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Indications for Use: Polyurethane probe covers are indicated during diagnostic ultrasound procedures in cases where patient sensitivity to latex is speculative.

The Sheathing Technologies, Inc Ultrasound Probe Cover provides a thin, conformal covering to fit various and specific ultrasound transducer shapes. The cover is made in a general cylindrical shape. It is closed at the proximal end and open at the distal end for insertion of the ultrasound transducer. This device is an accessory used on diagnostic probes to help minimize cross contamination. The cover material is a polyether-based polyurethane. Various sizes and shapes of covers are offered to address the variations in Ultrasound Transducer configurations.

Product categories/models include

• General Purpose Sheathes Ultrasound 1. Probe Covers (sterile and non-sterile)
  Covers are packaged in both sterile and nonsterile, individually wrapped or in bag/box quantities.

The sole difference between this device and the predicate is a labeling change (addition of "viral barrier" to labeling, based on bench testing) to our line of seamless and seamlesstipped ultrasound probe covers. Please see section 13, labeling, for full wording. Please note that seamless and seamless-tipped probe covers are only a subset of the product line. The labeling for the remaining products would remain unchanged.

The provided text is a 510(k) summary for the "Sheathes Ultrasound Probe Covers" by Sheathing Technologies, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove a device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy for a medical AI device.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as this document does not contain that type of data.

This document describes a medical device (ultrasound probe covers) and highlights non-clinical bench testing to demonstrate a viral barrier and mechanical properties, not the diagnostic performance of an AI algorithm.

Here's a breakdown of what the document does discuss in relation to testing:

• Acceptance Criteria and Reported Device Performance: This information is not present in the context of an AI device's performance metrics. The document instead discusses non-clinical tests and their conclusions.
  • Bench Testing:
    • Viral Penetration Testing using Minute Mouse Virus
    • Burst Testing
    • Tensile Testing
    • Tear Propagation and Tear Resistance testing
    • Leak testing
  • Conclusion from Non-Clinical Tests: "The seamless probe cover device provides a viral barrier to viruses of the size of Minute Mouse Virus (20 nm) or larger." "Based on bench testing, the device is substantially equivalent or superior to the predicate device, and is safe and effective for its intended use."

The device in question is an ultrasound probe cover, which is a physical accessory, not a diagnostic AI algorithm. Therefore, the types of studies and performance metrics requested (e.g., sensitivity, specificity, human reader improvement with AI) are not applicable to the content provided.

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