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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 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.

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The US SA 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 bridges, or overdenture.

The US SA 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. The US Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.

The provided text describes a 510(k) premarket notification for the "US SA Implant System," a dental implant device. The document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study for a new device on its own merits against specific criteria.

Therefore, many of the requested details about acceptance criteria, specific device performance numbers, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not directly applicable or available in this type of submission document.

However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.

Here's a breakdown of the information that can be gleaned from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document in the format of specific numerical acceptance criteria and corresponding device performance metrics. The document instead focuses on demonstrating substantial equivalence through comparison of materials, design, indications for use, and non-clinical testing results against predicate devices. The fatigue testing was conducted according to a guidance document, implying the device met the requirements outlined in that guidance, but specific numerical thresholds and results are not detailed.

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

• Test set sample size: Not specified. The document states "fatigue testing was conducted." The number of devices or iterations in this testing is not mentioned.
• Data provenance: The testing was conducted by the manufacturer, OSSTEM IMPLANT Co., Ltd., likely in a laboratory setting. The country of origin for this specific testing is implied to be Republic of Korea, where the company is based. The nature of the testing is non-clinical (laboratory).

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

• Not applicable. This relates to clinical studies and human interpretation of data. The submission focuses on non-clinical engineering testing (fatigue, sterilization).

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

• Not applicable. This relates to clinical studies and human interpretation of data.

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, an MRMC study was not done. This type of study is for comparing human performance, often in diagnostic imaging, with and without AI. This submission is for a dental implant, which is a physical device, and does not involve AI.

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

• Not applicable. This device is a physical dental implant, not an algorithm or AI system.

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

• For the fatigue testing, the "ground truth" would be the engineering standards and requirements for mechanical strength and durability of dental implants, aligned with ISO standards and FDA guidance. The determination of "success" or "failure" would be based on whether the device passed these mechanical tests without fracture or significant deformation.
• For sterilization validation, the "ground truth" is established by adherence to recognized international standards (ISO 11137 series for gamma sterilization and ISO 17665 series for steam sterilization), demonstrating acceptable sterility assurance levels.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical device, not an AI model or a system that requires machine learning training.

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

• Not applicable. As above, there is no training set for this type of device submission.

Summary of Non-Clinical Testing Performed (from the document):

• Fatigue testing: Conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment." This testing confirms the mechanical strength and durability of the implant and abutment components. The document indicates that a fatigue test was specifically performed for the US Multi Angled Abutment due to differences in connection structure and shape compared to a predicate, to confirm its strength.
• Gamma Sterilization Validation: Performed with the Fixture System according to ISO 11137-1, ISO 11137-2, and ISO 11137-3.
• Steam Sterilization Validation: Provided according to ISO 17665-1 and ISO 17665-2.
• Biocompatibility and Surface Coating Characterization: The document states that the subject devices are made of the same materials, manufacturing process, chemical composition, and body contact as predicate devices (TS Fixture System, K121995 and Multi Angled Abutment, K123755), thus demonstrating substantial equivalence in these areas.

In conclusion, this 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, indications for use, and adherence to recognized non-clinical testing standards (fatigue, sterilization) rather than presenting a clinical study with detailed acceptance criteria and performance statistics for a completely novel device.

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SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Customized 3D Pre-Formed Titanium Membrane. SMARTbuilder System (SB1) is the nonabsorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder System (SB1) is made of pure titanium metal and supplied sterile.

The provided text is a 510(k) summary for the OSSTEM Implant Co., Ltd. SMARTbuilder System (SB1). This document states that no clinical studies were submitted and no biocompatibility evaluation was conducted for the SMARTbuilder System (SB1) because it has the same material and manufacturing process as its predicate device and uses Pure Titanium Grade 2 (ASTM F67), which is widely used as a dental material. Therefore, the device's acceptance criteria and studies demonstrating its adherence to these criteria are not detailed in this document.

The submission focuses on establishing substantial equivalence to a predicate device (SMARTbuilder System, K120951) based on shared materials, intended use, and similar design and technological characteristics.

Here is a summary of the requested information based only on the provided text, with many fields necessarily left blank or marked as "Not Applicable (N/A)" due to the absence of clinical study data:

Acceptance Criteria and Device Performance Study Summary for SMARTbuilder System (SB1)

This 510(k) submission, K130840, relies on substantial equivalence to a predicate device and does not include clinical study data to demonstrate the device meets specific acceptance criteria. Therefore, most of the requested information regarding performance metrics, sample sizes, and ground truth establishment is Not Applicable (N/A) in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical studies were submitted, there are no specific performance-based acceptance criteria or reported device performance metrics in this document. The "performance" assessment is based on demonstrating substantial equivalence to the predicate device in terms of material, intended use, and similar design.

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

• Test Set Sample Size: Not Applicable (N/A) - No clinical studies or test sets with patient data were submitted.
• Data Provenance: Not Applicable (N/A) - No clinical data was used.

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

• Not Applicable (N/A) - No clinical studies requiring expert-established ground truth were performed or submitted.

4. Adjudication method for the test set

• Not Applicable (N/A) - No clinical studies were performed.

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 (N/A) - This device is a physical medical implant (bone plate/membrane), not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not conducted.

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

• Not Applicable (N/A) - This device is a physical medical implant, not an algorithm or software. No standalone algorithm performance was assessed.

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

• Not Applicable (N/A) - No clinical studies requiring ground truth were performed or submitted.

8. The sample size for the training set

• Not Applicable (N/A) - No machine learning or AI components are involved, and thus no training set was used.

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

• Not Applicable (N/A) - No training set was used.

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SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Customized 3D Pre-Formed Titanium Membrane. SMARTBuilder is the non-absorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder is made of pure titanium metal and supplied sterile. The SMARTbuilder system is used with GS3 System (K091208) of OSSTEM Implant Co., Ltd. and US.SS.GS System (K073247) of OSSTEM Implant Co., Ltd.

The provided 510(k) summary for the OSSTEM Implant Co., Ltd. SMARTbuilder System indicates that it is a substantially equivalent device, not a new device requiring extensive performance studies with acceptance criteria. Therefore, the document does not describe acceptance criteria or a study that proves the device meets such criteria in the way a novel medical device would.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Neo Titanium mesh, CTi-mem, K111761, and SQ IS SYSTEM, K090825). This is a common regulatory pathway for devices that have similar intended use, design, and materials to devices already on the market.

Here's an analysis of the provided information in the context of your request:

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

• No explicit acceptance criteria or reported device performance are provided in the traditional sense of a clinical or analytical study with defined endpoints/thresholds.
• The document presents "Substantial Equivalence Matrix" tables, comparing the SMARTbuilder System (and its components like Healing Abutment, Height, Cover Cap) to predicate devices on characteristics such as:
  • Design
  • Intended use
  • Material
  • Dimensions (Width, Diameter, Height)
  • Sterilization
  • Shelf life
• The "performance" demonstrated is that these characteristics are "same" or "similar" to the predicate devices. For example:
  • Material: "Pure Titanium Grade 2 (ASTM F67)" for SMARTbuilder membrane, "Pure Titanium Grade 2 (ASTM F67)" for predicate.
  • Intended Use: "SMARTbuilder is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites." for SMARTbuilder, "For Stabilization and support bone grafts in dento-alveolar bony defect sites" for predicate.
  • Sterilization: "Sterile" for both.
  • Shelf life: "5 years" for SMARTbuilder, no information for predicate (implies it isn't a distinguishing factor for substantial equivalence).
  • Width (D): SMARTbuilder offers 8, 9, 10, 12, while predicate is 12. This shows similarity with some additional options.

2. Sample size 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 or performance data from a specific study is presented. The comparison is based on the specifications of the devices themselves, not on a study with a test subject sample.

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. There was no "test set" requiring ground truth established by experts. Substantial equivalence relies on regulatory review of design, material, and intended use claims against predicate devices.

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

• Not applicable. No test set or adjudication process 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

• Not applicable. This device is a dental bone plate/membrane system, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this submission.

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 consensus, pathology, outcomes data, etc)

• Not applicable. There is no "ground truth" established from studies in this submission. The "truth" for substantial equivalence is based on the characteristics and regulatory status of the predicate devices.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/algorithm device.

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

• Not applicable. No training set or ground truth for it is mentioned.

Summary of what the document does communicate regarding evidence for market clearance:

The submission focuses entirely on demonstrating substantial equivalence to already legally marketed predicate devices. The arguments for equivalence are based on:

• Identical Intended Use: The SMARTbuilder system shares the same intended use (stabilizing and supporting bone graft in dento-alveolar bony defect sites) as the predicate devices.
• Similar Design and Technological Characteristics: Dimensions are shown to be similar or within a comparable range. The overall design concept (a pre-formed titanium membrane and associated abutments/caps) is presented as similar.
• Identical Materials: The core materials (Pure Titanium Grade 2, Pure Titanium Grade 4, Titanium alloy Ti 6Al 4V) are identified as the same or highly similar (ASTM F67, ASTM F136) to those used in the predicate devices.
• Identical Sterilization Method: Both the proposed device and predicates are supplied sterile.
• Known Biocompatibility: The submission explicitly states, "Biocompatibility evaluation for SMARTbuilder System is not considered because SMARTbuilder System, which is made with titanium alloy, has been generally and widely used as a dental material such as implant for a long time." This leverages the known safety profile of the materials.
• No Clinical Studies: The submission explicitly states, "No clinical studies are submitted." This reinforces that clearance is based on substantial equivalence to existing devices, not new clinical performance data.

In essence, the "acceptance criteria" for this 510(k) was to successfully argue that the SMARTbuilder System is as safe and effective as the predicate devices based on a comparison of their fundamental characteristics, without requiring new performance studies.

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