Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

ET System: The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System: The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

The ET US SS Prosthetic system is intended for use as an aid in prosthetic restoration. It is consisted of abutments, components and abutment screws.

The provided document is a 510(k) Premarket Notification from the FDA for a dental prosthetic system. It details the device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, it does not contain acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria in terms of clinical effectiveness or accuracy.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving novel performance. Substantial equivalence is established by showing that the new device has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device.

Here's an analysis of the information available in the document, keeping in mind that it's a substantial equivalence filing rather than a performance validation study against acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily identifies the device's characteristics (materials, dimensions, intended use) and compares them to predicate devices to establish substantial equivalence. It does not list quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or success rates) or specific performance metrics that the device is intended to meet.

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

This information is not applicable in the context of the provided document. The submission explicitly states:

• "No clinical studies are submitted." (Page 22)
• The nonclinical testing primarily involves fatigue testing and biocompatibility evaluations, which are typically performed on samples of the device components rather than a "test set" of patient data. The sample sizes for these engineering tests are not specified in this summary.
• Data provenance for clinical data is not applicable as no clinical data was submitted.

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

This information is not applicable as no clinical studies with a test set requiring ground truth establishment by experts were submitted.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies with a test set requiring adjudication were submitted.

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

This information is not applicable. The device described is a physical dental prosthetic system (abutments, screws, caps), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.

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

This information is not applicable for the same reason as point 5. The device is a physical prosthetic, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no clinical studies requiring ground truth were submitted. The basis for safety and effectiveness is substantial equivalence to predicate devices, supported by nonclinical testing (fatigue, biocompatibility, sterilization validation).

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this device is not an AI/machine learning product and no clinical data or algorithms are being trained.

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

This information is not applicable as there is no training set mentioned in relation to this device.

Summary of the Study and "Acceptance Criteria" (as interpreted from the document's context):

The "study" described in the document is primarily focused on nonclinical testing and demonstrating substantial equivalence to predicate devices rather than fulfilling specific performance acceptance criteria for clinical outcomes.

Acceptance Criteria (Implicit from Substantial Equivalence):

From the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the device can demonstrate that it is as safe and effective as a legally marketed predicate device. This is achieved by showing:

• Same Intended Use: The ET US SS Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations (crowns, bridges, over-dentures), which is identical to the indications for use of its identified predicate and reference predicate devices (e.g., K062030, K130662).
• Same Technological Characteristics OR Equivalent Safety/Effectiveness with Different Characteristics:
  • Material: Titanium Alloy, PEEK, Polymer (Polycarbonate, POM) – consistent with predicate devices.
  • Design & Function: Described as similar in various components (e.g., Quick Temporary Abutment, Solid Abutment, ComOcta Abutment, Healing Abutment, Ti Screw, O-ring Abutment, Multi Angled Abutment, Esthetic-low Temporary Cylinder). Where there are differences (e.g., new dimensions, slight shape changes, different connection structures for Multi Angled Abutments), the submission asserts that these differences "do not raise new questions of safety and effectiveness" and that the device maintains "same principles of operation, function, material, characteristic and intended use."
  • Biocompatibility: Stated to be the same as predicates, thus requiring no additional testing.
  • Sterilization: For Cover Screw and Healing Abutment, considered substantially equivalent to a predicate. Other components are non-sterile and require steam sterilization validation according to ISO 17665-1:2006. The results implicitly meet the standard.
  • Fatigue Testing: Performed according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with a worst-case scenario. The implied acceptance is that the device met the fatigue strength requirements comparable to the predicate devices or within safe limits for its intended use, ensuring structural integrity. Specific results or detailed criteria are not laid out, but the successful completion of these tests supports substantial equivalence.

Reported Device Performance (from the perspective of 510(k) substantial equivalence):

The document reports the device's performance by demonstrating its similarities to predicate devices across various characteristics:

• Materials: Predominantly Titanium Alloy (ASTM F 136), Titanium (ASTM F 67), and various polymers (PEEK, Polycarbonate, PolyOxy Methylene). These are well-established materials in dental prosthetics, matching those of the predicate devices.
• Dimensions: Various diameters and heights are listed for each component, often including new dimensions that are added to existing product lines. The claim is that these new dimensions do not alter the fundamental safety or effectiveness and maintain the "same principles of operation, function, material, characteristic and intended use" as the predicate devices.
• Functional Principles: Described for each component (e.g., "Used to make temporary prosthesis," "Used in producing ordinary cement-retained prosthetics," "Connect an abutment with fixture by screw"). These are consistently aligned with the predicate device functions.
• Nonclinical Test Results:
  • Biocompatibility: Implicitly deemed acceptable due to using the same materials, manufacturing processes, surface treatments, and sterilization methods as legally marketed predicate devices.
  • Sterilization Validation: Cover Screw and Healing Abutment results are "considered to be substantial equivalent" to a specific predicate, indicating adequate sterilization protocols. Other non-sterile devices underwent steam sterilization validation to ISO 17665-1:2006, implying successful validation.
  • Fatigue Testing: Performed on a "worst-case scenario" sample, suggesting that the device's mechanical durability was assessed and found satisfactory based on the relevant guidance document, thereby supporting its structural integrity and equivalence.

In conclusion, the document demonstrates that the ET US SS Prosthetic System meets the "acceptance criteria" for a 510(k) submission by establishing its substantial equivalence to predicate devices through a comparison of technological characteristics and successful nonclinical testing for biocompatibility, sterilization, and fatigue. No clinical performance criteria or studies are presented.

Ask a specific question about this device

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.

Ask a specific question about this device

Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid to prosthetic rehabilitation.

Inclusive® Titanium Abutments for Hiossen HG Implant System are made of Titanium Alloy (Ti-6Al-4V) and are premanufactured prosthetic components connected directly to the endosseous dental implant and intended as an aid in prosthetic rehabilitation. They are compatible with Hiossen HG Implant System (Mini and Standard). The anti-rotational feature for Inclusive® Titanium Abutment is a hexagon. The numerical value which defines the across flats of the hexagon is 2.10 mm for the Mini, and 2.50 mm for Standard. Both have a tolerance range of ±0.05 mm.

This is a 510(k) summary for a dental device, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria based on this document.

Here's the information regarding the non-clinical testing and acceptance criteria for the Inclusive® Titanium Abutments compatible with Hiossen HG Implant System:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and then "reported device performance." Instead, it states that non-clinical testing was performed based on FDA Guidance and relevant ISO/ASTM standards to demonstrate "implant to abutment compatibility" and "substantial equivalence" to predicate devices. The "reported device performance" is a general statement that the testing results and evaluations demonstrate this compatibility.

However, we can infer the acceptance criteria from the mentioned tests and standards:

Study Details (Not applicable for AI/ML, but details for this medical device are provided):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not specify the exact sample sizes (e.g., number of abutments tested) for the fatigue and static load failure tests. It refers to "finished assembled implant/abutment systems." The data provenance is not explicitly mentioned, but it would be from internal testing conducted by Prismatik Dentalcraft, Inc. (Irvine, CA, USA). These are non-clinical bench tests (prospective under controlled lab conditions).

2. 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, as this is a physical medical device and its performance is evaluated through engineering bench tests, not expert interpretation of data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Device performance is determined by meeting engineering specifications and test outcomes, not by expert adjudication.

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:
   Not applicable, as this is a physical medical device, not an AI/ML system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for this device's performance is based on established engineering principles, material science, and performance standards as outlined in ASTM F136-12a, ISO14801:2007, and the FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." For biocompatibility, it's based on prior successful predicate devices with identical materials and processes.

7. The sample size for the training set:
   Not applicable, as this is a physical medical device, not an AI/ML system.

8. How the ground truth for the training set was established:
   Not applicable, as this is a physical medical device.

Ask a specific question about this device

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

The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutments, Protect caps and Abutment Screws. Its surfaces are partially Tin coated and uncoated.

The provided document describes a 510(k) submission for a medical device, the "Prosthetic System," which is a dental abutment. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.

Therefore, the requested information elements related to acceptance criteria, diagnostic performance, sample sizes, expert involvement, and ground truth for a study proving device performance are largely not applicable (N/A) in the context of this 510(k) submission.

Here's a breakdown based on the information available:

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

• Acceptance Criteria: Not explicitly stated as diagnostic performance metrics. Instead, the acceptance criteria are based on demonstrating substantial equivalence to predicate devices in terms of:
  • Material composition
  • Intended use
  • Design
  • Technological characteristics
  • Performance characteristics
  • Safety (biocompatibility)
  • Mechanical fatigue testing according to relevant standards.
• Reported Device Performance:

  Performance Aspect	Description
  Substantial Equivalence	The device is deemed substantially equivalent to the HU/HS/HG Prosthetic System (K081575) and HS/HG Prosthetic System (K100245) of Osstem Implant Co., Ltd. for the intended use and technological characteristics.
  Fatigue Testing	Conducted for Custom Abutment and Multi Angled Abutment according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801. Results are reported to be in compliance.
  Biocompatibility	Performed to ensure compliance with applicable international and US regulations. Results implied compliance.
  Other Safety/Performance	The Prosthetic System has been "subjected to safety, performance, and product validations prior to release," with an overall conclusion that it is "safe and effective."

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

• N/A. No diagnostic performance test set is described as this is not a diagnostic device and the submission focuses on mechanical and material equivalence, not clinical diagnostic accuracy. The fatigue testing would involve a certain number of samples, but the specific sample size is not detailed in this summary. The tests were likely conducted in a lab environment.

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)

• N/A. Not applicable as there is no diagnostic test set or ground truth established by experts in the context of diagnostic accuracy. The "ground truth" for the fatigue test would be the standard's pass/fail criteria, derived from engineering principles and industry consensus, not expert medical opinion.

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

• N/A. Not applicable as there is no diagnostic test set requiring expert adjudication.

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

• N/A. This is a dental prosthetic system (abutment), not a software or AI-enabled diagnostic device. No MRMC study was performed.

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

• N/A. This is a physical prosthetic device, not an algorithm, so standalone performance in the context of AI/software is not relevant.

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

• N/A for diagnostic ground truth. For the fatigue testing, the "ground truth" would be the engineering specifications and pass/fail criteria defined by ISO 14801 and FDA guidance documents. For biocompatibility, it would be the compliance with relevant international and US regulations.

8. The sample size for the training set

• N/A. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

• N/A. Not applicable, as there is no training set for an AI/machine learning model.

In summary: The provided 510(k) summary is for a physical medical device (dental abutment) and focuses on demonstrating substantial equivalence to existing predicate devices through material, design, and limited performance (fatigue, biocompatibility) testing, rather than a clinical study evaluating diagnostic accuracy against specific performance criteria. Therefore, most of the requested information regarding AI/diagnostic performance studies is not applicable.

Ask a specific question about this device