(124 days)
MIS Dental Implant Systems 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 masticatory 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.
Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS short implants are to be used only with straight abutments.
The proposed MIS Dental Implant System entails a material modification and line extension of the MIS Lance+ Internal Hex Dental Implants and new offering of MIS Internal Hex Cobalt Chrome Abutments.
Lance+ Dental Implants: A modification and line extension to the originally cleared Lance implants (K040807). Manufactured from titanium alloy, Ti- 6Al-4V ELI, compared to the prior CP titanium grade 4. Additional sizes are being added as a line extension.
MIS Internal Hex Cobalt Chrome (CoCr) abutments: Pre-manufactured prosthetic components directly connected to the endosseous dental implant and intended for use as an aid in prosthetic rehabilitation. Intended for permanent restoration for single tooth or multiple units screw retained restorations. The lower part of the abutment is made of CoCr alloy, and the upper part is made of plastic (POM). The plastic part is dissolved during the casting process. The abutment is connected to the implant by a prosthetic screw.
This document is a 510(k) Pre-market Notification for the MIS Dental Implant System. It describes the device, its intended use, and comparative studies to establish substantial equivalence to previously cleared devices, rather than a study proving performance against acceptance criteria for a novel AI/software device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not applicable or cannot be extracted from this document.
However, I can extract the information related to the device's technical performance and the non-clinical studies conducted.
Here's a breakdown of the relevant information:
1. Table of acceptance criteria and the reported device performance:
Since this is not an AI/software device, there aren't traditional "acceptance criteria" for metrics like sensitivity, specificity, or accuracy. Instead, the acceptance criteria relate to engineering and biocompatibility standards. The reported device performance is demonstrated by meeting these standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Fatigue Testing (ISO 14801:2016) | Withstood 5,000,000 cycles without failure at a substantially equivalent load to predicate/reference devices. |
| CoCr Corrosion Testing | Very low corrosion rates, with the lowest rate for CoCr-titanium couple; low risk of galvanic corrosion. |
| Biocompatibility Testing (Cytotoxicity) | Results supported a conclusion of non-cytotoxicity for the CoCr abutments. (Implants made of same material as predicate, so no new testing needed). |
| Surface Treatment Characterization | Identical to predicate device implants (K180282) and reference device implants (K040807), characterized with reference to May 2004 FDA Guidance. |
| Packaging Integrity (ISO 11607-1:2009 & ASTM F1929-12) | Validation of package integrity over the specified shelf life supports the specified shelf-life. |
| Sterilization Validation (Radiation - ANSI/AAMI/ISO 11137-1 & 11137-2) | Supports a minimum sterility assurance level (SAL) of 10^-6 for dental implants. |
| Sterilization Validation (Moist Heat - ANSI/AAMI/ISO 17665-1 & 17665-2) | Supports a minimum sterility assurance level (SAL) of 10^-6 for abutments. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify a distinct "test set" in the context of an AI/software device. For the non-clinical performance tests like fatigue and corrosion, the sample sizes are determined by the respective ISO/ASTM standards. These details are not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data for an AI/software device. The non-clinical testing was conducted by MIS Implants Technologies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a medical device (dental implant and abutments), not an AI/software device that relies on expert interpretation for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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:
- No. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
7. The type of ground truth used:
- Defined by Engineering Standards and Material Properties: The "truth" for this device is its adherence to mechanical performance standards (e.g., fatigue strength), biocompatibility (e.g., non-cytotoxicity, corrosion resistance), and physical characteristics (e.g., dimensions, material composition). This is established through laboratory testing following ISO and ASTM guidelines.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/software device.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of applicable information from the document:
This 510(k) summary focuses on demonstrating the substantial equivalence of the modified MIS Dental Implant System (Lance+ Internal Hex Implants and Cobalt Chrome Abutments) to existing legally marketed predicate devices. The evidence presented primarily consists of non-clinical performance data:
- Fatigue testing: Conducted according to ISO 14801:2016 for the implants.
- Corrosion testing: For the Cobalt Chrome (CoCr) abutments, indicating low risk of galvanic corrosion when coupled with titanium.
- Biocompatibility testing: Cytotoxicity testing for the CoCr abutments, with implants relying on prior testing for the same materials.
- Surface treatment characterization: Confirmed to be identical to predicate devices.
- Packaging integrity validation: Conducted per ISO 11607-1:2009 and ASTM F1929-12.
- Sterilization validation: For both radiation (implants) and moist heat (abutments), adhering to relevant ANSI/AAMI/ISO standards to achieve an SAL of 10^-6.
The document explicitly states: "No human clinical data were included to support substantial equivalence." This means the device relies entirely on non-clinical engineering and material science data to prove its safety and effectiveness relative to existing, cleared devices.
§ 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.