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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 Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8mm, max 30°
• · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• Southern Compact Conical Abutments, 4.8mm
  • · MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• Keystone Multi Unit Abutment, 4.8mm, 0°
• · Neodent GM Mini Conical Abutment, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5mm, max 30°
• · Paltop Multi Unit Abutment, 5.0mm, max 17°

The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B.

This document is a 510(k) summary for a dental device, the Osteon Precision Milled Suprastructure. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, rather than presenting a study that proves the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's why and what information can be extracted:

• This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against a set of novel acceptance criteria through a clinical trial.
• Focus on Substantial Equivalence: The document compares features like indications for use, materials, design, and manufacturing processes to existing devices.
• Non-Clinical Testing Mentioned: The document refers to non-clinical tests performed, but these are primarily for demonstrating compatibility, material safety, and sterility, not performance against specific clinical efficacy or accuracy metrics.

Information that can be extracted or inferred:

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

This document does not present explicit "acceptance criteria" in the traditional sense of performance metrics for an AI/algorithm-driven device. Instead, it demonstrates similarity to predicate devices based on design specifications and material properties. The "performance" is implicitly deemed acceptable if it's shown to be substantially equivalent to the established predicate devices.

(Note: "Similar" indicates that the values or characteristics fall within or are comparable to those of the predicate/reference devices, with stated differences not impacting safety/efficacy from the manufacturer's perspective.)

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

• Test Set Sample Size: Not applicable. This submission relies on "non-clinical tests" (dimensional analysis, biocompatibility, sterilization validation) and comparison to existing predicate marketing clearances. It does not describe a "test set" in the context of an AI/ML algorithm evaluation with human interpretation or image analysis. The "test" consists of demonstrating manufacturing conformance and material properties for the physical device.
• Data Provenance: The device is manufactured by Implant Solutions PTY LTD (trading as Osteon Medical) in Mulgrave, Victoria, 3170 Australia. The non-clinical tests (e.g., biocompatibility and sterilization validation) would have been performed there or at certified labs. These are bench tests, not clinical data sets.

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

• Not applicable. There's no "ground truth" to establish in the context of an AI/ML algorithm or diagnostic accuracy study. The assessment is based on physical device characteristics and established standards.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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

• Not applicable. This is a physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. This is a physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. The "ground truth" for this medical device submission is compliance with engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, all demonstrated through non-clinical bench testing.

8. The sample size for the training set:

• Not applicable. This is a physical dental device. While it is manufactured using CAD/CAM technology, it does not involve an AI/ML model that requires a training set of data.

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

• Not applicable. See point 8.

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SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.

The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.

The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.

The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.

All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.

All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.

The provided document is a 510(k) summary for a medical device (SuperLine dental implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document discusses substantial equivalence to predicate devices based on non-clinical data and design comparisons.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study demonstrating device performance against those criteria.

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The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.

The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the dental device:

Acceptance Criteria and Device Performance for MegaGen Implant Co. Ltd.'s Multi-unit Abutment, Multi-unit Angled Abutment (K203808)

This submission is a 510(k) premarket notification for dental implant abutments. The primary method of demonstrating acceptance and substantial equivalence is through comparison to predicate devices and performance testing according to established international standards (ISO 14801) and FDA guidance documents. There is no AI component or related acceptance criteria described in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds within the document, as the submission focuses on demonstrating substantial equivalence to existing predicate devices. The performance is assessed by confirming that the subject device meets the requirements of relevant standards, implying that its performance is comparable to or better than the predicate devices.

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

The document does not explicitly state the sample sizes used for the non-clinical performance (bench) testing. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified beyond indicating they were performed in accordance with international standards. Given it's a Korean manufacturer, the testing likely occurred in Korea or at facilities that adhere to these international standards.

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

This section is not applicable as the device is a dental implant abutment, and the document describes a 510(k) submission based on substantial equivalence and non-clinical bench testing. There is no mention of a "ground truth" derived from expert consensus on patient cases for evaluation in the context of diagnostic or interpretive performance.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers independently assess cases and discrepancies are resolved. The submission relies on bench testing and comparison to predicates, not clinical interpretation studies.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The submission pertains to a physical dental device (abutments) and does not involve AI or human-in-the-loop performance evaluation.

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

No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/CADe (Computer-Assisted Detection/Diagnosis) devices. The submitted device is a mechanical component, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic or AI studies (expert consensus, pathology, outcomes data) does not apply here. For this device, the "ground truth" for demonstrating acceptance is adherence to engineering specifications, material standards, and performance benchmarks established by international standards (ISO 14801) and FDA guidance documents. The acceptable performance of the predicate devices acts as the benchmark.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product (dental implant abutment). There is no "training set" in the context of machine learning or AI algorithms for this type of submission.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it.

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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

The purpose of this submission is to change the sterilization method of Healing Abutments and Cover Screws. These devices which have been provided non-sterilized by gamma radiation.

Healing Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment. Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final abutment. Cover Screws are used provisionally as an accessory to protect the inner features of the implant.

The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only.

The provided document is a 510(k) premarket notification for "Healing Abutments and Cover Screws." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of rigorous, large-scale studies typically associated with AI/ML-based medical devices or novel technologies.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this specific submission. This document describes a change in the sterilization method for existing devices, not a new device with performance metrics that require extensive clinical validation studies beyond sterilization and biocompatibility.

Here's an analysis based on the information available in the document:

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

For a 510(k) submission concerning a change in sterilization method for mechanical components like healing abutments and cover screws, the "acceptance criteria" revolve around demonstrating that the new sterilization method achieves the required sterility assurance level and does not adversely affect the device's material properties or function, maintaining its substantial equivalence to the predicate.

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 explicitly stated as a separate "test set" in the context of clinical performance data typical for AI/ML devices. The "tests" here are primarily engineering and laboratory validations:
  • Sterilization Validation: ISO 11137 standards define the number of units and replicates required for sterility testing (e.g., bioburden determination, dose mapping, sterility testing), which are often small, specific lots. This is standard laboratory validation, not a patient-based test set.
  • Aging Studies: ASTM F1980 dictates sample sizes for accelerated aging, again, laboratory testing of physical samples.
  • Biocompatibility: Relies on a prior submission (K041368) which presumably included its own biocompatibility testing. No new "sample size" for a clinical test set is mentioned for biocompatibility here.
• Data Provenance: The studies are laboratory-based ("Non-clinical testing data"). The manufacturer is located in the Republic of Korea (Dentium Co., Ltd.). The data would be derived from their internal validation processes. It is neither retrospective nor prospective in the sense of patient studies.

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 submission does not involve image interpretation or clinical diagnosis where expert ground truth would be established. The "ground truth" for sterilization is a defined SAL, verified by microbiological and physical testing per ISO standards. The "ground truth" for material properties is based on ASTM standards and prior biocompatibility data.

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

• Not Applicable. As there is no clinical "test set" based on human interpretation or an AI algorithm's output requiring adjudication, this concept does not apply.

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

• Not Applicable. This is a traditional medical device (dental implants and accessories), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement, or AI assistance is 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)

• The "ground truth" for this submission is based on:
  • Standardized Sterility Assurance: Achieving a defined SAL of 10^-6, verified through validated sterilization processes and testing compliant with ISO 11137-1 and ISO 11137-2.
  • Material Standards: Biocompatibility established against Ti-6Al-4V ELI (ASTM F136) as per regulations and previous submissions.
  • Engineering Performance: Shelf-life demonstrated through accelerated and real-time aging studies per ASTM F1980.
  • Substantial Equivalence: Demonstrated by comparing engineering specifications and intended use against legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This involved physical device manufacturing and validation, not machine learning model training.

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

• Not Applicable. (See point 8)

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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 IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment). The IU 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. There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IU Implant System, extracted from the 510(k) summary:

The provided document (K172345) is a 510(k) Summary for a new medical device, the IU Implant System. In 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to establish new safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating equivalence to established standards and predicate devices, largely through non-clinical testing.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IU Implant System are implicitly set by the standards and characteristics of the identified predicate and reference devices, as well as relevant ISO standards. The "performance" being demonstrated is that the subject device meets these established benchmarks, thereby showing substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Study Details

Given this is a 510(k) submission, the "study" that proves the device meets the acceptance criteria is primarily a non-clinical comparative testing and documentation of material/design equivalence to predicate devices and recognized standards.

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

• Test Set Sample Size: Not explicitly stated in terms of a "test set" as one might refer to it in a clinical study. The non-clinical tests (biocompatibility, sterilization, shelf-life) would typically involve a sample of the manufactured device components. The exact number of samples for each specific test (e.g., cytotoxicity, sensitization, mechanical flexural strength) is not detailed in this summary.
• Data Provenance: The biocompatibility testing was conducted according to International Standard ISO 7405:2008 and ISO 10993-1:2009/AC:2010. Sterilization testing followed ISO 11137-1/2/3 and ISO 17665-1/2. Shelf-life testing followed ASTM F1980. Risk analysis followed ISO 14971. This indicates testing against internationally recognized standards. The country of origin of the data generation isn't specified beyond the device manufacturer being WARANTEC Co., Ltd. from Korea. This is a retrospective analysis of non-clinical design and safety data against known standards and predicate devices.

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

• This is not applicable in the context of this 510(k) submission. "Ground truth" in this scenario is established by adherence to recognized international standards (ISO, ASTM) and demonstrative equivalence to predicate devices, rather than expert consensus on a test set (e.g., interpretation of medical images). The experts involved would be those who conducted the laboratory tests and certified compliance with the standards (e.g., microbiologists, material scientists, toxicologists), but their number and specific qualifications are not detailed in this summary.

3. Adjudication method for the test set:

• Not applicable. There is no "adjudication method" in the sense of reconciling divergent expert opinions on test data. Compliance with each standard (e.g., passing a cytotoxicity test, achieving a certain SAL) is a binary outcome based on pre-defined criteria within the standard itself.

4. 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 an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. This type of study is irrelevant for this device.

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

• No, this is not an AI algorithm. This question is not applicable.

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

• The "ground truth" for this P(re-market) N(otification) is
  • Compliance with recognized international standards for biocompatibility (ISO 10993, ISO 7405), sterilization (ISO 11137, ISO 17665), shelf-life (ASTM F1980), and risk management (ISO 14971).
  • Substantial equivalence to predicate devices in terms of intended use, materials, design, and manufacturing processes, which implicitly means the predicate devices' established safety and effectiveness serve as the benchmark.

7. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a 510(k) submission for this type of device. The information refers to the manufacturing and testing of physical medical devices and their components, not machine learning models.

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

• Not applicable. As stated, there is no training set for this type of device.

Summary of the "Study" (Non-Clinical Evidence):

The "study" presented is a collection of non-clinical tests and comparisons to establish substantial equivalence. It confirms:

• The IU Implant System has the same intended use as the primary predicate device (Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155).
• Its technological characteristics (design, dimensions, material, surface treatment, connection, sterilization method) are similar to or identical to the predicate and reference devices.
• It meets all relevant biocompatibility standards (ISO 7405, ISO 10993-1) through specific lab tests (Cytotoxicity, Sensitization, Oral irritation, Systemic Toxicity, Genotoxicity, Implantation, Endotoxin).
• Its sterilization process achieves the required sterility assurance level (SAL 10^-6) validated by ISO standards.
• It has demonstrated shelf-life stability through accelerated aging testing (ASTM F1980).
• A risk analysis was conducted according to ISO 14971, finding all risks acceptable.

Key Point from the Submission: "No clinical data were included in this submission." This explicitly states that the substantial equivalence determination relies entirely on non-clinical data and comparison to legally marketed predicate devices, as is common for many Class II medical devices in the 510(k) process.

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The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, post height, collar height and angulation.

The CreoDent Solidex® Customized Abutment is a dental device intended to support prosthetic devices with endosseous implants in partially or completely edentulous patients. The study aimed to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The information provided does not explicitly state numerical "acceptance criteria" for performance metrics in a pass/fail format typical of many medical device studies. Instead, substantial equivalence is established by demonstrating that the device has the same intended use, fundamental scientific technology, and comparable technological characteristics and performance to predicate devices, with any differences being "mitigated" or demonstrated to be safe and effective.

The provided document details comparisons between the CreoDent Solidex® Customized Abutment and several predicate devices across various technological characteristics. The "reported device performance" is primarily qualitative, asserting mechanical strength and compatibility, and is supported by specific non-clinical tests.

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

The provided document describes non-clinical testing rather than a clinical study with a "test set" of patient data.

• Sample Size for Non-clinical Testing: The document does not specify the exact number of physical samples (e.g., abutments, screws, implants) used for static/fatigue testing or reverse engineering dimensional analysis. It refers to "worst-case scenario" testing for the abutment connection platform.
• Data Provenance: The data is from non-clinical bench testing rather than human patient data. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense.

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

Not applicable. This device's clearance is based on non-clinical testing and demonstration of substantial equivalence, not a clinical study requiring expert-established ground truth from patient data. The "ground truth" here is the adherence to mechanical performance standards and dimensional compatibility, verified by engineering and material science evaluations.

4. Adjudication Method for the Test Set

Not applicable, as there is no test set in the context of clinical images or data requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not the nature of this dental abutment device.

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

Not applicable. This is a physical dental device (abutment) and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Mechanical Standards: Adherence to established international standards for dental implants and abutments (e.g., ISO 14801:2007E for dynamic fatigue).
• Material Specifications: Compliance with material standards (ASTM F-136 for Ti-6Al-4V Eli titanium alloy).
• Dimensional Compatibility: Verification through reverse engineering dimensional analysis against original equipment manufacturer (OEM) compatible implant bodies, abutments, and fixation screws.
• Sterilization Standards: Compliance with ISO 17665-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical dental device; there is no "training set" in the machine learning sense. The design and manufacturing processes are likely informed by extensive engineering knowledge and design principles accumulated over time for similar devices.

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

Not applicable, as there is no training set for an AI/algorithm. For a physical device, the "ground truth" for design and manufacturing is established through engineering principles, material science, and adherence to accepted industry standards and regulatory requirements.

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Dentium abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium CAD/CAM Abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Dentium CAD/CAM Abutments are titanium abutments to be used in fabricating patient-specific abutments. Each patient-specific abutment is individually prescribed by the clinician. Dentium CAD/CAM Ti-Blank Abutments are abutments with a pre-manufactured precision interface and are used by a validated milling center to fabricate patient-specific abutments. Ti-Blanks are available in three cylinder diameters (10 mm, 14 mm, and 15.8 mm) and three connection designs (Hex, Long Hex). Dentium CAD/CAM Custom Abutments are patient-specific abutments fabricated by Dentium. Custom Abutments are available for fabrication in three connection designs (Hex, Long Hex, and Non-hex). Dentium CAD/CAM Abutments are available for four corresponding implant platform diameters (3.6 mm. 4.0 mm, 4.5 mm, 5.0 mm). Each abutment is supplied with a corresponding abutment screw, cleared previously in K141457. All subject device abutments are compatible with Implantium dental implants.

I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for Dentium CAD/CAM Abutments does not contain any information about acceptance criteria or a study proving that an AI/device meets acceptance criteria related to diagnostic performance.

The document is a clearance letter for a dental device (CAD/CAM abutments), not an AI or diagnostic imaging device. It focuses on demonstrating substantial equivalence to predicate devices based on:

• Non-clinical performance data: steam sterilization validation, biocompatibility, and dynamic compression-bending testing.
• Design similarities: material, size, and interface.
• Intended use.

Therefore, I cannot extract the information required by your request, such as a table of acceptance criteria for diagnostic performance, sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, or training set details, because this document is for a medical device that does not involve such diagnostic performance evaluations.

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