Search Results

The Gongdong Disposable Sharps Container is intended to be used in the healthcare facilities for the safe disposal of hazardous sharps.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Gongdong Disposable Sharps Container." This document primarily focuses on the regulatory clearance of a physical medical device (a sharps container) rather than a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details, which are typically relevant for AI/ML-based medical devices, is not present in this document.

The document confirms that:

• Trade/Device Name: Gongdong Disposable Sharps Container
• Regulation Number: 880.5570
• Regulation Name: Hypodermic Single Lumen Needle (This seems to be the regulation under which the sharps container is being evaluated, perhaps because it handles these items).
• Regulatory Class: II
• Product Code: MMK
• Indications For Use: "The Gongdong Disposable Sharps Container is intended to be used in the healthcare facilities for the safe disposal of hazardous sharps."
• The device was found Substantially Equivalent to legally marketed predicate devices.

The information you are asking for is specific to the performance evaluation of AI/ML algorithms, which is not applicable to a physical sharps container.

Ask a specific question about this device

The Gongdong Disposable Vaginal Speculum is non sterile products and is intended to be used by a medical professional to expose the interior of the vagina to facilitate visualization during the obstetrical and gynecological procedures.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a "Gongdong Disposable Vaginal Speculum," indicating its substantial equivalence to a predicate device. It specifies general controls, regulatory class, and indications for use.

Therefore, I cannot provide the requested information, including tables of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Ask a specific question about this device