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Cavity Preparation Removal of decayed and sound tooth structure Removal of restoration materials Prep for pit and fissure sealant Modification of enamel and dentin for increased bond strength

The Jetstream System is a pneumatic device which combines pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The Jetstream is capable of removing dental caries, old composite restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small handpiece which is approximately the size of a highspeed dental drill. The Jetstream consists of a console, handpiece, and a footswitch. Specifications for the Jetstream System are provided in the table below. The console houses the system pneumatics, simple, easy to use controls, and canisters for holding the particulate supply. The system is designed for easy service and maintenance with easily accessed and refillable canisters for the particulate supply.

This document does not contain the information requested for acceptance criteria and study details.

The provided text is a "Summary of Safety and Effectiveness Information" (a 510(k) premarket notification) for a dental device called the "Jetstream Cavity Preparation System." This type of document is used to demonstrate substantial equivalence to existing devices, not to present a detailed study proving the device meets specific acceptance criteria in the way you've described.

Here's why the information is missing:

• Acceptance Criteria/Performance Table: The document provides a comparison table of features between the Jetstream and predicate devices, but this is a comparison of specifications, not a table of pre-defined acceptance criteria (e.g., sensitivity, specificity, accuracy, precision) and the performance of the device against those criteria.
• Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document explicitly states: "As of September 1995, Dove Systems, Inc. conducted a database search of the published literature to identify adverse use experience with cavity preparation systems. This literature review revealed the following adverse event experience with cavity preparation systems." This indicates a literature review was performed for adverse events, not a dedicated study to assess the Jetstream's performance against specific metrics. There is no mention of a test set, training set, ground truth establishment, expert involvement, or any form of a comparative effectiveness study.
• Training Set Sample Size/Ground Truth: Not applicable as no specific study of the device's diagnostic or performance metrics is described.

Instead, the document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices by comparing technical specifications (e.g., cutting material, velocity settings, operating modes) and noting similar indications for use and adverse event profiles. The conclusion is based on this comparison, not on a new clinical performance study.

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