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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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ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.

ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured and bonded into the ET Link Abutment by Hiossen only with design input using CAD software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics.

This document is a 510(k) summary for the ET Hybrid Abutment by HIOSSEN Inc., intended for use with HIOSSEN ET dental implants to support prosthetic restorations. The submission relies on the substantial equivalence to a primary predicate device, ET Hybrid Abutment (K162390), and two reference predicates: Straumann Variobase Abutments (K132219) and ET SmartFit Abutment (K123627). No clinical studies were submitted. Therefore, the information provided below will be based on the non-clinical testing and comparison to predicate devices, rather than a clinical study establishing the device's meeting of acceptance criteria from human data.

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

The document does not explicitly state "acceptance criteria" in a quantitative format for the entire device. Instead, it relies on demonstrating substantial equivalence to predicate devices through material similarity, manufacturing processes, intended use, and non-clinical testing (biocompatibility and fatigue). The performance is demonstrated by conformance to relevant ISO standards for dental implants.

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: Specific sample sizes for the fatigue tests (ISO 14801) are not explicitly stated in this 510(k) summary. ISO standards typically specify minimum sample sizes for such tests.
• Data Provenance: The origin of the testing data is not explicitly stated in terms of country, but it would have been conducted by or for HIOSSEN Inc., which is based in Fairless Hills, Pennsylvania, USA. The testing is prospective as it was conducted to support the
  510(k) submission.

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

Not applicable. This is a medical device (dental abutment) undergoing non-clinical mechanical and biological testing for substantial equivalence, not an AI or diagnostic device requiring expert consensus for a ground truth in image interpretation or patient diagnosis.

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

Not applicable. As this is not a diagnostic device or a study involving human interpretation of data, there is no adjudication method used. The testing relies on objective, standardized physical and material property measurements.

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-assisted diagnostic device, and therefore, no MRMC study or AI-related effectiveness study was conducted.

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

Not applicable. This is a physical medical device (dental abutment), not an algorithm or software.

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

The "ground truth" in this context refers to the established standards and specifications for material properties, mechanical performance, and biocompatibility of dental implant abutments. These are based on:

• International Standards: Primarily ISO 14801 for fatigue testing, and ISO 17665-1, ISO/TS 17665-2 for sterilization validation.
• Predicate Device Data: The performance and safety profile of the legally marketed predicate devices (K162390, K132219, K123627) serve as the benchmark for demonstrating substantial equivalence.
• Material Specifications: Established specifications for Titanium Alloy Ti-6AL 4V and Zirconia Oxide.

8. The sample size for the training set

Not applicable. There is no training set as this is not a machine learning or AI device.

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

Not applicable. No training set was used.

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ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.

ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured by Hiossen only with design input using CAD/CAM software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics. The coping is straight only and the ET Link abutment is not intended to provide an angle and/or divergence correction.

The provided text is a 510(k) summary for the "ET Hybrid Abutment" by HIOSSEN Inc. This document focuses on demonstrating substantial equivalence to predicate devices, rather than providing detailed acceptance criteria and a study proving that the device meets those criteria.

Therefore, most of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available in the provided text, as this type of information is typically part of performance studies, which are not included here.

However, based on the non-clinical testing summary, we can glean some information regarding the sterilization validation.

Here's what can be extracted and what is explicitly not available:

1. Table of acceptance criteria and the reported device performance:

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

• Not available. The document states "No additional biocompatibility testing was necessary for this device" as it relies on predicate devices. For sterilization validation, the specific sample size for the test set is not provided. Data provenance is also not specified beyond adherence to ISO standards.

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

• Not applicable/Not available. No specific ground truth establishment by experts for performance testing is detailed, as most of the evaluation relies on substantial equivalence to predicates and adherence to international standards for sterilization.

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

• Not applicable/Not available. No adjudication method is mentioned as there were no clinical studies or reported performance evaluations that would typically require such a 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 dental abutment, not an AI-powered diagnostic device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

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

• Not applicable. This device is a dental abutment, not a software algorithm.

7. The type of ground truth used:

• For biocompatibility: Implicitly, the "ground truth" relies on the established biocompatibility of the materials (Titanium Alloy Ti-6AL 4V and Zirconia) in the predicate devices and their manufacturing processes, which were deemed safe and effective.
• For sterilization validation: The "ground truth" is adherence to the validated sterilization parameters and protocols defined by ISO 17665-1 and ISO/TS 17665-2.

8. The sample size for the training set:

• Not applicable. As this is a medical device (dental abutment) and not an AI/machine learning system, there is no "training set."

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

• Not applicable. No training set exists for this type of device.

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The ETIII SA Fixture System (03.2mm) is indicated for use in mandibular and maxillary lateral and central incisor, 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 ETIII SA Fixture System (Ø3.2) 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 ETIII SA Fixture System (Ø3.2mm) is made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The ETIII SA Fixture System (Ø3.2mm) is indicated for use in mandibular and maxillary lateral and central incisor, 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.

This document is a 510(k) premarket notification for the ETIII SA Fixture System (Ø3.2mm) to the FDA. It declares substantial equivalence to existing predicate devices, rather than presenting a study to prove a device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove it cannot be found in this document.

Here's an analysis of the provided text in relation to your request:

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

• Not Applicable. This document does not present specific acceptance criteria or performance metrics for the ETIII SA Fixture System (Ø3.2mm) in the way one would expect for a new diagnostic or AI-driven device. Instead, it aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. The "performance" is implicitly deemed equivalent to these predicates.
• The document does list various tests conducted, such as biocompatibility tests (Subchronic Toxicity, Bacterial reverse mutation, Chromosome aberration, Cytotoxicity, Skin sensitization, Oral Mucosa Irritation, Acute Systemic Toxicity, Pyrogen tests), sterility tests, and mechanical tests (adaptation accuracy, static and dynamic fatigue). However, it does not provide specific numerical outcomes or acceptance thresholds for these tests that could be presented in a performance table. It merely states that "All tests were conducted in accordance with relative standards without any discrepancies."

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

• Not Applicable. This document describes a medical device (dental implant), not a software or AI device that would typically have a "test set" in the context of data analysis. The testing involved material properties, biocompatibility, and mechanical performance, not a clinical data set for algorithm validation.
• Therefore, there is no information on sample size for a "test set" as would be relevant for an AI study, nor data provenance (country of origin, retrospective/prospective).

3. 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 (dental implant) and not an AI or diagnostic software, there is no "ground truth" established by experts in the context of data labeling or diagnosis for a test set. The validation relies on standard engineering, material, and biological safety testing.

4. Adjudication method for the test set

• Not Applicable. No test set or adjudication method as typically defined for AI or diagnostic studies is mentioned.

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 document pertains to a physical dental implant, not an AI or diagnostic tool, so an MRMC study is not relevant and was not conducted.

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.)

• Not Applicable. For the physical properties and safety of a dental implant, the "ground truth" is established through adherence to recognized international standards (e.g., ISO, ASTM, USP) for material science, biocompatibility, and mechanical testing. There isn't a "ground truth" in the sense of clinical diagnosis or outcomes data detailed here for a study to prove acceptance criteria.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model, 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, this question is not applicable.

Summary based on the document:

The document describes the ETIII SA Fixture System (Ø3.2mm) dental implant and seeks FDA clearance based on substantial equivalence to predicate devices. It references various non-clinical tests performed in accordance with international standards (ISO, USP) to demonstrate safety and performance, but does not provide the specific results or acceptance criteria values for these tests. It explicitly states, "No clinical studies are submitted." The focus is on demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety and effectiveness as legally marketed predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel technology.

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A-Oss® is applicable in filling of the bone defect and bone augmentation in the following dental areas.

• Filling in the missing part of a bone due to periodontal disease, cystectomy, or dental extraction
• Filling in the missing part of a bone surrounding an implant
• Maxillary sinus lift for implant
• Alveolar bone augmentation/restoration

Bone Grafting Material

The provided text is a 510(k) premarket notification letter from the FDA to Hiossen Inc. regarding their device, A-Oss®. It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria, device performance testing, or study details.

Therefore, I cannot extract the requested information regarding design verification, validation, and performance studies. The document primarily focuses on regulatory approval and compliance.

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ETIII Bio-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 terminal or intermediate abutment support for fixed bridgework. The ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.

ETIII Bio-SA Fixture has features of single threads, internal hex connection, taper body, and Bio-SA surface treatment. ETIII Bio-SA Fixture System is permanent dental implant made with Pure titanium Grade 4 (ASTMF67-06). The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations).

The provided text is a 510(k) summary for a dental implant system (ETIII Bio-SA Fixture System) and does not contain information about an AI/ML-driven medical device. Therefore, it does not describe acceptance criteria, a study proving an AI device meets those criteria, or other details typically associated with the evaluation of AI/ML performance.

The document discusses:

• Device Description: An endosseous dental implant system made of pure titanium, with specific design features and surface treatment.
• Intended Use: For partially or fully edentulous mandibles and maxillae to support various dental restorations.
• Predicate Devices: Comparison with existing dental implant systems, highlighting the key difference of an added hydrophilic coating for improved wettability.
• Non-Clinical Testing:
  • Wettability and blood affinity observations.
  • Surface analysis (EDS, FE-SEM, ICP-AES).
  • Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, chromosome aberration, implantation, pyrogenicity) conducted according to ISO and FDA guidelines.
  • Animal study (Beagle dogs): Measured removal torque, bone loss, and bone-to-implant contact.
• Clinical Testing: A study with 45 subjects and 66 implants, evaluating primary stability, bone resorption, complications, and other factors, reporting a 100% success rate after 16.3 months average follow-up.
• Shelf-life validation and sterilization.

Summary of missing information relevant to AI/ML device evaluation:

Since this document pertains to a physical dental implant device and not an AI/ML-driven device, it does not contain any of the requested information regarding AI/ML performance criteria or studies.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance.

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The HIOSSEN 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, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ETIII SA Ultra Wide Fixture is intended to be used in the molar region.

The HIOSSEN Implant 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 HIOSSEN Implant System include length 18mm implant. The HIOSSEN Implant System is a revised product that Dimension and code(art#) are changed and added from predicate product, ETII SA Fixture, HTIII SA Fixture and ETIII SA Ultra Wide Fixture therefore there is no difference about material, indication for use and design from predicate as above. And the subject devices and the predicate devices encompass the same range of physical dimensions except length 18mm and characteristics, including implant diameter and surface treatment.

The provided document is a 510(k) premarket notification for the HIOSSEN Implant System. It does not describe a study involving algorithms, AI, or human readers, but rather demonstrates substantial equivalence to predicate devices through non-clinical testing.

Therefore, many of the requested categories related to algorithm performance, expert ground truth, and human-in-the-loop studies are not applicable to this document.

Here's a breakdown of the information that is available in the document:

1. Table of acceptance criteria and reported device performance:

The document describes the HIOSSEN Implant System as substantially equivalent to predicate devices based on various characteristics, primarily focusing on materials, indications for use, and design. The "acceptance criteria" are implied by the comparison to the predicate devices, meaning the new device should not raise new questions of safety and effectiveness regarding these characteristics.

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: Not applicable. The "test set" in this context refers to non-clinical testing of the physical device. The document mentions "engineering analysis, dimensional analysis, static and dynamic compression-bending testing" and "fatigue testing in air." Specific sample sizes for these tests are not provided in this summary.
• Data provenance: Not applicable. This refers to physical device testing, not data from human subjects or images.

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

Not applicable. This document is for a dental implant system, not an AI/algorithm-based diagnostic device requiring expert interpretation for ground truth.

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

Not applicable for a physical medical device submission.

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

Not applicable. This is a physical dental implant, not an AI-assisted diagnostic device.

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

Not applicable. This is a physical dental implant.

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

The "ground truth" for demonstrating substantial equivalence for this device is based on established engineering standards for medical devices (e.g., ASTM F67 for material, "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" for mechanical testing). The comparison is against predicate devices that have already demonstrated safety and effectiveness.

8. The sample size for the training set:

Not applicable. There is no algorithm or AI model requiring a training set.

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

Not applicable. There is no algorithm or AI model requiring a training set.

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Multi Angled Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures.

The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System, K62030 and connected to HTIII SA Fixture in the HTIII SA Fixture System, K101096. The Multi Angled Abutment system consists of Abutment combined carrier that is tool to carry Multi angled abutment. and Abutment Screw. The Multi Angled Abutment system is exactly same with Multi Angled Abutment (K123755) except combined carrier. Carrier is just to carry the Multi Angled Abutment to implanted Fixture.

The provided document is a 510(k) summary for the OSSTEM Multi Angled Abutment system. This submission does not describe a study to prove a device meets acceptance criteria related to its performance in terms of accuracy, sensitivity, specificity, or other similar metrics.

Instead, this 510(k) summary is for a medical device (dental abutment). The "study" described herein is a comparison to a legally marketed predicate device to establish substantial equivalence for market clearance. This is a common regulatory pathway for medical devices and does not involve the types of performance studies or acceptance criteria typically associated with artificial intelligence or diagnostic software.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission and device.

Here's a breakdown of the relevant information from the document in response to your request:

1. Table of acceptance criteria and the reported device performance

Not applicable. This is a 510(k) submission for a mechanical dental device, not a diagnostic or AI-driven aid with performance metrics like sensitivity or specificity. The "performance" assessment here is focused on mechanical and material equivalence to a predicate device.

Instead, the submission states:
"The Multi Angled Abutment system is merely improved for movement convenience of abutment by combination of carrier therefore, The Multi Angled Abutment is nothing changed from predicated Multi Angled Abutment (K123755) except combined carrier"

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. No "test set" in the context of performance metrics was used. The evaluation centered on design and material comparison to a predicate device.

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 a "ground truth" or expert review of performance data was conducted for this type of device submission. The assessment was done by the manufacturer's engineers and subsequently by the FDA reviewers.

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

Not applicable.

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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The "ground truth" equivalent in this context is the design specifications, material properties, and intended use of the legally marketed predicate device (K123755). The new device is compared against these established characteristics to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. No training set was used.

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

Not applicable.

Summary of the Study/Evaluation for Substantial Equivalence:

The "study" or evaluation performed for the K132067 submission was a comparison of the Multi Angled Abutment system to a legally marketed predicate device (Multi Angled Abutment, K123755).

• Acceptance Criteria (Implicit for Substantial Equivalence): The primary "acceptance criterion" was to demonstrate that the new device is as safe and effective as the predicate device, or is substantially equivalent. This means:
  • Same intended use.
  • Same or similar technological characteristics.
  • If there are differences in technological characteristics, those differences do not raise different questions of safety and effectiveness.
• Reported Device Performance (in context of substantial equivalence): The document reports that the Multi Angled Abutment system is "exactly same with Multi Angled Abutment (K123755) except combined carrier." The carrier is described as "just to carry the Multi Angled Abutment to implanted Fixture." This modification is stated to be "merely improved for movement convenience of abutment."
  • Intended Use: Identical for both new and predicate device: "intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures."
  • Abutment Angle (°): 17, 30 (same for both)
  • Platform (Ø): 4.8 (same for both)
  • Connection: The core abutment components are identical to the predicate (K123755). The only difference is the addition of a combined carrier.
• Nonclinical Testing: "The risks associated with the modification were evaluated via a DCAS table and it was determined that no performance testing is needed. However, minor modifications were made to the labeling." This indicates that the manufacturer determined the change (addition of a carrier) did not warrant new mechanical or material testing as the core functional components of the abutment remained unchanged from the predicate.
• Clinical Testing: "No clinical studies are submitted."

In essence, the entire argument for meeting the "acceptance criteria" for market clearance (substantial equivalence) is built on the claim that the device is fundamentally the same as its predicate, with a minor, non-performance-affecting addition.

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

The ET SmartFit Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. That is customized abutment considering shape of the finial prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. All manufacturing processes of ET SmartFit abutment such as CAD/CAM manufacturing and milling are conducted in the Hiossen factory. The ET SmartFit Abutment is used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. Use only the basal screws provided for the Customized Abutment. The surgical procedure for Customized abutment is the same as the surgical procedure for the cement-retained abutments.

Acceptance Criteria and Device Performance Study for ET SmartFit Abutment

The ET SmartFit Abutment is a dental device made of titanium alloy intended for use as an aid in prosthetic restoration, specifically for cement-retained crowns, bridges, or overdentures with dental implants.

1. Table of Acceptance Criteria and Reported Device Performance

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

The summary does not mention a specific "test set" for the ET SmartFit Abutment's performance. The primary approach for demonstrating safety and effectiveness was via substantial equivalence to a predicate device (K110308).

• For Fatigue Testing: While not explicitly stated as a "test set" with a specific sample size, the fatigue testing was conducted according to ISO 14801 using a "worst-case scenario." This implies that a sufficient number of samples were tested to meet the requirements of the standard, but the exact number is not provided.
• Data Provenance: The document does not specify the country of origin for the data if the testing took place outside of the US. The studies were likely prospective in nature as they describe mechanical tests performed on the device.

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

Given that this is a 510(k) submission primarily relying on substantial equivalence and non-clinical bench testing, there is no mention of experts establishing a ground truth for a clinical test set. The "ground truth" for the non-clinical tests would be the established international standards (e.g., ISO 14801) and the performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there was no clinical test set for which an adjudication method would be required. The evaluation was based on compliance with international standards and comparison to a predicate device's characteristics.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of device (dental abutment) and submission. MRMC studies are typically used for diagnostic or imaging devices to assess human reader performance with and without AI assistance.

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

Not applicable. The ET SmartFit Abutment is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

• For Non-Clinical Testing (Fatigue, Biocompatibility): The "ground truth" was established by recognized industry standards (e.g., ISO 14801) and regulatory compliance requirements for biocompatibility. The performance was also benchmarked against the predicate device.
• For Substantial Equivalence: The ground truth for comparative purposes was the characteristics and performance of the legally marketed predicate device (K110308).

8. The Sample Size for the Training Set

Not applicable. The ET SmartFit Abutment is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Hiossen Inc. ET SmartFit Abutment demonstrated its safety and effectiveness through a 510(k) Pre-market Notification pathway by establishing substantial equivalence to a legally marketed predicate device, The Prosthetic System (K110308) from Osstem Implant Co., Ltd.

The key study performed was non-clinical bench testing, specifically fatigue testing, conducted according to ISO 14801. This testing focused on the "worst-case scenario" to ensure the device's mechanical integrity under simulated oral conditions. The results of this fatigue testing were reported to be in compliance with the standard and similar to previously cleared predicate devices.

Additionally, biocompatibility testing was performed to confirm that the device materials (Titanium Alloy - Ti-6Al-4V) comply with applicable international and US regulations.

The manufacturer explicitly states that no clinical studies were submitted because the ET SmartFit Abutment shares the same materials, manufacturing process, chemical composition, indication for use, and body contact characteristics as the predicate device (K110308). This strong similarity, supported by the non-clinical testing, formed the basis for the FDA's determination of substantial equivalence.

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