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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 Fixture 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 Fixture System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ST Internal Fixtures are made with Grade 4 titanium. 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 submission are ST internal fixture, screw and abutment. The diameters of ST internal fixtures are 3.5 mm, 4.0 mm, 4.5 mm, and 5.0 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm.

The applicant, T-Plus Implant Tech. Co., Ltd., is seeking 510(k) clearance for their ST Internal Fixture System. The device is a dental implant system intended for placement in the upper or lower jaw to support prosthetic devices and restore chewing function, for both two-stage and single-stage surgical procedures. It is also intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The submission aims to demonstrate substantial equivalence to two predicate devices: the Ti Star Implant System (K132992), also from T-Plus Implant Tech. Co., Ltd., and the ExFeel Dental Implant System (K052369) from MegaGen Co., Ltd.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document provides details on non-clinical testing. For the performance tests conducted, such as "Fatigue test" and "RBM surface coating," specific sample sizes are not explicitly stated in the provided text. The data provenance is derived from these non-clinical tests performed on the "proposed device." There is no indication of clinical data, so discussions of country of origin or retrospective/prospective studies are not applicable to the testing mentioned.

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

This information is not applicable as the provided document details non-clinical laboratory testing, not studies involving human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the provided document details non-clinical laboratory testing, not studies involving human subjects or expert assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No additional clinical testing was necessary for a determination of substantial equivalence."

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the device is a physical medical implant, not an algorithm or software. The "performance testing" described refers to the physical properties of the implant.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 14801) and scientific methods (e.g., cleaning validation, SEM/EDX analysis). For biocompatibility and sterilization, it is implied that the predicate devices had established ground truth based on their respective testing protocols and regulatory approvals.

8. Sample Size for the Training Set:

This information is not applicable as the document describes a medical device seeking substantial equivalence based on non-clinical testing, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for the described device.

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The A Plus Internal Fixture 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. It is intended for delayed loading.

The A Plus internal fixtures are made with Grade 4 titanium. 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 submission are A Plus internal fixture, screw, abutment and some accessories. The diameters of A Plus internal fixtures are 3.4 mm, 3.8 mm, 4.3 mm, 4.8 mm, and 5.3 mm, and the lengths are 8 mm, 10 mm, 12 mm, and 14 mm.

This document describes a 510(k) premarket notification for a medical device called the "A Plus Internal Fixture System," which is an endosseous dental implant. The core of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness through extensive studies as might be required for a novel device. Therefore, the information provided focuses on non-clinical performance and design similarity rather than complex clinical trial data or AI performance metrics.

Based on the provided text, the device itself is an endosseous dental implant, not an AI-powered diagnostic or assistive tool. Consequently, questions related to AI performance, human reader improvement with AI assistance, expert consensus for ground truth establishment in a diagnostic context, and training/test set sample sizes for algorithms are not applicable to this submission.

Here's an analysis based on the information provided, addressing the relevant points and noting the non-applicability of others:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified for any of the non-clinical tests. For mechanical and material tests like fatigue and surface analysis, samples of the physical device components are tested according to the relevant ISO standards, but a "test set" in the context of clinical or AI validation is not applicable here.
• Data Provenance: The device manufacturer is T-Plus Implant Tech. Co., Ltd. in New Taipei City, Taiwan. The non-clinical testing was performed either directly by the manufacturer or by a contracted lab, with the results provided as part of the 510(k) submission. No information on the country of origin of "data" in a patient or imaging context is relevant or provided. The studies are not clinical human studies; they are bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable. "Ground truth" established by experts is relevant for diagnostic devices, especially those using AI, where a human expert's interpretation (e.g., radiologist's reading) is compared to the device's output. For an endosseous dental implant, "ground truth" is established by engineering specifications, material science standards, and the results of physical and chemical tests (e.g., measuring forces, observing material degradation, analyzing surface composition).

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or multi-reader studies to resolve discrepancies among expert readers when establishing a "ground truth" for a diagnostic task. The tests performed for this dental implant are non-clinical bench tests (e.g., fatigue, biocompatibility), where results are determined by objective measurements against predefined standards.

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

• This question is not applicable. The "A Plus Internal Fixture System" is a physical dental implant, not an AI-powered diagnostic or assistive device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was performed or is relevant to its substantial equivalence determination.

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

• This question is not applicable. The device is an endosseous dental implant, not an algorithm. There is no "standalone algorithm" performance to report.

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

• The "ground truth" for this device's performance is based on established engineering standards, material specifications, and regulatory requirements. For example, for the fatigue test, the "ground truth" is that the implant must withstand a certain number of load cycles at a specified force as per ISO 14801. For biocompatibility, the "ground truth" is that the materials must not elicit adverse biological reactions as defined by ISO 10993 series for medical devices. For surface coating, the "ground truth" is the absence of residual particles.

8. The sample size for the training set

• This question is not applicable. There is no "training set" for this type of device, as it is not a machine learning or AI-based system.

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

• This question is not applicable. As there is no training set, there is no ground truth to be established for it.

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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.

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.

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