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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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The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore 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.

This submission is to add new implants and abutments to the previously cleared device, Magicore System (K152520). The newly added implants and abutments are below: Fixture - Magicore (4mm of Neck length Implants) . - . Magicore (Cutting Edge) Abutment - Magicore Solid Abutment - Healing Cap For Magicore Solid Abutment Cap, no other changes are being made to the previous clearance except for product name change. 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, 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 document describes the Magicore System, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics. The information provided is for regulatory clearance (510(k)) and focuses on comparing the new components of the Magicore System to previously cleared devices.

Therefore, many of the requested categories related to clinical study design, performance metrics, and ground truth establishment are not applicable.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the Magicore System or clinical performance results. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on design, materials, indications for use, and non-clinical testing.

The acceptance criteria for this 510(k) submission are based on meeting the requirements for substantial equivalence to legally marketed predicate devices. This means showing that the new components of the Magicore System are as safe and effective as the predicate devices and do not raise new questions of safety or effectiveness.

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." However, it does not specify what those "criteria" were in terms of quantifiable device performance. It refers to compliance with ISO and ASTM standards for non-clinical aspects.

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

Not applicable. This document is a 510(k) submission for new dental implant components, not a clinical study assessing performance with a test set of data. The testing mentioned is non-clinical (material properties, sterilization, biocompatibility, etc.).

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 establishment by experts for a test set is not relevant to this type of regulatory submission, which relies on engineering and biological testing against established standards and comparison to predicate devices.

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

Not applicable. No test set requiring expert adjudication for ground truth was used in this submission.

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 a study assessing AI performance or human reader improvement.

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

Not applicable. This product is a physical dental implant system, not an algorithm.

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

Not applicable. The concept of "ground truth" as it applies to diagnostic or treatment efficacy studies is not relevant here. The "truth" in this context is adherence to recognized standards and demonstrated equivalence to already approved devices through non-clinical testing.

8. The sample size for the training set

Not applicable. This product is a physical dental implant system, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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

CCM Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. CCM Abutment System consists of UCLA Abutment and titanium abutment screws. All subject abutments are intended to be cast at zero angulations and placed on dental implant bodies which do not require angle correction.

This document is a 510(k) Premarket Notification from the FDA, asserting "substantial equivalence" of the CCM Abutment System to previously marketed devices. These types of documents focus on comparing a new device to existing ones to demonstrate similar safety and effectiveness, rather than presenting a detailed study proving the new device meets specific, pre-defined quantitative acceptance criteria through clinical trials or standalone performance evaluations (especially relevant for AI/ML devices). This document describes a dental implant abutment system, which is a physical device, not an AI/ML-driven medical device. Therefore, the information typically requested for AI/ML device performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this document.

The document primarily relies on non-clinical data to demonstrate substantial equivalence, focusing on materials, design, indications for use, and manufacturing processes compared to predicate devices.

Here's the information that can be extracted relevant to acceptance and performance for this physical device, framed in the context of "substantial equivalence" rather than "meeting acceptance criteria" in the way an AI/ML device would:

Acceptance Criteria and Device Performance (for a physical dental abutment system)

The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices. The performance is assessed through non-clinical testing and comparison of attributes.

Since this is a 510(k) for a physical dental abutment, the "acceptance criteria" are not quantitative performance metrics in the same way they would be for an AI/ML device. Instead, they are about demonstrating that the device is as safe and effective as predicate devices.

Table of "Acceptance Criteria" (Implicit for 510(k)) and Reported Device Performance:

Study Details (as applicable to a physical device 510(k) submission):

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

   • Not applicable in the context of an AI/ML device. This document does not refer to a "test set" of patient data for algorithm evaluation.
   • For the non-clinical tests (biocompatibility, galvanic reaction), the "sample size" would refer to the number of physical device units tested according to the respective ISO/ASTM standards. These details are not provided in this summary but would be part of the full submission. The provenance is internal lab testing for a new device.

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

   • Not applicable. "Ground truth" in this context is implicitly established by the standards themselves (e.g., ISO 10993 specifications for biocompatibility) and engineering principles for mechanical functionality. Human expert consensus on a test set of images or data is not a component of this submission.

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

   • Not applicable. This refers to a process for resolving discrepancies in expert labeling or diagnoses, which is not relevant for this physical device testing.

4. 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 study design for evaluating diagnostic AI, not a physical dental device.

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

   • Not applicable. This pertains to AI/ML software.

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

   • For the non-clinical tests, the "ground truth" is defined by the specific criteria and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization). For galvanic reaction, it's based on "corrosion potential" and "couple potential" as assessed per FDA guidance for dental implants.

7. The sample size for the training set:

   • Not applicable. This is for AI/ML model development.

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

   • Not applicable. This is for AI/ML model development.

In summary, this document is a regulatory communication for a Class II physical medical device, not an AI/ML-driven diagnostic tool. As such, the requested details related to AI/ML study design and performance criteria are not present because they are not relevant to the type of device and submission being reviewed. The "study" proving the device meets "acceptance criteria" is the set of non-clinical bench tests and comparisons performed against established predicate devices and international standards, demonstrating "substantial equivalence."

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