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Dentis s-Clean SQ-SL Fixture 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 SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis 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 Acid-etching).

The dimensions of fixtures are as following:

Tolerance of dimension shall be within ± 1% range.

s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:

s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:

Denis s-Clean SQ-SL Fixture is provided sterilized.

Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

This document is a 510(k) Summary for the Dentis s-Clean SQ-SL Fixture, a dental implant. It does not contain information about the acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information regarding AI/algorithm acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The "Non-Clinical Test Data" section describes engineering and biocompatibility tests conducted on the device, not an AI algorithm.

Non-Clinical Test Data Summary (from the document):

• Tests performed on the subject device: Fatigue Testing (ISO 14801:2016).
• Tests performed on predicate devices and leveraged for the subject device:
  • Sterilization Validation Test on Fixtures (ISO 11137-1,2,3 referenced in K192688).
  • Shelf-Life Test on Fixtures (ASTM F1980 referenced in K153639).
  • Biocompatibility testing on fixtures (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639).
  • Bacterial Endotoxin Test Report on Fixtures (ANSI/AAMI ST72:2011, USP , and USP referenced in K192688).
• Acceptance Criteria for these non-clinical tests: "met the criteria of the standards" (e.g., ISO 14801:2016 for fatigue).
• Study Design/Purpose: To demonstrate substantial equivalence to predicate devices.
• MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to evaluate magnetic safety, addressing magnetically induced displacement force and torque.

This document describes a traditional medical device (dental implant) clearance process, not one involving Artificial Intelligence.

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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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The device is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.

SAVE GBR is manufactured by Ti-6Al-4V ELI. The SAVE GBR is composed of GBR Screw and Bone Tack and these screws and tacks are used to fix barrier membranes in bone regeneration procedures.

The diameter of the GBR screw is 1.4 and length is 3.9, 4.38, 5.9, 6.38, 7.9 and 8.38mm. The diameter of the Bone Tack is 2.5 and length is 2.6 and 4.1mm.

These screws and tacks are implanted for a maximum duration of 6 months. The SAVE GBR is provided sterile.

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

The provided document is a 510(k) premarket notification for the "SAVE GBR" device, which is an intraosseous fixation screw or wire used in guided bone/tissue regeneration in the oral cavity. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, accuracy, or human reader improvement with AI) is not applicable to this type of regulatory submission.

The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the device compared to its predicates. The "acceptance criteria" here are typically compliance with relevant international standards and equivalence to predicate devices in terms of material, design, and performance characteristics.

Here’s a breakdown of the information that can be extracted from the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) process for this device type doesn't establish numerical "performance" criteria in the way a diagnostic AI device might have sensitivity/specificity targets. Instead, "acceptance criteria" are compliance with standards and demonstration of equivalence to legally marketed predicates. The "reported device performance" reflects how the device met these engineering and material standards.

The following questions are not applicable to this 510(k) submission as it concerns a physical medical device (implants) and not a diagnostic or AI-driven system that would typically undergo such evaluations.

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

• Not Applicable. This document describes non-clinical (biocompatibility, mechanical, sterilization) testing of a physical implant device, not a diagnostic algorithm tested on a dataset of patient cases.

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 a diagnostic algorithm is not relevant here. The ground truth for device safety and performance relies on validated laboratory methods and engineering standards.

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

• Not Applicable. This pertains to expert review of diagnostic cases, which is not relevant for this physical 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. MRMC studies are for diagnostic interpretation improvement with AI. This document is for a physical implantable device.

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

• Not Applicable. This refers to the performance of an algorithm; it is not relevant for this physical device.

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

• The "ground truth" for this device's regulatory clearance is compliance with recognized international standards (e.g., ISO, ASTM for materials, sterilization, mechanical properties) and demonstration of substantial equivalence to legally marketed predicate devices through comparative testing and analysis. This is based on objective measurements and verified material properties, not clinical expert consensus on diagnostic images or patient outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI algorithm for this device. Testing involves samples of the physical device for non-clinical evaluations.

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

• Not Applicable. No training set; ground truth is established by engineering and materials science standards.

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

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

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

The dimension of the device is as below:

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

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

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

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

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s-Clean Link 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 Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center.

The s-Clean Link Abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of two-piece abutment that is a link abutment at the bottom, a coping (CAD/CAM patient specific superstructure) at the top and screw. The bottom link abutment portion of the s-Clean Link Abutment is pre-manufactured (stock) made from a titanium alloy conforming to ASTM F136. The Top half of the s-Clean Link Abutment is composed of zirconia conforming to ISO 6872 reference to prior cleared ceramic, K141724.

s-Clean Abutment Screw s-Line is made of Ti-6AI-4V ELI (ASTM F136)

The diameters of s-Clean Link Abutment are 4.5 and 4.8mm.

s-Clean Link Abutment is provided non-sterile therefore must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment.

The proposed devices are compatible with the following device.

Raw material blanks

• K141724, Upcera Dental Zirconia Blank & Dental Zircornia Pre-Shaded Blank by Liaoning Upcera Co.. Ltd.
  Raw material cement
• K191122, 3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M ESPE Dental Product .
  The coping that composes the final abutment should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the link abutment.

The coping would be manufactured by Dentis only with design input using CAD/CAM Software from and by Dentis milling center.

Design Limitation for Superstructure:

| | Zirconia for s-Clean Link Abutment
Regular | Zirconia for s-Clean Link Abutment
Mini |
|-------------------------------------------------------------|-----------------------------------------------|--------------------------------------------|
| Minimum wall thickness | 0.5 | 0.5 |
| Minimum/Maximum Post Height for
single-unit restorations | 4.45 | 4.45 |
| Maximum gingival height in the
zirconia superstructure | 0 | 0 |
| Minimum gingival height in the Link
Abutment | 1 | 1 |
| Maximum angulation | 0 | 0 |

This FDA 510(k) summary focuses on demonstrating substantial equivalence of the s-Clean Link Abutment to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/ML medical device. The document describes a dental implant abutment, which is a physical device, not an AI/ML algorithm.

Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, and human-in-the-loop performance, is not applicable to the provided document.

The document primarily addresses non-clinical testing for a physical medical device. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical quantitative performance metrics sense for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it demonstrates "substantial equivalence" to a predicate device based on design, materials, indications for use, and non-clinical testing.

The key "performance" is demonstrated through:

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

• Test Set (Non-Clinical): Not directly applicable in the terms of a "test set" for an AI/ML algorithm. For the physical device, non-clinical tests (sterilization, biocompatibility, cytotoxicity) were performed. The sample sizes for these specific lab tests are not detailed in this summary document, but standard methods for such tests typically involve a sufficient number of samples to ensure statistical validity for the physical properties being measured.
• Data Provenance: Not applicable as it's not a data-driven AI/ML study. The data provenance would refer to the lab where tests were conducted which is not specified.

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

• Not applicable. Ground truth, in the context of an AI/ML device, is established by expert annotation or clinical outcomes. For this physical dental abutment, "ground truth" is established by manufacturing specifications, material standards, and benchmark testing against established predicate devices and recognized international standards (e.g., ISO, ASTM, AAMI).

4. Adjudication method for the test set:

• Not applicable. This is relevant for clinical studies or expert labeling in AI/ML.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is explicitly stated: "Clinical testing was not necessary to establish substantial equivalency of the device." MRMC studies are for assessing diagnostic or clinical performance with human readers.

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

• Not applicable. This device is a physical dental implant component, not an algorithm.

7. The type of ground truth used:

• For a physical device, "ground truth" refers to compliance with material specifications (e.g., ASTM F136 for titanium alloy, ISO 6872 for zirconia), design parameters, and the results of standardized non-clinical performance tests (e.g., sterilization effectiveness, biocompatibility). The predicate device (DIO CAD/CAM Abutment, K181037) also serves as a "ground truth" for substantial equivalence comparison.

8. The sample size for the training set:

• Not applicable. There is no "training set" for a physical device.

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

• Not applicable. There is no "training set" for a physical device.

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The Dentis s-Clean Abutment Mini is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means 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.

Dentis s-Clean Abutment Mini is composed of Abutments are made of Ti-6AI-4V ELI according to ASTM F136 and Cobalt-28Chromium-6Molybdenum Alloy ASTM F1537. The s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment is screw assembled design but s-Clean CCM UCLA Abutment s-Line is screw separation design. The s-Clean TiN Half Coating Sub-Octa Abutment is always to be combined with a casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading. The minimum post height of s-Clean TiN Half Coating Sub-Octa Abutment when combined with casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading is 4mm. The minimum post height of s-Clean CCM UCLA Abutment s-Line for single-unit loading is 4mm. The Subject device is compatible with implants cleared in K210080. Compatible fixture diameters are Ø5.8. 6.8 and Ø7.8 and lengths are 7.5. 9.5, 11.4 and 11.5mm. Compatible fixture, K210080, has dual screw-joint (structured with Upper and Lower screw joint) and a hex anti-rotation design connection. As explained in K210080, there are two-screw-joint features, 1.6M screw (Lower part) or 2.0M Screw (Upper Part) for diverse screw connection with other abutments. s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment have Upper M2.0 Screw and s-Clean CCM UCLA Abutment s-Line has Lower M1.6 screw. When dividing screw assemble design, screw assembled one-piece abutment is connected with upper screw and screw separated twopiece abutment is connected with lower screw.

The Dentis s-Clean Abutment Mini is an endosseous dental implant system, and the provided document is a 510(k) summary for its FDA clearance. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a standalone study with specific acceptance criteria and performance data for the subject device itself. Therefore, much of the requested information regarding acceptance criteria, performance data, sample sizes, expert ground truth, and specific study types (MRMC, standalone) as typically described for AI/ML device evaluations is not applicable or available in this kind of regulatory submission.

Instead, the document asserts substantial equivalence based on:

1. Similarities in intended use, materials, and product specifications with predicate devices.
2. Leveraging non-clinical testing data from predicate devices for biocompatibility and sterilization, as the materials and manufacturing processes are considered equivalent.
3. Scientific rationale and literature review for MRI safety, rather than new testing.

Here's a breakdown of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the context of specific performance metrics for the Dentis s-Clean Abutment Mini against defined acceptance criteria. The regulatory approval is based on demonstrating that the device is substantially equivalent to predicate devices already on the market, implying that it meets the accepted safety and effectiveness standards without necessarily requiring new, specific performance studies for this particular submission.

The document highlights the following characteristics of the subject devices (Dentis s-Clean Abutment Mini: s-Clean O-Ring Abutment s-Line, s-Clean TiN Half Coating Sub-Octa Abutment, and s-Clean CCM UCLA Abutment s-Line) and compares them to predicate devices:

2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a new clinical or non-clinical test set specifically for the Dentis s-Clean Abutment Mini for performance evaluation against acceptance criteria. The approach relies on substantial equivalence to predicate devices and leveraging existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No specific "test set" with expert-established ground truth is described for this submission, as it focuses on demonstrating equivalence rather than proving new performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. As there's no defined test set for performance, adjudication methods are not relevant here.

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 device is a physical dental implant abutment, not an AI/ML diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No new ground truth data was established for performance evaluation of the subject device in this submission. The "ground truth" for the clearance is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set
Not applicable. This device is a physical product, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established
Not applicable. This device is a physical product, not an AI/ML model that requires training data.

Summary of the Study (Compliance with Standards and Leveraged Data):

The "study" described in this 510(k) submission is primarily a non-clinical review and comparison to predicate devices, leveraging previously established data and scientific rationale.

• Biocompatibility Testing: Performed for predicate devices and "leveraged for the subject device" because the materials (Ti-6Al-4V ELI and Cobalt-28Chromium-6Molybdenum Alloy) and manufacturing processes are substantially equivalent. Tests were conducted according to ISO 10993-1:2009.
• End User Sterilization Validation Test Report: Performed for predicate devices (K210080 for Ti-6Al-4V, K161244 for Cobalt-28Chrominum-6Molybdenum, and K171027 for Ti-6Al-4V with TiN Coating) and "leveraged for the subject device." Tests were conducted according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1. The report also mentions a test article for Cobalt-27Chrominum-6Molybdenum that was the "largest surface area among the devices that have the same manufacturing process and material," likely representing a worst-case scenario.
• Fatigue Testing: Not performed for the subject device itself, as it does not include angled abutments. This decision is based on FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," which states fatigue testing is not necessary for systems without angled abutments.
• Surface Modification Information: Not tested or provided for the subject device because it was "provided in the predicate devices and can be leveraged for the subject device," implying similar surface characteristics.
• MR Environment Condition: A non-clinical worst-case MRI review was performed. This involved evaluating the device's components (materials) against scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to assess magnetically induced displacement force and torque. The FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" was referenced.
• Clinical Testing: This was explicitly stated as "not necessary to establish substantial equivalency of the device."

In conclusion, this regulatory submission focuses on demonstrating substantial equivalence through a rigorous comparison of the subject device's features (materials, dimensions, intended use, sterilization, surface treatment) to already-cleared predicate devices, coupled with leveraging existing non-clinical test data and scientific literature for safety aspects. It is not a performance study in the sense of establishing new acceptance criteria and demonstrating achievement through new testing specific to the subject device alone.

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