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The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring 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:

• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• · BioHorizons Multi Unit Abutment, 4.8mm, max 30°
  • · CONELOG® Implant System
• · Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
  • · TSXTM Implants
  • · Tapered Screw-Vent Implant
• · DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
  • · 3i OSSEOTITE®
  • · Astra Tech OsseoSpeed™
  • · Neodent Grand Morse
  • NobelReplace® Trilobe
  • · NobelReplace® Conical
  • · Nobel Brånemark System®
  • · Straumann BLX Implants
• · DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
  • · NobelActive® NobelParallel Conical
  • Straumann® Bone Level
  • · Zimmer Screw Vent® and Tapered Screw-Vent®
• · Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
• · Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• KDG Abutments, 4.8mm, max 30°
• · Keystone Multi Unit Abutment, 4.8mm, 0°
• · Medentika Multi Unit Abutments, 4.8mm, max 30°
  • · EV Series Dentsply® Implants Astratech Osseospeed®
  • · F Series Nobel Biocare NobelActive® NobelReplace® Conical
  • · H Series Biomet 3i Certain®
  • L Series Straumann Bone Level
  • · N Series Straumann Soft tissue Level
  • · R Series Zimmer Dental Tapered Screwvent®
• Medentika Multi Unit Abutments, 4.8mm, 0°
  • E Series Nobel Biocare Replace™ Select
  • · I Series Biomet 3i Osseotite®
  • K Series Nobel Biocare™ Branemark
  • · S Series Astra Tech OsseoSpeedTM
  • · T Series Dentsply Friadent® Frialit/Xive®
• · MegaGen Multi Unit Abutments, 4.8mm, max 30°
• · Xpeed® AnyRidge® Internal Implant System
• AnyOne® Internal Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® External Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® Internal Implant System
• Rescue Internal Implant System
• 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°
• · Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• · Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
• · Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
• · Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• · OSSTEM Multi Unit Abutment, 4.8mm, max 30°
  • SS SA Fixture Implants
  • SA Implant System
  • · ET US SSS Prosthetic System
• · Paltop Multi Unit Abutment, 5.0 mm, max 17°
• · Southern Compact Conical Abutments, 4.8 mm
  • MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• · Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

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

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

• Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
• . Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).

The provided FDA 510(k) summary (K233083) describes the acceptance criteria and study for the Osteon Precision Milled Suprastructure.

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) for an expansion of an existing device (K221019) to add compatibility with new OEM abutment systems and introduce three new Type B Nexus Fixed Bars. The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and material composition.

The tables below synthesize the design specifications (acceptance criteria) and the device's performance (reported as meeting these specifications) by demonstrating substantial equivalence to predicate devices.

Table 1: Comparison of General Characteristics and Materials (summarized for clarity)

Table 2: Design Specifications (Acceptance Criteria vs. Reported Performance)

*Note for Suprastructure Height: The Minimum Suprastructure Height for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3*-22 mm, where * indicates variability for this new bar.
**Note for Suprastructure Width: The Minimum Suprastructure Width for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3.4**-12 mm, where ** indicates variability for this new bar.

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

The submission is a 510(k) for an expansion of an existing device (K221019). The "study" proving the device meets acceptance criteria primarily relies on non-clinical data and demonstration of substantial equivalence to predicate devices.

• Test set/Sample size: The document does not describe a "test set" in the traditional sense of a clinical or imaging study with a defined sample size for statistical analysis. Instead, it relies on:
  • Reverse engineering analysis of OEM abutments and OEM abutment screws: This was done to confirm compatibility. The sample size for this analysis is not explicitly stated but would involve the specific OEM abutments listed for compatibility with the subject device.
  • Fatigue testing: The document states, "Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments..." This indicates that engineering analysis and design specifications, rather than physical fatigue testing, were used to demonstrate performance in this regard.
• Data provenance: Not directly applicable as there isn't a "test set" from patients. The data relies on engineering analysis, existing predicate device data, and compliance with standards.

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 requiring expert readers to establish ground truth. Substantial equivalence claims are based on engineering, material, and design comparisons to legally marketed devices.

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

Not applicable. There is no "test set" or diagnostic performance study that would require an adjudication method.

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 suprastructure, 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 device is a physical dental suprastructure, not an algorithm.

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

The "ground truth" equivalent for this submission is the established safety and effectiveness of the primary predicate device (K221019) and various reference devices, supported by:

• Compliance with recognized standards: Biocompatibility (ISO 10993-5, ISO 10993-12), sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 14937).
• Material specifications: Conformance to ASTM F136 for titanium alloy.
• Engineering analysis and design specifications: Comparison of design features to predicate devices and confirmation of compatibility through reverse engineering.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, there is no training set for this device.

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The ET Abutment System are indicated for use with ET Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

The ET Abutment System are indicated for use with ET dental implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients. Manufactured from medical grade titanium alloy and delivered non-sterilized. The ET Abutments are available in various lengths and diameters; configurations are listed in the table below.

This document describes a 510(k) premarket notification for a medical device called the "ET Abutment System," which is an endosseous dental implant abutment. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through de novo clinical trials.

Therefore, the submission does not contain information about specific "acceptance criteria" for an AI algorithm's performance, nor does it detail a study proving such a device meets these criteria in the typical sense of AI/ML performance evaluation. The "studies" referenced are non-clinical bench tests demonstrating the physical and material properties of the dental abutments are comparable to existing, legally marketed devices.

Based on the provided text, here's an analysis of the "acceptance criteria" and "proof" in the context of this 510(k) submission:

The acceptance criteria and proof fundamentally revolve around demonstrating substantial equivalence to predicate devices, not performance against a specific clinical metric for an AI algorithm.

Missing Information:

The document concerns a physical dental device (abutment system), not an AI/ML powered device. As such, the concept of "acceptance criteria" for AI performance, clinical study design for AI (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, etc.) are not applicable to this submission. The FDA letter confirms the device type: "Endosseous Dental Implant Abutment."

However, to address the prompt's implied need for "acceptance criteria" and "studies" as they relate to this specific device (dental abutment), I will interpret the request within the context of a 510(k) submission for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a Dental Abutment System)

In a 510(k) submission for a dental abutment, "acceptance criteria" are typically defined by demonstrating that the proposed device has the same technological characteristics and similar performance to legally marketed predicate devices, or that differences do not raise new questions of safety and effectiveness. The "reported device performance" comes from non-clinical bench testing.

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

Since this is a physical medical device submission and not an AI/ML algorithm:

• Sample Size for Test Set: Not applicable in the context of an AI test set. For physical device testing, the sample sizes would be determined by the relevant ISO standards (e.g., ISO 14801 for fatigue testing). These specific numbers are not detailed in the summary but are typically part of detailed test reports that support the conclusion of substantial equivalence.
• Data Provenance: The data comes from non-clinical testing (bench tests) performed to standard specifications (e.g., ISO 14801). The "ET Abutment System are contract manufactured by the predicate device manufacturer," implying the manufacturing process and potentially some historical performance data are shared or directly comparable.
  • Country of Origin: Not specified for the non-clinical test data itself, but the applicant (Hiossen Inc.) is in Fairless Hills, Pennsylvania, USA. The predicate manufacturer (Osstem Implant Co., Ltd.) is generally based in South Korea, suggesting potential international collaboration or shared manufacturing data.
  • Retrospective or Prospective: Not applicable in the context of patient data. The non-clinical tests would be conducted prospectively on newly manufactured devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• This concept is not applicable as this is not an AI/ML diagnostic or image analysis device that requires expert labeling or interpretation for "ground truth." The "ground truth" here is the adherence to material specifications, dimensional tolerances, and performance under specific mechanical and biological test conditions as defined by international standards.

4. Adjudication Method for the Test Set

• This concept is not applicable as there is no "test set" in the sense of clinical cases requiring interpretation or adjudication by multiple readers/experts. Performance is based on mechanical, material, and sterilization testing against predefined standards.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• Not applicable. This type of study is for evaluating human performance with or without AI assistance, typically in image interpretation or diagnosis. This submission is for a physical dental implant component. The document explicitly states: "No clinical performance report(s) is being submitted."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This pertains to AI algorithm performance.

7. Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering standards, material specifications, and performance data from validated non-clinical bench tests. This includes:
  • ASTM (American Society for Testing and Materials) standards for materials (e.g., ASTM F136 for titanium alloy).
  • ISO (International Organization for Standardization) standards for testing medical devices (e.g., ISO 14801 for fatigue testing of dental implants, ISO 17665-1 for moist heat sterilization).
  • FDA guidance documents (e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
  • Direct comparison to the established characteristics and performance of the legally marketed predicate devices.

8. Sample Size for the Training Set

• Not applicable. This concept relates to AI/ML model development. There is no "training set" for a physical dental abutment. The device's design and manufacturing rely on established engineering principles and prior knowledge from the predicate device.

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

• Not applicable. Again, this refers to AI/ML model training. The "ground truth" for developing a physical device is derived from engineering design principles, material science, and the performance history of similar devices.

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

Osstem Abutment System is compatible with the following implant systems.
Osstem Implant Co., Ltd. TS SA Fixture Internal Hex 3.2, 3.5, 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.8, 4.9, 5.05, 5.08, 5.1, 5.25, 5.92, 5.95, 6, 6.2, 6.8, 7.1
Osstem Implant Co., Ltd. US SA Fixture External Hex 3.6, 4.2, 5.1, 5.2
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.

The provided text is a 510(k) Summary for the Osstem Abutment System, which aims to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information related to an AI/ML-driven medical device, nor does it conduct a study measuring medical device performance against specific acceptance criteria in the manner one would see for an AI/ML model for diagnostic or prognostic purposes.

The document discusses non-clinical performance testing to support substantial equivalence, primarily focusing on materials, design, and mechanical properties (fatigue testing). It explicitly states:

• "Non-clinical testing data are submitted to demonstrate substantial equivalence." (Page 10)
• "No clinical studies are submitted." (Page 11)

Therefore, I cannot fulfill the request as it asks for information typically found in submissions for AI/ML-driven diagnostic devices, such as:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics like sensitivity, specificity, AUC)
• Sample sizes for test sets, data provenance
• Number of experts and their qualifications for ground truth
• Adjudication methods
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth
• Training set sample size and ground truth establishment

The document presents a comparison to predicate devices, stating that new dimensions or minor design changes are not considered "worst-case" for fatigue given existing predicate device testing, thus negating the need for additional testing in some instances. It relies on the substantial equivalence principle, which means the device is as safe and effective as a legally marketed device.

In summary, the provided text does not contain the specific information required to answer your detailed questions about acceptance criteria, study design, and performance metrics for an AI/ML device.

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The AnyOne External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

AnyOne External Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance. AnyOne External Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic restore a patient's chewing function.

Here's a breakdown of the acceptance criteria and study information for the AnyOne External Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details the equivalence to predicate devices rather than explicit, stand-alone acceptance criteria with specific numerical thresholds for each component. However, the core acceptance criteria revolve around demonstrating substantial equivalence to existing, legally marketed devices (predicates and reference devices). The reported performance across all components is that they met the pre-set criteria for the conducted tests.

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

The document does not explicitly state the numerical sample size for the test set used in the performance bench tests (static compression-strength and fatigue tests). It mentions "test was performed on the subject device and predicate device" and "representative specimen".

• Sample Size (Test Set): Not explicitly stated as a numerical value for each test (e.g., how many implants were tested for fatigue). It generally refers to "the subject device and predicate device" and "representative specimen" in singular form, implying at least one of each worst-case scenario. However, for a regulatory submission of this nature, multiple samples would typically be tested to establish statistical confidence, even if not explicitly detailed in this summary.
• Data Provenance: The study is non-clinical bench testing. The country of origin of the data is not specified, but the applicant and correspondent are located in the Republic of Korea. The tests are prospective as they were conducted specifically for this submission to demonstrate substantial equivalence.

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

This is not applicable as the studies are non-clinical bench tests (physical properties, biocompatibility, sterilization, etc.). Ground truth in this context is established by adherence to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts interpreting test results for "ground truth" in the way it might apply to a clinical study involving medical image analysis, for example.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical bench testing. Passing or failing criteria are determined by adherence to established engineering and material science standards (e.g., force applied, number of cycles, endotoxin concentration limits).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a submission for a dental implant system involving physical components. MRMC studies are typically performed for AI/CAD systems that assist human readers in tasks like medical image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. As above, this is for a physical medical device. There is no algorithm involved.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Standardized Test Methods: Adherence to international standards such as ISO 14801 for mechanical testing, ISO 10993-1 for biocompatibility, ISO 11137 and ISO 17665-1, 2 for sterilization, ASTM F1980 for shelf life, and USP 39 for endotoxin testing.
• Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device's performance, materials, and design are comparable to legally marketed predicate and reference devices. The predicate devices themselves serve as a form of "ground truth" for acceptable performance and safety within their intended use.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

Not applicable. See point 8.

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The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following stuations and with the clinical protocols:

-Delayed loading.

-Immediate loading when good

primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.

AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.

AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.

Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function.

The proposed AnyOne Onestage Implant System is consisted of the following components: Fixture Products (AnyOne Onestage Fixture), Closing Screw & Cover Screw & Healing Abutment (Closing Screw, Cover Screw, Healing Abutment), Fixture Level Prosthesis (Multi Post, Multi Post Cap, EZ Post Abutment, Angled Abutment, Gold Abutment, CCM Abutment, Multi Post Screw, Abutment Screw), Abutment Level Prosthesis (Solid Abutment, Solid Cap, Solid Post Abutment, Solid Post Cap, Octa Abutment, Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Abutment Screw), Overdenture Prosthesis (Meg-Loc Abutment, Meg-Ball Abutment, Meg-Magnet Abutment, Magnet, Meg-Rhein Abutment).

The provided text does not describe an AI/ML device but rather a dental implant system. Therefore, details regarding AI/ML device performance, such as acceptance criteria, test set sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or training set specifics, are not applicable and not present in the document.

The document focuses on demonstrating the substantial equivalence of the "AnyOne Onestage Implant System" to predicate devices, primarily through comparison of design, materials, indications for use, and mechanical performance testing (biocompatibility, surface treatment, endotoxin, sterilization, and static/fatigue tests).

Acceptance Criteria and Device Performance (Not Applicable for AI/ML):

Since this is a non-AI/ML device, the concept of "acceptance criteria" as it relates to algorithm performance (e.g., sensitivity, specificity, AUC) and "reported device performance" in that context is not relevant. Instead, the document demonstrates that the new device meets established standards and is equivalent to legally marketed predicate devices through various non-clinical tests.

However, if we interpret "acceptance criteria" as the criteria for demonstrating substantial equivalence for this medical device (dental implant system) and "reported device performance" as the results of the non-clinical tests, we can extract details regarding the physical property tests performed. The acceptance criterion for these tests is that the device must meet "pre-set criteria" according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment," and the reported performance is simply that the test results "met the pre-set criteria."

Summary of Non-Clinical Testing Performance for Dental Implant System:

Further details as requested (adapted for a non-AI/ML device):

2. Sample size used for the test set and the data provenance:
   The document focuses on non-clinical (bench) testing. For the physical properties (static compression-strength and fatigue tests), representative specimens were selected "under the consideration of worst case." The exact number of samples tested for each component is not explicitly stated in this summary, but it would have been part of the full testing report. The provenance of the "data" would be the internal testing laboratories of MegaGen Implant Co., Ltd. (Republic of Korea). The tests are prospective in the sense that they are specifically conducted to support this 510(k) submission.

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 physical tests is established by standardized testing protocols (e.g., ISO 14801) and engineering measurements, not human expert consensus.

4. Adjudication method for the test set: Not applicable for physical property testing. Test results are objectively measured against predefined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a dental implant system (physical device), not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used:
   For physical properties (static compression-strength and fatigue), the "ground truth" is based on the performance requirements specified in international standards (ISO 14801) and FDA guidance documents ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment"). For biocompatibility and sterilization, it's adherence to ISO standards (ISO 10993-1, ISO 11137, ISO 17665-1, 2) and ASTM standards (ASTM F1980), as well as USP for endotoxin.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

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

URIS OMNI Narrow System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI Straight and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMNI Tapered implant has a tapered wall with a single thread design. The OMNI Straight implant has straight wall with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have Narrow (Ø 3.15 mm) platform sizes. Both implant lines share the following diameters and lengths.

Ø 3.15 x 10, 11.5, 13, 14.5mm (L)

URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Ball Abutment, Retainer, T LOC Straight Abutment, T Loc Titanium Cap, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment, Multi-Unit Healing Cap, Multi-Unit Ti Cylinder, Multi-unit temporary cylinder, Multi-Unit Cylinder screw, URIS DS, URIS Base. No additional angulation is to be included in the when using a coping or cylinder (i.e., Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base) with any of the Multi-unit Abutments.

URIS Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).

The provided document is a 510(k) Summary for a dental implant system. It discusses the substantial equivalence of the "URIS OMNI Narrow System & Prosthetic" to predicate devices based on non-clinical testing. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of human reader performance or a standalone algorithm performance for AI/ML-driven devices.

The document states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through comparisons of technological characteristics and non-clinical test data.

Therefore, I cannot provide the requested information for an AI/ML device related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, as these types of studies are not discussed in this 510(k) summary for this device.

The "acceptance criteria" presented in this document are primarily related to the successful completion and results of non-clinical tests to demonstrate equivalence to predicate devices. These are not performance metrics for an AI/ML algorithm.

Here's an analysis of what is provided regarding acceptance criteria in the context of this traditional medical device:

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

The document implicitly defines acceptance criteria by listing the standards to which tests were performed and stating that "the results have met the criteria of the standards." The "reported device performance" is that it successfully met these standards, thereby demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of non-clinical, non-AI device study. The document refers to testing on the device itself (e.g., fatigue testing, sterilization testing, biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth as typically understood for AI/ML performance is not relevant here. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ISO/ASTM standards and FDA guidance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a human reader or AI performance study.

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. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of AI/ML device performance. For the described non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the referenced ISO/ASTM standards. For example, for biocompatibility, the ground truth is whether the materials meet the criteria specified in ISO 10993-1.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The Sample Size for the Training Set

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

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

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

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Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.
The document then lists various components of the system including Transfer Abutment, Angled Abutment, Link Abutment for Cerec, Temporary Abutment, Multi Angled Abutment, Multi NP-Cast Cylinder, Multi Combination Cylinder, Convertible Angled Cylinder, Stud Abutment, O-ring, O-ring Retainer Cap, Port Abutment, Port Angled Abutment, Port Angled Abutment Head, Port Male, Port Extended Male, Port Male Cap, Port Male Kit, Abutment Screw, Cylinder Screw, Esthetic-low Temporary Cylinder, and Temporary Cap (Narrow Ridge), along with their descriptions, materials, and dimensions.

The provided document is a 510(k) premarket notification for the Osstem Abutment System. It outlines how the device is considered substantially equivalent to already marketed predicate devices, rather than providing a performance study against specific acceptance criteria for a new AI/software device.

Therefore, many of the requested details, such as those related to AI/algorithm performance (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance), are not applicable to this type of submission. The document focuses on material properties, design, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not present explicit acceptance criteria in the typical sense of performance metrics for an AI/software device (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is claimed based on similarities in:

• Intended Use
• Technology (design principles)
• Material Composition
• Performance Characteristics (mechanical properties, biocompatibility, sterilization)

The performance is "reported" by demonstrating that the device is equivalent to known predicate devices through non-clinical testing (biocompatibility, sterilization validation, mechanical properties, specifically fatigue testing and retention testing). The document states: "Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence."

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

This information is not applicable and not provided. The submission relies on non-clinical (laboratory) testing for mechanical properties and biocompatibility, as well as comparison to predicate devices, not on a clinical test set with patient data.

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

Not applicable. No clinical test set or human expert review of "truth" data for diagnostic performance is described.

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 is not an AI/software device that assists human readers.

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

Not applicable.

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

For mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and designs as measured in laboratory tests, and compared against established industry standards (ISO 14801) and FDA guidance for dental abutments. For biocompatibility, it's adherence to ISO 10993 standards. No clinical ground truth from patients is established or used for this 510(k) submission.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device submission.

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

Not applicable.

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