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8plant Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implant bodies with a diameter of 5mm or more are intended to be used in the molar region.

8plant Implant System consists of SF Fixtures, Cover Screw, Abutment, and Abutment Screw.

1. 8plant Implant System (SF Fixtures and Cover Screw)
   This titanium dental implant features a SLA (Sandblasted with Large-grit and Acid-etched) surface with the alveolar bone and is designed to support single or multiple-unit restorations in partially or fully edentulous patients. It is secured to the upper structure using an internal hex fastening system.
2. 8plant Abutment System (Abutment and Abutment Screw)
   8plant Abutment System is compatible with the SF Fixtures. 8plant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. The 8plant Abutment System consists of the following; Healing Abutment, Rigid Abutment, Locator Abutment, Transfer Abutment, Angled Abutment, Temporary Abutment, Abutment Screw.

The provided document describes a 510(k) premarket notification for the "8plant Implant System." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with reported device performance.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including specific details like sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, and training set sample size/ground truth establishment, is not available in this document.

The document primarily highlights:

• Substantial Equivalence Comparison: The core of the submission is a comparison of the subject device (8plant Implant System) to a primary predicate device (ZENEX Implant System) and several reference devices. This comparison is presented in tables detailing similarities and differences in intended use, structure, dimensions, material, surface treatment, and sterilization methods for various components (fixture, cover screw, abutments, abutment screw).
• Non-clinical Testing: The document lists bench tests conducted to "verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device." These tests were performed to ensure compliance with standards relevant to dental implants:
  • Mechanical Performance: Fatigue testing (ISO 14801:2016).
  • Surface Analysis: Utilizing EDS and SEM evaluations for SLA treated surfaces.
  • Sterilization, Shelf-life, and Packaging: Gamma sterilization validation (ISO 11137 series), End User Sterilization Validation (ISO 11138-1, ISO 17665 series, ISO 11737 series), and real-time aging tests (ASTM F88, ASTM F1929).
  • MR Environment Condition: Non-clinical worst-case MR review based on scientific rationale and published literature.
  • Bacterial Endotoxin: Testing to ensure endotoxin levels are below 0.5 EU/mL (USP ).
  • Biocompatibility: Evaluations according to ISO 10993-1 and ISO 10993-12.

The document concludes that the "results of the below tests have met the standards and demonstrated the substantial equivalence with the predicate device." However, it does not provide specific numerical acceptance criteria or detailed performance data from these tests. It simply states that the device 'met the standards' or 'demonstrated substantial equivalence.'

Without a dedicated clinical study or further non-clinical performance data with explicit acceptance criteria and corresponding results, it's impossible to fill out the table and provide the in-depth study information requested.

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Dentis s-Clean SQ-SL Fixture 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. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL 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 Hex.

The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).

The dimensions of fixtures are as following:

Tolerance of dimension shall be within ± 1% range.

s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:

s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:

Denis s-Clean SQ-SL Fixture is provided sterilized.

Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

This document is a 510(k) Summary for the Dentis s-Clean SQ-SL Fixture, a dental implant. It does not contain information about the acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information regarding AI/algorithm acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The "Non-Clinical Test Data" section describes engineering and biocompatibility tests conducted on the device, not an AI algorithm.

Non-Clinical Test Data Summary (from the document):

• Tests performed on the subject device: Fatigue Testing (ISO 14801:2016).
• Tests performed on predicate devices and leveraged for the subject device:
  • Sterilization Validation Test on Fixtures (ISO 11137-1,2,3 referenced in K192688).
  • Shelf-Life Test on Fixtures (ASTM F1980 referenced in K153639).
  • Biocompatibility testing on fixtures (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639).
  • Bacterial Endotoxin Test Report on Fixtures (ANSI/AAMI ST72:2011, USP , and USP referenced in K192688).
• Acceptance Criteria for these non-clinical tests: "met the criteria of the standards" (e.g., ISO 14801:2016 for fatigue).
• Study Design/Purpose: To demonstrate substantial equivalence to predicate devices.
• MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to evaluate magnetic safety, addressing magnetically induced displacement force and torque.

This document describes a traditional medical device (dental implant) clearance process, not one involving Artificial Intelligence.

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Dentis s-Clean Regular Abutment 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. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean Regular Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components, and Abutment screws.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies. It's important to note that this document is a 510(k) summary for a dental implant abutment, and as such, it focuses on demonstrating "substantial equivalence" to existing cleared devices rather than establishing novel safety and effectiveness criteria from scratch. Therefore, the "acceptance criteria" here are largely implied by the equivalence to predicate devices and adherence to relevant standards.

General Observation: The document primarily focuses on demonstrating substantial equivalence (SE) based on comparing the subject device's (Dentis s-Clean Regular Abutment) technical characteristics, materials, and intended use to various predicate and reference devices. The "performance" being evaluated is largely through compliance with international standards and leveraging prior testing on similar devices. There isn't a direct "device performance" in terms of clinical outcomes with AI assistance or human reader improvement, as this is a physical medical device (dental abutment).

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

Given the nature of the device (dental abutment) and the submission type (510(k) for substantial equivalence), the "acceptance criteria" are predominantly about meeting material specifications, standardized mechanical testing, and demonstrating equivalence in design and intended use to legally marketed predicate devices. The "reported device performance" is largely the successful completion of these tests or the justification for leveraging prior testing.

• Resistance to fatigue under worst-case scenario. (ISO 14801:2016) | - "Fatigue Testing under the worst-case scenario according to ISO 14801:2016" was performed on the subject device and "results of the above tests have met the criteria of the standards." |
  | Sterilization Efficacy (for SAVE Wide Cap):
• Validation of sterilization process. (ISO 11137-1,2,3) | - "Sterilization Validation Test for SAVE Wide Cap according to ISO 11137-1.2,3" was "performed for predicate devices and leveraged for the subject device." Implied to have met criteria. |
  | Shelf Life (for SAVE Wide Cap):
• Confirmation of product stability over time. (ASTM F1980) | - "Shelf Life Test for SAVE Wide Cap according to ASTM F1980 referenced in K171027" was "performed for predicate devices and leveraged for the subject device." Implied to have met criteria. |
  | End User Sterilization Efficacy (for Abutments):
• Validation of end-user sterilization methods for various materials. (ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, ISO 11138-1) | - "End User Sterilization Validation Test Report for Abutments made with Ti-6Al-4V ELI according to [standards] referenced in K111364" was "performed for predicate devices and leveraged for the subject device."
• "End User Sterilization Validation Test Report for Abutments made with PEEK, POM and CP Titanium Grade 4 according to [standards]" was performed.
• All implied to have met criteria. |
  | Biocompatibility:
• Safety concerning biological interaction with human tissue. (ISO 10993-1:2009) | - "Biocompatibility testing for subject Abutments according to ISO 10993-1:2009 referenced in K171027, K171694, and K222913" was performed on the "predicate device and leveraged for the subject device because both products are manufactured with same materials and manufacturing process."
• "Demonstrates that the subject device is biocompatible and substantial equivalence with the predicate." |
  | Design and Material Equivalence:
• Comparison of dimensions, materials, and general design to predicate devices. | - Detailed comparison tables are provided for each component of the Dentis s-Clean Regular Abutment against specific predicate/reference devices, showing "same indications for use," similar or same dimensions (with differences justified as not impacting performance), and identical materials where applicable.
• Example for s-Clean Couple Abutment: "Subject Device and Primary Predicate(K171027) have same indications for use, similar sizes...material, and sterilization method. Both devices are substantial equivalent." |
  | Intended Use Equivalence:
• The subject device's intended use matches that of predicate devices. | - "This system has the same intended use and fundamental scientific technology as its predicate devices." The Indications for Use statement is provided and implicitly compared to predicate devices. |
  | Manufacturing Process / Facility Equivalence:
• For leveraged testing, assurance that processes are similar/identical. | - For leveraged end-user sterilization tests: "because the product category, material, manufacturing process, facility, and packaging of the both products are exactly same." |

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

The document specifies "Fatigue Testing under the worst-case scenario according to ISO 14801:2016" was performed on the subject device. However, it does not specify the sample size used for this specific test item.

For the other tests (Sterilization Validation, Shelf Life, End User Sterilization Validation, Biocompatibility), the data provenance is that they were "performed for predicate devices and leveraged for the subject device" or "conducted on the predicate device and leveraged."

• Sample Size: Not explicitly stated for any of the tests.
• Data Provenance: Retrospective (leveraged from previously cleared predicate/reference devices) and some prospective (Fatigue Testing on the subject device). The country of origin of the data is not specified, but the manufacturer is Dentis Co., Ltd. (Korea) and the US correspondent is Withus Group Inc. (USA). The tests were presumably conducted in facilities capable of meeting the cited international standards.

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 to this type of device submission. This is a physical dental implant component, not an AI/software device that requires expert adjudication for ground truth establishment. The "ground truth" here is compliance with engineering standards and material specifications, verified through laboratory testing.

4. Adjudication method for the test set

This question is not applicable. There is no human adjudication process described for the engineering tests performed on a physical dental abutment. The outcome of the tests (e.g., fatigue strength, material composition) is objectively measured against a standard.

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. This device is a physical dental abutment, not an imaging or diagnostic AI device that would involve human readers or AI assistance.

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

This question is not applicable. This device is a physical dental abutment, not an algorithm or software.

7. The type of ground truth used

The "ground truth" for the performance of this dental abutment is based on:

• Engineering Standards and Specifications: Adherence to international standards like ISO 14801 (fatigue), ISO 11137 (sterilization), ASTM F1980 (shelf life), ISO 10993-1 (biocompatibility), and material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI).
• Material Composition Analysis: Ensuring materials match specified standards (e.g., Ti-6Al-4V ELI, Pure Titanium Gr4, PEEK, POM).
• Dimensional Accuracy: Ensuring dimensions are within acceptable tolerances.
• Demonstrated Performance of Predicate Devices: Relying on the established safety and effectiveness of legally marketed predicate devices through showing substantial equivalence in design, materials, and intended use.

8. The sample size for the training set

This question is not applicable. This is a physical device, not an AI/machine learning model, so there is no "training set."

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

This question is not applicable. Since there is no training set, there is no ground truth established for it.

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s-Clean Link Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center.

The s-Clean Link Abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of two-piece abutment that is a link abutment at the bottom, a coping (CAD/CAM patient specific superstructure) at the top and screw. The bottom link abutment portion of the s-Clean Link Abutment is pre-manufactured (stock) made from a titanium alloy conforming to ASTM F136. The Top half of the s-Clean Link Abutment is composed of zirconia conforming to ISO 6872 reference to prior cleared ceramic, K141724.

s-Clean Abutment Screw s-Line is made of Ti-6AI-4V ELI (ASTM F136)

The diameters of s-Clean Link Abutment are 4.5 and 4.8mm.

s-Clean Link Abutment is provided non-sterile therefore must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment.

The proposed devices are compatible with the following device.

Raw material blanks

• K141724, Upcera Dental Zirconia Blank & Dental Zircornia Pre-Shaded Blank by Liaoning Upcera Co.. Ltd.
  Raw material cement
• K191122, 3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M ESPE Dental Product .
  The coping that composes the final abutment should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the link abutment.

The coping would be manufactured by Dentis only with design input using CAD/CAM Software from and by Dentis milling center.

Design Limitation for Superstructure:

| | Zirconia for s-Clean Link Abutment
Regular | Zirconia for s-Clean Link Abutment
Mini |
|-------------------------------------------------------------|-----------------------------------------------|--------------------------------------------|
| Minimum wall thickness | 0.5 | 0.5 |
| Minimum/Maximum Post Height for
single-unit restorations | 4.45 | 4.45 |
| Maximum gingival height in the
zirconia superstructure | 0 | 0 |
| Minimum gingival height in the Link
Abutment | 1 | 1 |
| Maximum angulation | 0 | 0 |

This FDA 510(k) summary focuses on demonstrating substantial equivalence of the s-Clean Link Abutment to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/ML medical device. The document describes a dental implant abutment, which is a physical device, not an AI/ML algorithm.

Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, and human-in-the-loop performance, is not applicable to the provided document.

The document primarily addresses non-clinical testing for a physical medical device. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical quantitative performance metrics sense for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it demonstrates "substantial equivalence" to a predicate device based on design, materials, indications for use, and non-clinical testing.

The key "performance" is demonstrated through:

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

• Test Set (Non-Clinical): Not directly applicable in the terms of a "test set" for an AI/ML algorithm. For the physical device, non-clinical tests (sterilization, biocompatibility, cytotoxicity) were performed. The sample sizes for these specific lab tests are not detailed in this summary document, but standard methods for such tests typically involve a sufficient number of samples to ensure statistical validity for the physical properties being measured.
• Data Provenance: Not applicable as it's not a data-driven AI/ML study. The data provenance would refer to the lab where tests were conducted which is not specified.

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

• Not applicable. Ground truth, in the context of an AI/ML device, is established by expert annotation or clinical outcomes. For this physical dental abutment, "ground truth" is established by manufacturing specifications, material standards, and benchmark testing against established predicate devices and recognized international standards (e.g., ISO, ASTM, AAMI).

4. Adjudication method for the test set:

• Not applicable. This is relevant for clinical studies or expert labeling in AI/ML.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is explicitly stated: "Clinical testing was not necessary to establish substantial equivalency of the device." MRMC studies are for assessing diagnostic or clinical performance with human readers.

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

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

7. The type of ground truth used:

• For a physical device, "ground truth" refers to compliance with material specifications (e.g., ASTM F136 for titanium alloy, ISO 6872 for zirconia), design parameters, and the results of standardized non-clinical performance tests (e.g., sterilization effectiveness, biocompatibility). The predicate device (DIO CAD/CAM Abutment, K181037) also serves as a "ground truth" for substantial equivalence comparison.

8. The sample size for the training set:

• Not applicable. There is no "training set" for a physical device.

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

• Not applicable. There is no "training set" for a physical device.

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MU System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

MU Ti Cylinder is manufactured by titanium alloy conforming to ASTM F136 and is used with s-Clean MU Angled Abutment and s-Clean MU Straight Abutment to provide support for multiple unit prosthetic restoration such as bridges, or overdentures. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations and supplied non-sterile.

s-Clean MU Healing Cap is manufactured by titanium alloy conforming to ASTM F136 and used with our cleared device, K210134 such as s-Clean MU Angled Abutment and s-Clean MU Straight Abutment and used for protecting inner hole of fixture and adjusting the appropriate height during the healing period.

This document, K222976, is a 510(k) premarket notification for the "MU System," an endosseous dental implant abutment. The review provided focuses on establishing substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific acceptance criteria in the context of diagnostic or treatment efficacy.

This submission is for a dental implant abutment, which is a physical component, not a device that makes diagnostic or treatment decisions based on data. Therefore, the questions related to clinical performance, such as diagnostic accuracy, human reader improvement, and ground truth establishment, are not applicable in the typical sense for this type of device.

Instead, acceptance criteria for this device are related to its physical properties, biocompatibility, and mechanical performance, which are assessed through non-clinical testing and comparison to predicate devices. The "study" here refers to the non-clinical testing performed to demonstrate that the device is safe and effective and performs as intended.

Here's an attempt to answer your questions based on the provided text, reinterpreting where necessary due to the nature of the device:

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

The document doesn't explicitly list "acceptance criteria" in a numerical format that would be typical for a diagnostic algorithm. Instead, the acceptance criteria for a dental implant abutment are implicitly met by demonstrating:

• Substantial equivalence to predicate devices regarding design, material, sterile method, and indications for use.
• Compliance with relevant international and FDA standards for non-clinical testing (biocompatibility, fatigue, sterilization).

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

This device is a physical component, not a data-driven diagnostic or AI system. Therefore, there isn't a "test set" in the context of images or patient data. The "testing" involves physical and material tests.

• Sample Size for Physical Tests: Not explicitly stated in terms of number of units for each test (e.g., number of abutments fatigued). Regulatory documents often refer to "representative test articles" without specifying the exact quantity for each test.
• Data Provenance: The "data" comes from non-clinical laboratory testing performed to international and US standards (ISO, ASTM, ANSI/AAMI, FDA guidance). It is not patient or clinical data. The manufacturer is Dentis Co., Ltd. in Korea.

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. Ground truth, in the context of clinical expert consensus, is not relevant for the physical testing of an implant abutment. The "ground truth" here is established by the validated methods of material science, mechanical engineering, and biocompatibility testing standards.

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

Not applicable. This is not a study involving expert adjudication of clinical findings.

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 dental implant abutment, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this medical device approval is based on:

• Material Standards: Adherence to ASTM F136 for Ti-6Al-4V ELI.
• Biocompatibility Standards: Compliance with ISO 10993 series.
• Sterilization Standards: Compliance with ISO 17665 series and ANSI/AAMI ST79.
• Mechanical Testing Standards: Compliance with ISO 14801 for fatigue.
• MRI Safety Considerations: Compliance with FDA guidance on MR environment testing.
• Substantial Equivalence: Demonstrated comparison to already legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. See point 8.

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