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Mill Pond, Inc. Stainless Steel Suture used with the Mill Pond, Inc. Suturer has applications in gynecological, orthopedic, and general abdominal and thoracic endoscopic surgical wound closure procedures including creation of anastomoses and hernia repair.

The subject device is a reuseable hand-held instrument that places stainless steel sutures in an open or minimally invasive surgical procedure. The suture material is supplied in a sterile disposable format that involves structures for dispensing the suture and for mounting this to the instrument. The device consists of a handle, a shaft, and a jaw at the end of the shaft. The jaw, which opens and closes via a manual lever on the handle, holds the tissue to be sutured. An electric switch also on the handle activates a battery-powered motor mechanism that drives the suture wire through the tissue.

The jaw is then used to grab both strands of wire near where they emanate from the tissue. A second electric switch on the handle activates another motor that rotates the jaw causing the wire ends to twist about themselves bringing the tissue together until the desired amount of tension is developed. Another manual lever on the handle is used to cut the wire. The device is now ready for the next suture.

This document is a 510(k) premarket notification for a surgical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical trial report or performance study.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• 510(k) Summary Nature: A 510(k) summary (or premarket notification) primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a dedicated study. It describes the device, its intended use, and compares its technical aspects to existing devices.
• Lack of Performance Data: The provided text details the device's design, materials, and intended use. It does not include any sections on:
  • Performance metrics (e.g., tensile strength of sutures, speed of application, clinical success rates).
  • Study design (e.g., patient population, endpoints, methodology).
  • Results of any clinical or non-clinical performance studies.
  • Statistical analysis.

Therefore, I cannot fulfill your request for the specific information points because the provided document does not contain that level of detail regarding acceptance criteria and a study proving their fulfillment.

What the document does state (in terms of regulatory approval):

• Substantial Equivalence: The FDA has determined the device to be "substantially equivalent" (K984151) to predicate devices: Lukens® Stainless Steel Surgical Suture, U.S. Surgical Corporation Auto Suture® Powered Endoscopic GIA Stapler, and aspects of the 3M Maxi-Driver II Battery-Powered System. This means the FDA believes it is as safe and effective as these existing devices, based on the information provided in the 510(k) submission.
• Intended Use: "Surgical device to connect tissue." More specifically, the FDA letter clarifies: "abdominal wound closure, hernia repair, sternal closure, and certain orthopedic procedures including cerclage and tendon repair." The "Statement of Indications for Use" adds: "gynecological, orthopedic, and general abdominal and thoracic endoscopic surgical wound closure procedures including creation of anastomoses and hernia repair."
• Material Specification: The device "may not be manufactured from any metal other than 316L stainless steel." This is a critical regulatory limitation acting as a de facto acceptance criterion for material.
• Sterilization: "Sterilization guidelines of both the instrument and the disposable will be verified according to the referenced AAMI documents." This indicates a requirement for the device to meet AAMI sterilization standards, but no data on conducted verification is provided in this summary.
• Prescription Use: The device is restricted to prescription use (21 CFR 801.109).

To obtain the information you requested, a comprehensive clinical or performance study report for this device would be necessary.

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