(174 days)
TiXos dental implants are permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient in order to restore their original dental function and aesthetic features by providing support for fixed and/or removal prosthesis. TiXos dental implants can support single tooth, multiple tooth, or total prosthesis restorations and are compatible with the following dental abutments manufactured by Leader Italia that were previously cleared under K062931.
Leader Italia's line of TiXos dental implants are titanium endosseous implants that are fabricated by a process called Direct Laser Metal Forming ("DLMF"). This fabrication process results in the production of an implant with a porous surface characterized by open intercommunicating cavities and networks. The implants are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient to provide support to be their fixed and/or removal prosthesis, and to restore their original dental and/or masticatory function. TiXos dental implants are permanent devices for single use and can support single tooth, multiple tooth, or total prosthesis restorations. These implants are designed to be used exclusively with Leader Italia's line of prosthetic abutments and surgical instruments. TiXos dental implants are gamma sterilized, have two basic model configurations called Cylindrical and S-Type, and a number of different sizes and diameters as shown below.
The provided text describes the submission of the TiXos Implant System for 510(k) clearance, asserting its substantial equivalence to the predicate IMPLUS Implant System. The document focuses on demonstrating that the new device does not raise new questions of safety and effectiveness, primarily through non-clinical bench testing and a summary of existing clinical literature.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device in the form of specific quantitative thresholds for performance metrics. Instead, the approach is focused on demonstrating "substantial equivalence" to a predicate device (IMPLUS Implant System). The performance is shown by stating that the TiXos implants were "compared to the predicate device and found it to be similar" in fatigue testing and met other applicable standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Fatigue Resistance: To simulate worst-case loading conditions and demonstrate similar performance to the predicate device per ISO 14801. | "Testing was performed on the TiXos dental implants to simulate worst-case loading conditions and was compared to the predicate device and found it to be similar." (Tested in dry environment). |
| Biocompatibility: To meet regulatory requirements. | "TiXos dental implants also underwent extensive validation activities for biocompatibility... in accordance with Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document... and all applicable recognized FDA consensus standards for dental implants, including but not limited to, ISO 10993-5." |
| Cleaning, Packaging, Shelf-life, and Sterilization: To meet regulatory requirements. | "TiXos dental implants also underwent extensive validation activities for... cleaning, packaging, shelf-life and sterilization in accordance with Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document... and all applicable recognized FDA consensus standards for dental implants." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that a "number of its dental implants" were submitted for fatigue testing. It also refers to a "prospective summary report, and radiographic images, to the FDA that were part of its European clinical study" and "201 Direct Laser Metal Forming Implants" in one of the cited clinical articles. However, specific sample sizes for each non-clinical bench test or the full clinical study report are not provided within this summary.
- Data Provenance:
- Non-Clinical Data: Likely conducted in a laboratory setting, not explicitly stated as retrospective or prospective given it's bench testing.
- Clinical Data: "European clinical study" and "prospective summary report." One cited article mentions a "1-Year Prospective Multicenter Study." This indicates some clinical data is prospective and originates from Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the establishment of a ground truth for a "test set" in the context of an algorithm or AI performance. The clinical data cited are from existing peer-reviewed studies which would have had their own methods for diagnosis and outcome assessment, implicitly involving medical experts. However, the exact number and qualifications of experts for the purpose of establishing ground truth in this submission are not specified.
4. Adjudication Method for the Test Set
Since the document does not detail a process for establishing ground truth for an AI algorithm's test set, there is no mention of an adjudication method (like 2+1 or 3+1). The "ground truth" in the clinical studies cited would have been established through standard clinical practice for dental implant outcomes (e.g., radiographic analysis, clinical examination, histological analysis).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size
No MRMC comparative effectiveness study is mentioned. This submission is for a medical device (dental implant), not an AI algorithm intended for human-in-the-loop assistance for diagnosis or treatment planning. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this document describes a physical medical device (dental implant), not an AI algorithm. Therefore, no standalone algorithm performance study was performed or is relevant to this submission.
7. The Type of Ground Truth Used
For the clinical data, the "ground truth" for the effectiveness and safety of the dental implants appears to be based on:
- Clinical outcomes: Restoration of original dental function and aesthetic features, osseointegration.
- Radiographic images: Used in the European clinical study.
- Histological reports: One cited study is titled "Early Human Bone Response to Laser Metal Sintering Surface Topography: A Histological Report."
- Histomorphometric studies: One cited study mentions "A Histomorphometric Study In Humans."
- SEM and X-Ray Dispersive Spectrometry Evaluation: Mentioned in a case series for surface and bone interface.
8. The Sample Size for the Training Set
This question is not applicable as the document describes a physical medical device and not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as the document describes a physical medical device and not an AI algorithm requiring a training set.
§ 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.