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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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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.

Ask a specific question about this device

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.

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 is 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). The Fixture diameters are 4, 4.5, 5, 5, 6, 6.5mm and lengths are 7, 9, 11, 13mm in this system. The contained various abutments and accessories in the system are abutment screw, magicore abutment &cap, healing cap (color anodizing: yellow, blue, green, and purple). The abutments are provided straight only and that they are no intended to be modified to provide an angle correction. Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.

The provided document is a 510(k) premarket notification for a dental implant system (Magicore System). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data for acceptance criteria and device performance as would be required for novel or higher-risk devices.

Therefore, the document does not contain the detailed information requested about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

Instead, the submission focuses on comparing the Magicore System to predicate devices to demonstrate substantial equivalence based on:

1. Indications for Use: The Magicore System is intended to replace missing teeth to restore chewing function, similar to the predicate devices.
2. Materials: All devices are made of Titanium Alloy Ti-6Al-4V Eli (ASTM F136).
3. General Shape Design, Surface, Connection Method, Application Method, and Sterilization Method: These are stated to be similar between the subject device and the predicate devices.
4. Non-clinical Data: This includes sterilization validation (ISO 11137-1:2006, ISO 11137-2:2006), surface treatment analysis, biocompatibility evaluation (relying on predicate materials or FDA consensus standards), and shelf-life validation (ASTM 1980).

The document states: "Any differences between the Mazicore System and predicate device do not raise new types of safety or effectiveness issues. Accordingly we can claim the substantially equivalence of the Magicore System to predicate device."

In summary, none of the requested information regarding acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device), sample sizes for clinical test sets, expert ground truth, adjudication, or MRMC studies are present in this 510(k) submission. This is standard for 510(k) applications for dental implants, which typically rely on non-clinical data and comparison to predicates for demonstration of substantial equivalence.

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