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The OSI O-ball Abutment implant is a self-tapping titanium threaded screw indicated for long term intra-bony fixation of upper and lower dentures in edentulous cases. These devices will permit immediate splinting and ability and short-term fixation of failing crown and bridge installations, for full or partial edentulism. They can be used in the anterior regions of the maxillary and mandibular arches and are indicated for immediate loading when there is good primary stability and appropriate occlusal load.

The JUELL OSI O-Ball Abutment Dental Implant is available with a gingival collar in four diameters: 3.0mm, 3.5mm, 4.0mm and 4.5mm. The JUELL OSI O-Ball Abutment Dental Implant is available in thread lengths ranging from 10mm to 18mm. The implant is manufactured from ASTM F136 Ti6Al4V. The threaded surface is blasted with particulate media to increase the surface area.

The provided FDA 510(k) summary for the Juell OSI O-ball Abutment Dental Implant focuses on establishing Substantial Equivalence to legally marketed predicate devices, rather than performing a rigorous study to prove the device meets specific acceptance criteria with quantifiable metrics.

Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this document as these types of studies are not typically required for 510(k) clearances focused on substantial equivalence through material and design comparison and existing test standards.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

Acceptance Criteria and Device Performance for Juell OSI O-ball Abutment Dental Implant (K110348)1

The primary "acceptance criterion" for this 510(k) clearance is Substantial Equivalence to existing predicate devices, particularly regarding materials, design, indications for use, and successful fatigue testing.

The study presented is a comparison to predicate devices and demonstration of compliance with an industry standard for mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated for fatigue testing. Fatigue testing according to ISO 14801 typically involves multiple samples (e.g., 10-20 per condition) to establish a statistically significant endurance limit, but the exact number is not provided in this summary.
• Data Provenance: The fatigue testing was conducted by or for Juell Dental. The country of origin of the data is not specified, but the company is based in Ardmore, OK, USA. The testing is prospective for the device being submitted.

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

Not applicable. This type of submission relies on engineering standards (ISO 14801) and comparison to predicate devices, not on expert-established ground truth for a test set in the clinical or diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical or diagnostic "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not relevant for this type of device (dental implant) and submission, which focuses on mechanical performance and substantial equivalence.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical medical device (dental implant), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for the fatigue test was established by the ISO 14801 standard, which defines how dental implants should be subjected to cyclic loading to assess their durability. The outcome is whether the device successfully met the standard's criteria (i.e., did not fracture within a specified number of cycles at a given load).

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. The device design and materials are based on established engineering principles and comparison to existing, already "trained" (i.e., clinically proven) predicate devices.

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

Not applicable. As there's no training set, there's no ground truth establishment for it.

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