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K3 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.

K3, Dental Unit and Chair, is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with ISO 7494-1, ISO 7494-2 and ISO 6875. The 3way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel K3 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.

This FDA 510(k) summary describes the K3 dental unit, which is a dental operative unit and accessories, including a dental chair. The submission aims to establish substantial equivalence to a predicate device, the Sirona C8 (K983242).

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet for a particular clinical task. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended use. The "reported device performance" is largely framed within compliance with various international standards and the comparison table.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details:

This document is a 510(k) summary for a Class I medical device (Dental Operative Unit and Accessories). For such devices, clinical studies and elaborate performance evaluations focusing on diagnostic accuracy (like those for AI/ML devices) are typically not required. The primary mechanism for clearance is demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing and comparison of technical specifications and intended use.

Therefore, many of the requested details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample sizes for test sets, ground truth establishment, MRMC studies) are not applicable to this submission.

Here are the answers based on the provided text, indicating "Not Applicable" where appropriate for this type of device submission:

1. A table of acceptance criteria and the reported device performance: See the table above based on inferred criteria and the comparison tables in the document.

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

   • Sample Size for Test Set: Not applicable. The document describes non-clinical engineering and safety compliance testing (e.g., electrical safety, EMC, biocompatibility, sterilization, cleaning validation) rather than testing on a "test set" of patient data as would be used for an AI/ML diagnostic device. These tests are performed on either components or the assembled device.
   • Data Provenance: Not applicable. The tests are laboratory-based and standard compliance tests. The manufacturer is Osstem Implant Co. Ltd. from Seoul, Republic of Korea.

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):

   • Number of Experts: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant here. Compliance with standards and technical specifications is verified by testing facilities and potentially by internal engineering teams.

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

   • Adjudication method: 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:

   • MRMC Study: No. This is a physical dental unit, not an AI/ML diagnostic or assistive device that would involve human readers.

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

   • Standalone Performance: No. This is not an algorithm; it's a dental chair and associated components.

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

   • Type of Ground Truth: Not applicable. The "ground truth" here is compliance with established international standards (e.g., IEC, ISO, EN) for safety, electrical characteristics, biocompatibility, cleaning, and sterilization.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

   • Ground Truth for Training Set: Not applicable.

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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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The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

EXARO, Xray2GO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, Xray2GO, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The operating principle of EXARO, Xray2GO starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)

This device contains a high frequency inverter that converts direct to alternating current. X-ray tube head, electrical protective devices, and other elements. The EXARO, Xray2GO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

The provided document is a 510(k) premarket notification for a Portable X-ray System (Model: EXARO, Xray2GO). This notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Portable X-Ray System, Model: EXARO, K122124).

The document does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.

Instead, the submission relies on demonstrating substantial equivalence through a comparison of technical specifications and adherence to safety and performance standards.

Here's a breakdown of the information that can be extracted based on your request, and what is missing:

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

This information is not explicitly present in the document in the form of diagnostic accuracy or clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) and reported device performance against those criteria. The acceptance criteria for the submission appear to be centered around meeting established electrical and radiation safety standards, along with demonstrating comparable technical specifications to a predicate device.

The table provided in the document (pages 4-5) lists technical characteristics of the proposed device and compares them to the predicate device. This is used to demonstrate substantial equivalence, not to report on diagnostic performance against pre-defined clinical acceptance metrics.

The "acceptance criteria" here implicitly are that the proposed device's characteristics are comparable to the predicate such that it does not raise new questions of safety or effectiveness, and that it meets the listed IEC standards.

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

This information is not provided. The submission states: "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." (page 5). However, no details about the "clinical evaluation" such as sample size, type of data (retrospective/prospective), or country of origin are given. This suggests the clinical evaluation performed was likely not a formal diagnostic performance study with a test set in the way you're asking.

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)

This information is not provided. Since no detailed clinical performance study with a test set validation is described, there's no mention of experts establishing ground truth.

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

This information is not provided for the same reasons as point 3.

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

An MRMC study was not conducted or described. This device is an X-ray system, not an AI-powered diagnostic tool. The document focuses on the hardware's safety and performance characteristics and its substantial equivalence to a predicate X-ray system. Improvement with AI assistance is not relevant to this device's submission.

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

A standalone algorithm performance study was not applicable and not done. This is a hardware device for generating X-rays, not a standalone algorithm.

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

This information is not provided as no detailed clinical performance study with a test set is described. For a device like an X-ray generator, the "ground truth" for its output is typically assessed through physical measurements (e.g., radiation output, image quality parameters using phantoms) rather than clinical diagnostic ground truth.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary of what the document indicates for "acceptance criteria" for this type of device:

For this 510(k) submission, the "acceptance criteria" are implicitly met by:

• Demonstrating the device is substantially equivalent to a predicate device (K122124) in terms of intended use, technology, design, functions, and principle of operation.
• Showing that any differences (e.g., anode current, expose time, battery specifications) do not raise new questions of safety and effectiveness.
• Conforming to recognized safety, EMC (Electromagnetic Compatibility), and performance standards, specifically:
  • IEC 60601-1 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)
  • IEC 60601-2-7 (Medical electrical equipment - Part 2-7: Particular requirements for the safety of medical photographic X-ray equipment)
  • IEC 60601-2-28 (Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
  • IEC 60601-2-32 (Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment for X-ray equipment)

The study proving the device meets these acceptance criteria is the technical comparison to the predicate device and the implied testing to relevant IEC standards. The document explicitly states: "No additional testing was added for this submission based on the modifications" (page 5), and "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices" (page 5). However, no details of these specific tests or evaluations are provided beyond the table of characteristic comparisons.

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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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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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The Portable X-ray System(Model:EXARO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

EXARO, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack, The X-ray tubehead, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, EXARO, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of EXARO starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor). This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The EXARO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.

The provided text is a 510(k) summary for the OSSTEM Implant Co., Ltd. Portable X-Ray System (Model: EXARO). It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific information regarding acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment for a study proving the device meets acceptance criteria.

The document focuses on regulatory compliance, specifically demonstrating that the EXARO system is substantially equivalent to a legally marketed predicate device (GENORAY Co.,Ltd.'s Portable X-Ray System, Model: PORT X II). This type of submission relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.

The "Safety, EMC and Performance Data" section states:
"The compliance of EXARO will satisfy the applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. All required documents and reports will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements. EMS test was performed by SGS Testing Korea Co., Ltd. for EXARO in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements."

And under "Safety and Effectiveness, comparison to Predicate":
"The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices."

To answer your request, based only on the provided text, I can state what is mentioned and what is explicitly not mentioned.

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the acceptance criteria are adherence to various international safety and performance standards (UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, EN/IEC 60601-1-2 for EMC).
• Reported Device Performance: The document states, "All test results were complied with the requirements" for the EMC test and that "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." However, no specific numerical performance metrics are provided in a table format within this document.

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

• The document mentions "bench and clinical evaluation" but does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

• The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.

4. Adjudication method for the test set

• The document does not provide any information about an adjudication method for a test set.

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

• The document describes a portable X-ray system, which is a hardware device for image acquisition, not an AI or software device for image interpretation. Therefore, no MRMC study with AI assistance would typically be applicable or described for this type of device.

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

• As this is a hardware X-ray system, a standalone algorithm-only performance study is not applicable. The device's primary function is to generate X-ray images, not to interpret them autonomously.

7. The type of ground truth used

• The document does not specify the type of ground truth used for any evaluations. Given it's an X-ray system, ground truth for imaging performance might involve phantom studies, expert review of images, or correlation with clinical outcomes, but these details are not provided.

8. The sample size for the training set

• The document describes a hardware medical device and does not involve a "training set" in the context of machine learning algorithms.

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

• As there is no mention of a training set, this information is not applicable and not provided.

In summary: The provided 510(k) summary focuses on demonstrating regulatory compliance and substantial equivalence to a predicate device through adherence to recognized safety and performance standards for an X-ray hardware system, rather than detailing a study with specific acceptance criteria and performance metrics for an AI-enabled diagnostic device. Therefore, much of the requested information, which is highly relevant for AI/software devices, is not present in this document.

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The TS 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 TS 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 and Plastic and it is intended for use to make temporary prosthesis. It consists of Abutment and Abutment Screw.

This document is a 510(k) premarket notification for the "TS Implant System" by OSSTEM Implant Co., Ltd. It seeks to establish substantial equivalence to previously marketed predicate devices, not to prove performance against specific acceptance criteria for a new AI/software-driven medical device. Therefore, the information typically required for an AI/software device's acceptance criteria and study proving its performance is not present in this document.

The document focuses on comparing the design, materials, and intended use of the TS Implant System to existing dental implants (predicate devices) to demonstrate that it is "substantially equivalent" and thus safe and effective.

Here's why the requested information cannot be extracted from this document:

1. Nature of the Device: The TS Implant System is a physical dental implant made of titanium metal and does not appear to incorporate artificial intelligence or sophisticated software for diagnosis or treatment.
2. Type of Submission: A 510(k) Pre-market Notification primarily assesses "substantial equivalence" to a predicate device, rather than requiring extensive clinical trials or performance studies against predefined acceptance criteria like a PMA (Pre-market Approval) or De Novo submission for novel AI/software devices.
3. Absence of Clinical Studies: The document explicitly states under "7. Summary of clinical testing": "No clinical studies are submitted." This confirms that no clinical data was presented to establish performance metrics against acceptance criteria.
4. Lack of AI/Software-Specific Information: There is no mention of algorithms, data sets (training or test), ground truth, expert readers, or adjudication methods, which are standard for AI/software device evaluations.

In summary, this document does not contain the information needed to answer your request regarding acceptance criteria and performance studies for an AI/software device because the device described is a physical dental implant, and the submission type does not necessitate such detailed performance data as would be required for a novel AI/software medical device.

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

NP-Cast Abutment System is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constraints. After customization, be sure to use only dental nonprecious metal (Co-Cr-Mo alloy) for casting to make the prosthesis When cast a prosthesis with NP-Cast Abutment System, Post height above the transmucosal collar of NP-Cast Abutment System has to be taller than 4mm and Maxmimum angulation has to be less than 30°. The NP-Cast Abutment System consists of Abutment and Abutment Screws.

The provided document is a 510(k) premarket notification for a medical device (NP-Cast Abutment System), not a study report detailing performance against acceptance criteria for an AI/ML diagnostic or predictive device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or available in this document.

However, I can extract information related to the device's non-clinical testing which serves as the "study" for this type of device and the "acceptance criteria" through comparison with predicate devices.

1. Acceptance Criteria and Reported Device Performance

For this type of device (a dental abutment), "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices and meeting relevant performance standards, particularly mechanical safety. The document focuses on showing that the NP-Cast Abutment System is equivalent in material, indication for use, design, and technological characteristics to its predicates.

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

• Sample Size: Not applicable in the context of a clinical test set. For non-clinical (fatigue) testing, the sample size would typically be specified by the relevant ASTM or ISO standard used, but it is not explicitly reported in this document.
• Data Provenance: Not applicable for clinical data. For manufacturing and testing, the company's address is listed as Busan, Republic of Korea.

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

• Not applicable as this involves non-clinical (mechanical and biocompatibility) testing, not diagnostic performance assessed against a ground truth established by experts. The "ground truth" for mechanical testing is compliance with a recognized standard.

4. Adjudication Method 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

• No MRMC clinical study was performed or submitted. The document explicitly states: "No clinical studies are submitted." This device also does not involve AI.

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

• Not applicable. This is a physical dental device, not an algorithm.

7. The type of ground truth used

• For biocompatibility: Adherence to international and US regulations/standards for material safety.
• For mechanical fatigue: Compliance with the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and related ASTM/ISO standards. The "ground truth" is passing the specified mechanical performance thresholds.

8. The Sample Size for the Training Set

• Not applicable. There is no training set for an AI/ML algorithm.

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

• Not applicable. There is no training set for an AI/ML algorithm.

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The TS Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

TS Fixture System is compatible with abutment in the ET/SS Implant System

The TS Fixture 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 available in various lengths 7.0 to 15.0mm and diameters 3.5 to 6.8mm (TSII SA Fixture : 3.5, 4.2, 4.4, 4.9 / TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05, 5.08, 5.1 / TSIII SA Ultra-Wide Fixture : 5.92, 5.95, 6, 6.8) according to the anatomical situation.

Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated.

The TS Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided document is a 510(k) premarket notification for a dental implant system (TS Fixture System). It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the concept of "substantial equivalence" to predicate devices. The performance characteristics of the TS Fixture System are evaluated against those of the predicate devices. The key performance criteria for this type of device are primarily related to mechanical integrity (fatigue strength) and biocompatibility.

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" for clinical performance. The nonclinical testing (fatigue testing) implicitly involves mechanical test samples. No specific number for these samples is provided in this summary.
• Data Provenance: The fatigue testing was conducted by or for OSSTEM Implant Co., Ltd., which is based in Republic of Korea. The report is a 510(k) submission to the US FDA. The data itself is non-clinical bench testing data, not human clinical data.

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

This information is not applicable as the submission relies on non-clinical testing (fatigue and biocompatibility) and comparison to predicate devices, not on expert consensus or adjudication of a test set in the way a diagnostic AI device would. The "ground truth" for non-clinical testing is typically defined by engineering standards and measurement accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. The evaluation of mechanical fatigue data would involve standard engineering analysis and report generation, not a consensus-based adjudication process.

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

No. A MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a dental implant (a physical medical device) and does not involve image reading or diagnostic interpretation.

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

No. This question is not applicable as the device is a physical dental implant, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation hinges on:

• Engineering Standards and Specifications: For mechanical fatigue testing, the "ground truth" is adherence to established standards (e.g., ISO, ASTM) and successful completion of test cycles without failure, relative to the performance of predicate devices. The "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" serves as a key reference for methodology.
• Biocompatibility Standards: For biocompatibility, the "ground truth" is compliance with applicable international and US regulations, typically demonstrated through standardized in vitro and in vivo tests (e.g., ISO 10993 series).
• Predicate Device Characteristics: The ultimate "ground truth" in a 510(k) submission is the demonstration of substantial equivalence to already legally marketed devices.

8. The Sample Size for the Training Set:

This information is not applicable. Dental implants are physical devices, not machine learning algorithms, and therefore do not have "training sets" in the conventional sense. The design and manufacturing process are informed by engineering principles and previous device designs, but not a data training set.

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

This information is not applicable for the reasons stated above.

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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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