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The ORA Implant Abutment System is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into SFI Abutments which are screwed into endosseous implants.

The ORA Implant Abutment is a precision machined ball shaped abutment that connects a compatible dental implant system with a removable partial or complete overdenture. The implant abutment is screwed into the dental implant. Connection to and retention of a denture is provided by a rubber o-ring, which may or may not be held within a metal housing. There are two color o-rings, a red processing o-ring and a white final o-ring. The retaining ring (metal housing) comes with the red o-ring (which is a firm rubber) inside. The retaining ring (metal housing) with the red o-ring is pushed over the wide part of the ball until seated. The stiffness of the red o-ring holds the housing in position. Any exposed areas of the abutment are blocked out so that only the metal housing is exposed. The retaining ring (metal housing) is then processed into the denture. After the material has cured, the denture is removed. The red o-ring is pulled out of the metal housing and the white o-ring is inserted into its place. The white o-ring is more flexible making insertion and removal easier. The bottom portion of the abutment (cuff area to end of threads) is an exact replica of the SFI Implant Abutments previously cleared by K130183 and K132814. ORA Implant Abutments are available in sixteen different platforms and each platform is compatible with one or more implant types.

Here's a breakdown of the acceptance criteria and the study information for the ORA Implant Abutment System, based on the provided text:

ORA Implant Abutment System

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not explicitly state quantitative performance acceptance criteria (e.g., specific thresholds for force, displacement, or reliability percentages). Instead, the acceptance criterion for the ORA Implant Abutment System is substantial equivalence to its predicate devices in terms of design, materials, intended use, operating principles, and manufacturing.

The reported device performance is that it meets this criterion through application and functional testing.

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

The document mentions "non-clinical test data" and "application and functional testing" to evaluate performance characteristics.

• Sample Size for Test Set: Not explicitly stated as a number of devices tested. The testing involved "tolerance analysis of platforms to identify worst case test samples." This suggests a selection of representative samples based on design variations, rather than a large statistical sample size of identical units.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be internal (conducted by or for Sterngold Dental, LLC) and is retrospective in the sense that it's comparing a new device to existing predicate devices' performance characteristics, rather than collecting new clinical data.

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

This section is not applicable as the study described is non-clinical performance testing for substantial equivalence, not a study involving human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This section is not applicable as the described study is non-clinical performance testing, not a study requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary." The comparison is for substantial equivalence to predicate devices based on technical characteristics and non-clinical performance.

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

This question is not applicable as the ORA Implant Abutment System is a physical medical device (implant abutment), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is demonstration of equivalent performance characteristics to legally marketed predicate devices through non-clinical testing. The predicate devices themselves represent established safe and effective designs in the market.

8. The Sample Size for the Training Set

This section is not applicable as the ORA Implant Abutment System is a physical device and no machine learning algorithm was described that would require a "training set."

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

This section is not applicable for the same reasons as point 8.

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