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The LW 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 terminal or intermediate abutment support for fixed bridgework. The LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.

The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw. The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment. The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).

The provided text is a 510(k) Summary for the LW Implant System. It outlines substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data for this device. Therefore, a table of acceptance criteria and direct device performance is not explicitly available in the provided text in the way one would typically find for a new, de novo device or a clinical study.

The document focuses on demonstrating that the LW Implant System is "substantially equivalent" to already legally marketed predicate devices. This means that the device meets the same safety and effectiveness standards, often by showing it performs as well as, or better than, a known predicate device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't present specific acceptance criteria and performance data in a dedicated table for the LW Implant System, as it's a 510(k) submission focused on substantial equivalence. Instead, it describes various non-clinical tests performed to demonstrate that the device meets established standards and performs comparably to predicate devices. The "acceptance criteria" are implied by adherence to relevant ISO and ASTM standards and FDA guidance documents, and the "reported device performance" is essentially that the device "met the acceptance criteria" or "demonstrated substantial equivalence."

Here's an interpretation of the implied acceptance criteria and the summary of reported performance:

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

The document does not explicitly state the specific sample sizes for each non-clinical test performed (e.g., how many devices were subjected to fatigue testing, or how many samples for biocompatibility). It references standards like ISO and ASTM, which inherently define sample size requirements, but the exact numbers are not reported in this summary.

Data Provenance: The tests are non-clinical (laboratory-based) and were conducted to support the safety and performance of the device against established standards and predicate device comparisons. The "country of origin of the data" is not explicitly stated for each test, but the applicant, Ossvis Co., Ltd., is based in the Republic of Korea. The data is retrospective in the sense that the tests were completed before this submission.

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

This information is not applicable to the provided document. The "ground truth" in this context is established through adherence to recognized international standards (ISO, ASTM) and national regulations (FDA guidance documents). These standards typically involve scientific and engineering principles, and the "experts" are the scientific and engineering professionals who developed these standards and those who conducted the tests in accordance with them. There is no mention of a ground truth established by a panel of clinical experts for a test set in a diagnostic or clinical performance study for this device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple readers (e.g., radiologists, pathologists) to establish a consensus ground truth. Since the reported studies are non-clinical performance and safety tests, a human adjudication method is not used. The "adjudication" is essentially the determination of whether the device passed the specified test according to the defined acceptance criteria in the relevant standards.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance and safety to demonstrate substantial equivalence, not on the comparative effectiveness of human readers with or without AI assistance. This device is a physical dental implant system, not an AI/software as a medical device.

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

No, this is not applicable. This device is a physical medical device (dental implant system), not an algorithm or software. The concept of "standalone performance" without human-in-the-loop is relevant to AI/software applications, not to this type of medical device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and regulatory guidance limits. For example:

• Sterility: Defined by ISO 11137 with an SAL of 10-6.
• Biocompatibility: Defined by ISO 10993 standards.
• Fatigue: Defined by ISO 14801.
• Bacterial Endotoxin: Defined by USP and .
• Surface Characteristics: Defined by FDA special controls guidance for dental implants.

The comparison is also made against the performance and characteristics of legally marketed predicate devices, implying that their established safety and effectiveness serve as a practical "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The LW Implant System is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model.

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

This information is not applicable, as there is no "training set" for this physical medical device.

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Premilled Titanium Block System is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.

The subject Premilled Titanium Block System has two types of blocks, Premilled Titanium Block (Hex, Non-Hex) and Magic Premilled Titanium Block (Hex, Non-hex) based on the compatible implant system.

This document describes a 510(k) premarket notification for the "Premilled Titanium Block System" by InnoBioSurg Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device to an existing one, rather than conducting a de novo study to establish new performance criteria. Therefore, the information provided below is extracted based on the principles of substantial equivalence as demonstrated by the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify general "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or accuracy for the device itself, as this is a dental abutment system and not an AI/diagnostic device. Instead, the "acceptance criteria" can be inferred from the non-clinical testing performed to establish substantial equivalence with the predicate device. The performance is assessed against established standards for dental implants and abutments.

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

For the fatigue tests performed on the subject device:

• Sample Size: The document indicates that fatigue tests were conducted "under the worst-case scenario." While a specific number isn't given, standard ISO 14801 testing protocols usually involve a predefined number of samples (often 10 for each test condition) to establish fatigue limits. It specifies only the "worst-case scenario" (smallest diameter with maximum angulation) was tested for the new device.
• Data Provenance: Not explicitly stated (e.g., country of origin). It is a non-clinical, mechanical test, not patient data. The study type is a laboratory-based equivalency testing study, not retrospective or prospective clinical data.

For biocompatibility and sterilization validation tests:

• These tests were leveraged from predicate devices (K152520, K173120, K192197). This means new tests with a specific sample size for the subject device were not performed for these aspects. The sample sizes and provenance for these predicate studies are not detailed in this document.

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

N/A. This document describes a submission for a mechanical dental device (abutment system) based on substantial equivalence and non-clinical testing, not an AI/diagnostic device that requires expert-established ground truth for a test set. There were no human readers or expert panels involved in determining the "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

N/A. As this is not an AI/diagnostic device, no adjudication method (e.g., 2+1, 3+1) was used for a test set in the context of clinical or diagnostic performance. The evaluation was based on adherence to ISO standards for mechanical and material properties.

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

No. An MRMC study is not applicable to this type of device. This is a physical dental abutment system, and its performance is evaluated through engineering and materials testing, not through reader perception or diagnostic accuracy.

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

No. This is not an AI algorithm or a software-only device. The evaluation focuses on the physical properties and performance of the dental abutment system itself.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests (fatigue, biocompatibility, sterilization) is defined by the successful adherence to the specified international standards (ISO, ANSI/AAMI). For example, for fatigue, the "ground truth" is that the device withstands a certain number of load cycles at a specified force without failure, as per ISO 14801. For biocompatibility, it's the absence of adverse biological reactions as defined by ISO 10993 standards.

8. The Sample Size for the Training Set

N/A. This submission is for a physical medical device (dental abutment system) and does not involve AI or machine learning algorithms that require a "training set."

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

N/A. Not applicable, as there is no training set for this type of device submission.

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The Magic UCLA Abutment System is intended to replace missing teeth to restore chewing function. The Magic UCLA Abutment System can be placed in support of single or multiple-unit restorations including: cement retained, screw retained, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

The Magic UCLA Abutment System is used with a dental implant to provide support to prosthetic restorations such as crowns, bridges, and overdentures in partially or fully edentulous patients. The system includes Magic UCLA Screw Retained Type (Hex, Non-Hex) and Magic UCLA Cement Retained Type (Hex, Non-Hex) abutments. The abutments are fabricated from Co-Cr-Mo Alloy with Poly Diacetate, provided non-sterile, and packaged separately. They must be sterilized before use. The abutments are not intended to be cast at angulation or placed to provide angular correction.

The provided document is a 510(k) premarket notification for a dental device, the "Magic UCLA Abutment System." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for a new AI/medical image analysis device.

Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/medical image analysis device.

The relevant sections of your request (acceptance criteria, test set details, expert ground truth, MRMC study, standalone performance, training set details) are specific to the validation of AI/image analysis algorithms, which is not the subject of this 510(k) submission. This submission is for a physical dental implant component and leverages non-clinical testing performed on predicate devices to demonstrate equivalence.

Here's a breakdown of why this document cannot fulfill your request:

• No AI/Image Analysis: The "Magic UCLA Abutment System" is a physical dental implant component (abutment). There is no mention of it being an AI device or involving image analysis.
• No Performance Study Against Acceptance Criteria (as you defined them): The document confirms "Non-clinical testing was not performed for the subject device" (page 9) because it's considered substantially equivalent to predicate devices based on material, manufacturing, and design similarities. The "tests" mentioned are biocompatibility, galvanic reaction, and sterilization tests, which are standard for physical medical devices and not related to AI performance metrics like sensitivity, specificity, F1-score, etc., nor do they involve human expert review for ground truth in the context of image analysis.
• No Test/Training Sets: Since there's no AI component, there are no test or training sets of data/images to evaluate an algorithm's performance.
• No Experts for Ground Truth (in the context of AI): The document doesn't discuss establishing ground truth by experts for image analysis.
• No MRMC Study: An MRMC study is relevant for evaluating human reader performance with and without AI assistance. This is not applicable here.
• No Standalone Performance: Standalone performance refers to an algorithm's performance without human intervention. This is not reported.

In summary, the provided text describes a regulatory submission for a physical dental device, not an AI or image analysis device, and thus does not contain the information requested about acceptance criteria and performance studies typical for AI/medical imaging products.

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The Magicore II System is intended to replace missing teeth to restore chewing function. The Magicore II System can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore II System consists of dental implants, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore II implant is treated with SLA (sand-blasted, large-grit, acid-etched). The Fixture diameters are 4.0, 4.5, 5.0, 5.5, 6.0, 6.5mm and threaded lengths are 7, 8, 9, 10, 11, 12, 13mm in this system. The contained various abutments and screws in the system are Short Abutment, Magic Multi Abutment, Magic Multi Cylinder, Magic Multi Abutment ST, Abutment Screw, Healing Cap, Magicore Angled Abutment.

This document is a 510(k) summary for the Magicore II System, an endosseous dental implant system. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone clinical study on device performance. Therefore, many of the requested details regarding clinical study design, expert adjudication, MRMC studies, and ground truth establishment are not present in this document, as they are not typically required for a 510(k) submission for this type of device.

The acceptance criteria provided here are primarily based on non-clinical performance testing (fatigue testing) and comparison to predicate devices in terms of material, design, indications for use, and manufacturing processes, rather than a clinical trial demonstrating specific performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are aligned with demonstrating substantial equivalence to its predicate devices through non-clinical testing and comparison of characteristics. The primary performance metric mentioned is fatigue strength.

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

• Sample Size for Test Set: This document does not describe a clinical "test set" in the sense of patient data. The "test set" here refers to the physical devices undergoing non-clinical laboratory testing. The sample sizes for these specific non-clinical tests (e.g., how many implants were used for fatigue testing) are not specified in this summary document.
• Data Provenance: The data provenance is primarily from non-clinical laboratory testing (e.g., fatigue, sterilization, biocompatibility tests). Some test results are "leveraged" from previous 510(k) clearances (K152520, K162099, K140806, K173120), implying the data originated from other studies performed by the manufacturer or their affiliates. The country of origin for the data is implicitly where the manufacturer (InnoBioSurg Co., Ltd. - Republic of Korea) and referenced test labs are located. The data is retrospective in the sense that results from previously cleared devices are referenced.

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

• Not applicable. This submission relies on non-clinical engineering and materials testing standards (e.g., ISO, ASTM, USP) rather than a test set requiring expert clinical ground truth establishment.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not applicable. As there is no clinical test set requiring subjective interpretation by experts, no adjudication method is mentioned or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs. Without AI Assistance

• Not applicable. This device is a dental implant system, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted or relevant.

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

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

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Ground Truth Type: For the non-clinical tests, the "ground truth" is defined by established international and national standards (e.g., ISO 14801 for fatigue limits, ISO 10993 for biocompatibility thresholds). The device's performance is compared against these engineering and material science standards.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device that would require training data.

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

• Not applicable. As above, no training set for an algorithm is involved.

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The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading.
• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
  Larger implants are dedicated for the molar region.

The AnyRidge Octa 1 Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136-13) except the CCM Abutment. The CCM Abutment is made of Cobalt Chrome Molybdenum (ASTM F1537-11). Also for the Fuse Abutment, the post is covered with provisional restoration that is made of plastic (POM). The system offers various components including the AnyRidge Octa 1 Fixture, EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, Meg-Rhein Abutment, CCM Abutment, Cover Screw, Healing Abutment, Temporary Abutment, Fuse Abutment, Abutment Screw, and Multi-unit Abutment Screw, in various sizes.

The provided document is a 510(k) Premarket Notification from the FDA for the AnyRidge Octa 1 Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a standalone study with acceptance thresholds.

The document discusses non-clinical testing performed to support the substantial equivalence claim. Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., minimum accuracy percentages, AUC values) or corresponding device performance results in the context of clinical effectiveness or diagnostic accuracy, as it is a 510(k) submission focusing on substantial equivalence to predicate devices rather than novel performance claims.

However, it mentions that fatigue tests were performed on the subject devices in accordance with ISO 14801. The acceptance criterion for this would be that the fatigue test results of the subject device are substantially equivalent to the predicate device. The document states:

• "The fatigue testing demonstrates that the results of the subject devices are substantially equivalent to the predicate device."
  This indicates that the subject device met the implied acceptance criterion of demonstrating comparable mechanical durability to the predicate under the specified test conditions.

Other non-clinical tests mentioned also have implicit acceptance criteria:

• Sterilization validation testing (ISO 11137 and ISO 17665-1, 2): To verify a sterility assurance level (SAL) of 10^-6. The document states this was performed to verify SAL (10^-6), implying it met this standard.
• Shelf life validation testing (ASTM F1980): To validate a 5-year shelf life using accelerated aging. The document states "the test results validated 5 year shelf life," indicating the criterion was met.
• Surface Morphology (EDS), Surface Roughness, GC/LC Analysis, IC Analysis: These tests were done to evaluate SLA treatment. The implicit acceptance would be that the characteristics are consistent with acceptable dental implants and/or comparable to the predicate device's surface treatment.
• Endotoxin testing (USP 39 ): The testing limit is below 0.5 EU/mL. This will be conducted on every batch, implying this is the ongoing acceptance criterion for endotoxin levels.

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

The document does not describe a "test set" in the context of patient data or a clinical study for performance evaluation. The "tests" performed are non-clinical, laboratory-based tests on the device itself. Therefore, information on sample size for patient data or data provenance (country of origin, retrospective/prospective) is not applicable or provided.

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

Not applicable. This is a non-clinical 510(k) submission, not a clinical study requiring expert ground truth for a test set.

4. Adjudication Method

Not applicable. This is a non-clinical 510(k) submission.

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

Not applicable. This is a non-clinical 510(k) submission for a dental implant system, not a diagnostic device typically evaluated with MRMC studies with human readers and AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This product is a physical medical device (dental implant system), not an algorithm or AI system.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" refers to established scientific standards and regulatory guidelines.

• Mechanical Fatigue: ISO 14801, and comparison to the performance of legally marketed predicate devices.
• Sterilization: ISO 11137 and ISO 17665-1, 2.
• Shelf Life: ASTM F1980.
• Biocompatibility: Likely established through previous 510(k) submissions for the predicate devices using similar materials.
• Endotoxin: USP 39 .

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/algorithm-based product that requires a training set.

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

Not applicable.

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