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The BlueSky VISTA™ Wound Vacuum System is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing.

The product is a portable suction pump that may promote wound healing when used with accessory wound sealing kits.

The provided text K061367 is a 510(k) summary for the BlueSky VISTA™ Wound Vacuum System, which is a portable suction pump. This document describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the 510(k) summary does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device. The product described is a physical medical device (a wound vacuum system), not an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies. These concepts are not applicable to the type of medical device described in the provided text.

The 510(k) states: "Performance testing has been completed to demonstrate the safe and effective use of the BlueSky VISTA™ Wound Vacuum System for the intended use." and "Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use."

This indicates that some performance testing was done, but the details of that testing, including specific acceptance criteria and detailed results, are not included in this summary document. For a traditional medical device, this performance testing typically involves engineering bench testing, biocompatibility, electrical safety, and sometimes limited clinical testing, but not the AI-specific metrics you've requested.

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