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Protective Cap is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdenture, and can be used for a minimum of 1 day to maximum of 10 days.

The Protective Cap is a dental implant superstructure made of PC(Polycarbonate) according to ASTM F997. It is used temporarily, such as less than 10 days before the final restoration is connected. The Protective Cap is supplied nonsterile and intended for single use. It is to be sterilized by end users before use.

This FDA 510(k) premarket notification for the "Protective Cap" device does not involve an AI/ML algorithm. Therefore, the requested information about acceptance criteria, study details, ground truth, and sample sizes for AI/ML performance evaluation is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the non-clinical testing data provided, which serves as the "study" to meet the "acceptance criteria" for safety and effectiveness in this context:

Non-Clinical Testing Data (Acceptance Criteria & Device Performance):

Explanation for Missing AI/ML-Specific Information:

Since this submission is for a physical medical device (a protective cap for dental implants) and not an AI/ML software device, the following points are not discussed in the document:

• Sample size for test set and data provenance: No test sets of data were used in the AI/ML sense. Physical samples of the device were used for sterilization, biocompatibility, and cleaning validation.
• Number of experts and their qualifications for ground truth: No ground truth establishment by experts for AI/ML performance was required.
• Adjudication method: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. There is no human reader component that would be "augmented" by an AI.
• Standalone (algorithm-only) performance: Not applicable, as there is no algorithm.
• Type of ground truth used: For physical device testing, the "ground truth" is adherence to established engineering and medical standards (e.g., successful sterilization, non-toxic, effectively cleaned).
• Sample size for training set: Not applicable, as there is no AI model to train.
• How ground truth for training set was established: Not applicable.

The document concludes that the Protective Cap is substantially equivalent to its predicate device based on these non-clinical tests, sharing the same intended use, material, functions, principle of operation, sterilization method, and similar designs and dimensions, with differences not affecting fundamental function.

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IS-III active Short Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. The IS-III active Short Implants are indicated for the molar region with delayed loading.

IS-III active Short Implant is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The Fixture's diameters are 5.0/5.5/6.0mm and the length is 6.6 mm. Tolerance of dimension shall be within ± 1% range.

The provided text describes a 510(k) premarket notification for a medical device (IS-III active Short Implant) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing efficacy through clinical trials with specific acceptance criteria as you might find for a new diagnostic device or a drug. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to a diagnostic AI/ML device or a drug is not directly applicable in the same way here.

However, we can infer "acceptance criteria" from the performance characteristics and safety evaluations that the FDA requires for substantial equivalence, and "the study" refers to the non-clinical testing performed to meet these requirements.

Here's an attempt to structure the information based on your request, interpreting "acceptance criteria" as the performance and safety benchmarks for substantial equivalence and "study" as the non-clinical testing conducted.

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

Since this is a 510(k) for an endosseous dental implant, the acceptance criteria are primarily focused on mechanical performance, biocompatibility, and sterility, demonstrating that the new device is as safe and effective as existing legally marketed predicate devices.

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

The document describes non-clinical bench testing. For such tests, the "sample size" refers to the number of physical device samples tested.

• Fatigue Testing: "under the worst-case scenario" implies specific configurations were chosen for testing, but a numerical sample size is not explicitly stated. Typically, multiple samples (e.g., n=5, n=10) would be tested per configuration to ensure statistical robustness.
• Axial Pull-Out Testing: "under the worst-case scenario" implies specific configurations were chosen, but a numerical sample size is not explicitly stated.
• Biocompatibility Testing: The biocompatibility testing was performed on a "reference device, K181138." The sample size for that testing is not specified in this document.
• Sterilization Validation: Tests would involve multiple samples to validate the process to achieve SAL 10^-6, but numerical sample size is not specified.
• Shelf Life Testing: "The worst-case construct was tested," implying specific samples of the device and packaging system were aged and then tested. Numerical sample size is not specified.
• Surface Area Analysis / Comparative Bone to Implant Contact Surface Area Analysis: These are analytical comparisons, likely involving measurements on a set number of devices or designs, but a specific numerical sample size is not given.

Data Provenance: All testing is non-clinical (bench testing), not human data. The data originates from the manufacturer's internal testing and analysis or contracted laboratories, performed to comply with international standards (ISO, ASTM) and FDA guidance documents.

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

This section is not applicable. The evaluations are based on internationally recognized standards (ISO, ASTM) and FDA guidance for medical device performance (mechanical, material, sterility). There isn't a "ground truth" established by human experts in the context of diagnostic interpretation for these types of non-clinical tests. The "truth" is whether the device meets the specified standard (e.g., maximum load before fracture in fatigue testing, or specific material properties).

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or reader studies where human interpreters are evaluating diagnostic images or clinical outcomes, and their interpretations need to be reconciled to establish a consensus ground truth. Here, the "test set" consists of physical devices subjected to mechanical, chemical, and biological tests governed by objective, quantitative standards.

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

This section is not applicable. MRMC studies are specific to diagnostic performance evaluations, particularly when assessing the impact of AI on human reader performance for tasks like image interpretation. This submission is for an endosseous dental implant, which is a physical device, not an AI/ML diagnostic tool.

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

This section is not applicable. There is no AI algorithm being evaluated in this submission. The device is a physical dental implant.

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

As mentioned in point 3, the concept of "ground truth" in the context of diagnostic performance (like pathology or expert consensus) is not directly applicable here. The "truth" or reference for evaluating performance of the dental implant consists of:

• International Standards: e.g., ISO 14801 (dental implant fatigue), ASTM F543-17 A3 (mechanical testing), ISO 10993 series (biocompatibility), ISO 11137-1:2006 (radiation sterilization), ASTM F1980 (accelerated aging/shelf life).
• Manufacturer Specifications: Ensuring the device meets its design specifications (e.g., dimensions, material composition).
• Existing Predicate Device Performance: The primary "ground truth" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by matching or exceeding its established performance in relevant tests.

8. The sample size for the training set

This section is not applicable. There is no AI/ML model for which a "training set" would be used.

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

This section is not applicable, as there is no AI/ML model or corresponding training set.

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IS Multi Unit Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as bridges.

IS Multi Unit Abutments are premanufactured dental implant abutments directly connected to the endosseous dental implant with internal hex connections (multiple tooth). IS Multi Unit Abutment System is made of Titanium ELI according to ASTM F136.

IS Multi Unit Abutment System is composed of IS Multi Unit Abutment, IS Multi Unit Angled Abutment, Multi Unit Abutment Cylinder, Multi Unit Healing Cap, Multi Unit Temporary Cylinder, IS Multi Unit Angled Abutment Screw and Cylinder Screw.

All Multi-Unit Abutments (Straight/Angled) are intended only for multi-unit loaded restoration.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets them in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a dental implant abutment system (IS Multi Unit Abutment System) and focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for traditional medical devices, not typically AI/ML-driven ones.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily details device descriptions, indications for use, material specifications, and comparisons to predicate devices in terms of physical characteristics and intended use. It also mentions non-clinical testing data related to sterilization and fatigue testing for the physical dental device components.

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The IS-III active System S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The IS-III active System S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IS-III active System_S-Narrow System is composed of IS-III active S-Narrow Type fixtures and Abutments. IS-III active Fixture S-Narrow Type is a thread type implant made of Titanium ELI according to ASTM F136 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex.

Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body.

The Fixture's diameters are 3.2 mm and the lengths are 8.5/10.0/11.5/ 13.0/ 15.0 mm. Tolerance of dimension shall be within ± 1% range.

IS-III active System S-Narrow Type Abutments are composed as below: IS Cover Screw, IS Healing Abutment, IS Cemented Abutment, IS Temporary Abutment and IS Abutment Screw

This document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the Neobiotech IS-III active System S-narrow Type dental implant system to legally marketed predicate devices.

This document describes a premarket notification for a dental implant system. It does NOT contain information about an AI/ML-driven medical device or a study involving human-in-the-loop performance, expert consensus, or ground truth establishment for a test set.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as this document does not pertain to such a device or study.

The provided document focuses on:

• Device Description: What the dental implant system is composed of (fixtures, abutments, screws), materials used (Titanium ELI), dimensions, and surface treatments.
• Indications for Use: Where and how the device is intended to be used in dental procedures.
• Substantial Equivalence Comparison: A detailed comparison of the subject device (IS-III active System S-narrow Type) with various predicate devices (both primary and reference predicates) across technological characteristics such as device name, classification, materials, design, dimensions, surface treatment, sterilization, and principle of operation.
• Non-Clinical Testing Data: A list of performance tests conducted on the subject device (e.g., sterilization validation, shelf life, bacterial endotoxin) and tests leveraged from predicate devices (e.g., biocompatibility testing). The conclusion states that these tests met the criteria of the standards and demonstrated substantial equivalence.

Without information on an AI/ML component or a clinical study that evaluates its performance against acceptance criteria using a human-in-the-loop or standalone approach, I cannot fulfill the request for the specific points listed.

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The IT-III active 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 terminal or intermediate Abutment support for fixed bridgework. IT-III active system is dedicated for two stage surgical procedures and for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IT-III active System is composed of Fixture and Abutments. IT-III active Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Octa. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The IT -III active System Abutment are composed as below; IT Cover screw, IT Healing Abutment, IT Solid Abutment, IT Excellent Solid Abutment, Protective Cap, IT Cemented Abutment, IT Pre Angled Abutment, IT Collared Abutment, IT Gold UCLA Abutment, IT Cemented Abutment Screw and IT Angled Abutment Screw.

The provided text describes the Neobiotech Co., Ltd. IT-III active System, an endosseous dental implant system, and its substantial equivalence to predicate devices, but does not contain a study comparing the device's performance against specific acceptance criteria and reporting its performance metrics in a way that directly answers all the questions in the prompt.

The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to already legally marketed devices rather than presenting a detailed study with acceptance criteria and device performance metrics in the format requested.

However, I can extract the information provided that is relevant, or indicate where the information is not present.

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the requested format. Instead, it states that "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." This implies that the device did meet the criteria of the standards listed, but doesn't quantify the performance against those criteria.

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

The document lists non-clinical testing performed, such as Fatigue Testing, Sterilization Testing, Shelf Life Testing, Bacterial Endotoxin Test, and Biocompatibility Evaluation. However, it does not specify the sample sizes used for these tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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 type of information is not applicable to the non-clinical testing (fatigue, sterility, etc.) described in the document. Ground truth as typically established by experts (e.g., radiologists for imaging studies) is not relevant for the engineering and biological tests conducted for dental implant device clearance.

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

This information is not applicable to the non-clinical testing described. Adjudication methods are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, which is not the nature of the tests performed here.

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 comparative effectiveness study was performed or mentioned in this document. This study type is far more common for diagnostic imaging AI devices, rather than for a dental implant system.

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

This concept is not applicable to the IT-III active System, which is a physical dental implant. Standalone algorithm performance refers to the performance of AI software independent of human intervention, which is not relevant for this device.

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

For the non-clinical tests conducted, the "ground truth" is defined by the standards themselves (e.g., ISO 14801 specifies the methodology and interpretation for fatigue failure, ISO 11137 for sterility). The tests measure whether the device meets the predefined physical, mechanical, and biological properties as stipulated by these recognized standards. It's not about an expert diagnosis or clinical outcome but rather adherence to engineering/material specifications.

8. The sample size for the training set

No training set is mentioned or applicable. This document is not describing a machine learning or AI algorithm, but rather a physical dental implant device undergoing non-clinical validation.

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

Not applicable, as there is no training set described.

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The IS-III active System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and terminal or internediate Abutment support for fixed bridgework. IS-III active System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

IS-III active System is composed of IS-III active fixtures and Abutments. IS-III active Fixture is a thread type implant made of TI CP4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). There are 4 types of fixtures in this system and the dimensions are as following: Tolerance of dimension shall be within ± 1% range. IS-III active System Abutments are composed of IS Cover Screw, IS Healing Abutment, IS Encoded Healing Abutment, IS Solid Abutment, Protective Cap, IS Cemented Abutment, IS Shapable Abutment, IS Angled Abutment, IS Gold UCLA Abutment, IS Temporary Abutment, IS Ball Abutment, IS Ball Abutment Component (Housing, Retainer, O-ring) and IS Abutment Screw. The dimensions of abutments are as following: Tolerance of dimension for Abutments shall be within ± 1% range. The purpose of Anodizing for Cover Screw is to distinguish the sizes with the naked eyes for convenience. The surface of IS Solid, cemented, Shapable, Angled Abutments was treated with TiN-Coated. IS-III active Fixture, IS cover screw, and healing Abutments are provided sterilized. And other Abutments are provided non- sterilized. IS-III active Fixture is enclosed with Cover Screw in a packing. Other Abutments are enclosed with Abutment Screw in a packing. The Solid Abutment is enclosed with Protective cap. All of above products including enclosed product are packed separately for convenience.

The provided document is a 510(k) Premarket Notification for a dental implant system. It outlines the characteristics of the IS-III active System and compares it to predicate devices to demonstrate substantial equivalence, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics for an AI/ML powered device.

Therefore, many of the requested elements for an AI/ML device (like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not present in this document.

However, I can extract information related to the device's non-clinical testing and comparison to acceptance criteria (standards).

Here's the closest representation of the requested information based on the provided document:

Acceptance Criteria and Device Performance Study for the Neobiotech IS-III active System (K181138)

This 510(k) submission establishes the substantial equivalence of the IS-III active System to legally marketed predicate devices primarily through comparison of technological characteristics and non-clinical performance testing against recognized standards. The acceptance criteria are derived from these international and internal standards, and the device's performance data is reported as meeting these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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: Specific sample sizes for each non-clinical test (e.g., number of implants for fatigue testing or biocompatibility animal models) are not detailed in this summary document.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data nor if it was retrospective or prospective, as these are typically not relevant for non-clinical bench or lab testing. The testing was conducted to international and US FDA recognized standards.

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 applicable as the document describes non-clinical engineering and biological tests conducted against established standards, not a clinical study involving expert interpretation or "ground truth" establishment in a diagnostic context.

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

This information is not applicable as the document describes non-clinical engineering and biological tests.

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

This information is not applicable. This document is for a dental implant system (a physical device), not an AI/ML powered medical device.

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

This information is not applicable. This document is for a dental implant system (a physical device), not an AI/ML powered medical device.

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

For biocompatibility and mechanical testing, the "ground truth" is defined by the established criteria and methodologies within the cited international ISO and ASTM standards, as well as the FDA guidance document. For example, for fatigue, the "ground truth" is that the device must withstand a certain number of cycles at a specified load without failure, as per ISO 14801.

8. The sample size for the training set

This information is not applicable. This document is for a physical medical device. There is no AI/ML algorithm or "training set" involved in its development or evaluation as described here.

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

This information is not applicable. No training set is mentioned or relevant to the information provided in this 510(k) summary for a physical dental implant.

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The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136. The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping. The fixtures' diameters and lengths are available as: Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L). Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.

The provided text is a 510(k) summary for the "S-mini active Fixture," an endosseous dental implant. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a study that proves the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or human reader improvement with AI assistance. This is because the device in question is a dental implant, a physical medical device, not a software or AI-based diagnostic tool.

Therefore, many of the requested points in your prompt are not applicable to the information contained within this document. The "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device based on material, design, sterilization, and non-clinical bench testing.

Here's how the provided information relates to your request, with an emphasis on what's not applicable:

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

The acceptance criteria for a 510(k) for a physical device like a dental implant are primarily centered around demonstrating "substantial equivalence" to a predicate device, as opposed to performance metrics like sensitivity or specificity for a diagnostic algorithm.

The document states:

• "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
• "Performance testing has been finished to ensure the devices comply with the applicable International and US FDA Guidance."

Acceptance Criteria (Implicit from Non-Clinical Testing):
The device must meet the criteria of the following standards and tests, demonstrating bio-compatibility, structural integrity, and durability:

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

• Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the number of physical devices tested in the non-clinical bench studies (e.g., how many implants were used for fatigue testing), which is not specified.
• Data Provenance: The tests are non-clinical, meaning they are laboratory/bench tests, not studies on human patients. The manufacture is located in South Korea.

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

• Not Applicable. This document describes a physical medical device (dental implant), not an AI or diagnostic software. Therefore, there is no "ground truth" in the diagnostic sense, nor experts interpreting images or data for a test set. The "truth" is established through engineering and biological testing against predefined standards.

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

• Not Applicable. See 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:

• Not Applicable. This is a physical device, 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 is a physical device.

7. The type of ground truth used:

• Not Applicable in the context of diagnostic AI. For this physical device, "ground truth" is defined by established engineering standards (e.g., ISO, ASTM, ANSI, USP) and the physical properties and performance characteristics demonstrated by the predicate devices. For instance, the "ground truth" for biocompatibility is defined by meeting the criteria of the ISO 10993 series.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set" and thus no "ground truth" establishment process for one.

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The IS-III HActive Fixture is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IS-III HActive Fixture is composed of fixtures and cover screw. Fixtures are thread type implants made of titanium alloy which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Titanium Alloy based on ASTM F136. Surface treatment is HA Coating. This device has connection between the upper prosthesis and the internal hex. Surface is treated with RBM (Resorbable Blasting Media) using Hydroxyapatite powder. Residues are removed through a washing procedure after Plasma-spray with Hydroxyapatite and formation of the HA coating. It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The diameters are 3.5/4.0/4.5/5.0/6.0/7.0mm and the lengths are 7.3/ 8.5/10.0/ 11.5/13.0/15.0mm. (Do not offer 3.5 x 7.3mm implant, 6.0 x 15mm implant, or 7.0 x 15mm implant). Cover Screw intended to protect the inside of the implant during osseointegration. It is made of titanium alloy according to ASTM F136. The surface treatment of the cover Screw is anodizing or non-anodizing. The purpose of anodizing is to distinguish the sizes with the naked eyes for convenience. The diameter of cover screw is 3.45/3.6mm. IS-III HActive Fixture is enclosed with Cover Screw in a packing. IS-III HActive Fixture and Cover Screw can be packed separately for convenience.

The provided text describes the submission of a new dental implant device (IS-III HActive Fixture) to the FDA for substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a diagnostic AI/ML device submission would.

The document focuses on demonstrating that the new device is as safe and effective as previously approved devices by comparing their characteristics (intended use, materials, design, etc.) and presenting results from non-clinical testing. This type of submission (510(k)) does not typically include clinical studies with acceptance criteria for device performance as would be seen for AI/ML-driven diagnostics.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.

However, I can extract the following relevant information:

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

This document does not provide a formal table of acceptance criteria and reported device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it refers to meeting criteria of various engineering and biocompatibility standards.

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. The document describes non-clinical bench testing and biocompatibility assessments, not a diagnostic test on a test set of human data.

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. Ground truth for diagnostic performance is not established in this type of submission. Performance is based on material properties and mechanical integrity.

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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

For the non-clinical testing, the "ground truth" or reference was based on established industry standards (ISO, ASTM, ANSI/AAMI, USP) and FDA guidance documents for mechanical, material, and biological properties of medical devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable.

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Neo GBR System is intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.

The Neo GBR System is made of Titanium Alloy. This product is a sterilized single use medical device. This system consists of Tent screw and CTi Cover Screw. The function of the Tent Screw is temporarily Intraosseous Fixation Screw that places in the maxilla or mandible bone area to be combined with a titanium membrane of K 111761 and CT cover screw. Second surgery for removal is required. The product diameters are 2.0mm and the lengths are 7.2/8.7/10.2/11.7/13.2/15.2/18.2mm. The Tent Screw and CTi-Cover screw are always packaged together. But CTi-Cover Screw is packaged separately for the convenience. 4 pcs of Tent Screw can be packaged in a box as a bundle set.

The provided document does not describe a study that uses acceptance criteria to prove the device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for the "Neo GBR System," which is an implantable medical device (intraosseous fixation screw or wire).

The document details bench testing conducted for the Neo GBR System to confirm its physical properties, but this testing is not an AI/ML performance study as typically described with acceptance criteria like sensitivity, specificity, or AUC, nor does it involve human readers or ground truth derived from expert consensus, pathology, or outcomes data in the way an AI/ML study would.

Here's an analysis based on the information available, noting the absence of AI/ML specific information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "The testing results meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific quantitative acceptance criteria and the detailed performance results for each test (visual test, compressive loads, pull out, driving torque, and insertion-elimination tests) are not provided in this summary. It only states that they meet the requirements.

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

This information is not available in the provided summary. The document mentions "bench testing," which implies physical tests on the manufactured device, not a test set of data (images, clinical records, etc.) as would be used for an AI/ML algorithm.

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

This information is not applicable as the device is a physical fixation system, not an AI/ML algorithm requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above.

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

This information is not applicable. The device is a physical implant, not an AI/ML system that enhances human reader performance.

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

This information is not applicable as it is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be the physical properties and mechanical thresholds established for the device's function (e.g., maximum compressive load before failure, torque required for insertion/removal). The biocompatibility tests also have established standards (ISO 10993-1). However, specific quantitative values are not provided in the summary.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

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

• Tests: Visual test, compressive loads, pull out, driving torque, and insertion-elimination tests.
• Standards: Conducted in accordance with ASTM F543-13.
• Biocompatibility: Cytotoxicity, irritation, and sensitization tests in accordance with ISO 10993-1.
• Stability and Compatibility: Tests between the tent screw and CTi-cover screw to evaluate adaptation accuracy.

Conclusion from document: "The testing results meet the requirements of its pre-defined acceptance criteria and intended uses."

In essence, the provided document describes the regulatory submission for a physical medical device and does not contain the kind of AI/ML performance study information requested in the prompt.

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The CMI Implant IS II active is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Neo CMI Implant IS II active system is dental implant consist of pure titanium, grade 4. The titanium implant surface was sandblasted with large grits and acid etched (S.L.A.) This implant system can be used for all oral endosteal implant indications in the mandible and maxilla, for functional and esthetic oral rehabilitation of edentulous. The fixture diameters are 3.8, 4.3, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 and the lengths are 7.3, 8.5, 10.0, 11.5, 13.0, and 15.0.

This is not an AI/ML device and therefore the acceptance criteria and related study information are not applicable. The provided document is a 510(k) premarket notification for a dental implant, the CMI Implant IS II active, seeking substantial equivalence to a predicate device. The information details the device characteristics and comparison to the predicate, focusing on mechanical and material properties rather than AI/ML performance metrics.

Reasoning for Inapplicability:

The document describes a physical medical device (dental implant) that does not incorporate artificial intelligence or machine learning. The "Non Clinical Study Data" section refers to a "Static Compressive Load Test Data," which is a standard engineering test for mechanical strength, not an AI/ML performance study. The comparison criteria listed (product name, 510(k), manufacturer, shape, intended use, material composition, device design, surface treatment, biocompatibility, sterilization) are all related to the physical and biological characteristics of the implant, not to any AI/ML algorithm's performance.

Therefore, the requested details regarding acceptance criteria for AI/ML models, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not present in this document and are not relevant to this type of medical device submission.

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