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This instrument will be used to cut and clamp the umbilical cord in normal and abnormal deliveries. The instrument will cut and clamp both mother's side and baby's side of the univilical cord, simultaneously.

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This document is an FDA 510(k) clearance letter for a medical device called "Dr. Jahanger's Cutter (Umbilical Cord Cutter/Clamp)", dated October 29, 1999. It states that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria.

Here's why and what information is missing:

• Type of Document: This is an FDA clearance letter, which confirms that a device has been found substantially equivalent to a predicate device. It is not a study report or a summary of device performance testing.
• Purpose of 510(k): The 510(k) pathway for medical device clearance primarily relies on demonstrating substantial equivalence to a device already on the market (the "predicate device"). While some performance data might be submitted, the full details of clinical studies, acceptance criteria, and ground truth establishment are typically not included or summarized in the clearance letter itself.
• Specific Device: The device is a mechanical "Umbilical Cord Cutter/Clamp." For such a device, performance criteria would likely revolve around mechanical integrity, cutting efficiency, clamping effectiveness to prevent blood loss, biocompatibility of materials, and sterilization validation. These are engineering and performance specifications, not often clinical efficacy metrics in the same way an AI diagnostic would have.

Therefore, I cannot provide the requested table and study details because the provided document does not contain that information.

To answer your request, I would need a different type of document, such as:

• A clinical study report for the device.
• A premarket approval (PMA) application summary (which requires more extensive clinical data than a 510(k)).
• A detailed technical file or design history file from the manufacturer.

The provided text only includes the device name, its intended use (to cut and clamp the umbilical cord), and the FDA's determination of substantial equivalence. It does not elaborate on the specific tests, acceptance criteria, or the methodology of any studies conducted to demonstrate its performance.

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