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The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, screw 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.

The fixtures and abutments in this system are below:

1. Fixture

• Magicore (RBM)
• Magicore (RBM Cutting Edge)
• Magicore II (SLA) .
• Magicore II (SLA Cutting Edge)

2. Abutment

• Magic Angled Abutment (Screw type _Hex, Non-Hex) ●
• Magic Motion
• Magic Motion Housing ●
• Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ●
• Magic Multiunit Abutment (Cement type Hex, Non-Hex)
• Magic Multiunit Cap .
  An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched).

The provided text is a 510(k) summary for the IBS System, an endosseous dental implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance data against acceptance criteria from a study on the IBS System itself. Therefore, I cannot extract the full details you requested regarding acceptance criteria and the study that proves the device meets them.

The document primarily shows a comparison of technological characteristics between the subject device (IBS System) and various predicate and reference devices. The "SE Discussion" (Substantial Equivalence Discussion) sections explain why the differences are not considered to affect safety and effectiveness, thus supporting the claim of substantial equivalence.

However, I can extract the following information based on the provided text, particularly from the "Non-Clinical Data" section, which outlines the types of tests performed and the standards met:

Inferred Acceptance Criteria and Reported Device Performance (Summary based on tests performed for substantial equivalence):

Further Breakdown of Requested Information (where available):

1. A table of acceptance criteria and the reported device performance: See table above. It's important to note that these are inferred from the standards cited as being met for establishing substantial equivalence, not explicit performance metrics from a comparative study of the new device against specific performance criteria.

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

   • Sample Size: Not specified in the provided text for any of the non-clinical tests (e.g., number of abutments for sterilization, number of implants for fatigue testing, number of participants for human factors).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is InnoBioSurg Co., Ltd. from the 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): Not applicable. This document describes non-clinical engineering and biological tests, not studies involving human expert assessment for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. As above, this is for non-clinical testing.

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 an endosseous dental implant, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

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

   • For Sterilization: Ground truth is defined by the demonstrated sterility assurance level (SAL) of 10^-6, verified by biological indicators and physical parameters outlined in the referenced ISO and AAMI standards.
   • For Biocompatibility: Ground truth is established by the cellular responses and tissue reactions observed in tests, interpreted against the criteria of the ISO 10993 series.
   • For Fatigue Testing: Ground truth is the material's resistance to fracture under cyclic loading, compared to the ISO 14801:2016 standard.
   • For Surface Modification: Ground truth involves microscopic and chemical analysis (e.g., surface roughness, composition analysis, SEM imaging) against established benchmarks or predicate device characteristics.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

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The Magicore Narrow System (3.0, 3.5mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.
   The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The Magicore Narrow 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 Narrow implant is treated with RBM (Resorbable Blasted media) or SLA(sand-blasted, large-grit, acid-etched).

This document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. For dental implants, substantial equivalency is typically demonstrated through engineering and material characteristic comparisons to predicate devices, and performance testing, rather than clinical studies with patient outcomes. Therefore, the questions typically associated with clinical studies (like sample size for test sets, number of experts for ground truth, MRMC studies, training set details, etc.) are not directly applicable in the context of this 510(k) summary.

The manufacturer is demonstrating substantial equivalence by comparing the "Magicore Narrow System" to several predicate and reference devices. The acceptance criteria and the "study" proving the device meets these criteria are primarily based on comparative technical characteristics and non-clinical performance testing, rather than a clinical trial with human subjects.

Here's a breakdown based on the provided document, addressing the closest equivalents to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The term "acceptance criteria" here refers to demonstrating that the new device's characteristics and performance are substantially equivalent to legally marketed predicate devices, meaning they do not raise new questions of safety or effectiveness. The performance is "reported" by showing that the subject device's features align with or are within acceptable ranges of the predicate devices, and by outlining non-clinical tests performed.

• Inner Connection: Internal hex, non-submerged (similar to predicates).
• Endosseous Implant: Tapered, macro threads (similar to predicates).
• Platform Diameters: Ø 4.0.
• Fixture Diameters: Ø 3.0, Ø 3.5 (similar to predicates, with Ø 3.3 for one predicate and Ø 3.0 for another).
• Implantable Lengths: 11.0, 13.0, 15.0 mm (longer lengths supported by reference device K093321).
• Modified Surface: RBM & SLA (Primary predicate K161244 uses SLA; reference device K093321 uses RBM. Differences justified).
• Surgical Technique: 1 and 2 stage, self-tapping (similar to predicates).
  Abutments: Various abutments (Closing Screw, Short Abutment, Magic Abutment, Magicore Solid Abutment, Magicore Solid Abutment Cap, Magicore Healing Cap, Healing Cap Screw, Abutment Screw) are compared to various reference devices (K152520, K192197, K212517, K201981, K173120). Differences in dimensions (diameters, lengths) are noted but justified as not affecting fundamental functions or safety due to similarity in intended use, fundamental scientific technology, principle of operation, general design, technology, functions, and materials. |
  | Sterilization | Device must be sterile or sterilizable, and sterilization methods must be validated and equivalent to predicate devices. | Fixtures are provided sterile via Gamma sterilization (similar to predicates). Closing Screw and Magicore Healing Cap also Gamma sterilized. Other abutments are provided non-sterile for end-user sterilization, with validation tested to ANSVAAMI ST79, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1 (leveraged from predicate K202479 and K140806). |
  | Biocompatibility | Device materials must be biocompatible. | Biocompatibility testing for fixtures (ISO 10993-1, 3, 5, 6, 10, 11) and abutments made of Titanium ELI (ISO 10993-1, 5, 6, 10) was leveraged from predicates (K140806 & K162099), demonstrating equivalence with same materials and manufacturing processes. |
  | Non-Clinical Performance | Mechanical and packaging integrity must be demonstrated as safe and effective. | Shelf Life: Tested for subject fixtures according to ASTM F1980 (results met criteria).
  LAL Testing: Performed for subject fixtures according to USP (referenced in K140806 & K162099, results met criteria).
  Surface Modification Analysis: Surface roughness, surface composition analysis, and SEM imaging compared between subject (RBM and SLA surfaces) and predicate devices (K152520 and K192197) to demonstrate substantial equivalence.
  MR Environment Condition: Non-clinical worst-case MRI review performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque based on FDA guidance.
  Fixture Packaging Performance: Human Factors testing (usability evaluation for aseptic presentation per ISO 11607-1:2019 and FDA guidance), low and high magnification imaging after removal from packaging to check for damage, and Quality System plan for packaging acceptance activities were provided. Results indicated devices conform to product specifications with packaging design. |

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

This document is a 510(k) summary for a dental implant, which does not typically involve a "test set" or "training set" of patient data in the way an AI/ML device would. Instead, substantial equivalence is demonstrated through comparative engineering data and non-clinical performance testing.

• Sample Size for Testing: The document refers to various standards (e.g., ASTM F1980, ISO 11137-1/2, USP , ANSV/AAMI ST79 series, ISO 17665-1/2, ISO 11737-1/2, ISO 11138-1, ISO 10993 series) for non-clinical performance tests. The specific sample sizes for these engineering tests are not detailed in this summary but would be part of the full test reports. For example, biomechanical tests (fatigue, static strength) are typically conducted with small sample sizes (e.g., n=5 or n=10 per group, as per ISO standards for implants).
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer (InnoBioSurg Co., Ltd.) or leveraged from testing performed for predicate devices from other manufacturers. Data is implicitly prospective in the sense that the manufacturer conducted these tests for this specific submission or leveraged existing valid test data from similar devices. The country of origin for the non-clinical data is not specified but the manufacturer is based in the Republic of Korea.

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

Not applicable. "Ground truth" in the context of clinical expert consensus for image-based diagnostic or prognostic devices is not relevant for this type of medical device (dental implant). Substantial equivalence is based on engineering and material standards, and comparison to already-cleared predicate devices. The "experts" would be the engineers and quality assurance professionals who conducted and reviewed the non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of reconciling differences in expert annotations or diagnoses, as this is not a diagnostic device relying on human interpretation of complex data.

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

No. An MRMC comparative effectiveness study is not performed for dental implants. These studies are typically conducted for AI/ML-driven diagnostic or screening devices to assess how the AI assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm-based diagnostic device.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Engineering Standards: Compliance with recognized international and national standards for medical devices and dental implants (e.g., ASTM, ISO standards for materials, sterilization, biocompatibility, mechanical properties).
• Predicate Device Equivalence: The established safety and effectiveness of legally marketed predicate devices. The "ground truth" is that if the new device is sufficiently similar to a predicate device in termsally relevant characteristics (and any differences do not raise new safety/performance questions), then it is considered safe and effective.
• Non-Clinical Test Results: Data from physical, chemical, mechanical, and biological (biocompatibility) tests proving that the device meets specified performance requirements outlined in the relevant standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device requiring data to learn patterns.

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

Not applicable, as there is no training set.

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The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore System can be placed in support of single or multiple-unit restorations including; cement retained, screw 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.

This submission is to add new fixtures and abutments to the previously cleared device, Magicore System (K201981), Magicore II System (K201621), Magicore II System (K192197), and Magic UCLA Abutment System (K202418).
The fixtures and abutments in this system are below:

1. Fixture

• Magicore
• Magicore (Cutting Edge)

2. Abutment

• Magic Multiunit Abutment (Screw type - Hex, Non-Hex & Cemented type - Hex, Non-Hex)
• Magic Multiunit UCLA Cylinder
• Magic Multiunit Cap
• Magic Abutment (Screw type Hex, Non-Hex & Cemented type Hex, Non-Hex)
• Magic UCLA Cement Retained Type (Hex, Non-Hex)
• Magic Cylinder (Hex, Non-Hex, Post)
• Magic Multiunit Cylinder (Hex, Non-Hex, Post)
• Magicore Healing Cap
• Magicore Healing Cap Screw
• Cylinder Screw
  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 System consists of dental implants, Abutments, 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 implant is treated with RBM (Resorbable Blasted media).

The provided text describes the regulatory submission for the Magicore System, an endosseous dental implant system, and its determination of substantial equivalence (SE) to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device performance study (e.g., accuracy, sensitivity, specificity, or clinical outcomes).

The document is a 510(k) summary for a dental implant system. The "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device, as required for FDA 510(k) clearance, rather than performance metrics of an AI model. The studies mentioned are primarily non-clinical (material, mechanical, sterilization, biocompatibility testing) and are leveraged from predicate devices or performed to show equivalence in basic structural and material properties. There is no mention of an AI/ML component in the Magicore System.

Therefore, I cannot provide the requested information about acceptance criteria for AI performance, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document.

The document discusses physical and material properties of a dental implant system, comparing them to legally marketed predicate devices to establish substantial equivalence.

However, if we were to interpret "acceptance criteria" in the context of this device's type (dental implants), it would refer to regulatory requirements and engineering performance specifications needed to demonstrate safety and effectiveness. Based on the provided text, here's what can be inferred about the "study" for this traditional medical device type regarding its acceptance for market clearance:

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

Since this is a 510(k) submission for a non-AI/ML dental implant device, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices, material safety, mechanical performance, and sterility. The document outlines comparisons to predicate devices for various characteristics, implying these characteristics meeting equivalent or acceptable standards are the acceptance criteria.

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

• Sample Size: Not applicable in the context of an AI/ML test set. The document refers to non-clinical testing (e.g., sterilization, biocompatibility, fatigue, shelf-life). These tests typically involve a defined number of device units or material samples per standard requirements, not "patient data samples." Specific numbers of units tested are not detailed in this summary, but the tests themselves rely on established sample size methodologies for their respective standards.
• Data Provenance: Not applicable for patient data. The "data" provenance in this context refers to the source of non-clinical test reports, which are largely leveraged from previous 510(k) submissions for predicate devices by the same manufacturer (e.g., K201981, K201621, K192197, K202418, K152520, K173120). These are lab-based tests, not human study data.

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

• Not applicable. This pertains to establishing ground truth for AI model training/testing which is not relevant here. For dental implants, the "ground truth" for material, mechanical, and biological properties is established through adherence to recognized international standards (e.g., ASTM, ISO) and laboratory testing protocols.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus methods for AI/ML ground truth, which is not relevant to this device's clearances.

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 type of study is relevant for diagnostic imaging AI. The document describes a physical dental implant.

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

• Not applicable. No AI algorithm is involved.

7. The type of ground truth used:

• For physical and material properties: The ground truth is based on established engineering principles, material science definitions, recognized industry standards (e.g., ASTM, ISO), and performance specifications determined through laboratory testing (e.g., mechanical strength, biocompatibility, sterility assurance levels).
• For substantial equivalence: The "ground truth" for the FDA's decision is the demonstration that the device's characteristics (intended use, design, materials, etc.) are as safe and effective as a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. There is no AI model to train.

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

• Not applicable. There is no AI model to train.

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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 IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutunent support for fixed bridgework. This system is for one or two stage surgical procedures and not for immediate loading. This system is intended for delayed loading.

The IBS Implant System consists of dental implants, abutments, 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 system has been treated with RBM (Resorbable Blasted media). This submission is to add implants and abutments to the previously cleared device, IBS Implant System (K153350).

The provided document is a 510(k) Premarket Notification from the U.S. FDA, which focuses on demonstrating substantial equivalence of a new device (IBS Implant System) to existing predicate devices. It does NOT describe a study that proves the device meets predefined acceptance criteria for AI/ML performance.

Instead, the document primarily discusses:

• The Indications for Use for the IBS Implant System (dental implants).
• A detailed comparison of the subject device with predicate devices, highlighting similarities and differences in design, materials, dimensions, and manufacturing processes.
• The non-clinical data leveraged from predicate devices (e.g., sterilization validation, biocompatibility, fatigue testing) to support the substantial equivalence claim for the new components being added.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and performance studies for an AI/ML powered medical device. The provided document is for a traditional dental implant system and does not involve AI/ML.

To answer your question meaningfully, I would need a document related to an AI/ML medical device submission.

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