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

Dentis i-Clean system is intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment screws.

The Dentis i-Clean System is a dental implant system consisting of abutments and abutment screws. The device is not an AI/ML device, and therefore the standard acceptance criteria for such devices, along with the study design elements listed, do not apply.

Here's an overview of the non-clinical testing performed to demonstrate substantial equivalence, as described in the provided document:

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

Since this is not an AI/ML device, there are no performance metrics like sensitivity, specificity, or AUC with acceptance criteria described in the document. The substantial equivalence is based on meeting engineering and biological safety standards for medical devices.

The non-clinical tests performed and their respective standards are:

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 does not specify a "test set" in the context of AI/ML. The tests mentioned are non-clinical (mechanical, sterilization, biocompatibility, MRI review). The sample sizes for these engineering and biological tests are not detailed in this summary but are typically defined by the respective ISO standards. The data provenance is presumed to be from laboratory testing performed by, or on behalf of, Dentis Co., Ltd. (Korea, as per submitter address) or the referenced predicate device manufacturers. These are not human data, so "retrospective or prospective" does not apply.

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, as this is not an AI/ML device involving human experts for ground truth establishment.

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

Not applicable, as this is not an AI/ML device.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

Not applicable in the context of AI/ML. For medical devices, "ground truth" is typically defined by adherence to established engineering standards (e.g., ISO 14801 for fatigue) and biological safety standards (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization).

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

The Dentis s-Clean SQ-SL Narrow Implant System may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The Dentis s-Clean SQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal connection, intended for single use. Dentis s-Clean SQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implant is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

The provided text is a 510(k) summary for a dental implant system. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a study to prove a device meets specific performance acceptance criteria for a novel function. As such, the information required for a study proving device performance against acceptance criteria (sections 1-9 of your request) is largely absent from this type of regulatory document.

However, I can extract information related to the acceptance criteria for ensuring safety and performance based on the type of testing performed, which is primarily non-clinical (bench) testing.

Here's an attempt to answer your questions based on the provided text, highlighting where information is absent or not applicable to this type of regulatory submission:

Device: Dentis s-Clean SQ-SL Narrow Implant System

Indications for Use (from K230246): The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

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

The document does not provide a table of acceptance criteria with specific numerical performance metrics. Instead, it lists the types of tests performed and states that the device was found "substantially equivalent." For specific performance criteria, one would typically refer to the referenced ISO standards (e.g., ISO 14801:2016 for fatigue). The "reported device performance" is implicitly that it met the requirements of these standards.

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 specified for any of the tests. For fatigue testing per ISO 14801, a minimum number of samples is typically tested, but the exact number isn't provided here.
• Data Provenance: Not specified, but the submission is from Dentis Co., Ltd. in Korea. The studies are described as "non-clinical test data," implying bench testing, not patient data. Therefore, "retrospective or prospective" is not applicable in the clinical trial sense.

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 510(k) submission for a dental implant system, demonstrating substantial equivalence through non-clinical (bench) testing, not through expert-reviewed clinical imaging data or diagnostic performance studies. "Ground truth" in this context refers to the defined metrics and standards of the bench tests (e.g., fatigue cycles to failure, material composition analysis).

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

Not applicable. This concept applies to clinical studies involving human readers and interpretations, not to non-clinical bench testing.

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. The device is a dental implant system, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. The device is a physical dental implant, not an algorithm.

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

The "ground truth" for this device's non-clinical testing is defined by international and national standards for material properties, mechanical performance, biocompatibility, and sterilization (e.g., ISO 14801:2016, ISO 10993-1:2009, ANSI/AAMI ST79). For the MR environment assessment, it relies on "scientific rationale and published literature."

8. The sample size for the training set

Not applicable. This is not a machine learning model.

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

Not applicable. This is not a machine learning model.

Summary of the "Study" (Non-Clinical Testing):

The "study" described in this 510(k) summary is a set of non-clinical (bench) tests designed to demonstrate that the Dentis s-Clean SQ-SL Narrow Implant System is as safe and effective as previously cleared predicate devices.

• Purpose: To demonstrate substantial equivalence to predicate devices (K161244, K182194, K210080, K171027, K171694) in terms of materials, design, mechanical performance, biocompatibility, and sterilization, rather than proving performance against novel clinical acceptance criteria.
• Key Tests Performed:
  • Fatigue Testing: Performed on the subject device according to ISO 14801:2016 under worst-case scenarios.
  • Biocompatibility Testing: Leveraged from predicate devices (K171694) and based on ISO 10993-1:2009. The rationale is that the subject device uses the same materials and manufacturing process.
  • End User Sterilization Validation: Leveraged from predicate devices (K171694 and K171027) based on ANSI/AAMI ST79, ISO 17665-1,-2, ISO 11737-1,-2, and ISO 11138-1. The rationale is similar product category, material, manufacturing process, facility, and packaging.
  • Surface Modification (TiN Coating): Data provided to compare chemical composition, SEM, EDS, adhesion, and thickness between subject and predicate (K171694).
  • MR Environment Compatibility: Non-clinical worst-case MRI review performed based on scientific rationale and published literature, referencing FDA guidance.
• Conclusion: The device "constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use," based on these non-clinical tests and comparisons to predicate devices.

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Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.

Dentis I-FIX Abutment consists of I-FIX Angled Type Fixture Healing Abutment, I-FIX Angled Type Fixture Healing Abutment Screw, and I-FIX Abutment Screw.

I-FIX Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are compatible with following Implant Systems:
Proprietary Name: I-FIX System (Angled Type Fixture)
Compatible Implants (K number): K083586
Implant diameter size: Ø 2.0, 2.5, 3.0 mm
Implant length: 10~16 mm

I-FIX Abutment Screw is only used with I-FIX Cemented Abutment and I-FIX Free Abutment cleared in K083586.

The dimensions of abutments are as following:

1. I-FIX Angled Type Fixture Healing Abutment: (D) 4.03 X (L) 3.2, 4, 5 and 7 mm, Angulation 0°
2. I-FIX Angled Type Fixture Healing Abutment Screw: (D) 2.15 X (L) 4.0, 4.8, 6.1 and 8.0 mm, Angulation 0°
3. I-FIX Abutment Screw: (D) 2.15 X (L) 4.7 mm, Angulation 0°

Tolerance of dimension for Abutments shall be within ± 1% range.

The Abutments have below featured:

• I-FIX Angled Type Fixture Healing Abutment: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Titanium Grade 4.
• I-FIX Angled Type Fixture Healing Abutment Screw: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Ti-6Al-4V ELI.
• I-FIX Abutment Screw: Uses - I-FIX Abutment screw is used with the previously cleared devices, K083586 such as I-FIX Cemented and Free Abutment for connecting with fixture. Surface - Non. Materials - Ti-6Al-4V ELI.

I-Fix Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are packaged as a set and provided sterilized. I-FIX Abutment Screw is provided non-sterilized.

Materials:

• I-FIX Angled Type Fixture Healing Abutment is fabricated from pure titanium (Conforming to ASTM Standard F67)
• I-FIX Angled Type Fixture Healing Abutment Screw and I-FIX Abutment Screw are fabricated from Ti-6Al-4V ELI (Conforming to ASTM Standard F136)

This FDA 510(k) submission for the Dentis I-FIX Abutment indicates that the device is substantially equivalent to predicate devices, meaning it does not require a new study to prove its effectiveness or safety. Instead, the submission relies on existing data from predicate devices and non-clinical testing. Therefore, there is no specific de novo study described for this device with acceptance criteria and reported device performance in the traditional sense of a clinical trial.

However, I can extract the acceptance criteria that were met through non-clinical testing by referring to the standards and guidance mentioned.

Here's a breakdown of the requested information based on the provided document:

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

The document does not provide a table with quantitative acceptance criteria and specific numerical reported device performance for the Dentis I-FIX Abutment as one would expect from a de novo clinical study. Instead, it states that various non-clinical tests were performed and that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."

Here are the types of criteria that were met, based on the standards cited:

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

The document does not specify sample sizes for the non-clinical tests performed. These tests are typically conducted on a limited number of device samples in a laboratory setting. The data provenance is also unspecified beyond the general reference to "Non-Clinical Test Data" and the identification of Dentis Co., Ltd. as the manufacturer 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)

This section is not applicable as the submission relies on non-clinical engineering and materials testing, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is objective measurement against established engineering and biocompatibility standards.

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

This section is not applicable as there was no clinical study with a test set requiring adjudication of 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

This section is not applicable. The Dentis I-FIX Abutment is a physical dental device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This section is not applicable. The device is a physical medical device, not an algorithm.

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

The "ground truth" used for non-clinical testing was based on:

• Established international and national standards (e.g., ISO, ASTM, ANSI/AAMI).
• Material specifications (e.g., ASTM F67, ASTM F136).
• Engineering specifications (e.g., dimensional tolerances).

8. The sample size for the training set

This section is not applicable. There was no "training set" in the context of machine learning or AI development for this physical device. The device design and manufacturing processes are based on established engineering principles and materials science.

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

This section is not applicable for the reasons stated in point 8.

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SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dentoalveolar bony defect sites.

The SAVE GBR consists of Healing Cap, Cover Cap and Spacer. The SAVE GBR are manufactured by Ti-6A1-4V ELI and used with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

The subject device is compatible with the OssBuilder membrane cleared in K172354.

The dimension of the device is as below:

The healing cap and cover cap have same functions and uses but have different design and name. The SAVE GBR are removed from the patient after such time when sufficient bone regeneration is done.

I am sorry, but the provided text (K222451_Decision_Letter[1].pdf) does NOT contain information about acceptance criteria, device performance results, sample sizes for test and training sets, expert qualifications, ground truth establishment, or any details related to an AI/ML-driven medical device study.

The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "SAVE GBR." This device is a metal component used with dental implants to stabilize and support bone grafts. The core of this FDA submission is to demonstrate substantial equivalence to already legally marketed predicate devices, not to present performance data from an AI/ML model.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI-driven device based on this input. The document focuses on material composition, dimensions, sterilization, shelf life, and intended use as compared to predicate devices, rather than AI performance metrics.

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The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following stuations and with the clinical protocols:

-Delayed loading.

-Immediate loading when good

primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.

AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.

AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.

Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function.

The proposed AnyOne Onestage Implant System is consisted of the following components: Fixture Products (AnyOne Onestage Fixture), Closing Screw & Cover Screw & Healing Abutment (Closing Screw, Cover Screw, Healing Abutment), Fixture Level Prosthesis (Multi Post, Multi Post Cap, EZ Post Abutment, Angled Abutment, Gold Abutment, CCM Abutment, Multi Post Screw, Abutment Screw), Abutment Level Prosthesis (Solid Abutment, Solid Cap, Solid Post Abutment, Solid Post Cap, Octa Abutment, Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Abutment Screw), Overdenture Prosthesis (Meg-Loc Abutment, Meg-Ball Abutment, Meg-Magnet Abutment, Magnet, Meg-Rhein Abutment).

The provided text does not describe an AI/ML device but rather a dental implant system. Therefore, details regarding AI/ML device performance, such as acceptance criteria, test set sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or training set specifics, are not applicable and not present in the document.

The document focuses on demonstrating the substantial equivalence of the "AnyOne Onestage Implant System" to predicate devices, primarily through comparison of design, materials, indications for use, and mechanical performance testing (biocompatibility, surface treatment, endotoxin, sterilization, and static/fatigue tests).

Acceptance Criteria and Device Performance (Not Applicable for AI/ML):

Since this is a non-AI/ML device, the concept of "acceptance criteria" as it relates to algorithm performance (e.g., sensitivity, specificity, AUC) and "reported device performance" in that context is not relevant. Instead, the document demonstrates that the new device meets established standards and is equivalent to legally marketed predicate devices through various non-clinical tests.

However, if we interpret "acceptance criteria" as the criteria for demonstrating substantial equivalence for this medical device (dental implant system) and "reported device performance" as the results of the non-clinical tests, we can extract details regarding the physical property tests performed. The acceptance criterion for these tests is that the device must meet "pre-set criteria" according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment," and the reported performance is simply that the test results "met the pre-set criteria."

Summary of Non-Clinical Testing Performance for Dental Implant System:

Further details as requested (adapted for a non-AI/ML device):

2. Sample size used for the test set and the data provenance:
   The document focuses on non-clinical (bench) testing. For the physical properties (static compression-strength and fatigue tests), representative specimens were selected "under the consideration of worst case." The exact number of samples tested for each component is not explicitly stated in this summary, but it would have been part of the full testing report. The provenance of the "data" would be the internal testing laboratories of MegaGen Implant Co., Ltd. (Republic of Korea). The tests are prospective in the sense that they are specifically conducted to support this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical tests is established by standardized testing protocols (e.g., ISO 14801) and engineering measurements, not human expert consensus.

4. Adjudication method for the test set: Not applicable for physical property testing. Test results are objectively measured 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: Not applicable, as this is a dental implant system (physical device), not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used:
   For physical properties (static compression-strength and fatigue), the "ground truth" is based on the performance requirements specified in international standards (ISO 14801) and FDA guidance documents ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment"). For biocompatibility and sterilization, it's adherence to ISO standards (ISO 10993-1, ISO 11137, ISO 17665-1, 2) and ASTM standards (ASTM F1980), as well as USP for endotoxin.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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Dentis s-Clean s-Line Mini 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 s-Line Mini is composed of Fixture and Abutments. s-Clean SO-SL Fixture Mini 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 subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. The surface of fixture 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 system includes various abutments (Cover Screw, Healing Abutment, Sole Abutment, TiN Half Coating Sole Abutment, Couple Abutment, TiN Half Coating Couple Abutment, Angled Abutment, TiN Half Coating Angled Abutment, Abutment Screw, Temporary Abutment, MU Straight Abutment, MU Angled Abutment, MU Angled Abutment Screw) made from Pure titanium (ASTM F67), Ti-6Al-4V (ASTM F136), or PEEK material. Some abutments have Anodizing (Gold Color) or TiN-Coating surface treatments.

This document (K210080) describes the Dentis s-Clean s-Line Mini, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than an AI/ML-driven device requiring a study to prove meeting acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).

The acceptance criteria described in this document are related to the physical, chemical, and mechanical properties, as well as the sterility and biocompatibility of the dental implant components, and their substantial equivalence to already marketed devices. The "study" proving acceptance is a series of non-clinical tests and comparisons to predicate devices.

Therefore, I cannot provide a table with "acceptance criteria and reported device performance" as typically found for AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, I will describe the non-clinical tests and their outcomes as presented in the document to demonstrate the device meets its acceptance criteria for safety and effectiveness as a physical medical device.

1. Table of Acceptance Criteria (for a physical dental implant) and Reported Device Performance

Since this is a physical dental implant, the "acceptance criteria" are based on meeting established standards and demonstrating substantial equivalence to predicate devices in terms of material, design, performance, and biocompatibility.

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

• Sample Size for Test Set: The document doesn't specify a "test set" in the context of an AI/ML diagnostic algorithm. For the physical device, fatigue testing per ISO 14801 would involve a specific number of samples, but the exact count is not provided. Other tests like biocompatibility, sterilization, and shelf-life are typically performed on a limited number of samples representative of the product. The document states a comparative fatigue test was conducted.
• Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to the results of non-clinical bench testing and material characterization. The manufacturer is Dentis Co., Ltd. from South Korea. The testing was performed according to international standards (ISO, ASTM, USP) and FDA-recognized guidance. It's a "prospective" assessment in that the tests were done on the manufactured devices to demonstrate their properties.

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

• This is not applicable for a physical medical device submission like this one. "Ground truth" in this context refers to established standards (e.g., ISO for fatigue, ASTM for materials, ISO/AAMI for sterilization), which are derived from broad expert consensus in relevant fields (engineering, microbiology, toxicology, dentistry).

4. Adjudication Method for the Test Set:

• Not applicable as this is not an AI/ML diagnostic study with human readers. Test results are compared against defined standard criteria.

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

• No, this type of study is not relevant for a physical dental implant. MRMC studies are typically for evaluating the diagnostic performance of AI/ML systems, often with human readers.

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

• Not applicable. There is no algorithm or AI component in this dental implant.

7. The Type of Ground Truth Used:

• The "ground truth" for proving the device's acceptance is based on:
  • International Standards: Conformance to recognized standards such as ISO 14801 (fatigue), ISO 10993 series (biocompatibility), ISO 11137 series (sterilization), ASTM F67, F136, F1980 (materials, shelf-life), and AAMI/USP guidelines for bacterial endotoxins.
  • Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device has the "same intended use and fundamental scientific technology" as legally marketed predicate devices, and any differences "do not raise different questions of safety and effectiveness."

8. The Sample Size for the Training Set:

• Not applicable. There is no AI/ML training set for this physical device.

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

• Not applicable. There is no AI/ML training set.

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Dentis s-Clean s-Line 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 s-Line is composed of Fixture and Abutments. 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 Acidetching). The device includes various abutments made from Ti-6A1-4V (ASTM F136) and Chrome-cobalt-molybdenum (CCM) alloy material (ASTM F1537). Some abutments have a TiN coating. Some components are provided sterile, while others are non-sterilized.

The provided text describes a 510(k) premarket notification for a dental implant system (Dentis s-Clean s-Line). This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it does not present a typical device performance study with specific acceptance criteria and reported numerical performance metrics.

Instead, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to predicate devices through various tests and comparisons, particularly in terms of:

• Indications for Use
• Design and dimensions
• Materials
• Surface treatments
• Sterilization methods
• Biocompatibility
• Dynamic fatigue and static strength

The "study that proves the device meets the acceptance criteria" is fundamentally the comparative analysis against the predicate and reference devices, along with performance testing (dynamic fatigue, static strength) and biological assessment (biocompatibility).

Here's an attempt to structure the information based on your request, acknowledging that the format of a 510(k) summary is different from a clinical study report.

Implied Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices. The performance data presented is in comparison to these predicates rather than against pre-defined numerical thresholds for novel performance.

• Dynamic Fatigue Strength
• Static Strength | Tests conducted according to FDA guidance and ISO 14801:2016 for worst-case scenario. Results are implied to be equivalent to predicate (as no significant differences were cited to impact performance). |
  | Material Characteristics:
• Adherence to ASTM standards (F67, F136, F1537)
• Surface characteristics (SLA, TiN coating) | Fixtures made of CP Titanium Gr4 (ASTM F67). Abutments from Ti-6Al-4V (ASTM F136) and Chrome-cobalt-molybdenum (ASTM F1537).
  SLA surface identical to K153639. TiN coating identical to K171694. EDX, SEM, surface roughness, coating thickness, porosity, adhesion leveraged from predicates. |
  | Biocompatibility:
• Non-cytotoxic, non-sensitizing, non-irritating | Biological assessment performed according to ISO 10993-1:2009 and FDA Guidance. Device has equivalent nature of body contact, duration, material formulation, and sterilization methods compared to predicates, thus no new issues raised. |
  | Sterilization:
• Sterility Assurance Level (SAL) of 10^-6
• Shelf Life Validation
• Pyrogenicity | Validated in accordance with ISO 11137-1:2006.
  Shelf life of 8 years for sterile devices, validated per ASTM F1980.
  LAL Endotoxin Analysis (testing limit 20 EU/device) meets pyrogen limit specifications. |
  | Dimensional Tolerance:
• Fixtures and Abutments | Stated tolerance of ± 1% range for dimensions. The dimensions of the subject device are stated to be "in range" or "similar" to the predicate devices and not to impact device performance. |

Detailed Information as Requested:

1. A table of acceptance criteria and the reported device performance: (See table above).

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 does not specify a "test set" in the context of a clinical study or human subject data. The samples for mechanical testing (dynamic fatigue, static strength) and biocompatibility are laboratory samples/implants, not patient data.
   • The document does not provide details on the number of samples used for these specific tests.
   • Data Provenance: The mechanical and surface characteristic data were leveraged from previous clearances (K153639, K171694, K082843, K150344, K171027), indicating prior existing test results. It is prospective testing for the elements that are different or new, but retrospective use of data for elements deemed identical to predicates. Country of origin for testing is not specified.

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 question is not applicable to a 510(k) submission based on mechanical and biocompatibility testing. There is no "ground truth" established by experts in the clinical sense for this type of submission. The "ground truth" for material properties and mechanical performance would be the universally accepted standards (ASTM, ISO) and the empirical results of the tests themselves, interpreted by qualified engineers/scientists.

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

   • Not applicable. This type of adjudication method is used in clinical trials or diagnostic accuracy studies involving expert panel reviews, which are not part of this 510(k) submission for mechanical equivalence.

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 pertains to AI/CAD devices, not dental implants. No MRMC study was conducted or relevant to this submission.

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

   • Not applicable. This pertains to AI/CAD devices, not dental implants.

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

   • For the mechanical and material aspects, the "ground truth" is defined by international standards (ISO, ASTM) and regulatory guidance (FDA Guidance Documents) for dental implants. The device components are compared against these established specifications and the validated characteristics of the predicate devices.
   • For biocompatibility, the ground truth is established by recognized biological evaluation standards (ISO 10993-1).

8. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

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The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore 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.

This submission is to add new implants and abutments to the previously cleared device, Magicore System (K152520). The newly added implants and abutments are below: Fixture - Magicore (4mm of Neck length Implants) . - . Magicore (Cutting Edge) Abutment - Magicore Solid Abutment - Healing Cap For Magicore Solid Abutment Cap, no other changes are being made to the previous clearance except for product name change. An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The Magicore System consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media).

This document describes the Magicore System, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics. The information provided is for regulatory clearance (510(k)) and focuses on comparing the new components of the Magicore System to previously cleared devices.

Therefore, many of the requested categories related to clinical study design, performance metrics, and ground truth establishment are not applicable.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the Magicore System or clinical performance results. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on design, materials, indications for use, and non-clinical testing.

The acceptance criteria for this 510(k) submission are based on meeting the requirements for substantial equivalence to legally marketed predicate devices. This means showing that the new components of the Magicore System are as safe and effective as the predicate devices and do not raise new questions of safety or effectiveness.

The document states: "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." However, it does not specify what those "criteria" were in terms of quantifiable device performance. It refers to compliance with ISO and ASTM standards for non-clinical aspects.

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

Not applicable. This document is a 510(k) submission for new dental implant components, not a clinical study assessing performance with a test set of data. The testing mentioned is non-clinical (material properties, sterilization, biocompatibility, etc.).

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 establishment by experts for a test set is not relevant to this type of regulatory submission, which relies on engineering and biological testing against established standards and comparison to predicate devices.

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

Not applicable. No test set requiring expert adjudication for ground truth was used in this submission.

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 not a study assessing AI performance or human reader improvement.

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

Not applicable. This product is a physical dental implant system, not an algorithm.

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

Not applicable. The concept of "ground truth" as it applies to diagnostic or treatment efficacy studies is not relevant here. The "truth" in this context is adherence to recognized standards and demonstrated equivalence to already approved devices through non-clinical testing.

8. The sample size for the training set

Not applicable. This product is a physical dental implant system, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System 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 Magicore II System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore II implant is treated with SLA (sand-blasted, large-grit, acid-etched). The Fixture diameters are 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm and threaded lengths are 7, 8, 9, 10, 11, 12, 13mm in this system. The contained various abutments and screws in the system are Short Abutment, Magic Multi Abutment, Magic Multi Cylinder, Magic Multi Abutment ST, Abutment Screw, Healing Cap, Magicore Angled Abutment.

This document is a 510(k) summary for the Magicore II System, an endosseous dental implant system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone clinical study on device performance. Therefore, many of the requested details regarding clinical study design, expert adjudication, MRMC studies, and ground truth establishment are not present in this document, as they are not typically required for a 510(k) submission for this type of device.

The acceptance criteria provided here are primarily based on non-clinical performance testing (fatigue testing) and comparison to predicate devices in terms of material, design, indications for use, and manufacturing processes, rather than a clinical trial demonstrating specific performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are aligned with demonstrating substantial equivalence to its predicate devices through non-clinical testing and comparison of characteristics. The primary performance metric mentioned is fatigue strength.

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

• Sample Size for Test Set: This document does not describe a clinical "test set" in the sense of patient data. The "test set" here refers to the physical devices undergoing non-clinical laboratory testing. The sample sizes for these specific non-clinical tests (e.g., how many implants were used for fatigue testing) are not specified in this summary document.
• Data Provenance: The data provenance is primarily from non-clinical laboratory testing (e.g., fatigue, sterilization, biocompatibility tests). Some test results are "leveraged" from previous 510(k) clearances (K152520, K162099, K140806, K173120), implying the data originated from other studies performed by the manufacturer or their affiliates. The country of origin for the data is implicitly where the manufacturer (InnoBioSurg Co., Ltd. - Republic of Korea) and referenced test labs are located. The data is retrospective in the sense that results from previously cleared devices are referenced.

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

• Not applicable. This submission relies on non-clinical engineering and materials testing standards (e.g., ISO, ASTM, USP) rather than a test set requiring expert clinical ground truth establishment.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable. As there is no clinical test set requiring subjective interpretation by experts, no adjudication method is mentioned or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance

• Not applicable. This device is a dental implant system, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or 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.)

• Ground Truth Type: For the non-clinical tests, the "ground truth" is defined by established international and national standards (e.g., ISO 14801 for fatigue limits, ISO 10993 for biocompatibility thresholds). The device's performance is compared against these engineering and material science standards.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that would require training data.

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

• Not applicable. As above, no training set for an algorithm is involved.

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s-Clean SQ-SL Implant System Mini 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 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.

s-Clean SQ-SL Implant System Mini is composed of Fixture and Abutments. s-Clean SQ-SL Implant System Mini 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.

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 s-Clean SQ-SL Implant System Mini Abutments are composed as below;

s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Mini Fixture Cover Screw

s-Clean SQ-SL Fixture and s-Clean Mini Fixture Cover Screw are provided sterilized. And the other Abutments are provided non-sterilized.

s-Clean SO-SL Fixture is enclosed with s-Clean Mini Fixture Cover Screw in a set packing. s-Clean Mini Fixture Cover Screw is also provided separately.

Based on the provided text, the document is a 510(k) Premarket Notification from Dentis Co., Ltd. for their s-Clean SQ-SL Implant System Mini. This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

The document discusses the design, materials, and intended use of the dental implant system and compares it to predicate devices. However, the provided text does not contain any information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or human reader improvement with AI assistance.

The "Non-Clinical Test Data" section lists various tests performed on the predicate devices and leveraged for the subject device to demonstrate substantial equivalence, specifically regarding sterilization, shelf life, biocompatibility, and bacterial endotoxin. These are safety and manufacturing standard compliance tests, not performance studies as typically understood for AI/diagnostic devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the manner you've outlined for AI or diagnostic devices, as this information is not present in the provided FDA 510(k) summary. The document focuses on demonstrating substantial equivalence to similar dental implants based on material, design, and manufacturing standards, rather than clinical performance outcomes or AI accuracy.

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