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The Ospol AB, Ospol Dental Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

The Ospol Dental Implant System consists of 4 implants, diameter 4,0 mm, and length from 8,0 to 15,0 mm, 2 standard Abutments (high and low) and 2 Anatomic Abutments (high and low) including healing abutments, cover and abutment screws.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria or performance metrics in the typical sense (e.g., success rates, survival rates, functional outcomes with specific thresholds). Instead, the acceptance is based on a demonstration of substantial equivalence to predicate devices. The "performance" is implicitly deemed equivalent if the device shares fundamental characteristics with predicate devices that have already been cleared.

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

• Sample Size: Not applicable in the context of this 510(k) submission. The clearance is based on a determination of substantial equivalence, not on a clinical or performance study with a "test set" of patients.
• Data Provenance: Not applicable. There is no clinical "test set" of patient data mentioned in this submission. The "data" provenance would refer to the characteristics of the predicate devices themselves (e.g., their clearance information, which would be from the US FDA).

3. Number of Experts and Qualifications for Establishing Ground Truth for the Test Set:

• Not applicable. No "ground truth" was established for a test set in this 510(k) submission because there was no clinical study conducted. The comparison is based on technical specifications and indications for use.

4. Adjudication Method for the Test Set:

• Not applicable. There was no clinical study requiring adjudication of a test set. The review and determination of substantial equivalence are made by the FDA (Office of Device Evaluation).

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

• No, a multi-reader, multi-case comparative effectiveness study was not done. This submission focuses on a dental implant system (a physical medical device), not an AI or imaging diagnostic tool that would typically undergo an MRMC study.

6. Standalone Performance Study (Algorithm Only):

• No, a standalone performance study was not done. This device is a physical dental implant, not an algorithm or software. Its performance is evaluated through material properties, design, and comparison to existing devices.

7. Type of Ground Truth Used:

• The "ground truth" in this context is the established safety and efficacy of the predicate devices (Nobel Biocare TiUnite Endosseous Implants K050705 and Astra Tech Fixture Micro Thread™ Osseo Speed™ K053384). The assumption is that if the new device is substantially equivalent in its fundamental characteristics, it will also be safe and effective.

8. Sample Size for the Training Set:

• Not applicable. As this is not an AI/ML device, there is no "training set."

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

• Not applicable. There is no training set for this device.

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