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Surgical Gowns 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 microorganisms, body fluids, and particulate material.

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This document explicitly states that the submission is for a "Surgical Gown" and is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring formal clinical studies with acceptance criteria and ground truth in the way medical imaging or diagnostic AI devices do.

Therefore, the provided text does not contain information about:

1. A table of acceptance criteria and the reported device performance: This is not applicable to a 510(k) for a surgical gown in the context of clinical performance metrics. The relevant acceptance criteria for a surgical gown would typically involve performance standards outlined in recognized standards (e.g., AAMI PB70 for liquid barrier performance or ASTM F1670 for synthetic blood penetration), and these results would be presented in a different format than a clinical study's performance table.
2. Sample size used for the test set and the data provenance: Not applicable for this type of device and submission. Performance tests for gowns would involve material samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for algorithm performance (e.g., expert consensus on medical images) is not relevant here. Performance is measured against physical standards.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for assessing diagnostic performance with and without AI assistance, which is outside the scope of a surgical gown.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used: Not applicable in the context of clinical/diagnostic ground truth; performance is measured against physical material standards.
8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable.

The "study" in this context refers to the testing performed against recognized standards to demonstrate the physical performance characteristics of the surgical gown, such as barrier effectiveness, strength, and breathability. The provided document is simply the FDA's clearance letter and the "Indications for Use" statement, not the detailed testing report itself.

To answer your request, if this were an AI device, the FDA submission would contain a separate section detailing the clinical performance study, including the elements you listed. Since this is a surgical gown, the "performance" discussed in such a 510(k) would be related to how well the gown meets established material and barrier standards, and the "study" would be the associated lab testing.

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Cobes Sterile Disposable Surgical Gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Cobes Sterile Disposable Surgical Gown Model: G200XB Series (G2001B, G2002B and G2003B) G200XG Series (G2001G, G2002G and G2003G)

I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or any of the other specific points you've requested regarding a medical device's performance evaluation.

The document is a 510(k) premarket notification letter from the FDA to a company called Cobes Industries Company, Limited, regarding their "Cobes Sterile Disposable Surgical Gown." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. The enclosure provides the indicated uses and model details of the surgical gowns.

Therefore, I cannot extract the information needed to answer your request based on this document.

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Cobes Sterile Surgical Drape is a single use product used as a protective barrier for patient, such as to isolate a site of surgical incision from microbial and other contamination.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA regarding a sterile surgical drape, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general information but does not contain any details about performance metrics, study designs, sample sizes, or ground truth establishment.

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