(371 days)
The TRI-matrix® Implant Line is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® Implant Line allows for one and two stage surgical procedures. When a onestage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® Implants are intended for delayed loading only.
The TRI-matrix® Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the TRI-matrix® Crown Abutment to the endosseous implant.
The purpose of this submission is to obtain marketing clearance for the TRI-matrix® Implant Line, a series of bone-level and tissue-level root-form endosseous dental implants, corresponding healing components, abutments, and abutment screws intended for use in the mandible or maxilla to restore chewing function. The permanent abutment design in the product line is a patient-specific abutment manufactured using CAD-CAM technology, which also may be manufactured as a direct final direct restoration. The manufacture of these abutments and restorations will be at TRI Dental Implant Int. AG facilities after receipt of the digital design file of the patient-matched components from the dentist or dental lab.
TRI-matrix Bone-Level implants are intended for bone-level placement and are available in three (3) body diameters (3.75, 4.1 and 4.7 mm). The 3.75 mm body diameter is provided in five (5) lengths (8. 10. 11.5, 13, and 16 mm) and the 4.1 and 4.7 mm body diameters are provided in six (6) lengths (6.5, 8, 10, 11.5, 13, and 16 mm). TRI-matrix Bone-Level 3.75 and 4.1 mm diameter implants have a platform diameter of 3.7 mm and TRI-matrix Bone-Level 4.7 mm diameter implants have a platform diameter of 4.5 mm.
TRI-matrix Tissue-Level implants are intended for tissue-level placement and are available in four (4) body diameters (3.3. 3.75. 4.1 and 4.7 mm). The 3.3 mm body diameter is provided in three lengths (10, 11.5, and 13 mm). The 3.75 mm body diameter is provided in four lengths (8, 10, 11.5, and 13 mm). The 4.1 and 4.7 mm body diameters are provided in five lengths (6.5, 8, 10, 11.5, and 13 mm). TRI-matrix Tissue-Level 3.3 mm diameter implants have a platform diameter of 3.7 mm. TRI-matrix Tissue-Level 3.75 and 4.1 mm diameter implants are available in two platform diameters: 3.7 and 4.5 mm. TRI-matrix Tissue-Level 4.7 mm diameter implants have a platform diameter of 4.5 mm.
Healing components and abutment components for the TRI-matrix Implant Line include Surgical Cover Screw, Healing Collar, Provisional Abutment (Temporary Abutment), and patient-specific Crown Abutment. Abutment screws for the TRI-matrix Implant Line include Replacement Retaining Screw, which are designed to attach the subject device Provisional Abutment, Crown Abutment, or direct final restoration to the implant.
Crown Abutments are patient-specific abutments, fabricated using CAD/CAM technology at a TRI Dental Implants Int. AG manufacturing site. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained prosthesis. The Crown Abutment is different from a normal Titanium Blank abutment because the implant-abutment connection is manufactured at the same time as the patient-specific portion (i.e., there is no stock component). Crown Abutments are fabricated in two platform diameters of 3.7 and 4.5 mm and are attached to the compatible implant with a separate screw. Crown Abutments are available as Zirconia Crown Abutments or Titanium Crown Abutments. The material of Zirconia Crown Abutments will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). The material of Titanium Crown Abutments will conform to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
A Crown Abutment also may function as a substructure in zirconia that serves as the single-unit or multiunit final restoration, using the full digital workflow with third-party planning software. For each material there is an associated CAD software file within the full digital workflow that defines the specific screw, interface, and torque used for the direct restoration.
The design parameters for patient-specific Crown Abutments, direct final restorations or direct provisional restorations are:
Abutment diameter range - 4 to 13 mm Maximum abutment height - 15 mm Minimum abutment height above the trans-mucosal collar (post height) for single-unit restorations - 4 mm Maximum gingival height from the implant/abutment interface: 5 mm for a restoration on a bone-level implant, 3 mm for a restoration on a tissue-level implant Minimum gingival height - 0.5 mm Maximum angulation correction - 15°
Zirconia Crown Abutments and Titanium Crown Abutments willed from zirconia blanks and titanium alloy blanks respectively, each conforming to the standards cited above. Design parameters shown above are specified in labeling and are included in the CAD library provided by TRI Dental Implants Int. AG.
The subject device implants, healing components and abutments (except for the Zirconia Crown Abutment), and abutment screws are made of titanium alloy conforming to ASTM F136.
The grit-blasting and acid-etching procedure is applied to the endosseous surface of all subject device dental implants and is identical to the process used to manufacture the dental implants cleared in K151916.
Selected implants and abutments manufactured from titanium alloy (ASTM F136) are anodized using standard electrolytic passivation processing to increase the thickness of the natural oxide layer on the surface and to impart a distinctive surface color; no dyes or coloring additives are used. This anodization process is identical to the anodization process used on abutments cleared in K151916. Titanium allov subject device components are manufactured from the same materials, are treated with the same surface treatments and are manufactured in the same facilities using the same manufacturing processes as used for devices previously cleared in K151916.
The document provided is a 510(k) summary for a medical device (TRI-matrix® Implant Line) seeking substantial equivalence to existing predicate devices. It focuses on the equivalence of the new device's design, materials, and intended use, primarily through non-clinical performance data. It does not describe an acceptance criteria study for a diagnostic AI/ML device.
Therefore, I cannot provide the requested information about acceptance criteria, efficacy studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI/ML device. The document is for an endosseous dental implant, which is a physical device, and the "performance data" refers to mechanical, sterilization, and biocompatibility testing, not diagnostic accuracy.
§ 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.