Search Results

The ST Internal 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 ST Internal Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ST Internal Implant System are made with Grade 4 titanium and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The systems 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 system are ST internal implant, screw and abutment. The implants in this system are provided in lengths from 7.0-15.0 and in diameters from 3.7-5.1. The 3.7 diameter implant is not provided in the 7.0 length. The ST implants have two types, one is mini and the other is regular. The mini type diameters of ST implants are 3.7 mm and the lengths are 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. The regular type diameters of ST implants are 4.2 mm, 4.6 mm, and 5.1 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. EZ Post abutments, solid abutments, Cylinder abutments, angled abutments, mount screws, cover screws, abutment screws and fixture mounts are included in the system.

The provided text describes a 510(k) premarket notification for a medical device, the "ST Internal Implant System." The approval is based on a determination of substantial equivalence to existing predicate devices, rather than a de novo clinical study with specific acceptance criteria based on human performance.

Therefore, many of the requested details about acceptance criteria, study design with human readers, and ground truth establishment (especially for AI or image analysis devices) are not applicable (N/A) to this 510(k) submission. The performance testing focuses on mechanical and biological properties of the dental implant itself, not on an algorithm's ability to interpret data.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, but does not provide a specific table of quantitative acceptance criteria for all performance parameters and their corresponding reported values in a standardized format. Instead, it states:

• Sterilization Test: "leveraged from own K132992 predicate" - implies meeting standards leveraged from prior approval.
• Shelf Life Test: "leveraged from own K132992 and K152787 predicate" - implies meeting standards leveraged from prior approval.
• Biocompatibility testing:
  • Cytotoxicity Test
  • Intracutaneous Reactivity Test
  • Maximization Sensitization Test
  • Systemic Injection Test (Intravenous Injection)
  • Pyrogen Test
  • "All the test results demonstrate that ST Internal Implant System meets the requirements of its pre-defined acceptance criteria and intended use." (General statement, no specific values given).
• 90-Day Bone Implantation Study: Listed as performed.
• Fatigue test:
  • Acceptance Criteria Statement: "A fatigue test is required to evaluate the stability of implant system in oral cavity. The fatigue testing has been conducted on the proposed device in accordance with ISO 14801."
  • Reported Performance: "Test results comply with ISO14801." (No specific numerical values or pass/fail thresholds are explicitly provided in the document, only a statement of compliance).
• SLA surface treatment (cleaning validation and SEM/EDX analysis):
  • Acceptance Criteria Statement: "to verify that any particles or chemicals used to remove particles have been washed from the surface."
  • Reported Performance: "The SEM/EDX analysis verifies that there were no elements besides titanium found on the surface of the implant."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified for any of the non-clinical tests (e.g., number of implants tested for fatigue). These are typically lab-based tests, not human data.
• Data Provenance: The device manufacturer, T-Plus Implant Tech. Co., Ltd., is located in Taiwan. The tests are "non-clinical testing," implying laboratory or animal studies, not human data from a specific country.
• Retrospective or Prospective: N/A for these non-clinical tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• N/A. The testing described is for the physical and biological properties of a dental implant, not for an algorithm where expert radiologist ground truth would be established. The ground truth for mechanical and biocompatibility tests are defined industry standards (e.g., ISO 14801) and established laboratory protocols.

4. Adjudication Method for the Test Set

• N/A. Not relevant for non-clinical, lab-based performance tests of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, N/A. This type of study is relevant for diagnostic imaging AI systems and not for a dental implant's mechanical or biological performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• N/A. The device is a dental implant, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical testing (e.g., fatigue), the ground truth is compliance with international standards (ISO 14801).
• For biocompatibility, the ground truth is compliance with established biological safety requirements (e.g., ISO 10993 series through tests like cytotoxicity, sensitization, implantation, etc.).
• For surface analysis, the ground truth is the absence of foreign elements as determined by analytical techniques like SEM/EDX.

8. The Sample Size for the Training Set

• N/A. This device does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• N/A. As there is no training set for an algorithm, this question is not applicable.

Ask a specific question about this device