healing caps, abutments and superstructures.
The MIS short 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.
This 510(k) summary describes a submission for MIS Short Implants. The document establishes substantial equivalence to predicate devices through a comparison of technological characteristics and performance. No specific acceptance criteria or a dedicated study proving performance against them are explicitly detailed in the provided text. Instead, the focus is on demonstrating equivalence based on existing data and non-clinical tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a specific study designed to meet them. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly tied to the safety and effectiveness demonstrated by the predicate devices and confirmed through non-clinical testing and literature review for the new device.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Safety & Effectiveness | Equivalent to predicate devices (4.5x6.0mm, 6.0x6.0mm, 5.0x6.0mm from Bicon, Inc., and OsseoSpeed 4.0S-6mm from Astra Tech Inc.). | Non-clinical fatigue tests performed, and results "found satisfying." Clinical evaluation based on literature review and case studies (30 months follow-up) found "no additional concerns regarding safety and effectiveness." |
| Material | Made of Ti6AL4V ELI complying with ASTM F 136-11 standard. | Made of Ti6AL4V ELI (Titanium-6Aluminum-4Vanadium ELI) complying with ASTM F 136-08 standard (as stated under "Description of the device"). |
| Sterility | Supplied sterile. | Supplied sterile (as per comparative table). |
| Re-use | Not reusable. | Not reusable (as per comparative table). |
| Shape | Screw type. | Screw type (as per comparative table). |
| Length | 6.0 mm. | 6.0 mm (as per comparative table). |
| Thread Diameter | 4.2, 5.0, and 6.0 mm (for MIS Short Implants). | 4.2, 5.0, and 6.0 mm (as per comparative table). |
| Abutment Type | Used only with straight abutments. | Used only with straight abutments (as per "Indications for Use" and comparative table). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Non-clinical/Fatigue Test: Not explicitly stated. The document mentions "Fatigue test was performed on MIS short implants and its results were found satisfying." The number of implants tested is not provided.
- Clinical Evaluation: "case studies with 30 months follow up" – the number of cases/patients is not explicitly stated. The phrasing "case studies" suggests an unspecified number of individual cases rather than a large cohort.
- Data Provenance:
- The fatigue tests were performed by the manufacturer, MIS Implants Technologies Ltd. (Israel).
- The clinical evaluation was "based on literature review and case studies," suggesting a mix of published research and internal data. The geographic origin of the literature or specific case studies is not specified beyond the company being located in Israel. The statement that "MIS short implants are manufactured to the same Titanium alloy" as the predicate devices implies reliance on the established performance of those devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document does not describe a process of establishing ground truth by experts for a specific test set. The clinical evaluation references "literature review and case studies," which would rely on diagnoses and outcomes made by clinicians in those cases, but no specific expert panel or their qualifications for establishing ground truth are mentioned.
4. Adjudication Method for the Test Set
Not applicable. No explicit adjudication method is described for defining a ground truth or reconciling discrepancies, as there isn't a dedicated "test set" in the sense of a dataset requiring expert labeling for a performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a dental implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. As noted above, this is a physical medical device (dental implant), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the assessment of the MIS Short Implants relies on:
- Biocompatibility/Material Standards: Compliance with ASTM F 136-08 for the titanium alloy.
- Mechanical Performance: Results of fatigue testing.
- Clinical Outcomes/Experience: "Literature review and case studies with 30 months follow up" to assess safety and effectiveness. This would implicitly rely on clinical diagnoses, radiographic evaluations, and patient-reported outcomes to determine the success or failure of the implants.
- Substantial Equivalence: The primary "ground truth" or benchmark is the established safety and effectiveness of the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is a physical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.
§ 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.