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DGA Abutment is a patient-specific prosthetic component directly connected to the endosseous dental implant (details as below) and is intended for use as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

DGA Abutment is endosseous implant abutment which is placed into a corresponding dental implant to provide support for a prosthetic restoration. DGA Abutment is made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F136). The DGA Abutment is mounted on the implant with a screw. Each abutment is supplied with two identical screws which are used for:
a. For fixing into the endosseous implant.
b. For dental laboratory use during fabrication of restoration.
The screw is also made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136).

The provided text is a 510(k) summary for the DGA Abutment, a dental implant component. It addresses substantial equivalence rather than presenting an AI/ML device study with acceptance criteria and performance data. Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies for an AI/ML device.

The document discusses the mechanical properties and biocompatibility of the DGA Abutment, comparing it to predicate devices. It states that fatigue testing was conducted according to ISO 14801:2016 and FDA guidance, and biocompatibility testing was done as per ISO 10993 series. However, it does not provide specific acceptance criteria or reported performance data in a table format for these tests, nor does it refer to an AI/ML algorithm.

Therefore, I cannot directly answer your prompt using the provided text. The prompt's questions pertain to acceptance criteria and study methodologies for an AI/ML device, which are not found in this 510(k) submission for a physical dental abutment.

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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, 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.

This 510k is to add the following abutments to Kisses Plus Implant System: Multi Straight Abutment, Multi Angled Abutment, CCM Abutment, and Multi CCM Abutment. The description includes details on the material composition (Ti 6A14V ELI or Co Cr Mo) and dimension ranges for each abutment type. It also mentions the abutment screws used with these abutments.

The provided text is a 510(k) summary for a dental implant system (Kisses Plus Implant System) and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than reporting on the performance of an AI/ML powered device.

Therefore, the document does not contain any information regarding:

• Acceptance criteria for an AI/ML powered device.
• Study details (e.g., test set sample size, provenance, expert qualifications, adjudication method, MRMC studies, standalone performance, ground truth type, training set details) that would prove an AI/ML device meets specific performance criteria.

The document describes non-clinical testing performed for the Kisses Plus Implant System, which includes:

• Fatigue test in accordance with ISO 14801.
• Biocompatibility tests: Cytotoxicity, Sensitization, and Irritation tests per ISO 10993-5 and ISO 10993-10, with additional leveraging from K172630.
• Steam sterilization validation in accordance with ISO 17665-1 and ISO 17665-2.

These tests are designed to ensure the safety and effectiveness of the physical dental implant components and demonstrate substantial equivalence to predicate devices, not AI/ML performance.

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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 Kisses Mini is indicated for use in partially or fully edentulous maxilla, in support of single or multiple-unt restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Kisses Mini is for single and two stage surgical procedures. It is for delayed loading.

The intended use of the 3.2 mm Internal Hex fixtures is limited to the replacement of maxillary lateral incisors.

The intended use of the single-piece post type fixture to replacement of mandibular central and lateral incisors.

The ball-type single-piece implant is intended for stabilization and retention of overdentures.

KJ Mini offers three different types of implants: 2-Piece Type, Post Type, and Ball Type.

The 2-piece type fixture is a substructure of a dental implant system to replace a single 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. It offers single hex type and double hex type.

The post type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.

The ball type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.

The document is a 510(k) Summary for the "Kisses Mini" dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a traditional clinical study with outcome metrics.

Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, type of ground truth) related to a clinical study or AI model evaluation are not applicable in this context, as this is a regulatory submission for a medical device based on showing equivalence to existing devices.

The document discusses non-clinical testing to support substantial equivalence and safety/performance.

Here's a summary of the non-clinical testing performed as described in the document (Section 8):

1. Table of Acceptance Criteria and Reported Device Performance (as related to non-clinical testing for equivalence):

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

• Not applicable for a clinical study as described. The testing refers to non-clinical (laboratory/bench) tests. Specific sample sizes for each non-clinical test are not provided in this summary, but generalized statements about the tests being performed are made. Data provenance is implied to be from the manufacturer's internal testing.

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

• Not applicable. No expert ground truth establishment for a clinical test set is mentioned.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication is mentioned.

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 document is for a physical dental implant, not an AI-powered diagnostic or assistive device.

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

• Not applicable. This document is for a physical dental implant, not an algorithm.

7. The type of ground truth used:

• Not applicable for a clinical study. For non-clinical tests, physical and chemical standards (e.g., ISO for sterilization, USP for endotoxin) serve as the "ground truth" or reference for performance. Specific product specifications and predicate device characteristics also serve as comparators for "ground truth" for substantial equivalence.

8. The sample size for the training set:

• Not applicable. This document does not describe a machine learning model or a training set.

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

• Not applicable. This document does not describe a machine learning model or a training set.

In summary: This 510(k) summary is a regulatory submission for a physical medical device (dental implants) and demonstrates substantial equivalence through comparisons to predicate devices and non-clinical bench testing. It does not involve AI, clinical trials with human subjects for performance evaluation (beyond what's typically implicit in dental implant use), or the associated concepts of acceptance criteria tables, sample sizes, expert ground truth, or MRMC studies that would be relevant for an AI/CAD product.

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The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System II is consists of dental fixtures, screws and multiunit abutment cylinders.

The provided document is a 510(k) summary for the IBS Implant System II, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical testing. It does not describe an acceptance criteria study with the requested details (number of experts, sample size for test/training set, ground truth methods, MRMC study, or standalone performance).

Instead, the document details a comparison of the new device to existing devices (predicates) regarding various technical specifications and non-clinical test results.

Since the document does not contain the information for acceptance criteria and a study proving device meets it as requested, I cannot complete the table or answer the specific questions.

No information for the requested table and study details is available in the provided text. The document focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests (biocompatibility, endotoxin, sterilization validation, shelf-life validation, fatigue). These are not presented as a study with specific acceptance criteria that the device performed against in the way an AI/software performance study would be evaluated.

Therefore, the requested table of acceptance criteria and reported device performance cannot be generated. Similarly, specific details about sample size (training/test), data provenance, expert involvement, adjudication, MRMC, or standalone performance are not provided as these types of studies are typically associated with performance claims for diagnostic or prognostic devices, not for substantial equivalence of an endosseous dental implant based on physical and material properties.

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