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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.

TS Abutment System is made of titanium alloy. TS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. TS Abutment System is similar to other commercially available products based on the intended use, technology used, material composition employed and performance characteristics.

The provided document is a 510(k) summary for the Osstem Implant Co., Ltd. TS Abutment System. It describes the device and claims substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, nor does it involve expert reviews or clinical trials for such metrics.

Instead, the submission focuses on demonstrating substantial equivalence through comparisons of technical characteristics and performance testing (bench testing, biocompatibility, sterilization validation, etc.) against existing predicate devices and established standards.

Therefore, most of the requested information regarding acceptance criteria for device performance (accuracy, sensitivity), sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment would not be applicable to this type of regulatory submission. This submission does not pertain to an AI/ML powered device, but rather a physical dental implant component.

However, I can extract information related to the technical comparisons that demonstrate substantial equivalence.

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

The document does not present explicit acceptance criteria in terms of numerical performance metrics (e.g., specific thresholds for accuracy, sensitivity). Instead, the acceptance is based on demonstrating that the subject device's characteristics and performance are "substantially equivalent" to predicate devices, often by adhering to established standards or by justifying that any differences do not raise new questions of safety or effectiveness. The reported "performance" for most components is implicitly that they function equivalently to their predicates and meet relevant mechanical and biological standards.

Here's a summary of the non-clinical performance and "acceptance criteria" through comparative analysis:

• Same design, function, connection, and platform as predicate.
• Adherence to ISO 14801 standard (maintaining 11mm distance between embedding plane and hemispherical loading member).
• Differences (e.g., added lengths or diameters) not creating a new worst-case scenario. | Rigid Abutment: No additional fatigue testing conducted, as the proposed device has the same design, function, connection, platform, and moment arm as the reference/predicate, and added lengths are within acceptable ranges or previously cleared for similar components.
  Transfer Abutment: No additional fatigue testing conducted for similar reasons, justifying that changes in connection features were evaluated and not a new worst case, and that the device has the same moment arm.
  Angled Abutment: No additional fatigue testing conducted, as differences in feature (guide for connecting with implant body) do not change the fundamental design or platform and the proposed device's fatigue is considered equal to or greater than the predicate.
  FreeForm ST Abutment: No additional fatigue testing conducted, as added dimensions are within the range of the reference device and it maintains the same moment arm.
  Temporary Abutment: No additional performance test needed as it's for temporary use, and the proposed gingiva height has primary predicate clearance.
  Multi Abutment: No additional fatigue testing conducted, as added dimensions (gingival height) are covered by primary predicates and it maintains the same moment arm.
  Ti Cylinder Screw: No fatigue testing considered necessary as it's a component using with cylinder, and material biocompatibility is established.
  Convertible Abutment: No additional performance tests as difference is sterilization process. Its mechanical performance is expected to be equivalent to predicate. |
  | Biocompatibility | The device materials must have acceptable biocompatibility, typically demonstrated by using materials already cleared in predicate devices or by following ISO 10993-1. | The TS Abutment System uses the same materials (e.g., Ti-6Al-4V (ASTM F136), Titanium Gr.3 (ASTM F67), Titanium Gr.4 (ASTM F67)), manufacturer, manufacturing process, and surface treatment as primary predicate and reference devices. Therefore, no additional biocompatibility testing was conducted. |
  | Sterilization Validation | The sterilization process must be validated to ensure sterility, or justified if changes from predicates do not create a new worst-case scenario. For sterile devices, shelf-life must be validated. | For those components provided sterile, the validation of the gamma irradiation process was previously conducted for the predicate device. Changes in dimensions for the subject device do not create a new worst-case scenario for sterilization, thus no additional validation was required. Shelf-life for sterile components (e.g., Transfer Abutment, Angled Abutment, Multi Abutment, Convertible Abutment, Port Abutment, Stud Abutment, Healing Abutment) is established as 8 years. For non-sterile devices made of titanium, no specific shelf-life is considered for the material itself due to its known stability. |
  | Pyrogen Test | Absence of pyrogens to meet established standards (e.g., ISO 10993-11:2006 and USP). | Bacterial Endotoxin Test Report on implants was referenced from K161604, indicating previous compliance. |
  | MR Compatibility | Evaluation of magnetically induced displacement force and torque based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods et al., 2019), addressing parameters for magnetically induced displacement force and torque for all compatible implant bodies, abutments, and fixation screws and material composition. |

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

• Sample Size for Test Set: Not applicable. This submission relies on comparisons to predicate devices and existing standards, not a new test set for performance evaluation in the clinical sense (e.g., diagnostic accuracy).
• Data Provenance: The document references previously cleared 510(k) submissions (e.g., K182091, K161689, K221684, K163634, K161604, K120847) from Osstem Implant Co., Ltd. and one from Southern Implants (Pty) Ltd. The specific country of origin for the data from these predicate clearances is not detailed in this summary, but the manufacturer of the subject device is based in the Republic of Korea. The data is retrospective, as it refers to performance data and justifications from prior clearances.

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 "ground truth" as typically understood in AI/ML diagnostic performance studies was established or used for this device's submission. The evaluation is based on engineering principles, materials science, and conformity to recognized standards.

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

Not applicable. No adjudication method for a test set was used.

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-powered device.

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

Not applicable. This is not an AI-powered device.

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

Not applicable. No "ground truth" of this nature was used. The ground truth, in a regulatory sense for this type of device, is conformity to established material specifications, manufacturing processes, and recognized performance standards (like ISO 14801 for fatigue testing).

8. The sample size for the training set

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

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The Stella is intended to be surgically placed in the upper or lower jawbone to provide support for prosthetic devices, such as artificial teeth, restoring the patient's chewing capabilities. The Stella is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading. The Stella Abutment is intended to be connected to the dental implant to retain the overdenture or partial denture.

Stella is a dental implant fixture that is implanted in the jawbone to support and maintain prosthetic restoration teeth or dentures in case of partial or total loss of teeth as a material for dental surgery. The fixture is made of titanium (ASTM F67, Grade 4), and the retention area is surface treated by spraying with Al2O3 (alumina) powder and then pickling to roughen the surface. The system incudes Healing Abutment, Simple Abutment, Duo Abutment, Contour Abutment, Angled Abutment, and Temporary Abutment.

The provided text describes the regulatory clearance for the "Stella" dental implant system. It does not contain information about acceptance criteria or a study demonstrating the device meets performance criteria in the context of AI/ML or diagnostic applications. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria for a novel AI/ML algorithm.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies for an AI/ML device is not present in the provided document.

However, I can extract the non-clinical testing performed to support the substantial equivalence claim for the Stella dental implant system.

Here's the relevant information that is available:

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

This information is not provided in the context of an AI/ML device's diagnostic performance. The document only lists types of non-clinical tests performed for physical characteristics of the dental implant system, and states that the "Stella" has "similar fatigue testing results to the predicate devices in the market" without providing specific acceptance criteria or quantitative results for these comparisons.

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

Not applicable to this document. The document describes a medical device (dental implant), not a diagnostic algorithm.

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 to this document.

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

Not applicable to this document.

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 to this document.

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

Not applicable to this document.

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

Not applicable to this document. The "ground truth" for a physical device like a dental implant would be engineering specifications and material properties, validated through physical testing, not expert consensus on images or pathology.

8. The sample size for the training set:

Not applicable to this document, as it does not describe an AI/ML algorithm.

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

Not applicable to this document.

Summary of Non-Clinical Testing (as described in the document for the physical device Stella, not an AI/ML component):

The document highlights the following non-clinical tests performed to support substantial equivalence of the Stella dental implant system:

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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 Luna Dental 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 Luna Dental Implant System is intended for delayed loading and immediate loading is possible when good primary stability is achieved and with appropriate occlusal loading.

The Luna Dental Implant System is a device of pure titanium (ASTM F67) and titanium alloy (ASTM F1136) intended to be surgically placed in the bone of the upper or lower arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw. This 510k is intended to add the new models of the following abutments to the Luna Dental Implant System: Healing Abutment I, Duo Abutment, Duo Plus Abutment, Temporary Abutment.

The document provided does not contain information about the performance of an AI/ML powered device, but rather pertains to the 510(k) clearance of the Luna Dental Implant System, which is a traditional medical device (dental implants and their components).

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI/ML powered device from this document. The document describes the mechanical and material characteristics of dental implants and their substantial equivalence to previously cleared predicate devices, not AI/ML model performance.

To answer your request, I would need a document describing the study and acceptance criteria for an AI/ML powered medical device.

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The IM/ST Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, 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 proposed device, IM/ST Fixture System, is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Implant system contain dental implant and abutment. The dental implant system, IM Implant System and ST Implant System, both of which are divided into mini implant and regular implant. IM Implant and ST Implant have different designs for the external thread section. The external thread part of IM implant is composed of conical shape, double thread and spiral groove, while The external thread part of ST implant is composed of conical shape, single thread, neck micro thread and cutting groove. Both IM implant and ST implant are available in diameters of 3.75, 4.2, 4.6 and 5.05mm and lengths of 7, 8.5, 10, 11.5, 13 and 15mm, and both are bone level. The "mini" and "regular" differ in size, but abutments are cross-compatible with both IM and ST implant types, and the abutment is attached to the implant by abutment screw and fastened to the implant. The material of abutment screw is Titanium Alloy (Ti-6A1-4V, ASTM F136).

The implants are bone level. The implants were made of Pure Titanium Grade 4 and underwent sandblasting and acid etching process. Modified surface testing (SEM/EDS) for blasted/etched surfaces was conducted to demonstrate removal of particles and chemicals from implant surface.

Abutment can be divided into healing abutment, straight abutment, multi-abutment, multi-angled abutment and temporary abutment. And it is divided into mini abutment and regular abutment. In addition, abutment also has three types of cylinder, angled cylinder and temporary cylinder.

The provided document is a 510(k) summary for the Guilin FiTeeth Medical Instrument Co., Ltd. IM/ST Fixture System. It describes the device and its comparison to predicate and reference devices to demonstrate substantial equivalence, rather than establishing acceptance criteria and proving performance against them through a clinical study with detailed metrics like sensitivity, specificity, or AUC.

Therefore, the requested information for acceptance criteria and study details cannot be extracted as the document pertains to a medical device submission for substantial equivalence based on non-clinical tests and technological characteristics comparison, not an AI/Software as a Medical Device (SaMD) performance study with specific acceptance criteria, test sets, ground truth establishment, or human-in-the-loop effect sizes.

The document states:

• "No clinical study is included in this submission." on page 6.

Instead, the submission relies on:

• Non-clinical testing: This included biocompatibility (ISO 10993-1, USP ), dynamic fatigue (ISO 14801), material specifications (ASTM F136, ASTM F67), sterilization validation (ISO 17665-1, ISO 17665-2, ISO 11137-2, ISO 11137-1), accelerated aging (ASTM F1980), and MRI safety review. These tests verify that the device meets design specifications and complies with relevant standards.
• Technological characteristics comparison: The proposed device was compared in detail to a primary predicate device (K121995, OSSTEM IMPLANT CO.,LTD TS FIXTURE SYSTEM) and several reference devices for its abutment components. Differences in structure, body diameter, implant length, shelf life, and dimensions of various abutment types were assessed, and the manufacturer argued these differences do not affect substantial equivalence based on mechanical testing, coverage by predicate/reference ranges, or biocompatibility evaluations.

Since this is a submission for a traditional medical device (dental implant system) and not an AI/SaMD, the typical acceptance criteria and study details related to AI performance (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance, independent test sets, expert ground truth adjudication) are not applicable or provided in this document.

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CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture.

CORE1 Abutment intended for Single Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only.

CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°.

The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.

Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.

However, I can extract information related to the device's performance through non-clinical testing.

Here's a breakdown of the relevant information provided:

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

The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.

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

• Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
• Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the Republic of Korea.

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 device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.

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

Not applicable, as this is non-clinical bench testing against established 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. This is a dental implant, not an AI/diagnostic device.

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

Not applicable. This is a dental implant, not an AI/diagnostic device.

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

The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP for endotoxins).

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no "training set."

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

The OSSTEM Implant System - Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components and Abutment Screws.

This document is a 510(k) Premarket Notification of the OSSTEM Implant System - Abutment, indicating it is a dental device and not an AI/ML medical device. Therefore, the information requested in the prompt, which pertains to the acceptance criteria and study proving an AI/ML device meets those criteria, cannot be fully provided from this document.

The document discusses the substantial equivalence of the OSSTEM Implant System - Abutment to predicate devices. This typically involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through material comparisons, design comparisons, and performance testing for mechanical properties and biocompatibility, rather than clinical studies or performance against defined efficacy metrics tied to patient outcomes.

However, I can extract information related to the device and the type of testing performed that is relevant to its acceptance for market.

Here's a breakdown based on the provided text, addressing the points of your prompt where applicable, and highlighting what's not present due to the nature of the device:

Device Description: The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. It consists of Abutments, components, and Abutment Screws.

Acceptance Criteria and Device Performance (General):
For this type of device, "acceptance criteria" revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices. This means proving the new device is as safe and effective as the predicate. The performance is assessed through:

• Material composition: Comparing the materials used (e.g., Titanium Alloy, Zirconia, PEEK, PC, POM).
• Design and dimensions: Comparing the shapes, diameters, and lengths.
• Intended use: Confirming the device serves the same purpose.
• Technological characteristics: Ensuring the fundamental mechanism of action is similar.
• Nonclinical testing: Biocompatibility, sterilization validation, and mechanical properties.

Table of Acceptance Criteria and Reported Device Performance (as inferred from a 510(k) for a non-AI/ML device):

Here's how the remaining points of your prompt are addressed:

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

   • Test set sample size: Not applicable in the context of an AI/ML algorithm's test set. The "testing" here refers to nonclinical lab tests and comparison to predicates.
   • Data provenance: Not directly applicable. The "data" are internal company reports demonstrating compliance with standards or comparisons to their own previously cleared devices. The manufacturer is OSSTEM Implant Co., Ltd. and their correspondent is HIOSSEN Inc., based in Republic of Korea and Pennsylvania, USA, respectively. The data are typically generated in a prospective manner for regulatory submission (i.e., tests are performed specifically for the submission).

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

   • Not applicable as this is a physical medical device, not an AI/ML algorithm requiring ground truth from experts for image interpretation or diagnosis.

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

   • Not applicable. This concept pertains to consolidating expert opinions for ground truth in AI/ML performance studies.

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 MRMC study was done, as this is not an AI/ML device. The document explicitly states: "No clinical studies are submitted." (page 12)

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

   • Not applicable, as this is not an AI/ML device.

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

   • Not applicable. For this device, "ground truth" is embodied by established engineering specifications, material properties, and performance benchmarks for dental implants, which are verified through nonclinical laboratory testing against international standards (e.g., ISO, ASTM) and comparison to predicate device characteristics.

7. The sample size for the training set:

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

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

   • Not applicable. (See #7).

Summary of Acceptance:

The device's acceptance (clearance) by the FDA is based on demonstrating substantial equivalence to existing predicate devices (listed in section 3 and 6) in terms of:

• Indications for Use: Identical.
• Technological Characteristics: Very similar, with minor differences in design/dimensions that do not raise new safety/effectiveness concerns.
• Materials: Identical.
• Performance (Nonclinical): Biocompatibility is leveraged from predicate devices; sterilization validated according to relevant ISO standards.

The document explicitly states: "No clinical studies are submitted." This reinforces that the acceptance was based on nonclinical testing and comparison to predicates, as is common for many Class II medical devices in the 510(k) pathway.

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The ETII SA Fixture system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The ETII SA Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. ETII SA Fixture is composed of single threads with internal hex connection straight body of bone level for two stage surgery. It has SA surface. The ETII SA Fixture System is for single and two stage surgical procedures. ETII SA Fixture System is compatibly used with abutment in the ET/SS Implant System (K120847). The ETII SA Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The ETII SA Fixture is available in various lengths and diameters according to the anatomical situation.

This document describes a 510(k) premarket notification for the Hiossen ETII SA Fixture System, a dental implant. The purpose of the submission is to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through a declaration of substantial equivalence based on material, indication for use, and similar design/technological characteristics to predicate devices. The primary "acceptance" is the FDA's determination of substantial equivalence.

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

This submission is for a medical device (dental implant) and does not involve an AI algorithm with a 'test set' in the traditional sense of evaluating diagnostic or predictive performance on a dataset. The "test" in this context refers to non-clinical bench testing (fatigue testing, biocompatibility).

• Sample Size for Non-Clinical Testing: The specific number of devices tested for fatigue or biocompatibility is not provided in this summary. It only indicates that "fatigue testing was considered" and "biocompatibility have been performed."
• Data Provenance: The data provenance for the non-clinical tests (fatigue, biocompatibility) would be from the manufacturer's internal testing. The submission does not specify the country of origin of this testing, but Hiossen Inc. is located in Fairless Hills, PA, USA. The testing is prospective in the sense that it was performed 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

Not applicable. This is not an AI diagnostic device that requires expert-established ground truth on a test set of medical images or patient data. The "ground truth" for a dental implant's performance is established through material standards, engineering specifications, and biological compatibility, verified by laboratory testing as opposed to expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable, as there is no 'test set' requiring expert adjudication for ground truth establishment.

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

Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this submission.

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

For this type of device, the "ground truth" is defined by:

• Material Specifications: Adherence to standards like ASTM F67-06 for Pure Titanium Grade 4.
• Engineering Standards: Meeting performance criteria for mechanical properties, particularly fatigue resistance, often guided by industry standards and FDA guidance documents (e.g., "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment").
• Biocompatibility Standards: Compliance with ISO or FDA standards for biological evaluation of medical devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for a physical dental implant.

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