Search Results

The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional U-stitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit. For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications. Both configurations of the AMT Suture Passer feature identical components, except for the end-effectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures.

This document is an FDA 510(k) clearance letter for a medical device called the "AMT Suture Passer." It outlines the regulatory review process and the basis for the FDA's determination of substantial equivalence to previously cleared devices.

The request asks for details on acceptance criteria and a study proving the device meets these criteria. However, the provided document does not describe a study involving an AI/Machine Learning algorithm, human readers, or a test set with ground truth established by experts.

Instead, the document details the performance data for a physical medical device (AMT Suture Passer) through bench testing, biocompatibility testing, sterilization validation, and shelf-life testing. It explicitly states:

• "B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device."
• "E. Animal Study: Animal testing was NOT performed."
• "F. Clinical Study: Clinical testing was NOT performed."

Therefore, I cannot provide the requested information regarding an AI study, test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details from this document. The information requested aligns with studies typically performed for AI/ML-driven medical devices, which the AMT Suture Passer is not.

However, I can extract the acceptance criteria and performance data for the physical device as presented in the document:

Acceptance Criteria and Device Performance (Based on the Provided Document for a Physical Device)

The "AMT Suture Passer" is a physical medical device, not an AI/ML diagnostic tool. Therefore, the acceptance criteria and performance data relate to its physical properties, sterility, biocompatibility, and functionality as a surgical instrument. There is no mention of AI performance metrics like sensitivity, specificity, AUC, or reader improvement.

Here's a summary of the performance data and acceptance criteria as described:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device is a physical instrument without AI components, the following points as requested in the prompt are not applicable or detailed in the provided document:

2. Sample size used for the test set and the data provenance: Not applicable for a physical device's bench/biocompatibility testing in this context. These tests are typically performed on a statistically relevant sample size of manufactured devices/materials, but specific numbers are not provided. Data provenance would be from manufacturing and testing labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by direct measurement and compliance with engineering/material standards, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (no AI component).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (no AI algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, the "ground truth" for acceptance is determined by adherence to established material specifications, manufacturing tolerances, mechanical performance criteria, and sterility/biocompatibility standards as measured through laboratory testing.
8. The sample size for the training set: Not applicable (no AI component).
9. How the ground truth for the training set was established: Not applicable (no AI component).

Ask a specific question about this device