(85 days)
The Ti Star Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.
The Ti Star Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Ti Star Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Ti Star Implant System consist of one-stage and two-stage, root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options. The devices covered by this submission are Ti Star Implant Fixtures, abutments, cover screw, closing screw and healing screw. The diameters of implant fixture are 3.5mm, 4.1mm and 4.8mm, the lengths are 7.0mm, 8.5mm, 10.0mm, 11.5mm, 13.0mm and 15.0mm.
The provided 510(k) summary for the Ti Star Implant System is for a dental implant, which is a physical device, not an AI/ML powered SaMD (Software as a Medical Device). Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set sample size, etc.) are not applicable here.
However, I can extract the relevant information regarding the acceptance criteria and the study that proves the device meets those criteria, based on the document provided.
1. Table of Acceptance Criteria and Reported Device Performance
For the Ti Star Implant System, the acceptance criteria are based on compliance with established international and ASTM standards for dental implants. The performance is reported as meeting these requirements.
| Test Item | Standard and Regulations Applied | Acceptance Criteria Met (Reported Device Performance) |
|---|---|---|
| Biomechanical Testing | ISO 14801:2007 Dentistry. Implants. Dynamic fatigue test for endosseous dental implants | Met requirements |
| Sterilization | ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products | |
| ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | ||
| ISO 11137-2:2012 Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose | ||
| ISO 17665-1:2006 Sterilization of health care products – Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. (Sterility) | ||
| ISO 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1. (Sterility) | Met requirements | |
| Surface and Material | ASTM E3 - 11 Standard Guide for Preparation of Metallographic Specimens | |
| ASTM F746-04 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials. (Materials) | ||
| ISO 16700 Microbeam analysis -- Scanning electron microscopy -- Guidelines for calibrating image magnification | ||
| ASTM F67-06, Standard Specification for Unalloyed Titanium for Surgical Implant Applications | ||
| ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). | ||
| ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages. (Sterility) | ||
| ASTM F1929-98(04) Standard test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | ||
| ASTM F88 2007 Standard Test Method for Seal Strength of Flexible Barrier Materials | ||
| ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | ||
| ASTM F88/F88M 2009 Standard Test Method for Seal Strength of Flexible Barrier Materials | Met requirements |
The document states: "All the test results demonstrate Ti Star Implant System meets the requirements of its pre-defined acceptance criteria and intended uses."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the tests are non-clinical (bench testing). The document does not specify the exact number of units or batches tested for each standard, nor the country of origin of the test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a non-clinical device that was evaluated through physical and material testing against international standards, not through human expert review of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is related to human interpretation of data for AI/ML performance.
5. 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 is a physical medical device, not an AI/ML system, and no human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is the established performance requirements defined by the international and ASTM standards (e.g., ISO 14801 for dynamic fatigue, ISO 11737 for sterilization, ASTM F746 for corrosion). The device performance was compared against these technical specifications.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 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.