Search Results

Medline Prevention ™ Disposable Surgical Gowns are surgical apparel that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of body fluids, micro-organisms, and particulate material.

Not Found

This document is a 510(k) premarket notification from the FDA, specifically concerning the substantial equivalence of Medline Prevention Surgical Gowns to predicate devices. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter from the FDA to Medline Industries, Inc. states that the FDA has reviewed the 510(k) submission and determined that the device is substantially equivalent to legally marketed predicate devices. This determination is based on the comparison of the new device to existing devices, usually in terms of materials, intended use, and performance characteristics, but the letter itself does not detail the specific performance criteria or the study data demonstrating compliance.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance (algorithm only) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

These details would typically be found in the actual 510(k) submission documentation, which is not provided in the given text. The provided document is just the FDA's decision letter acknowledging the substantial equivalence.

Ask a specific question about this device

Medline Disposable Surgical Drapes are surgical apparel that are intended to be worn by Meditie Disposative Burgical procedures to protect both the surgical patient and the operating room personnel from transfer of body fluids, micro-organisms, and particulate material.

Medline Disposable Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and study that proves a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Medline Industries regarding their surgical gowns and drapes. It discusses the substantial equivalence of these devices to legally marketed predicate devices and outlines regulatory responsibilities. It does not include details about specific performance studies, acceptance criteria, or ground truth establishment.

Ask a specific question about this device