(126 days)
TRI-matrix® X-Force implants are intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI-matrix® X-Force implants allow for one and two stage surgical procedures. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. TRI-matrix® X-Force implants with lengths of 18, 20, or 22 mm, when placed in the maxilla, are indicated only for multiple unit restorations in splinted applications that utilize at least two implants.
The purpose of this submission is to obtain marketing clearance for TRI-matrix X-Force implants, a line extension of the TRI-matrix implant line previously cleared in K203660. TRI-matrix X-Force implants are tissue-level endosseous dental implants that are an adaptation of the TRI-matrix Tissue Level implants cleared in K203660, with the same prosthetic interface, but with modified external features. They are intended for use in the mandible or maxilla to restore chewing function. This submission includes only implants, and they are compatible with prosthetic components previously cleared in K203660 as part of the TRI-matrix implant line, including the TRI-matrix Crown Abutment.
TRI-matrix X-Force implants have a tapered body, double-lead threads and self-cutting flutes. A gritblasted and acid-etched surface, named the TRI SBA Surface, is applied to the endosseous portion of the implant. TRI-matrix X-Force implants incorporate a pink anodized, machined, 1.8 mm transgingival collar that is not treated with the TRI SBA Surface. Compared with TRI-matrix implants previously cleared in K203660, TRI-matrix X-Force implants have a modified thread design more suited to immediate placement and restoration, a more tapered apical portion (smaller apical diameter for a given coronal diameter), and more aggressive apical cutting flutes.
TRI-matrix X-Force 3.3 mm diameter implants have a platform diameter of 3.7 mm. TRI-matrix X-Force 3.7 mm and 4.1 mm diameter implants are available in two (2) platform diameters: 3.7 mm and 4.5 mm. TRI-matrix X-Force 4.7 mm diameter and 5.7 mm diameter implants have a platform diameter of 4.5 mm.
This document describes the marketing clearance for medical devices and does not contain information about acceptance criteria or a study proving that a device meets such criteria in terms of performance metrics or clinical outcomes.
The document discusses the substantial equivalence of the TRI-matrix® X-Force Implants to legally marketed predicate devices. This means that the FDA determined the device is as safe and effective as a predicate device and does not raise different questions of safety and effectiveness. This type of submission (510(k)) generally does not require proof of meeting specific performance acceptance criteria through the kind of studies you've outlined.
Specifically, the "PERFORMANCE DATA" section states:
- "Non-clinical data submitted to demonstrate substantial equivalence included: Referenced from the primary predicate device K203660: sterilization validation according to ISO 17665-1 and ISO 17665-2; . Provided in this submission: biocompatibility evaluation according to ISO 10993-5 and ISO 10993-12 worst-case analysis and static and dynamic testing according to ISO 14801 on subject devices to demonstrate that static and dynamic testing referenced from the primary predicate device K203660 demonstrates the subject implants do not create a new worst-case as compared to this predicate device with identical connection platform. No clinical data were included in this submission."
Therefore, I cannot provide the requested information for the following reasons:
- Table of acceptance criteria and reported device performance: This document does not specify general "acceptance criteria" for clinical performance or report clinical performance data. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and design comparisons.
- Sample size used for the test set and data provenance: No clinical test set was used or described. The non-clinical testing involved "worst-case analysis and static and dynamic testing according to ISO 14801," but specific sample sizes for these engineering tests are not detailed.
- Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical test set or ground truth determination by experts is mentioned.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as no clinical studies were included.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device (dental implant), not an AI algorithm.
- Type of ground truth used: Not applicable, as no clinical data or ground truth determination is described.
- Sample size for the training set: Not applicable, as no training set for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 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.