(158 days)
The TRI® Dental Implant System is intended for placement in the bone of the maxillary or mandibular arch for the rehabilitation of edentulous and partially edentulous patients. TRI® Dental Implant System allows 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 Dental Implant System 6.5 mm implants are intended for delayed loading only.
The TRI-Narrow and TRI-Vent implants are root form endosseous dental implants. They are available with two collar options, blasted or machined. TRI-Narrow is available in one implant diameter (3.3 mm) and three lengths (11.5, 13, and 16 mm). TRI-Narrow abutments include all abutment options with the exception of the Gingiva Former and the angled Screw Retained Abutment.
TRI-Vent is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Vent implant diameters have the same platform diameter (3.5 mm). TRI-Vent abutments include Healing Collar, Straight Temporary PEEK Abutment, Straight and 20° Angled Abutments, Straight and 30° Angled Screw Retained Abutment, PEEK Gingiva Former, Straight and 15° Angled Contoured Abutment, Gold-castable Abutment, Screw- retained Abutment, Ball Abutment, and applicable abutment fixation screws.
The TRI-Octa implants are root form endosseous dental implants. They have a pink, transgingival collar. TRI-Octa is available in three implant diameters (3.75, 4.1 and 4.7 mm) and six lengths (6.5, 8, 10, 11.5, 13, and 16 mm). Only the 4.1 mm and 4.7 mm diameter implant bodies are available in the 6.5 mm length. All three TRI-Octa implant diameters have the same platform diameter (4.8 mm). TRI-Octa abutments include Healing Collar, Straight PEEK Temporary Abutment, Straight and 20° Angled Abutments, Straight Screw Retained Abutment, Ball Abutment, and applicable abutment fixation screws.
Here's a breakdown of the acceptance criteria and study information for the TRI® Dental Implant System, based on the provided text:
Preamble: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing legally marketed devices. It typically describes non-clinical testing performed to show that the new device performs as safely and effectively as predicates, rather than extensive clinical efficacy studies with specific acceptance criteria in the clinical sense. Therefore, the "acceptance criteria" here refer more to the performance standards the device was tested against to prove equivalence, particularly in mechanical and biological compatibility. Clinical outcomes data (e.g., success rates in patients) often come from post-market surveillance or larger clinical trials not detailed in a 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2 | Sterilization validation performed (demonstrates substantial equivalence to predicate processes). |
| Biocompatibility | ISO 10993-1, ISO 10993-5 | Biocompatibility evaluation and testing performed (demonstrates substantial equivalence to predicate materials). |
| Mechanical Performance | ISO 14801: Dentistry – Implants – Dynamic fatigue test for endosseous dental implants | Fatigue testing demonstrates increased abutment angulation is substantially equivalent to identified predicates with respect to performance. |
| Dimensional Analysis | N/A (Engineering dimensional analysis) | Engineering dimensional analysis performed (implied to match or be acceptably similar to predicates). |
| Material Composition | Titanium Alloy, CPTi, PEEK, Gold alloy | "Slight differences in material composition... are demonstrated substantially equivalent by biocompatibility testing." The device utilizes Titanium Alloy and other materials consistent with predicates. |
| Surface Area (Osseointegration) | N/A (Surface area analysis) | Surface area analysis demonstrates smallest diameter/shortest length combinations are substantially equivalent to reference predicate K092035. |
| Overall Equivalence | Same intended use, operating principle, basic design, similar/same materials, similar packaging/sterilization process as predicates. | Concluded that the data demonstrate substantial equivalence to predicate devices. |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- The document does not explicitly state sample sizes for each non-clinical test (e.g., number of implants tested for fatigue). It only mentions that "Non-clinical testing data submitted, referenced, or relied upon" was provided.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). Given it's non-clinical lab testing against ISO standards, it would be prospective data generated for the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. The "ground truth" for non-clinical performance data is defined by the technical specifications outlined in the ISO standards themselves (e.g., a specific fatigue load, or a cytotoxicity response in a cell culture). There isn't typically expert consensus to establish a "ground truth" for these types of engineering and biocompatibility tests.
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Adjudication method for the test set:
- Not applicable as this is non-clinical testing against ISO standards, not a study involving human readers or clinical adjudication.
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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:
- Not applicable. This document describes a dental implant system, not an AI-powered diagnostic device. No MRMC studies were conducted or reported.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (dental implant), not an algorithm.
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The type of ground truth used:
- For non-clinical testing: The "ground truth" is defined by the physical, chemical, and biological properties and performance metrics specified in the referenced ISO standards (e.g., mechanical strength requirements, cytotoxicity levels, sterility assurance levels). It's based on established scientific and engineering criteria.
- For demonstrating equivalence: The ultimate "ground truth" for the 510(k) process is the safety and effectiveness of the legally marketed predicate devices.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm requiring a "training set."
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How the ground truth for the training set was established:
- Not applicable, for the same reason as above.
§ 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.