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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 IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II 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 magic Motion Abutment to the previously cleared device, IBS Implant System II (K162099).

The Magic Motion Abutment system is composed of Magic Motion Abutment, Housing and O-ring. The Magic Motion Abutment is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). Magic Motion is an attachment-retained prosthetic product, which is used with patients with a fully edentulous maxilla. It is a one-piece structure. Various collar heights of the magic motions can be selected based on the gingival height. Magic motion does not have movement and it is a solid type.

This FDA 510(k) K200753 letter is for a dental device, specifically an endosseous dental implant abutment called "IBS Implant System II" with an added component called "Magic Motion Abutment". As such, the approval is based on substantial equivalence to a predicate device, not on clinical performance criteria like those typically found in AI/ML device clearances. The document focuses on mechanical and material properties rather than AI model performance metrics.

Therefore, many of the requested elements for an AI/ML device study are not applicable or cannot be extracted from this documentation.

Here's an attempt to answer the questions based on the provided text, while highlighting what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as this is a dental implant abutment, not an AI/ML device. The "acceptance criteria" here relate to meeting standards for mechanical properties, biocompatibility, and manufacturing, rather than statistical performance metrics like sensitivity/specificity for an AI model.

The document discusses demonstration of substantial equivalence with the predicate device through design control activities and specific tests.

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

Not applicable for an AI/ML device. This is a mechanical device.

• Test set sample size: Not specified in terms of clinical samples. Testing refers to mechanical and material property assessments on manufactured parts.
• Data Provenance: Not mentioned in the context of clinical data. The tests performed are laboratory-based.

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

Not applicable as this is not an AI/ML device relying on human-established ground truth. Testing involves engineering standards and laboratory analyses.

4. Adjudication Method for the Test Set

Not applicable. This refers to methods for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.

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

No, a MRMC study was not done. This type of study is specifically for evaluating the effectiveness of an AI system with human readers, which is not relevant for a dental implant abutment.

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

Not applicable. There is no "algorithm" or "standalone performance" for this mechanical dental device.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For this device, "ground truth" would correspond to established engineering standards, material specifications, and regulatory requirements that the device's characteristics (dimensions, material, sterility, biocompatibility) must meet.

8. The Sample Size for the Training Set

Not applicable for an AI/ML device. There is no "training set" for a mechanical dental implant.

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

Not applicable for an AI/ML device. There is no "training set ground truth" for this mechanical device. The design, materials, and manufacturing processes adhere to established engineering principles and regulatory guidelines for dental implants.

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The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II 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 IBS Implant System II is consists of dental fixtures, screws and multiunit abutment cylinders.

The provided document is a 510(k) summary for the IBS Implant System II, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical testing. It does not describe an acceptance criteria study with the requested details (number of experts, sample size for test/training set, ground truth methods, MRMC study, or standalone performance).

Instead, the document details a comparison of the new device to existing devices (predicates) regarding various technical specifications and non-clinical test results.

Since the document does not contain the information for acceptance criteria and a study proving device meets it as requested, I cannot complete the table or answer the specific questions.

No information for the requested table and study details is available in the provided text. The document focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests (biocompatibility, endotoxin, sterilization validation, shelf-life validation, fatigue). These are not presented as a study with specific acceptance criteria that the device performed against in the way an AI/software performance study would be evaluated.

Therefore, the requested table of acceptance criteria and reported device performance cannot be generated. Similarly, specific details about sample size (training/test), data provenance, expert involvement, adjudication, MRMC, or standalone performance are not provided as these types of studies are typically associated with performance claims for diagnostic or prognostic devices, not for substantial equivalence of an endosseous dental implant based on physical and material properties.

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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, 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.

An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The IBS Implant 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) to increase junction strength by increasing the area of bone-implant interface.

There are 2 types of fixtures in this system, NR Fix and Magic FC. The NR Fix has diameters in 3.5mm and lengths in 9, 10, 11, 12, 13, 14 mm. The Magic FC has diameters in 4. 4.5. 5.0. 5.5. 6.0. 6.5mm and lengths in 7. 9. 11, 13. 15 mm.

The contained various abutments and accessories in the system are Magic Screw retained type Abutment & protect cap, Healing Abutment, Angled Abutment (hexa, non hexa), Pair Abutment (non hexa), Solid Abutment & Solid abutment cap, Magic abutcoping (transfer type, pick up type), Multiunit abutment, UCLA abutment.

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. But healing abutment is supplied sterile.

The provided text describes a 510(k) premarket notification for the IBS Implant System, primarily focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for device performance. As such, much of the requested information regarding specific acceptance criteria, detailed study parameters, ground truth establishment, sample sizes, and expert qualifications for performance evaluation (especially for AI/standalone algorithm performance) is not available in this document.

The document primarily discusses non-clinical data to support substantial equivalence.

Here's an attempt to extract the available information based on your request, followed by acknowledgments of what is missing:

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

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds (e.g., specific accuracy, sensitivity, specificity, or success rates) for the device. Instead, the reported "performance" is demonstrated through compliance with recognized standards and successful non-clinical testing to show substantial equivalence.

Missing Information (Not available in the provided text):

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

• The document mentions "non-clinical tests" and "fatigue test" but does not detail the sample sizes (e.g., number of implant samples tested) or data provenance (e.g., from which specific test batches or labs). No human or clinical data is mentioned, so no information on retrospective/prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no human-expert-evaluated test set is described. The "ground truth" for the non-clinical tests would be the established performance metrics or compliance standards.

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

• Not applicable as no human-expert evaluation/adjudication is described.

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

• No MRMC or AI-assisted study is mentioned. This filing is for a physical dental implant system, not an AI software device.

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

• Not applicable; this is not an AI algorithm.

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

• For the non-clinical tests (sterilization, fatigue, surface analysis), the "ground truth" would be established by the specifications of the relevant ISO and ASTM standards and the results obtained from laboratory testing (e.g., successful biological indicator kill for sterilization, passing cycles for fatigue).

8. The sample size for the training set

• Not applicable; this is not an AI algorithm.

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

• Not applicable; this is not an AI algorithm.

Summary of what the document confirms:

The IBS Implant System received 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. This was supported by:

• Matching intended use.
• Identical material composition (Ti-6AL-4V Eli conforming to ASTM F-136).
• Compliance with non-clinical testing standards including ISO 11137-1:2006, ISO 11137-2:2009 for sterilization validation, and ISO 14801:2007 for fatigue testing.
• Similar surface treatment (R.B.M.).
• A general statement of being "designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments."

The review process focused on these points to confirm that the new device does not raise new questions of safety and effectiveness compared to the already marketed predicate devices.

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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, 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.

Not Found

I am sorry, but the provided text is a letter from the FDA to InnoBioSurg Co., Ltd. regarding the clearance of their IBS Implant System. It does not contain any information about acceptance criteria for a device, a study that proves the device meets acceptance criteria, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set information.

Therefore, I cannot extract the requested information from the given text.

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