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TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: Astra OsseoSpeed EV (K130999, K120414), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF (II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Osstem TS (K161604), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221), BioHorizons Internal Implant System (K093321, K143022, K071638), MegaGen AnyRidge Internal Implant (K140091). All digitally designed abutments and/or copings for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: Astra OsseoSpeed EV (K130999), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF(II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221). All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: (1) For fixing the abutment into the endosseous implant. (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serew-retained restorations. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center.

TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. CAD/CAM customized superstructure that composes the final abutment is intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (TruAbutment DS, K203649) and does not detail an acceptance criteria table with reported device performance in the manner of a clinical study. The text describes non-clinical testing performed, but not a study designed to prove the device meets acceptance criteria related to a specific clinical outcome or diagnostic accuracy.

Therefore, many of the requested items (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable based on the content of this 510(k) summary, which is a premarket notification for a medical device primarily based on demonstrating substantial equivalence through engineering and mechanical testing, not clinical performance or AI algorithm validation studies.

However, I can extract the information provided regarding non-clinical testing for the devices.

Acceptance Criteria and Study for TruAbutment DS & TruBase

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are focused on non-clinical mechanical performance testing and demonstration of substantial equivalence to a predicate device, rather than a clinical study proving performance against specific clinical or diagnostic accuracy metrics with human or AI components.

Here's the relevant information extracted and presented based on the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside actual reported numerical performance results for the new devices in the context of a comparative study proving their performance against such criteria. Instead, it states that "The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices." This implies a qualitative "met standard" outcome rather than specific numerical performance data.

The tables provided describe the design limits of the devices and compare them to the predicate device, not performance data from a test:

TruAbutment DS Design Parameters (Acceptance Criteria are implied by meeting these limits)

TruBase Design Parameters (Acceptance Criteria are implied by meeting these limits)

For mechanical performance, the document states:
"Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

This confirms that the acceptance criteria for mechanical performance were "sufficient for their intended use" as defined by ISO 14801 and worst-case testing, but quantitative results are not provided.

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: The document mentions "worst-case constructs" were tested for mechanical performance, and "the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws)" was evaluated for MRI environment conditions. However, specific numerical sample sizes for these tests are not provided.
• Data Provenance: The data comes from non-clinical laboratory testing following international standards (ISO 14801, ISO 17665-1/2, ISO 10993 series). The country of origin and retrospective/prospective nature are not applicable as it's not a clinical data study.

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 is not applicable. The "ground truth" for this type of device (dental abutments) is established through adherence to engineering design specifications, material standards (ASTM F136), and performance under mechanical stress tests (ISO 14801), as well as compliance with sterilization and biocompatibility standards. It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• This is not applicable as there is no human interpretation or subjective assessment of data requiring adjudication. Testing is based on objective measurements against engineering 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

• This is not applicable. The device is an endosseous dental implant abutment, not an AI diagnostic tool.

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

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

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

• The "ground truth" for validating these devices is adherence to engineering specifications, material properties, and performance standards (e.g., passing specific load-bearing and fatigue tests per ISO 14801, meeting biocompatibility requirements, maintaining dimensional accuracy). "Dimensional analysis and reverse engineering" were used to confirm compatibility.

8. The sample size for the training set

• This is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

• This is not applicable for the reason above.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The "study" conducted was primarily non-clinical laboratory testing to demonstrate the mechanical performance, sterilization efficacy, and biocompatibility of the TruAbutment DS and TruBase devices. The objective was to show substantial equivalence to an existing legally marketed device (TruAbutment DS, K203649) by proving that the new devices meet established design limits and performance standards relevant to dental implant abutments.

• Mechanical Testing: Performed on "worst-case constructs" according to ISO 14801 for static compression and compression fatigue. The outcome was that "construct strengths [were] sufficient for their intended use."
• Sterilization Testing: Performed per ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
• Biocompatibility Testing: Performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
• MRI Environment Evaluation: A non-clinical worst-case MRI review was done using scientific rationale and published literature to assess magnetically induced displacement force and torque.
• Dimensional Analysis and Reverse Engineering: Conducted on the implant-to-abutment connection platform to assess critical design aspects and tolerances, confirming compatibility.

The overall conclusion was that the devices "met the criteria of the standard and demonstrated substantial equivalence with the reference devices," thus indicating they met their implied acceptance criteria for safety and performance as medical devices. Clinical testing was explicitly stated as "not necessary."

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The S-Plant Dental Implant System is indicated 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 smaller S-Plant Dental Implants (03.4, 3.6, 3.8, 4.2, 4.7, 5.2 mm) 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 is achieved with appropriate occlusal loading. The larger S-Plant Dental Implants (06.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Dual abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

The S-Plant Dental Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The S-Plant Dental Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The S-Plant Dental Implant System fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth roots providing a stable foundation for restorations. Geometrically, the implant is screw type. An abutment is connected to the implant through a tapered joint.

The Abutment made of Ti-6AL-4V ELI alloy (ASTM F136) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.

The Cover Screw made of Ti-6Al-4V ELI alloy (ASTM F136), is an essential component in dental implant procedures. This device safeguards the internal threads of dental implant fixtures during the healing phase, ensuring a sterile environment for successful osseointegration.

This document describes a 510(k) premarket notification for the S-Plant Dental Implant System, which is a Class II medical device. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. However, it does not contain information typically found in a study demonstrating the device meets acceptance criteria related to clinical performance or AI models.

The provided text solely focuses on establishing substantial equivalence based on comparisons to predicate and reference devices regarding design, materials, indications for use, and non-clinical testing (biocompatibility, sterilization, surface modification, and MRI compatibility). There is no mention of an AI component, human-in-the-loop performance, or specific performance metrics like sensitivity, specificity, or AUC against a clinical ground truth for the S-Plant Dental Implant System itself.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided document:

• A table of acceptance criteria and the reported device performance (for clinical performance/AI).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi Reader Multi Case (MRMC) comparative effectiveness study results or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
• Sample size for the training set.
• How the ground truth for the training set was established.

The provided text is a 510(k) summary for a dental implant system, which is a physical device, and not an AI/software device. The "acceptance criteria" discussed are related to regulatory conformance and manufacturing standards, not clinical performance metrics in the context of an AI study.

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The S-Plant Dental Implant System is indicated 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 smaller S-Plant Dental Implants (03.4, 3.6, 3.8, 4.2, 4.7, 5.2 mm) 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 is achieved with appropriate occlusal loading. The larger S-Plant Dental Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Dual abutments are intended for use with a dental implant to prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

The S-Plant Dental Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The S-Plant Dental Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The S-Plant Dental Implant System fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth roots providing a stable foundation for restorations. Geometrically, the implant is screw tvpe. An abutment is connected to the implant through a tapered joint.

The Abutment made of Ti-6AL-4V ELI alloy (ASTM F136) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Dual Abutment, and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.

The Cover Screw made of Ti-6Al-4V ELI alloy (ASTM F136), is an essential component in dental implant procedures. This device safeguards the internal threads of dental implant fixtures during the healing phase, ensuring a sterile environment for successful osseointegration.

The provided text describes the regulatory clearance of the S-Plant Dental Implant System and its components (Fixture, Dual Abutment, Healing Abutment, Abutment Screw, Cover Screw) by demonstrating substantial equivalence to predicate and reference devices. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing and comparison with existing, legally marketed devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the FDA's "substantial equivalence" framework, meaning the device must perform as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness. The reported device performance is demonstrated by comparing its design, materials, intended use, and technological characteristics to the predicate and reference devices, and by non-clinical testing that meets established industry standards.

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

The information provided does not describe a clinical study with a test set of patient data. Instead, it details non-clinical testing (bench testing, biocompatibility testing, sterilization validation, shelf-life determination, and MRI safety assessment) and a comparative analysis of the device's characteristics against predicate and reference devices.

• Sample Size for Test Set: Not applicable in the context of patient data. The "test set" refers to samples of the device components used for various laboratory tests (e.g., material samples for biocompatibility, sterility test units, accelerated aging samples, MRI phantom testing). The specific number of samples for each non-clinical test is not detailed in this summary but would be found in the full submission.
• Data Provenance: The studies are non-clinical (laboratory/bench testing) and therefore do not involve patient data from specific countries or have a retrospective/prospective nature in the typical clinical sense. The tests were conducted by the manufacturer (IDIS Co., Ltd. in Republic of Korea) or their designated testing facilities to demonstrate compliance with international standards (ISO, ASTM, ANSI/AAMI) as required for FDA clearance.

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

Not applicable. This is not a study involving expert readers interpreting medical images or clinical outcomes. Ground truth for non-clinical tests is established by adhering to defined scientific methodologies and international standards for material science, biomechanics, and biocompatibility.

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

Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data for ground truth establishment.

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 submission does not involve an AI-enabled device or MRMC studies.

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

Not applicable. This submission does not pertain to an algorithm or AI device.

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

The "ground truth" for the substantial equivalence determination and non-clinical testing is based on:

• Established Industry Standards and Regulations: ISO 7405, ISO 10993 standards (biocompatibility), ISO 11137-1/2, ANSI/AAMI ST79 (sterilization), ASTM F1980 (shelf life), ASTM F67, ASTM F136 (materials), and FDA guidance documents (e.g., "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
• Predicate and Reference Device Specifications: The detailed characteristics (materials, dimensions, surface treatment, intended use) of the legally marketed predicate and reference devices serve as the benchmark for comparison to claim substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable, as no training set is described.

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The ZENEX Implant System Narrow (3.0, 3.2mm) 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 ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.

The provided text is a 510(k) summary for the ZENEX Implant System Narrow, a dental implant device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.

The document details:

• Device Description: Components (fixtures, abutments), materials (Ti-6Al-4V ELI, Co-Cr-Mo Alloy), and surface treatments (SLA, TiN coated).
• Indications for Use: Single tooth replacement, multiple tooth replacement, denture stabilization.
• Predicate Devices: A list of previously cleared dental implants and accessories used for comparison.
• Substantial Equivalence Discussion: A comparative table outlining various characteristics of the subject device against its primary predicate and reference devices, focusing on design, connection, material, surface, sterilization, shelf life, and indications for use.
• Non-Clinical Data: Lists mechanical and material tests conducted (Bacterial Endotoxin, Fatigue Testing on fixture) and leveraged from predicate devices (Sterilization Validation, Shelf-Life, End User Sterilization Validation, Biocompatibility). It also mentions an MR environment review.

There is no information in this document about:

1. Acceptance criteria for an AI/ML device.
2. Reported device performance metrics (e.g., sensitivity, specificity, accuracy) of an AI/ML device.
3. Sample sizes for test sets in an AI/ML study.
4. Data provenance for an AI/ML study.
5. Number or qualifications of experts for AI/ML ground truth.
6. Adjudication methods for AI/ML ground truth.
7. MRMC comparative effectiveness study results for AI/ML.
8. Standalone performance of an AI/ML algorithm.
9. Type of ground truth used for an AI/ML study.
10. Sample size for the training set of an AI/ML model.
11. How ground truth for the training set was established for an AI/ML model.

This 510(k) summary is for a physical dental implant system, not a software or AI/ML-driven device.

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The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

• · Biomet 3i Certain® (K130949) 3.25, 4.0, 5.0, 6.0 mm
• · DIO UF(II) Internal Submerged (K161987, K170608, K173975) 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 mm
• Megagen AnyRidge® (K140091) 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 mm
• · Neoss ProActive® (K083561) 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:

• (1) For fixing into the endosseous implant
• (2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the custom abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

The proposed abutments are available in internal hex connection, and are compatible with Biomet 3i Certain® Implant/DIO UF(II) Internal Submerged Implant/Megagen AnyRidge® Implant/Neoss ProActive® Implant.

The device being discussed is "TruAbutment DS", a patient-specific CAD/CAM abutment for dental implants.

The acceptance criteria for this device are established by demonstrating substantial equivalence to a predicate device (TruAbutment DS K170259) through non-clinical testing, primarily mechanical performance (fatigue) testing, and biocompatibility assessments. The study described focuses on non-clinical testing to meet these acceptance criteria rather than a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample size (number of abutments or implants) used for the non-clinical mechanical and dimensional tests. It mentions "worst-case constructs" for fatigue testing.
Data provenance: The testing was conducted by the manufacturer (TruAbutment Inc.) as part of their 510(k) submission to the FDA, presumably in the USA (where the company is based). The data is retrospective as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device's performance is established by meeting recognized international and national standards (ISO, FDA guidance) through non-clinical laboratory testing, not by expert consensus on clinical cases.

4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of medical images. The studies performed for this device were non-clinical laboratory tests.

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
No, an MRMC comparative effectiveness study was not done. This device is a physical dental implant abutment, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance is assessed by its mechanical integrity and biocompatibility when used as intended.

7. The type of ground truth used
The "ground truth" used for this device is based on established engineering and materials science principles and validated standards:

• Mechanical Performance: Defined by the specified fatigue limits and static load capabilities as per ISO 14801 and FDA guidance thresholds for dental implant abutments.
• Biocompatibility: Defined by the absence of adverse biological reactions as per ISO 10993 series standards.
• Dimensional Accuracy: Defined by precise measurements confirming compatibility with target implant systems.

8. The sample size for the training set
This is not applicable. This device is not an AI model that requires a training set. The CAD/CAM design process for patient-specific abutments involves individual patient data rather than a large training dataset for device development in the AI sense.

9. How the ground truth for the training set was established
This is not applicable as there is no "training set" in the context of an AI device. The design principles for the TruAbutment DS are based on established dental implantology, engineering design, and manufacturing standards for patient-specific CAD/CAM abutments.

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The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

UF(II) Bar holder abutment and set screw is used for prosthetic restoration. Bar holder abutment is intended to be used in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients. UF(II) Bar holder abutments are made from Ti-6Al-4V ELI (ASTM F136). The UF(II) Bar holder abutment has two type shape which are Single body type and Cap type.

The UF(II) Bar holder abutment of single body type consists of abutment screw and set screw. The UF(II) Bar holder abutment of cap type consists of abutment screw, set screw and abutment cap. Both type Bar holder abutment has Hex, Non-Hex connection. Subject abutments are only intended for multi-unit restorations. It is provided non-sterile, this should be user steam sterilized before use. It is used for overdentures with clip for bar retention. The clip is fixed to the overdenture and used to supplement the retention of the bar and denture. The bar is used to fix the abutment and overdenture. It is held in place with the set screw. The cap is used to cover the bar holder abutment Cap Type. The components-clip, bar, and cap--are included in the device system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UF(II) Bar holder abutment:

This document is a 510(k) summary for a medical device (UF(II) Bar holder abutment). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical or standalone studies for a new type of AI/diagnostic device.

Therefore, the requested information elements related to AI algorithm performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in this context. This is a traditional medical device submission for an implant component, where the focus is on mechanical integrity, materials, and intended use comparison to existing devices.

However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are derived from established international standards for dental implants and abutments. Since no specific performance metrics like sensitivity/specificity are reported for this type of device, the "reported device performance" is successful completion of the specified tests, thereby demonstrating substantial equivalence.

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

• Sample Size for Fatigue Test: Not explicitly stated as a number of devices, but the test was performed on "finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation)." This implies a representative number of units for the specific configurations tested, as per the ISO standard.
• Data Provenance: The standard (ISO 14801:2007) is international. The testing itself would have been conducted by the manufacturer or a contracted lab. The document does not specify country of origin for the test results, but the submitter (DIO Corporation) is from the Republic of Korea. It is a prospective test, newly performed or leveraged for this submission.

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 mechanical/material performance test, not a diagnostic or AI-driven assessment requiring expert ground truth for interpretation. The "ground truth" is determined by the physical outcome of the tests (e.g., whether the device fractured at a certain load, whether the sterilization parameters were met).

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

• Not Applicable. See point 3.

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 diagnostic tool.

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

• Not Applicable. See point 5.

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

• For the fatigue test: The "ground truth" is the physical failure or non-failure of the device under specific, controlled dynamic loading conditions, as defined by the ISO standard.
• For sterilization: The "ground truth" is the measurable Sterilization Assurance Level (SAL), typically confirmed by biological indicators or other validated methods.
• For biocompatibility: The "ground truth" is the established safety profile of the material based on chemical composition and previous testing (ISO 10993).

8. The sample size for the training set

• Not Applicable. There is no training set as this is not an AI/machine learning device.

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

• Not Applicable. There is no training set.

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UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

UCLA CCM Abutment is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constrainsts. After customization, be sure to use only dental non-precious metal for casting to make the prosthesis. When cast a prosthesis with UCLA CCM Abutment, the post height above the transmucosal collar of UCLA CCM Abutment has to be taller than 4mm. The subject device is not to be used with any angulation and are straight only. UCLA CCM Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. Both abutments types are compatible implant bodies (K182194, K161987, K122519, K170608 and K173975). UCLA CCM Abutments are made from CCM Alloy. UCLA CCM Abutment consists of UCLA CCM Abutment and abutment screw. It is provided non-sterile, this should be user steam sterilized before use.

This document is a 510(k) Premarket Notification for a dental device, specifically an endosseous dental implant abutment. It does not pertain to an AI/ML medical device, and therefore does not contain the information required to answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML.

The document discusses:

• Device Name: UCLA CCM Abutment
• Regulation Number: 21 CFR 872.3630 (Endosseous Dental Implant Abutment)
• Regulatory Class: Class II
• Indications for Use: Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Predicate Devices: NP-Cast Abutment System (K121843), UV Active Implant System, CCM Cylinder (K182194), DIO CAD/CAM Abutment (K181037), and various UF implant systems.
• Non-clinical Testing: Refers to in-vitro testing for fatigue (though none was done as the design does not include angulation), sterilization validation, and biocompatibility, leveraging data from predicate devices.
• Clinical Testing: Explicitly states, "No clinical testing was performed for this submission."

Therefore, I cannot provide details on acceptance criteria and study data related to an AI/ML device's performance, as outlined in your request, because this document describes a physical medical device (dental abutment) and not an AI/ML algorithm.

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DIO CAD/CAM 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.

Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.

The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.

1. Hybrid Link abutment: Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm. Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment.

2. Patient-Specific Abutment: 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 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex). Patient-specific abutments are supplied with an abutment screw previous cleared device as K122519 and K161987 and provided non-sterile.

The document provided is a 510(k) Premarket Notification from the FDA for a dental implant abutment. It does not describe a study involving an AI/ML device, nor does it provide acceptance criteria or performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices through material properties, design specifications, and non-clinical testing for dental implant abutments.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance from this document. The sections you asked for, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, are not applicable to the content of this 510(k) summary for a physical medical device.

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The UV Active Implant System is indicated 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 narrow (Ø3.0, Ø3.3) implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading.

The Regular (Ø3.8 ~ Ø5.5) 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 is achieved with appropriate occlusal loading.

The Wide (Ø5.9 ~ Ø6.4) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

The UV Active Implant System includes UV Active Fixture, Abutments (Multi- unit abutment, Cemented abutment, Angled abutment, Solid abutment and Mill abutment), Cylinders (Temporary cylinder, Cemented cylinder, CCM Cylinder) and screws (Abutment screw, Cylinder screw). The UV Active Implant System is specially designed for using in dental implant surgery. A successfully osseointegrated fixtures will achieve a firm implant when the fixture is operated under the controlled conditions per well-known clinical studies. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.

The UV Active Fixture is made of pure titanium grade 4(ASTM F67) and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-atched). The fixtures have the diameter (3.06.4mm) and length (7.013.0mm).

The multi-unit abutment have the diameter of 4.8mm and the angle has straight, 20° and 30°. It is made from titanium alloy conforming to ASTM F136.

The Cemented abutment, Angled abutment, Solid abutment and Mill abutment has same diameter when comparing to each primary predicate device. The subject device and the predicate device are the same except for surface treatment change from machined surface to TiN Coated surface. The Cemented abutment, Solid abutment and Mill abutment made from titanium alloy confirming to ASTM F67. The Abutment screw and Cylinder screw are made of titanium alloy confirming to ASTM F136 and no surface treatment for these components.

The Fixtures are supplied gamma sterilization. The abutments, screws and cylinders are provided nonsterile, these should be user steam sterilized before use.

The provided text describes a 510(k) submission for the UV Active Implant System, which is an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study design for acceptance criteria based on performance metrics such as sensitivity, specificity, and AUC. The "acceptance criteria" discussed are related to meeting standards for medical devices and demonstrating substantial equivalence.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not in the format of sensitivity/specificity/AUC, but rather conformance to established medical device standards and demonstrated substantial equivalence to predicate devices.

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

The document does not describe a "test set" in the context of a clinical performance study with human subjects, nor does it refer to data provenance in terms of country of origin or retrospective/prospective collection for an AI/CAD-like device. The testing described is non-clinical testing on the device itself (e.g., sterilization, fatigue, biocompatibility). Therefore, there is no mention of sample size for human subjects or data provenance.

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

Not applicable. This device is not an AI/CAD system evaluated by experts for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No AI/CAD functionality is described in this submission.

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

Not applicable. No AI/CAD functionality is described in this submission.

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

The "ground truth" in this context is the fulfillment of established engineering, material, and biological standards through laboratory testing. For example:

• Sterilization: Measured sterility assurance level (SAL).
• Fatigue: Measured force resistance and cycles to failure against ISO 14801:2007.
• Biocompatibility: In vitro cytotoxicity assays and general biological evaluation against ISO 10993 series.
• Dimensional/Material: Conformance to specified dimensions and material properties (e.g., CP Ti Gr4 (ASTM F67), Ti-6Al-4V ELI (ASTM F136)).

8. The Sample size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/CAD device.

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

Not applicable.

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The UF(II) Implant System is indicated 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 UF(II) Implant System(Ø3.8 ~ Ø5.5) 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 is achieved with appropriate occlusal loading.

UF(II) Fixture is made of pure titanium grade 4 (ASTM F67) and the surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The diameters of fixture are 3.8, 4.0, 4.5, 5.0, 5.5mmand the lengths of fixture are 7.0, 8.5, 10.0, 11.5, 13.0, 15.0,16.0mm in this system. All fixture lengths are available in all diameters, except for the 7.0mm length, which is not available in 3.8 or 4.0mm diameters. The abutments and superstructures consist of Healing Abutment, Cemented Abutment Screw, Cover Screw, Solid Abutment, Cemented Cylinder, Cylinder Screw and Conical Abutment.

The provided text describes a 510(k) summary for the UF(II) Implant System, which relies on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against acceptance criteria in the way a clinical study for a novel device would. Therefore, much of the requested information regarding clinical study design, sample size, expert adjudication, MRMC studies, effect sizes, training sets, and ground truth establishment is not directly applicable or available in this document.

The document focuses on non-clinical testing to demonstrate that the device meets criteria of established standards and is substantially equivalent to predicate devices.

Here's an attempt to extract the closest available information based on your request, highlighting what is implicitly or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are meeting the criteria of the referenced standards and demonstrating substantial equivalence to predicate devices. The "reported device performance" is the outcome of non-clinical tests that conclude these criteria are met.

Non-Clinical Test Acceptance Criteria and Reported Performance for UF(II) Implant System

• Accelerated aging shelf life testing was conducted according to ASTM F1980 for devices provided sterile (real-time testing ongoing to support results). |
  | Fatigue Test | Compliance with ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants) and ISO 14801:2016. Testing performed on worst-case scenario as per FDA guidance. | - The subject device was tested and met the criteria of ISO 14801:2007 and ISO 14801:2016.
• The worst-case scenario was chosen for testing. |
  | Biocompatibility | Compliance with ISO 10993-1:2009 ("Biological evaluation of medical devices-Part 1: Evaluation and testing within risk management process") and FDA Guidance document "Use of International Standard ISO 10993-1..." for relevant tests (Sensitization, Acute systemic toxicity, Cytotoxicity, Intracutaneous Reactivity Test, Pyrogen Test, Implantation Test). Abutment and superstructure must raise no new biocompatibility issues compared to predicates. | Fixture:
• Sensitization: Conducted according to ISO10993-10.
• Acute systemic toxicity: Conducted according to ISO 10993-11.
• Cytotoxicity: Conducted according to ISO10993-5.
• Intracutaneous Reactivity Test: Conducted according to ISO 10993-10.
• Pyrogen Test: Conducted according to USP.
• Implantation Test: Conducted according to ISO 10993-6.
  Abutment and Superstructure:
• No new biocompatibility issues raised due to identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices. No additional testing required. |
  | Mechanical Testing | Confirm external appearance (smooth, no cracks/damage), dimensional analysis, measurement of fixture-to-abutment gap, rotational angle (no significant rotation), maximum/removal torque for screws, static shear strength (equivalent to ISO 14801), and adequate packaging. | - Appearance Test: Confirmed smooth external appearance without cracks or damage.
• Dimension Test: Confirmed same fundamental technology through dimensional analysis.
• Measurement of the gap between Fixture and abutment: Confirmed same fundamental technology through dimensions.
• Rotational Angle Test: Confirmed no significant rotation for the subject device.
• Maximum Torque for dental implant screw Test: Confirmed equivalent rotational torque.
• Removal Torque for dental implant screw Test: Confirmed equivalent removal torque.
• Static Shear Strength Test: Conducted according to ISO 14801, confirming equivalent static shear strength.
• Packaging Test: Confirmed adequate and equivalent packaging. |
  | Substantial Equivalence | The device is similar in design, dimensions, material, intended use, surface treatment, and technological characteristics to identified predicate devices (K122519, K161987, K060501, K070569), raising no new questions of substantial equivalence. | Documentation provided shows comparison tables demonstrating similarity to predicates. Differences (e.g., fixture diameter range, surface treatment for abutments) are addressed and stated not to raise new questions of substantial equivalence. |

Specific Information on Study Design (Not Applicable to this 510(k) submission)

As this is a 510(k) premarket notification primarily relying on substantial equivalence through non-clinical testing, there are no clinical studies of the type you describe (e.g., involving human readers, ground truth consensus for image interpretation, effect sizes of AI assistance). The document focuses on demonstrating that the device meets established engineering and biological safety standards, and is equivalent to previously cleared devices.

Therefore, the following points are not applicable to the provided document:

2. Sample size used for the test set and the data provenance: Not applicable, as this refers to clinical test data. Non-clinical tests would use physical samples of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical assessment is not established in this type of submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental implant system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as it pertains to clinical performance assessment. Ground truth for non-clinical tests would be established through reference standards, metrology, and validated test methods.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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