(84 days)
MIS Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic device, 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 stability is achieved and the occlusal load in appropriate.
Narrow implants (03.3mm) 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.
The proposed MIS Lance+ Conical Connection Implant are dental implants with a cvlindrical and conical shaped outer profile. The implants have an internal conical implant-abutment connection geometry with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform. The conical implant-abutment connection is identical to the internal conical connection geometry incorporated in the design of the reference device MIS C1 Conical Connection Implants (K172505). The implant abutment connection surface of the MIS Lance+ Conical Connection Implant is anodized for coloring coding purposes to indicate the platform. The color coding is identical to the reference devices MIS C1 Conical Connection Implant System (K172505).
The MIS Lance+ Conical Connection Implants are intended to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments and screwretained abutments, which were previously cleared for use with the MIS C1 Conical Connection Dental Implant System (K172505 for NP abutments and K112162 for SP and WP abutments). These abutments are manufactured with a conical connection compatible with the implants interface. Dental implant abutments are intended to be used in the upper or lower jaw used for supporting tooth replacements to restore chewing function. The abutments in combination with two-stage endosseous implants are intended to be used as a foundation for anchoring tooth replacements in either jaw. Restorations range from replacing one single tooth to fixed partial dentures using cementretained supra-constructions. No new Abutments are being proposed as part of this submission.
In addition, the proposed MIS Lance+ Conical Connection Implants will be provided in a wet package configuration immersed in NaCl solution as cleared under K200102 and branded as "CLEAR". The MIS CLEAR Lance+ Conical Connection Implants which are intended to be packaged in NaCl solution are not anodized.
The provided text is a 510(k) summary for a dental implant system (MIS Lance+ Conical Connection Dental Implant System) seeking FDA clearance. It describes the device, its intended use, and comparison to predicate devices, focusing on non-clinical performance data to demonstrate substantial equivalence.
There is no information in the provided text regarding acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device submission.
The document discusses:
- Device Type: Dental implants (physical medical device, not an AI/ML software device).
- Performance Testing: Mechanical fatigue testing (ISO 14801:2016), biocompatibility, sterilization, and shelf-life testing. These are standard tests for physical implants.
- Comparison to Predicate Devices: The submission aims to demonstrate substantial equivalence to existing dental implants (MIS Lance+ Internal Hex Dental Implant System and MIS C1 Conical Connection Dental Implant System).
- Absence of Clinical Data: The document explicitly states, "No human clinical data were included to support substantial equivalence."
- Absence of AI/ML components: The device described is a physical dental implant. There is no mention of any AI or machine learning components.
Therefore, I cannot extract the requested information (acceptance criteria for AI/ML performance, study details for AI/ML, human expert involvement, MRMC studies, standalone AI performance, ground truth for AI, training/test set sizes, etc.) from this document, as it pertains to a different type of medical device lacking AI/ML features.
§ 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.