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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.

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The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

The ST Internal Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The abutment is a superstructure of a dental implant system which is attached to the implants made of Ti-6A1-4V ELI with the surface treated by anodizing method(except healing and temporary abutment). 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. The system is consisted of the following components: ST Internal Fixture, EZ Post Abutment, Solid Abutment, Angled Abutment, Milling Abutment, Cover Screw, Healing Abutment, Temporary Abutment, and Abutment Screw.

The provided text is a 510(k) summary for the ST Internal Implant System. It does not describe a study to prove the device meets acceptance criteria in the traditional sense of a clinical trial or performance study with defined acceptance criteria for accuracy, sensitivity, specificity, etc.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence for a medical device is established by showing that the new device (subject device) is as safe and effective as a legally marketed device (predicate device) that is already cleared by the FDA. This is typically achieved by demonstrating that the new device has the same intended use and the same technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The "acceptance criteria" here are not performance metrics like sensitivity or specificity. Rather, the implicit acceptance criteria are that the differences between the subject device and the predicate(s) are minor and do not negatively impact safety or effectiveness, as demonstrated through non-clinical (bench) testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of (implicit) acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document does not specify exact sample sizes (number of units tested) for the non-clinical bench tests (static compression-strength and fatigue tests). It mentions that tests were performed "with combination of the fixture and the angled abutment, in consideration of the worst case" and refers to ISO 14801. ISO 14801 typically involves testing a certain number of samples (e.g., n=10 or more) for fatigue and static strength for statistical validity, but the exact count is not provided in this summary.
• Data Provenance: The tests were performed by MegaGen Implant Co., Ltd. which is based in Republic of Korea. The data is non-clinical bench test data, not human subject data, so "retrospective or prospective" doesn't directly apply in the same way it would for a clinical study.

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)

• This information is not applicable as there was no study involving human expert interpretation or establishing ground truth based on expert consensus. The "ground truth" for non-clinical tests like fatigue and strength is based on physical scientific principles and engineering standards (e.g., ISO 14801).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable as there was no study involving human interpretation or adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a dental implant system (physical product), not an AI diagnostic tool that assists human readers.

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

• No, a standalone algorithm performance study was not done. This device is a physical dental implant system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the non-clinical tests, the "ground truth" is defined by adherence to international standards and guidance documents like ISO 14801 and specific FDA guidance for root-form endosseous dental implants. This involves objective physical measurements (e.g., fatigue limit, static compression strength values) verified against predefined acceptable ranges or performance relative to a predicate.

8. The sample size for the training set

• This information is not applicable. The context is a 510(k) submission for a physical medical device (dental implant), not an AI/ML algorithm that requires training data.

9. How the ground truth for the training set was established

• This information is not applicable for the reasons stated above.

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