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The Echelon Contour™ Curved Cutter with Reload is intended for transection in colorectal surgical procedures.

The Echelon Contour™ Curved Cutter Stapler with reload is a multifire, single patient use device with a curved head that cuts and staples. The device will provide ligation of colorectal structures when permanent ligation is required.

The device delivers four staggered rows of titanium staples, with a knife between the second and third row of staples, and staples and creates a 40 mm curved transection. The device is designed with a feature which prevents closing if a used reload is in the instrument.

Another feature is provided to prevent firing unless the closure trigger is latched in the closed position. A retaining pin holds tissue in place and can be positioned either manually or by squeezing the closure trigger.

The instrument is preloaded with a either a blue or green reload. The instrument may be further loaded for a maximum of six firings per instrument during a single procedure.

Each reload includes a knife blade with two staggered rows of staples on each side, an anvil, a yellow cutting washer, a retaining pin, and a staple retainer.

The provided text describes a 510(k) premarket notification for the "Echelon Contour™ Curved Cutter Stapler with Reload." This device is a surgical stapler, and the supporting documentation focuses on demonstrating its substantial equivalence to a legally marketed predicate device.

The study presented is not for an AI/ML medical device, but rather a traditional medical device (a surgical stapler). Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance of an algorithm, etc.) are not applicable to this submission.

The document primarily details bench testing, biocompatibility testing, accelerated aging stability, sterilization, and animal studies to demonstrate substantial equivalence to a predicate device. It explicitly states: "Clinical Studies: This submission does not include data from Clinical Studies."

Here's an attempt to fill out the table and answer the questions based only on the provided text, noting where information is not applicable or not provided.

Acceptance Criteria and Device Performance for Echelon Contour™ Curved Cutter Stapler with Reload

1. Table of Acceptance Criteria and Reported Device Performance (as derived from the text):

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated for each bench test or animal study. The overall approach is to show "equivalence" to a predicate device, rather than derive absolute performance metrics from a large sample.
• Data Provenance: Not specified in terms of country of origin. The studies are described as "non-clinical data" and "animal study" conducted in accordance with FDA's Good Laboratory Practice Standard (21 CFR 58). It's a regulatory submission for a physical device, not an AI model, so "retrospective or prospective" doesn't directly apply in the usual sense of human clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a medical device (stapler) submission, not an AI/ML device that requires human expert annotation for ground truth. Performance is assessed through physical measurements, chemical tests, and animal models.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 refer to human experts reviewing and agreeing on ground truth in studies involving subjective interpretation (e.g., image analysis for AI). This device relies on objective measurements in bench and animal studies to demonstrate equivalence.

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. This is not an AI/ML device, nor is it a study involving human readers or comparative effectiveness in diagnosing or interpreting medical images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This category applies to AI algorithms. This submission is for a physical surgical stapler.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the bench tests: "Ground truth" is established by standard engineering and mechanical test methodologies (e.g., force measurements, physical dimensions of staples, pressure leakage tests).
• For biocompatibility: Adherence to ISO standards and toxicology findings.
• For animal studies: Physiological outcomes (hemostasis, survival) in animal models compared to the predicate device.
• No "expert consensus," "pathology," or "outcomes data" in the typical clinical study sense described for ground truth.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. As above, no training set for an AI/ML model.

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ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The ECHELON, ECHELON ENDOPATH and ECHELON FLEX families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX™ 45 mm Powered Plus instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section. The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload. The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads are sterile, single patient use devices. They come in five colors corresponding to different closed staple heights, with the intention of being used in different tissue thicknesses. They are loaded into a Linear Cutter and deliver staples into the tissue when the instrument is fired. There are 70 staples in the 45mm length reload.

This document is a 510(k) Premarket Notification from the FDA regarding the "Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm". It is a medical device approval document and does not contain information about an AI/ML device study. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements pertain to the evaluation of AI/ML device performance, which is not covered in this document.

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The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The Echelon Flex Powered Plus Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in two shaft lengths: regular and long. The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a battery pack that must be installed prior to use. The Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology) are designed for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Flex Powered and Echelon Flex Powered Plus) in a 60mm configuration.

This document describes a 510(k) submission for surgical staplers and reloads, focusing on substantial equivalence to predicate devices. It does not contain information about the acceptance criteria for an AI/ML powered device or a study proving that an AI/ML device meets such criteria.

The submitted text focuses on the device's mechanical and electrical performance, biocompatibility, and electromagnetic compatibility. It is a traditional medical device submission, not specifically related to software as a medical device (SaMD) or AI/ML.

Therefore, I cannot provide the requested information, such as acceptance criteria table, sample sizes for test/training sets, expert qualifications, or details about MRMC studies.

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