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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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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

The purpose of this submission is to change the sterilization method of Healing Abutments and Cover Screws. These devices which have been provided non-sterilized by gamma radiation.

Healing Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment. Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final abutment. Cover Screws are used provisionally as an accessory to protect the inner features of the implant.

The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only.

The provided document is a 510(k) premarket notification for "Healing Abutments and Cover Screws." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of rigorous, large-scale studies typically associated with AI/ML-based medical devices or novel technologies.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this specific submission. This document describes a change in the sterilization method for existing devices, not a new device with performance metrics that require extensive clinical validation studies beyond sterilization and biocompatibility.

Here's an analysis based on the information available in the document:

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

For a 510(k) submission concerning a change in sterilization method for mechanical components like healing abutments and cover screws, the "acceptance criteria" revolve around demonstrating that the new sterilization method achieves the required sterility assurance level and does not adversely affect the device's material properties or function, maintaining its substantial equivalence to the predicate.

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of clinical performance data typical for AI/ML devices. The "tests" here are primarily engineering and laboratory validations:
  • Sterilization Validation: ISO 11137 standards define the number of units and replicates required for sterility testing (e.g., bioburden determination, dose mapping, sterility testing), which are often small, specific lots. This is standard laboratory validation, not a patient-based test set.
  • Aging Studies: ASTM F1980 dictates sample sizes for accelerated aging, again, laboratory testing of physical samples.
  • Biocompatibility: Relies on a prior submission (K041368) which presumably included its own biocompatibility testing. No new "sample size" for a clinical test set is mentioned for biocompatibility here.
• Data Provenance: The studies are laboratory-based ("Non-clinical testing data"). The manufacturer is located in the Republic of Korea (Dentium Co., Ltd.). The data would be derived from their internal validation processes. It is neither retrospective nor prospective in the sense of patient studies.

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 submission does not involve image interpretation or clinical diagnosis where expert ground truth would be established. The "ground truth" for sterilization is a defined SAL, verified by microbiological and physical testing per ISO standards. The "ground truth" for material properties is based on ASTM standards and prior biocompatibility data.

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

• Not Applicable. As there is no clinical "test set" based on human interpretation or an AI algorithm's output requiring adjudication, this concept does not apply.

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 traditional medical device (dental implants and accessories), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

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

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

• The "ground truth" for this submission is based on:
  • Standardized Sterility Assurance: Achieving a defined SAL of 10^-6, verified through validated sterilization processes and testing compliant with ISO 11137-1 and ISO 11137-2.
  • Material Standards: Biocompatibility established against Ti-6Al-4V ELI (ASTM F136) as per regulations and previous submissions.
  • Engineering Performance: Shelf-life demonstrated through accelerated and real-time aging studies per ASTM F1980.
  • Substantial Equivalence: Demonstrated by comparing engineering specifications and intended use against legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This involved physical device manufacturing and validation, not machine learning model training.

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

• Not Applicable. (See point 8)

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The IT-III active system is indicated for use in partially or fully edentulous mandibles and maxillae, 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. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Octa. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The IT -III active System Abutment are composed as below; IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment, IT Cemented Abutment Screw and IT Angled Abutment Screw.

The provided text describes the Neobiotech Co., Ltd. IT-III active System, an endosseous dental implant system, and its substantial equivalence to predicate devices, but does not contain a study comparing the device's performance against specific acceptance criteria and reporting its performance metrics in a way that directly answers all the questions in the prompt.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to already legally marketed devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the format requested.

However, I can extract the information provided that is relevant, or indicate where the information is not present.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the requested format. Instead, it states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device did meet the criteria of the standards listed, but doesn't quantify the performance against those criteria.

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

The document lists non-clinical testing performed, such as Fatigue Testing, Sterilization Testing, Shelf Life Testing, Bacterial Endotoxin Test, and Biocompatibility Evaluation. However, it does not specify the sample sizes used for these tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 type of information is not applicable to the non-clinical testing (fatigue, sterility, etc.) described in the document. Ground truth as typically established by experts (e.g., radiologists for imaging studies) is not relevant for the engineering and biological tests conducted for dental implant device clearance.

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

This information is not applicable to the non-clinical testing described. Adjudication methods are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, which is not the nature of the tests performed here.

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 MRMC comparative effectiveness study was performed or mentioned in this document. This study type is far more common for diagnostic imaging AI devices, rather than for a dental implant system.

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

This concept is not applicable to the IT-III active System, which is a physical dental implant. Standalone algorithm performance refers to the performance of AI software independent of human intervention, which is not relevant for this device.

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

For the non-clinical tests conducted, the "ground truth" is defined by the standards themselves (e.g., ISO 14801 specifies the methodology and interpretation for fatigue failure, ISO 11137 for sterility). The tests measure whether the device meets the predefined physical, mechanical, and biological properties as stipulated by these recognized standards. It's not about an expert diagnosis or clinical outcome but rather adherence to engineering/material specifications.

8. The sample size for the training set

No training set is mentioned or applicable. This document is not describing a machine learning or AI algorithm, but rather a physical dental implant device undergoing non-clinical validation.

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

Not applicable, as there is no training set described.

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