(143 days)
The TS Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
TS Fixture System is compatible with abutment in the ET/SS Implant System
The TS Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
Fixture is available in various lengths 7.0 to 15.0mm and diameters 3.5 to 6.8mm (TSII SA Fixture : 3.5, 4.2, 4.4, 4.9 / TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05, 5.08, 5.1 / TSIII SA Ultra-Wide Fixture : 5.92, 5.95, 6, 6.8) according to the anatomical situation.
Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.
The TS Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The provided document is a 510(k) premarket notification for a dental implant system (TS Fixture System). It aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and study information:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the concept of "substantial equivalence" to predicate devices. The performance characteristics of the TS Fixture System are evaluated against those of the predicate devices. The key performance criteria for this type of device are primarily related to mechanical integrity (fatigue strength) and biocompatibility.
| Acceptance Criteria (Inferred from Substantial Equivalence and Predicate Devices) | Reported Device Performance (TS Fixture System) |
|---|---|
| Material Composition: Pure Titanium Grade 4 (ASTM F67) | Conforms: Made of Pure Titanium Grade 4 (ASTM F67). This is identical to the predicate devices (HGII Fixture System, GSIII System, ETIII SA Fixture System, ETIII SA Ultra wide Fixture). |
| Surface Treatment: (SA - Sandblasting and Acid etching) | Conforms: The TS Fixture System uses SA (Sandblasting and Acid etching) surface treatment. This is identical to the ETIII SA Fixture System (K101096) and ETIII SA Ultra wide Fixture (K103537). While different from HGII (RBM) and GSIII (RBM), the submission asserts equivalence based on the ETIII SA system. |
| Design Characteristics: (e.g., Internal Hex-connected, submerged fixture, body shape, cutting edges, body diameter, length) | Conforms: The TS Fixture System has an Internal Hex-connected, submerged fixture with tapered and straight body shapes and 4-sided cutting edges with self-tapping. Its dimensions (body diameter 3.5-5.1mm; length 7.0-15mm) are comparable to the ranges of the predicate devices, sometimes falling within one predicate's range or being a combination thereof. For the "TSIII SA Ultra-Wide Fixture" variant, design, diameter (5.92-6.8mm) and length (7.0-12.5mm) are also presented as comparable to its specific predicate (ETIII SA Ultra wide Fixture). The submission states "similar design" compared to predicates. |
| Intended Use: For partially/fully edentulous mandibles/maxillae, single/multiple-unit restorations, delayed loading. | Conforms: The intended use statement is essentially identical to the predicate devices, supporting single or multiple-unit restorations (cemented, screw, overdenture), and final/temporary abutment support for fixed bridgework, with delayed loading. |
| Biocompatibility: Meet applicable international/US regulations. | Conforms: "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (No specific data or reports are summarized beyond this statement.) |
| Fatigue Strength: Performance equivalent to predicate devices. | Conforms: Fatigue testing was conducted according to FDA guidance (worst-case scenario of GSIII Fixture/HGII Fixture with an angled abutment, supporting TSIII SA Fixture and TSII SA Fixture). The conclusion is that the submitted fatigue test result is sufficient "as a proof of TS Fixture system" due to shared material and similar design with GSIII Fixture and HGII Fixture. Note: No specific numerical performance values (e.g., load cycles at specific force) are provided in this summary, but the conclusion implies successful demonstration of equivalence. |
| Sterilization: Radiation Sterile | Conforms: Radiation Sterile, identical to all predicate devices. |
| Shelf Life: 8 years | Conforms: Shelf life of 8 years. Longer than the 5 years reported for all predicate devices; however, a longer shelf life would generally not be a basis for non-equivalence unless it impacted safety or effectiveness adversely, which is not indicated. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a separate "test set" for clinical performance. The nonclinical testing (fatigue testing) implicitly involves mechanical test samples. No specific number for these samples is provided in this summary.
- Data Provenance: The fatigue testing was conducted by or for OSSTEM Implant Co., Ltd., which is based in Republic of Korea. The report is a 510(k) submission to the US FDA. The data itself is non-clinical bench testing data, not human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the submission relies on non-clinical testing (fatigue and biocompatibility) and comparison to predicate devices, not on expert consensus or adjudication of a test set in the way a diagnostic AI device would. The "ground truth" for non-clinical testing is typically defined by engineering standards and measurement accuracy.
4. Adjudication Method for the Test Set:
This information is not applicable for the reasons stated above. The evaluation of mechanical fatigue data would involve standard engineering analysis and report generation, not a consensus-based adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a dental implant (a physical medical device) and does not involve image reading or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This question is not applicable as the device is a physical dental implant, not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance evaluation hinges on:
- Engineering Standards and Specifications: For mechanical fatigue testing, the "ground truth" is adherence to established standards (e.g., ISO, ASTM) and successful completion of test cycles without failure, relative to the performance of predicate devices. The "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" serves as a key reference for methodology.
- Biocompatibility Standards: For biocompatibility, the "ground truth" is compliance with applicable international and US regulations, typically demonstrated through standardized in vitro and in vivo tests (e.g., ISO 10993 series).
- Predicate Device Characteristics: The ultimate "ground truth" in a 510(k) submission is the demonstration of substantial equivalence to already legally marketed devices.
8. The Sample Size for the Training Set:
This information is not applicable. Dental implants are physical devices, not machine learning algorithms, and therefore do not have "training sets" in the conventional sense. The design and manufacturing process are informed by engineering principles and previous device designs, but not a data training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated 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.