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Delivery of restorative and impression material.

The OsteoGraf stainless steel syringe is a device used for the delivery of restorative and impression material. It is composed of a stainless steel barrel, polypropylene plunger, and rubber plunger tip.

The provided text is a 510(k) summary for a medical device: "OsteoGraf stainless steel syringe." This document describes the device, its intended use, and compares it to predicate devices.

However, the text does not contain any information about:

1. Acceptance criteria or reported device performance for clinical or diagnostic efficacy. This device is a syringe for delivering restorative and impression material, implying its performance would be related to material delivery consistency, sterility, biocompatibility, and mechanical integrity, not diagnostic accuracy.
2. Study design, sample sizes (test or training sets), data provenance, expert qualifications, adjudication methods, or ground truth establishment. These elements are typically found in clinical studies or performance validation reports for devices that make diagnostic or prognostic claims. A syringe is a delivery tool, not a diagnostic one.
3. MRMC comparative effectiveness studies or standalone algorithm performance. These are relevant for AI/ML-driven diagnostic devices, which this syringe clearly is not.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving the device meets them based on the provided text. The K962786 document is a regulatory submission focused on demonstrating substantial equivalence for a non-diagnostic device, not a performance study as you've outlined.

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