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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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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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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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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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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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s-Clean SQ-SL Implant System Regular 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 Regular is composed of Fixture and Abutments. s-Clean SQ-SL Fixture is a thread type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The device has an internal connection between the implant body and the abutment component. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The implant body is the only part to be implanted into bone (mandibular or maxillary bone), and is to be connected to the abutment. Abutments are composed as below; s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Cover Screw.

The provided text describes the regulatory clearance of a dental implant system (s-Clean SQ-SL Implant System Regular) through the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish performance against specific clinical acceptance criteria.

Therefore, the document does not contain information related to acceptance criteria, a clinical study proving device performance against such criteria, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets, as these are typically part of a different type of submission (e.g., PMA or de novo) or a separate clinical validation study.

Instead, the document details non-clinical test data performed to demonstrate substantial equivalence to predicate devices.

Here's the information that can be extracted from the provided text regarding device testing:

Non-Clinical Test Data and Performance (as described in the document):

Information Not Available in the Document:

• Sample sized used for the test set and the data provenance: Not applicable as no clinical test set for performance evaluation is described. The non-clinical tests were conducted on device components.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no described test set requiring expert ground truth for clinical performance.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is a dental implant system, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental implant system, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the non-clinical tests was the adherence to the specified international and national standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of the study/evidence provided:

The submission for the s-Clean SQ-SL Implant System Regular relies on a non-clinical testing approach to demonstrate substantial equivalence to its predicate devices, as typically done for Class II medical devices through the 510(k) pathway. The study involves demonstrating that the subject device meets various established biomaterials, sterilization, and shelf-life standards (e.g., ASTM, ISO, ANSI/AAMI, USP). In many cases, the results from specific tests conducted on the predicate devices (K153639, K171027, K171694) were leveraged to support the substantial equivalence of the subject device, implying that the subject device's design, materials, and manufacturing processes are sufficiently similar to those already proven safe and effective. The document explicitly states that "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." It also notes that fatigue testing per ISO 14801 was not conducted as it was deemed unnecessary based on device-specific guidance.

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An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.

The Biomate Dental Implant System consists of Bone Type Implant Plus, Shaping Abutment and Healing Abutment. The Biomate Dental Implant System is made of commercial pure titanium (ASTM F67, Grade 4). Threaded dental implants are with Precision Dimension Laser (PDLTM) surface treatment, while Shaping Abutment and Healing Abutment are with TiN coated surface treatment. The device is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to replace missing teeth.

The provided text is a 510(k) premarket notification for a medical device (Biomate Dental Implant System). This type of document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing. It does not describe a study involving an AI algorithm or human reader performance. Therefore, I cannot provide information on acceptance criteria and studies related to AI performance from this document.

The document discusses traditional medical device validation through non-clinical performance tests, and states that "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

To answer your request, I would need a document describing a study for an AI-powered medical device.

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