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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 EK Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is indicated for delayed loading. Ultra wide versions are indicated for use in the molar region only.

The EK Dental Implants (Ø3.5mm) are made of titanium alloy (Ti 6Al 4V) for Fixtures and Simple Mount and pure titanium for Cover Screw. The EK Dental Implants (Ø3.5mm) are 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 EK Dental Abutments are indicated for use with EK Dental Implants to provide support to prosthetic restoration such as crowns, bridges and overdentures in partially or fully edentulous patients.

The EK Dental Implants are intended to be surgically placed in the bone of the upper or lower jaw arches, providing support to prosthetic devices to restore normal chewing functions. There are two types: SA and NH, both are bone level implants with the exact same internal hex, tapered body, use the same EK Dental Abutments, are manufactured from the same medical grade titanium materials and sterilized via gamma radiation. They only difference is the surface; SA is sand blasted and acid etched and NH which is SA + Dglucose + NaCI.

The EK Dental Abutments are indicated for use with EK 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 EK Dental Implants and Abutments are available in various lengths and diameters; configurations are listed in the table below.

The provided document is a 510(k) premarket notification for dental implants and abutments. It focuses on demonstrating substantial equivalence to previously cleared devices, rather than proving the device meets specific acceptance criteria through a clinical or performance study with a test set, ground truth, or expert readers as typically seen for novel AI/ML medical devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not directly applicable to this type of submission.

Instead, the document demonstrates substantial equivalence by comparing the proposed EK Dental Implants and Abutments to predicate and reference devices across several key characteristics:

• Intended Use: The proposed devices have the same intended use as the predicate devices (supporting single or multiple-unit restorations in edentulous mandibles and maxillae, for delayed loading).
• Design/Structure: The proposed implants have an internal hex connection, are submerged fixtures, and have a tapered body shape, similar to the predicate devices. The abutments are also comparable in design to their reference devices.
• Material: The implants use Pure Titanium Grade 4 (ASTM F67) and Titanium alloy Ti-6Al-4V (ASTM F136), which are standard materials also used in the predicate devices. Abutments use similar materials (Ti-6Al-4V, Co-Cr-Mo Alloy, Gold alloy as per the reference devices).
• Surface Treatment: The implants employ SA (Sandblasted and Acid etched) and NH (SA + D-glucose + NaCl) surfaces, which are consistent with the predicate and reference devices.
• Sterilization: Implants are gamma irradiated, and abutments are provided non-sterile for steam sterilization by the user, matching the predicate/reference devices.
• Packaging: Similar packaging methods are used as the predicate devices.
• Performance Characteristics (Non-Clinical):
  • Biocompatibility: Not re-tested, as the materials and manufacturing processes are the same as predicate/reference devices.
  • Sterilization Validation: Not re-tested for implants (same process as predicate) or for abutments (provided non-sterile like reference devices, with user steam sterilization).
  • Shelf Life: Not re-validated for implants (same as predicate's 8-year validated shelf life and packaging) or for abutments (non-sterile, non-mechanical, no stated shelf life, similar to reference devices).
  • Surface Treatment Characterization: Not re-tested, as surfaces are manufactured using the same process and materials as predicate/reference devices.
  • Fatigue Testing: Conducted in accordance with ISO 14801. The worst-case implant and abutment configurations withstood 5,000,000 cycles without failure at a substantially equivalent load to the primary predicate.
• Clinical Performance Testing: No clinical performance report(s) were submitted, indicating that substantial equivalence was demonstrated through non-clinical data and comparison to predicates.

In a 510(k) substantial equivalence submission for a traditional medical device like a dental implant, the "acceptance criteria" are effectively the demonstration of sufficient similarity in technological characteristics and performance (often non-clinical) to a legally marketed predicate device. The "study" proving this device meets the "acceptance criteria" is the comprehensive comparison outlined above, coupled with relevant non-clinical testing (like fatigue testing).

Therefore, I cannot populate the table or answer the specific questions in the format requested, as they pertain to a different type of validation study (e.g., for an AI/ML diagnostic algorithm, which would involve a test set, ground truth established by experts, and statistical performance metrics).

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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 ET/SS 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. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.

The ET/SS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Its surfaces are partially Tin coated and uncoated.

This 510(k) premarket notification for the ET/SS Implant System does not contain the level of detail typically found in a study describing acceptance criteria and device performance for AI/ML-based medical devices. The submission focuses on demonstrating substantial equivalence to predicate dental implants through a comparison of physical characteristics, intended use, and a summary of nonclinical testing (fatigue testing).

Therefore, I cannot directly extract the specific information requested in your prompt regarding acceptance criteria, study details, ground truth, sample sizes, or MRMC studies, as the document is for a traditional medical device (dental implant) and not an AI/ML device.

However, I can extract the information provided about the nonclinical testing for this device and present it in a similar structure:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable as this is a nonclinical, component-level fatigue test, not a performance study on a test set of data.

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

Not applicable. Ground truth for fatigue testing is established by engineering standards and measurement.

4. Adjudication Method

Not applicable.

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

No, this type of study was not done. The device is a physical dental implant, not an AI system that assists human readers.

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

Not applicable. The "device" is a physical implant. The fatigue testing is a standalone test of the implant's physical properties.

7. The Type of Ground Truth Used

Engineering standards and measurements for fatigue life.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for physical fatigue testing of a dental implant in this context.

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

Not applicable.

Summary of Device Information from the Provided Document:

• Device Name: ET/SS Implant System
• Manufacturer: OSSTEM Implant Co., Ltd.
• Device Type: Endosseous Dental Implant
• Classification: Class II
• Key Feature: Made of pure titanium metal, SA (Sandblasting and Acid etching) treated surface.
• Intended Use: For use in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations (cemented, screw-retained, or overdenture), and for final or temporary abutment support for fixed bridgework. Intended for delayed loading.
• Nonclinical Testing: Fatigue testing performed according to ISO 14801 and relevant FDA guidance.
• Clinical Testing: No clinical studies were submitted.
• Basis for Equivalence: Substantial equivalence was claimed based on material, indication for use, and similar design and technological characteristics to predicate devices, supported by nonclinical testing results.

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