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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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