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The ETHICON ™ Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.

The ETHICON™ Linear Stapler delivers two staggered rows of titanium staples in order to approximate internal tissues. The Subject device is sterile, single patient, disposable device used in conjunction with reloadable ETHICON™ Linear Stapler 3D Reloads to staple tissue in one firing stroke. The Subject device is a next generation Linear Stapler to be used in open procedures requiring a surgical stapler. The Subject device incorporates proven Gripping Surface Technology (GST) Reload Technology, leveraged from Ethicon Endocutters, along with a 3-D staples developed for other Ethicon Endocutters and open mechanical devices.

The ETHICON™ Linear Stapler 30 mm, 60 mm and 90 mm Staplers are sterile, single- patient-use instruments that staple tissue. There are two staggered rows of staples, on either side of the staple line. This device may be used on the general population for routine wound closure via stapling. The 30 mm reload creates a 30 mm staple line. The 60 mm reload creates a 60 mm staple line. The 90 mm reload creates a 90 mm staple line.

The 90mm device and compatible reloads have also been developed. The 90mm device can be used by surgeons who prefer to use a 90mm device when transecting wider tissue such as completing the closure of a side-to-side anastomosis or when performing a sleeve gastrectomy. The Predicate device does not currently offer a 90mm size but the principles of operation are the 30mm and 60mm devices. Design verification testing demonstrates that the 90mm device and compatible reloads do not raise new types of safety or effectiveness questions.

The instruments are shipped 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 instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure. There are blue and green reload options for each device size.

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 provided text does not contain information about acceptance criteria or a study proving a device meets them in the context of an AI/ML powered medical device. Instead, the document is an FDA 510(k) clearance letter and summary for a surgical stapler and its reloads.

The information in the document details the substantial equivalence of the ETHICON™ Linear Stapler to a predicate device, focusing on bench performance testing and animal testing for mechanical, functional, and biological properties of the stapler itself, NOT an AI/ML algorithm.

Therefore, I cannot provide the requested information, such as:

• Acceptance criteria and reported device performance for an AI/ML product: The document outlines engineering specifications and performance evaluations for a mechanical device.
• Sample size for the test set and data provenance: No test set for an AI/ML algorithm is mentioned.
• Number of experts used to establish ground truth and their qualifications: Ground truth for AI/ML is not relevant here.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as it's not an AI-assisted device.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable for an AI/ML algorithms ground truth, but for the mechanical stapler, the "ground truth" would be successful stapling outcomes and tissue integrity observed in bench and animal tests.
• Sample size for the training set: No training set for an AI/ML algorithm is mentioned.
• How the ground truth for the training set was established: Not applicable.

The document focuses on:

• Bench Performance Testing:
  • Formed Staple Height (FSH)
  • Staple Form Quality (SFQ)
  • Staple Line Integrity (SLI)
  • Force to Close
  • Force to Fire
  • Jaw Aperture
  • No Spent Reload/Lockout
  • Human Factor Report/Usability Testing
  • Staple line Strength Test
• Animal Testing (In-vivo):
  • Acute Hemostasis evaluation study
  • Tissue Healing response, Survival Study
• Biocompatibility: Based on ISO 10993-1.

All of these tests "passed the criteria for success," indicating the device met the pre-defined performance requirements for a mechanical surgical stapler.

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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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The Echelon Endoscopic Linear Cutters and Cartridges are intended for transaction, resection, and/or 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 devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. These devices may be used in either open or Endoscopic procedures, depending upon the design. The device is intended for use in transection and resection of tissue during multiple open or minimally invasive surgical procedures. They are intended for use in the creation of anastomoses in these procedures. The instruments are reloadable and, as such, they may be reloaded with various cartridges depending on the thickness of tissue that is to be transected or resected.

The Echelon Zebra cartridge is a storage case that contains implantable staples. The cartridge is loaded into an Echelon instrument. When the instrument is deployed, it cuts a surgical wound while simultaneously delivering the staples into the tissue. As in the predicate Echclon cartridge, the Zebra cartridges are available in 60 mm lengths. Zebra cartridges will also be available in a 45 mm length for use with the 45mm instruments. There are 70 staples in the 45mm length cartridge and 88 staplers in the 60 mm length cartridge.

Cartridges deliver the staples in a predetermined staple row configuration or pattern in relation to the cut line. The staple row configurations of both the predicate and the new device have 6 staples, 3 staples on either side of the cut line. The staple row configuration (or pattern) of the prodicate device is straight. That is to say, all 6 staples are of the same height and formation. The Zebra cartridge staple row configuration is step-wise. This means that of the 6 staples, the two outer most staples are of a taller height and formation than the 4 inner staples.

The provided 510(k) summary for the Echelon Zebra Cartridges is for a medical device (stapling device) and describes its function and comparison to predicate devices. It does not present information about software or AI, nor does it describe specific acceptance criteria, performance metrics, or study designs typically associated with AI/software performance validation.

Therefore, I cannot extract the requested information (acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) as it is not present in the provided text.

The text states: "Performance Data. Bench testing was performed to demonstrate that the new device will perform as intended." This indicates that physical bench testing was done for the mechanical device, but no details of that testing, nor any information related to AI or software, are provided.

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