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The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multiple-unit cement retained restorations. For the BH 3.0 S. SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase. inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/CAM (types K2244.XXX) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: (list of compatible implant systems follows).

The Sirona Dental CAD/CAM System which is the subject of this premarket notification is a modification to the Sirona Dental CAD/CAM System as previously cleared under K111421. The modifications represented in the subject device consist of the implementation of a new "chairside" CAD/CAM software version, CEREC SW version 4.6.1, in which additional functionality for the control of critical CAD/CAM abutment dimensions has been added. Additionally, the modified Sirona Dental CAD/CAM System that is the subject of this premarket notification includes a line extension to the existing offerings of the Sirona TiBase titanium base component offerings. These additional TiBase variants facilitate compatibility with additional implant systems. The modified Sirona Dental CAD/CAM System which is the subject of this premarket notification consists of: CEREC SW version 4.6.1, "chairside" CAD/CAM software; CEREC AC digital acquisition unit; CEREC AC Connect digital acquisition unit; CEREC Omnicam 3D digital intraoral scanner; CEREC MCXL product family of CAM milling units; Sirona TiBase titanium base components; inCoris ZI zirconium mesostructure blocks. As subject to this premarket notification, the Sirona Dental CAD/CAM System is utilized to digitally acquire and record the topographical characteristics of teeth, dental impressions, or physical stone models in order to facilitate the computer aided design (CAD) and computer aided manufacturing (CAM) of two-piece "CAD/CAM" abutments. The patient-specific two-piece abutments consist of pre-fabricated "TiBase" components which are designed with interface geometry to facilitate compatibility and connection with currently marketed dental implant system. The CEREC SW 4.6.1 CAD/CAM software is utilized to drive the specified acquisition unit hardware to acquire the intraoral dental scans and to design the mesostructure component of the CAD/CAM abutments. Following the completion of the design, the CEREC SW 4.6.1 drives the CAM fabrication of the mesostructure component in the "chairside" workflow by utilizing the CEREC MCXL milling equipment and the defined zirconium block materials. The completed mesostructure is cemented to the TiBase component using PANAVIA F 2.0 dental cement in order to complete the finished, two-piece CAD/CAM dental abutment.

Here is the information about the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K111421) rather than explicitly detailing numeric acceptance criteria for each test. However, it lists the types of non-clinical performance data and states that the results support substantial equivalence. The implied acceptance criterion for all tests is "conformity" with the referenced standards or successful validation/analysis, and the reported performance is that these criteria were met.

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

The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of abutments for fatigue testing, number of software test cases). It refers generally to "testing" and "analyses."

The data provenance is implied to be internal testing conducted by Dentsply Sirona, as the document details their testing efforts to support the 510(k) submission. No information about country of origin of the data is provided, nor whether it was retrospective or prospective, although typically such a submission would involve prospective testing designed to meet the specified standards.

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

This information is not provided in the document. The document describes compliance with recognized standards and internal validation processes but does not detail the involvement of external experts for establishing ground truth on a test set.

4. Adjudication Method for the Test Set:

This information is not provided. The non-clinical testing appears to rely on objective measurements against established engineering and regulatory standards rather than subjective expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done or reported. This device is a CAD/CAM system for designing and fabricating dental abutments, not an AI or imaging diagnostic tool that would typically involve human reader performance studies.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study in the form of non-clinical performance data and software verification and validation testing was performed. The document describes:

• Testing to verify conformity with various IEC and ISO standards for medical electrical equipment, electromagnetic compatibility, and dynamic loading.
• Compatibility analyses of new TiBase interface geometries.
• System validation testing for the CAD/CAM software's design and fabrication workflow.
• Software verification and validation testing specifically for the abutment design library to demonstrate design restrictions and locked specifications.

These tests focus on the technical performance and safety of the device components and software, independent of human clinical application for their evaluation.

7. Type of Ground Truth Used:

The ground truth used for non-clinical testing is based on:

• Engineering specifications and design requirements: For confirming the functionality and outputs of the CAD/CAM system and software.
• Recognized international standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 62304, and ISO 14801 which define performance benchmarks and safety criteria.
• Original manufacturer's implant connection geometries: For compatibility analyses of TiBase interfaces.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. The Sirona Dental CAD/CAM System, as described, is not an AI/ML-based diagnostic device that typically requires a "training set" in the context of machine learning model development. It's a system for computer-aided design and manufacturing within predetermined parameters.

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

This information is not applicable, as there is no mention or indication of a "training set" for an AI/ML model for this device. The software functions based on established CAD/CAM principles and predefined parameters rather than learning from a training dataset.

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The Internal Octa Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The Internal Octa Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

An endosseous dental implant is a device made of Pure Titanium Grade 4. Internal Octa Implant System has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placements. Internal Octa Implant Systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The Internal Octa Implant System has an internal connection. The surface of the system has been treated with SLA (Sandblast, Large grit Acid etched).

There are 3different kinds of fixtures, BLT III, Precision III and LISA Implants. The only differences between these implants are designs and dimensions. The appearance of implants is different depending on the presence of cutting edge and taper. The Fixtures are supplied sterile.

This document describes the regulatory approval for the "Internal Octa Implant System," a dental implant. It is a 510(k) submission, meaning the manufacturer is demonstrating that their new device is "substantially equivalent" to existing, legally marketed devices (predicates).

Therefore, the performance data presented here is related to demonstrating substantial equivalence, primarily through bench testing and comparison to predicates, rather than extensive clinical studies or AI model performance as would be seen for a novel diagnostic AI device.

Given that this document is for a dental implant system, and not an AI-based diagnostic device, it does not contain the information required to populate a table of acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC), nor does it describe a study involving human readers or AI in the way your prompt defines. The performance data provided is focused on material biocompatibility and physical characteristics of the implant.

Let's break down why this document doesn't fit your prompt's requirements:

• No AI Component: The document describes a physical medical device (dental implants made of titanium). There is no mention of artificial intelligence, diagnostic algorithms, or image analysis performed by an AI.
• No Diagnostic Performance Metrics: Given the above, there are no references to sensitivity, specificity, AUC, or other metrics typically associated with AI diagnostic performance.
• No Human Reader Studies: Since it's a physical implant, there are no studies detailed that involve human readers (like radiologists) interpreting images with or without AI assistance.
• Ground Truth: The "ground truth" for a dental implant would be related to its physical properties, biocompatibility, and intended function in the human body, not an expert consensus on image interpretation.
• Training/Test Sets for AI: These concepts are irrelevant as there is no AI model being trained or tested.

However, to answer your prompt in the context of this specific document, I will interpret "acceptance criteria and reported device performance" as the basis for substantial equivalence for this medical device, and then address the other points by stating their inapplicability to this type of device submission.

Acceptance Criteria and Reported Device Performance (as applied to Substantial Equivalence for a Dental Implant):

For this Traditional 510(k) submission, the "acceptance criteria" revolve around demonstrating that the Internal Octa Implant System is as safe and effective as its predicate devices. This is achieved through various forms of bench testing and comparison of physical and material characteristics.

1. Table of Acceptance Criteria and Reported Device Performance (Interpreted for a Dental Implant):

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

• This document does not describe a "test set" in the context of an AI model evaluating data.
• For the bench testing (biocompatibility, surface characterization, endotoxin), the sample sizes would refer to the number of individual implant units or material samples tested. These specific numbers are not provided in this summary document but would be detailed in the full test reports referenced (e.g., in the ISO 10993 reports).
• Data Provenance: The bench testing would have been conducted in a laboratory setting, likely affiliated with the manufacturer (EBI Inc. in Republic of Korea) or a contract testing organization. The data is prospective in the sense that the tests were performed specifically for this submission.

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

• This concept is not applicable to this submission. "Ground truth" for a dental implant is established through engineering specifications, material science standards (ASTM, ISO), and regulatory requirements, not through expert consensus on images.
• The judgment of substantial equivalence is made by reviewers at the FDA based on the submitted technical data and comparison to predicates.

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

• This concept is not applicable to this submission, as there is no "test set" requiring adjudication by multiple readers or experts for diagnostic accuracy.

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 MRMC study was done. This is a submission for a physical dental implant, not an AI-assisted diagnostic device. Therefore, there is no "human-in-the-loop performance" or "effect size of human readers improving with AI" relevant to this document.

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

• No standalone algorithm performance was done. This document describes a physical medical device, not a software algorithm.

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

• The "ground truth" or standard for acceptance here is compliance with pre-defined engineering standards (ASTM, ISO), material properties, and biological compatibility as demonstrated through standardized bench testing. It's essentially a "comparison to technical specifications and regulatory standards" truth.

8. The sample size for the training set:

• Not applicable. There is no AI model being trained, so no training set exists.

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

• Not applicable. As there is no AI model, there is no training set and therefore no ground truth to be established for it.

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Hiossen Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

The Hiossen Prosthetic system is intended for use as an aid in prosthetic restoration. It consists of Abutments, overdenture components and Abutment Screws. The Hiossen Prosthetic system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a dental prosthetic system, and it primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's what is missing from the document based on your request:

• A table of acceptance criteria and reported device performance: The document mentions safety, performance, and product validations but does not provide a table with specific criteria and results.
• Sample size and data provenance for a test set: This information is not present.
• Number and qualifications of experts for ground truth: This is not discussed.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "No clinical studies are submitted."
• Standalone algorithm performance study: This is not a software device, and no such study is described.
• Type of ground truth used: Not applicable given the nature of the device and the lack of clinical studies.
• Sample size and ground truth establishment for the training set: Not applicable and not mentioned, as this is a hardware device approval, not an AI/software device.

The document states: "Proposed devices in this submission are substantially equivalent to the predicate devices Therefore we didn't consider conducting additional test but biocompatibility test and retention test of O-Ring are conducted because material of O-Ring is changed." This indicates that the primary method of demonstrating safety and effectiveness was through comparison to existing cleared devices, with limited specific testing mentioned for material changes.

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

The ET Prosthetic System is device made of titanium and titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. It's surfaces are partially TiN coated and uncoated. The ET Prosthetic System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The ET Prosthetic System is substantially equivalent in design, function and intended use to the Prosthetic System(K110308) and ET/SS Implant System (K120847)of Osstem Implant Co., Ltd. These proposed abutments are compatible with the HIOSSEN Implant fixture only. HTIII SA Fixture (K101096).

Here's an analysis of the provided text regarding the acceptance criteria and study for the OSSTEM ET Prosthetic System:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of typical AI/ML studies involving patient data. The nonclinical testing revolves around fatigue testing of the physical device.

For the nonclinical fatigue testing:

• Sample size for test set: Not explicitly stated, however, the phrase "worst case scenario" implies a focused, rather than large-scale, selection of samples for mechanical testing.
• Data provenance: Not applicable in the context of patient data. The tests were performed on the physical dental abutment devices.

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

Not applicable. The ground truth for the nonclinical fatigue testing is defined by the established international and national standards (ISO 14801 and FDA guidance) for mechanical performance of dental implants and abutments. This is a physical engineering standard, not an interpretation of medical images by human experts.

4. Adjudication Method for the Test Set

Not applicable. This is not a study where human disagreement would require adjudication. The compliance is determined by adherence to a defined mechanical testing protocol and performance metrics.

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

No. The document explicitly states: "No clinical studies are submitted." An MRMC study is a type of clinical study involving human readers.

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

Yes, in a way that is relevant to a medical device and not just software. The core of the evidence is standalone nonclinical (mechanical) testing of the ET Prosthetic System. This is an "algorithm only" in the sense that the device's inherent mechanical properties were evaluated without human intervention in the device's functional performance during the test.

7. The Type of Ground Truth Used

The ground truth used for the nonclinical testing is compliance with established international and FDA standards for fatigue testing of endosseous dental implants and abutments (ISO 14801 and specific FDA Guidance Document).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data. It is a physical dental prosthetic system.

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

Not applicable, as there is no training set for this type of device.

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

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

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

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

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

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

1. Table of acceptance criteria and the reported device performance

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

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

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

Not applicable. No "test set" in the context of performance metrics was used. The evaluation centered on design and material comparison to a predicate device.

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

Not applicable. No a "ground truth" or expert review of performance data was conducted for this type of device submission. The assessment was done by the manufacturer's engineers and subsequently by the FDA reviewers.

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

Not applicable.

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

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

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

Not applicable. This device is not an algorithm.

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

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

8. The sample size for the training set

Not applicable. No training set was used.

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

Not applicable.

Summary of the Study/Evaluation for Substantial Equivalence:

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

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

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

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

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

Acceptance Criteria and Device Performance Study for ET SmartFit Abutment

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

Summary of the Study Proving Device Meets Acceptance Criteria:

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

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

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

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

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

The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System. K62030 and connected to HTIII SA Fixture in the HT3 SA Fixture System, K101096. The Multi Angled Abutment consists of Abutment and Abutment Screw. The Multi angle Abutment is used to elevate restoration platform when restoration to implant level is not practical due to depth or angle of implant for the edentulous patients in Anterior and Posterior, not customizable and can't be use a single product.

This document describes the K12-3755 Multi Angled Abutment, a dental device. The 510(k) summary provided does not contain the typical details of a study proving a device meets acceptance criteria as this is a premarket notification for substantial equivalence. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not relevant or not provided for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission seeking substantial equivalence for a dental abutment, the "acceptance criteria" are primarily established by demonstrating equivalency in material, design, function, and intended use to a predicate device, and ensuring safety through non-clinical testing. Performance is measured against the predicate.

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

• Sample Size: Not applicable. This submission is for substantial equivalence and relies on non-clinical testing and comparison to a predicate device, not a human clinical trial with a "test set" in the traditional sense.
• Data Provenance: The manufacturer, OSSTEM Implant Co., Ltd., is located in Busan, Republic of Korea. The non-clinical testing data would originate from their internal processes or contracted labs. The data is "retrospective" in the sense that it's a comparison to an already marketed device.

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

• Number of Experts & Qualifications: Not applicable. Ground truth for a clinical test set is not relevant for this type of 510(k) submission, which focuses on non-clinical aspects and comparison to a predicate device's established performance and safety record.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for the reasons stated above.

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

• MRMC Study: Not applicable. This device is a passive dental abutment, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. This device is a physical dental component, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Prosthetic System, K110308). The new device demonstrates substantial equivalence through material comparison, design comparison, non-clinical safety tests (biocompatibility, risk analysis, dimension inspection), and alignment of intended use. There is no pathology or outcomes data from a clinical study for this specific device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Ground Truth for Training Set: Not applicable for the reasons stated above.

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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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