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The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.

Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.
This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium allov. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed titanium powder coating, and the surface of the external hex is anodized magenta in color.

The provided text describes a 510(k) submission for a dental implant and explicitly states "Performance Data: Not applicable." This indicates that no specific studies proving the acceptance criteria for the device were conducted or required for this particular submission. The submission relies on claiming substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because the document clearly states that performance data is not applicable.

However, if this were a different kind of medical device submission where performance data was applicable, here's how I would structure the answer based on your request, using placeholders for the missing information:

Acceptance Criteria and Study to Prove Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria (e.g., Accuracy, Sensitivity, Specificity, Precision, etc.) | Threshold/Target Value (e.g., >90%,

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