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The Kisses Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.

Kisses Plus Implant System offers three different types of implants: Double Hex, and Kisses Single Hex. The Double Hex type has the doubled hex part to be coupled to the superstructure, whereas, the Single Hex type and Kisses Single Hex type has single hex part.

The Double Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers double hex type.

The Single Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type.

The Kisses Single Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type.

Kisses Plus Implant System also includes the following components: Angled abutment, Duplex Abutment, Duplex Milling Abutment, Simplex Abutment, Temporary Abutment, Solid Screw Abutment, Ball Abutment, Ball Cap, Cover Screw, Healing Abutment.

The provided document is a 510(k) premarket notification for a medical device, the "Kisses Plus Implant System," and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel diagnostic AI algorithm.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth types are not applicable or not explicitly detailed in this type of regulatory submission for a dental implant system.

Instead, the document details physical and functional characteristics to show that the new device is as safe and effective as existing, legally marketed devices.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of acceptance criteria with corresponding device performance metrics in the way you might expect for a diagnostic AI. Instead, it compares the subject device's characteristics to those of predicate devices to establish substantial equivalence. The "performance" here refers to meeting safety and effectiveness standards through material composition, design similarities, and successful non-clinical testing.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated in terms of a "test set" for performance evaluation of an AI algorithm. The non-clinical tests (e.g., fatigue, rotational shear strength) inherently involve a sample size of physical devices, but the specific number tested for each criterion is not detailed.
• Data Provenance: Not applicable as this is a physical medical device, not an AI algorithm processing patient data. The tests were likely conducted in a controlled laboratory environment.

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

• Not Applicable. This is a physical dental implant device, not a diagnostic algorithm requiring expert-established ground truth from medical images or patient data. The "ground truth" for this device's performance is established through engineering standards, material specifications, and mechanical testing.

4. Adjudication method for the test set

• Not Applicable. This is a physical dental implant device, not a diagnostic algorithm where adjudication of results by multiple experts would typically occur. The non-clinical tests are performed according to established 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

• Not Applicable. This is a physical dental implant device and does not involve human readers or AI assistance in the context of diagnostic interpretation.

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

• Not Applicable. This is a physical dental implant device, not an algorithm.

7. The type of ground truth used

• Engineering Standards and Specifications: The "ground truth" for the performance of this dental implant is based on established international standards (e.g., ISO, ASTM), material properties, and the demonstrated performance of its predicate devices. The non-clinical tests verify that the device meets these engineering and safety benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical dental implant device, not an AI algorithm that requires a training set.

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

• Not Applicable. This is a physical dental implant device, not an AI algorithm that requires a training set with established ground truth.

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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 Biogenesis Implant System –Kisses is in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The Biogenesis Implant System - Kisses is for single and two stage surgical procedures. It is for delayed loading.

The Biogenesis 110 Implant System - Kisses is a dental implant system made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches. This product is a substructure of a dental implant system to replace a single tooth, partial tooth and the lost root of edentulous patients. It consists of the hex part to be coupled to the superstructure, the single thread part to be fixed to the bone, and the cutting edge part with the self-tapping function.

The Biogenesis™ Implant System offers bone level implants in the size range of 3.8 – 5.5 mm diameter with 7 – 14.5mm length.

The Biogenesis TM Implant System also offers the following components.

• · Duplex Abutment
• Duplex Milling Abutment
• Simplex Abutment
• Temporary Abutment
• · Solid Screw Abutment
• · Ball Abutment
• Ball Cap

The implants are intended for use with straight implant only straight implants are included in the submission.

The provided text is a 510(k) summary for the Biogenesis™ Implant System - Kisses, a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through the kind of studies you describe.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be fully extracted from this document. This kind of detailed study information is typically found in the full submission, not in the public 510(k) summary.

However, I can provide the limited information available regarding non-clinical testing and general acceptance of performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "the test results met the pre-set criteria" for various performance tests. However, it does not explicitly list quantified acceptance criteria or specific numerical reported device performance values. It only confirms conformance.

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

The document does not provide details on:

• Specific sample sizes used for the non-clinical tests (e.g., sterilization, shelf life, biocompatibility).
• Data provenance (e.g., country of origin, retrospective or prospective) for any test sets. Non-clinical studies like these are typically lab-based and not derived from clinical patient data in the same way clinical trials are.

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

This information is not applicable to the non-clinical bench testing described. These tests involve laboratory measurements and standards conformance, not expert assessment of clinical data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to the non-clinical bench testing described.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through comparison of technical characteristics and non-clinical bench testing to predicate devices, not on evaluating human reader performance with or without AI assistance.

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

No, a standalone (algorithm-only) performance study was not mentioned. The device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference points were established by recognized international and national standards:

• ISO 17665-1/2 and ANSI/AANI ST79 for sterilization validation.
• ASTM F1980 for shelf life testing.
• ISO 10993-1 for biocompatibility testing.
• FDA Guidance Document for Endosseous Dental Implants and Abutments for overall conformance.

These standards define methods and acceptable limits for the performance characteristics being evaluated.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a physical medical device (dental implant), not an AI/ML algorithm that would typically require a training set.

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

This information is not applicable, as there is no mention of a training set for an AI/ML algorithm.

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