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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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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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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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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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The IS-III HActive Fixture is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IS-III HActive Fixture is composed of fixtures and cover screw. Fixtures are thread type implants made of titanium alloy which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Titanium Alloy based on ASTM F136. Surface treatment is HA Coating. This device has connection between the upper prosthesis and the internal hex. Surface is treated with RBM (Resorbable Blasting Media) using Hydroxyapatite powder. Residues are removed through a washing procedure after Plasma-spray with Hydroxyapatite and formation of the HA coating. 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 diameters are 3.5/4.0/4.5/5.0/6.0/7.0mm and the lengths are 7.3/ 8.5/10.0/ 11.5/13.0/15.0mm. (Do not offer 3.5 x 7.3mm implant, 6.0 x 15mm implant, or 7.0 x 15mm implant). Cover Screw intended to protect the inside of the implant during osseointegration. It is made of titanium alloy according to ASTM F136. The surface treatment of the cover Screw is anodizing or non-anodizing. The purpose of anodizing is to distinguish the sizes with the naked eyes for convenience. The diameter of cover screw is 3.45/3.6mm. IS-III HActive Fixture is enclosed with Cover Screw in a packing. IS-III HActive Fixture and Cover Screw can be packed separately for convenience.

The provided text describes the submission of a new dental implant device (IS-III HActive Fixture) to the FDA for substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic AI/ML device submission would.

The document focuses on demonstrating that the new device is as safe and effective as previously approved devices by comparing their characteristics (intended use, materials, design, etc.) and presenting results from non-clinical testing. This type of submission (510(k)) does not typically include clinical studies with acceptance criteria for device performance as would be seen for AI/ML-driven diagnostics.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

However, I can extract the following relevant information:

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

This document does not provide a formal table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it refers to meeting criteria of various engineering and biocompatibility standards.

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

Not applicable. The document describes non-clinical bench testing and biocompatibility assessments, not a diagnostic test on a test set of human data.

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 for diagnostic performance is not established in this type of submission. Performance is based on material properties and mechanical integrity.

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

Not applicable.

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/ML device.

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

Not applicable. This is not an AI/ML device.

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

For the non-clinical testing, the "ground truth" or reference was based on established industry standards (ISO, ASTM, ANSI/AAMI, USP) and FDA guidance documents for mechanical, material, and biological properties of medical devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

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The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

The s-Clean TiN Coating Abutments are device made of pure titanium and titanium alloy intended for use as an aid in prosthetic restoration. The system consists of s-Clean TiN Half Coating Angled Abutment, s-Clean TiN Half and partial Coating Couple Abutment, s-Clean TiN Half Coating Free Abutment, s-Clean TiN Half Coating FreeMill Abutment, s-Clean TiN Half Coating MOA Abutment, s-Clean TiN Partial Sub-Octa Abutment, s-Clean TiN Partial Coating Sole Abutment, s-Clean DOA Ball Abutment, s-Clean DOA Snap Abutment, and s-Clean Sole Abutment Healing Cap. The surface of the abutments is partially or half TiN Coated by using PVD (Physical Vapor Deposition). The subject device is provided non-sterile and should be sterilized before use (End user sterilization).

This document is a 510(k) summary for a dental implant abutment, and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a standalone clinical study with detailed performance metrics.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. The information provided heavily relies on non-clinical testing and comparison to predicates.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on meeting the requirements of specific international and FDA guidance standards for medical devices, particularly for dental abutments. The reported device performance is that these tests were met.

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

• Not Applicable (N/A) for clinical data. This submission relies on non-clinical (laboratory) testing, not a clinical test set with patient data.
• The non-clinical tests (biocompatibility, fatigue, sterilization) are laboratory-based and would use a sample size appropriate for those specific engineering and biological tests, but this detail is not provided. The data provenance for these tests would be internal laboratory testing by the manufacturer or a contracted lab.

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

• N/A. As mentioned, this is a non-clinical submission. Ground truth, in the context of clinical studies and expert consensus, is not relevant here. Decisions are made based on adherence to engineering and biocompatibility standards.

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

• N/A. No clinical test set requiring expert adjudication was conducted or described.

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

• N/A. This is a dental implant abutment, not an AI-powered diagnostic or assistive device. MRMC studies are not relevant here.

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

• N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.

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

• For the non-clinical tests, the "ground truth" is defined by the validated and accepted international standards (e.g., ISO, ANSI/AAMI) for mechanical performance and biocompatibility. Passing these tests according to the established metrics within the standards constitutes meeting the "ground truth" of safety and performance.

8. The sample size for the training set

• N/A. There is no "training set" as this is not a machine learning or AI product.

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

• N/A. There is no "training set" as this is not a machine learning or AI product.

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The OneQ-SL s-Clean 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, 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.

The OneQ-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied sterile. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the predicate device, OneQ-SL s-Clean Implant System (K153639). This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344. The fixture is made of Ti-6A1-4V ELI and Pure Titanium Grade 4. The Cover screw was cleared in K073486. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.

This appears to be a 510(k) premarket notification for a medical device, specifically an endosseous dental implant system. The document states that the device, "OneQ-SL s-Clean Implant System," is substantially equivalent to legally marketed predicate devices, and therefore no new clinical studies are presented within this document to prove acceptance criteria through device performance.

The document does not describe acceptance criteria for a new device's performance through a clinical or non-clinical study directly comparing it to defined metrics. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technological features, materials, and existing non-clinical test data.

Therefore, many of the requested elements about acceptance criteria and device performance based on a new study (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth establishment for a new training set) are not applicable or available in this kind of regulatory submission. The "acceptance criteria" here is primarily about meeting the requirements for substantial equivalence to a predicate device.

Let's break down what can be extracted and what cannot:

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

This document doesn't provide a table of acceptance criteria and reported device performance for the new device that would typically come from a specific study designed to show such performance. Instead, it leverages test results from predicate devices and applies them to the current device to demonstrate substantial equivalence.

The acceptance criteria here would implicitly be that the subject device's performance in mechanical properties, sterilization, biocompatibility, and shelf life is equivalent to or better than the predicate devices, as demonstrated by meeting established standards.

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

• Sample Size: Not explicitly stated for each test (e.g., number of implants tested for fatigue). The document indicates that "Below tests were performed for predicate devices and leveraged for the subject device."
• Data Provenance: The tests were performed for predicate devices (K153639, K161244, K150344). No information regarding the country of origin of the data is provided, nor whether it was retrospective or prospective. It is non-clinical lab testing data.

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

This is not applicable as the document relies on non-clinical testing against recognized standards (ISO, ASTM, USP) for demonstrating substantial equivalence, not expert ground truth for a clinical dataset.

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

This is not applicable as there is no clinical test set requiring adjudication 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:

This is not applicable. This is a submission for an endosseous dental implant, which is a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable. This refers to AI/algorithm performance, which is not relevant for this device.

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

For the non-clinical tests, the "ground truth" or reference for acceptance is the specified performance criteria within the referenced international standards (ISO, ASTM, USP) which determine if the device (or its predicate) performed adequately.

8. The sample size for the training set:

This is not applicable as this is not a submission for an AI/machine learning device that would require a training set.

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

This is not applicable as there is no training set for an AI/machine learning device.

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The OneQ-SL s-Clean Implant System is in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented, 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.

The OneO-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied by gamma sterilized that is same with almost all dental implant. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the Dentis dental implant system (K073486) of DENTIS Co., Ltd., and Dentis dental implant system(K150344) of DENTIS Co., Ltd. The difference between the subject and the predicate device are slightly different shape and surface treatment. This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344.

This document describes the OneQ-SL s-Clean Implant System, an endosseous dental implant. The purpose of the submission is to demonstrate its substantial equivalence to predicate devices, thus no clinical testing was performed.

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

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

Since this is a 510(k) submission demonstrating substantial equivalence rather than a clinical trial with specific performance metrics defined by acceptance criteria for a novel device, the concept of "acceptance criteria" and "reported device performance" are framed differently. The acceptance criteria here are adherence to relevant standards and demonstration of equivalence to legally marketed predicate devices. The "reported device performance" is the successful completion of non-clinical tests meeting these standards and showing similarity to predicates.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The "test set" here refers to the non-clinical tests performed on the device itself and its components. These tests typically involve a specific number of samples required by the particular testing standard (e.g., a certain number of parts for fatigue testing). The document does not specify these exact numbers for each test but indicates tests were "performed to evaluate its substantial equivalence."
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. However, the manufacturer is Dentis Co., Ltd. located in Daegu, South Korea. It's highly probable the non-clinical testing was conducted there or arranged by them, adhering to international standards. The tests were prospective in the sense that they were performed specifically to support this regulatory submission, but they are non-clinical tests on the device materials and design, not human subject data.

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 physical medical device (dental implant), not an AI algorithm or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is established by its adherence to engineering and material strength standards and biocompatibility tests.

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

Not applicable. This type of adjudication method (common in clinical trials or AI studies with expert review) is not relevant for the non-clinical, bench-top integrity and performance tests described for this dental implant.

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 or treatment planning tool. It is a dental implant (physical device). No MRMC studies were conducted.

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)

For the non-clinical tests, the "ground truth" is defined by the established international and ASTM standards (e.g., ISO 10993 series for biocompatibility, ISO 11137-1 for sterilization, ISO 11607-1/-2 and ASTM F1980-07 for shelf life, and the FDA's Class II special controls guidance for fatigue testing). The device's performance is compared against the pass/fail criteria specified within these standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. As noted above, this involves no AI model or training set.

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