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Disposable sterile drapes are intended for use for :

• patient protective covering used to isolate incision sites and protect . against contamination during surgical procedures.
• cover a variety of surgical and non-surgical equipment in various settings . throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures

Drapes provided as sterile and non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 1135.

The document lists the following disposable surgical drape types and model numbers included in the submission:

I am sorry but this document is a 510(k) premarket notification decision letter from the FDA to a medical device manufacturer. It certifies that the device, a surgical and equipment drape, is substantially equivalent to a legally marketed predicate device.

The document does not contain information related to acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for evaluating an AI-powered device. It is a regulatory approval document for a non-AI medical device.

Therefore, I cannot provide the requested information based on the provided text.

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Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.

Gowns are provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.

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The provided document is a 510(k) premarket notification letter for a medical device (Jiehong Medical Surgical Gown). This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document primarily focuses on:

• Substantial equivalence determination for a physical product (surgical gown).
• Regulatory classifications and requirements.
• Indications for Use for the surgical gown.
• Material, gown style, sterility, sizes, and model numbers of the surgical gowns.

In summary, this document cannot be used to answer the questions you've posed about acceptance criteria and device performance studies related to AI/ML devices.

Ask a specific question about this device