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s-Clean Pre-Milled Abutment Mini 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.

All digitally designed abutments for use with s-Clean Pre-Milled Abutment Mini are intended to be manufactured at a Dentis validated milling center.

Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 5.8, 6.8mm and two connection designs (Hex, Non-hex).

s-Clean Pre-Milled Abutment Mini are supplied with s-Clean abutment screw Mini, previously cleared in K210080 and provided non-sterile.

The provided text describes a 510(k) premarket notification for a dental device, the "s-Clean Pre-Milled Abutment Mini." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in the context of a diagnostic or AI-driven system.

Therefore, many of the requested details about acceptance criteria, study design for performance, sample sizes, expert qualifications, and ground truth establishment are not applicable or available in this document. This is because the device is a dental abutment, not a diagnostic or AI-powered system that requires performance metrics like sensitivity, specificity, or human reader improvement.

However, I can extract information related to the device's testing and the conclusion of its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a dental abutment, "acceptance criteria" typically refer to meeting specified engineering and materials standards, rather than diagnostic performance metrics. The "performance" is demonstrated by passing these tests.

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

The document does not specify a distinct "test set" in the way a diagnostic study would. For the fatigue testing, it refers to "the worst-case scenario" (smallest diameter with maximum angulation) but does not provide the specific number of units tested. The provenance of this data is from the manufacturer's (Dentis Co., Ltd.) non-clinical testing, which is implicitly prospective testing done for the 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. This device is a physical dental abutment, not a diagnostic tool requiring expert interpretation or ground truth establishment.

4. Adjudication method for the test set

Not applicable. There is no diagnostic "test set" or human interpretation involved to require an adjudication method.

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 an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used

For a physical medical device, "ground truth" would refer to its adherence to engineering specifications and material properties, validated through physical testing against established technical standards (like ISO or ASTM standards) rather than expert consensus on diagnostic images or pathology. The "ground truth" here is compliance with these standards.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable. There is no training set for a machine learning model. The "ground truth" for the device's design and manufacturing is established by adherence to recognized engineering standards and quality control processes.

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s-Clean Pre-Milled 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 Pre-Milled Abutment is intended for use with the s-Clean SQ-SL Fixtures in the chart. All digitally designed abutments for use with s-Clean Pre-Milled Abutment are intended to be manufactured at a Dentis validated milling center.

Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.

The diameters of patient-specific abutment are 5.8, 6.8mm and two connection designs (Hex, Non-hex).

Patient-Specific Abutment is compatible with following Implant Systems:
Proprietary Name: Dentis s-Clean s-Line
Compatible Implants (K number): K210134
Implant diameter size: 5.8/6.8
Implant Interface Connection Type/Size (mm): Internal Connection type/ 2.5
Type of Implant-Abutment Connection: Hex/Non-Hex

Patient-Specific Abutments are supplied with s-Clean abutment screw and provided non-sterile.

Patient-Specific Abutment design Limitation (Unit :mm):
Model Name: DSCBA10H, DSCBA14H, DSCBA10N, DSCBA14N, DSCBM10H, DSCBM14H, DSCBM10N, DSCBM14N
Range (Diameter): 4.5-6.5
Range (Length): 7.3-17.9
Range (Angle): 0-30°

Materials:
S-Clean Pre-Milled Abutment and S-Clean Abutment Screw is fabricated from Ti-6A1-4V ELI (Conforming to ASTM Standard F136).

The provided text describes a medical device, the "s-Clean Pre-Milled Abutment," and its submission for FDA 510(k) clearance, which is based on demonstrating substantial equivalence to a legally marketed predicate device. This document does not detail acceptance criteria and a study proving device performance in the context of an AI/ML medical device, but rather the non-clinical testing performed for a dental implant abutment.

Therefore, many of the requested fields are not applicable to the information provided in the input, as the study described is a non-clinical, mechanical fatigue test for a physical dental device, not an AI/ML-based diagnostic or prognostic tool.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that fatigue tests were performed on the subject device "under the worst case scenario." It does not specify the exact number of samples used for this test. Data provenance is not specified, but it can be inferred that the testing was conducted for the purpose of this 510(k) submission, likely by or for Dentis Co., Ltd.

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

Not applicable. This is a physical device testing scenario (fatigue, biocompatibility, sterilization), not a diagnostic or AI/ML device requiring expert ground truth for interpretation or classification.

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

Not applicable. This is not a study requiring human adjudication. The "ground truth" for these tests comes from adherence to established engineering and biological standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a non-clinical evaluation of a physical dental abutment, not an AI-assisted diagnostic device.

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

Not applicable. This device is not an algorithm or AI system.

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

For fatigue testing, the ground truth is based on the failure criteria defined by ISO 14801:2016. For biocompatibility, it's based on ISO 10993-1:2009 standards. For sterilization, it's based on ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 standards. These are objective, quantifiable physical and biological standards.

8. The sample size for the training set

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

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

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

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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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