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The SATURNO™ Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla. The SODI is used to restore masticatory function for the patient and may be suitable for immediate function if sufficient primary stability of the implant is achieved at the time of placement.

The SATURNO™ Overdenture Implant (SODI) System is a one-piece, self-tapping, threaded, root-form . dental implant with the abutment portion being either straight or angled for overdenture prosthetic attachment. SODI implants are provided in three diameters (2.0, 2.4 and 2.9 mm), three lengths (10, 12. and 14 mm) and two cuff heights (2.0 and 4.0 mm). Each size SODI implant has a 1.8 mm attachment ball and is available with a straight or 200 angled abutment section.

The SATURNO™ Overdenture Implant System is a dental implant system designed to retain overdentures or partial dentures. The submission indicates that no clinical testing data was submitted, referenced, or relied upon to demonstrate substantial equivalence. Therefore, there is no study that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission states that "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing demonstrated the subject device to be equivalent to or stronger than the tested predicate device."

This means the acceptance criteria are not clinical performance measures but rather engineering and mechanical testing standards.

Here's a breakdown based on the provided text, while acknowledging the absence of a clinical study:

1. Table of Acceptance Criteria and Reported Device Performance

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

Since no clinical study was conducted or relied upon for this premarket notification, there is no "test set" in the context of patient data. The "test set" refers to the dental implants and materials used in the engineering and mechanical testing. The sample sizes for these non-clinical tests are not specified in the provided text. The data provenance is described as "Non-clinical testing data submitted."

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

This information is not applicable as there was no clinical test set requiring expert ground truth establishment for patient outcomes. The acceptance criteria were based on established engineering standards (like ISO 14801) and comparisons to predicate devices, which would involve engineering expertise during the testing and analysis.

4. Adjudication Method for the Test Set

This is not applicable as there was no clinical test set requiring adjuducation of patient outcomes.

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

No MRMC comparative effectiveness study was done. The submission explicitly states, "Clinical data were not submitted in this premarket notification." The focus was on demonstrating substantial equivalence through non-clinical testing.

6. Standalone Performance Study

No standalone performance study (in the context of an algorithm or human-in-the-loop performance) was done. The device is a physical medical device (dental implant system), and its performance was assessed through engineering and mechanical testing, not through an algorithmic or human-in-the-loop evaluation.

7. Type of Ground Truth Used

The "ground truth" for demonstrating equivalence was based on:

• Established engineering standards: Specifically, ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
• Comparison to predicate devices: The physical dimensions, characteristics, materials, and operating principles of the SATURNO™ Overdenture Implant System were considered "equivalent" to previously marketed and cleared devices.

8. Sample Size for the Training Set

This is not applicable. There was no "training set" in the context of machine learning. The "training" for this device involved its design and manufacturing process to meet the established engineering and safety standards.

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

This is not applicable. Since there was no "training set" in the machine learning sense, there's no ground truth establishment for it. The "ground truth" for the device's design and manufacturing revolves around adherence to established quality systems, materials science principles, and relevant engineering standards, as demonstrated through the non-clinical tests.

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