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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 s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean s-Line Mini is composed of Fixture and Abutments. s-Clean SO-SL Fixture Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The system includes various abutments (Cover Screw, Healing Abutment, Sole Abutment, TiN Half Coating Sole Abutment, Couple Abutment, TiN Half Coating Couple Abutment, Angled Abutment, TiN Half Coating Angled Abutment, Abutment Screw, Temporary Abutment, MU Straight Abutment, MU Angled Abutment, MU Angled Abutment Screw) made from Pure titanium (ASTM F67), Ti-6Al-4V (ASTM F136), or PEEK material. Some abutments have Anodizing (Gold Color) or TiN-Coating surface treatments.

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

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

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

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

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Dentis s-Clean s-Line is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean s-Line is composed of Fixture and Abutments. s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acidetching). The device includes various abutments made from Ti-6A1-4V (ASTM F136) and Chrome-cobalt-molybdenum (CCM) alloy material (ASTM F1537). Some abutments have a TiN coating. Some components are provided sterile, while others are non-sterilized.

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

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

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

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

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

Implied Acceptance Criteria and Reported Device Performance

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

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

Detailed Information as Requested:

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

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

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

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

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

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutunent support for fixed bridgework. This system is for one or two stage surgical procedures and not for immediate loading. This system is intended for delayed loading.

The IBS Implant System consists of dental implants, abutments, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media). This submission is to add implants and abutments to the previously cleared device, IBS Implant System (K153350).

The provided document is a 510(k) Premarket Notification from the U.S. FDA, which focuses on demonstrating substantial equivalence of a new device (IBS Implant System) to existing predicate devices. It does NOT describe a study that proves the device meets predefined acceptance criteria for AI/ML performance.

Instead, the document primarily discusses:

• The Indications for Use for the IBS Implant System (dental implants).
• A detailed comparison of the subject device with predicate devices, highlighting similarities and differences in design, materials, dimensions, and manufacturing processes.
• The non-clinical data leveraged from predicate devices (e.g., sterilization validation, biocompatibility, fatigue testing) to support the substantial equivalence claim for the new components being added.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and performance studies for an AI/ML powered medical device. The provided document is for a traditional dental implant system and does not involve AI/ML.

To answer your question meaningfully, I would need a document related to an AI/ML medical device submission.

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The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore II System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore II implant is treated with SLA (sand-blasted, large-grit, acid-etched). The Fixture diameters are 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm and threaded lengths are 7, 8, 9, 10, 11, 12, 13mm in this system. The contained various abutments and screws in the system are Short Abutment, Magic Multi Abutment, Magic Multi Cylinder, Magic Multi Abutment ST, Abutment Screw, Healing Cap, Magicore Angled Abutment.

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

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

8. The Sample Size for the Training Set

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

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

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

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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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