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The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynccologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials.

The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters 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 buttressing materials.

The ENDOPATH ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.

The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, and/or creation of anastomoses and can be used with stable line or tissue buttressing materials.

The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection, and can be used with staple line or tissue buttressing materials.

The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic surgery or other minimally invasive surgical procedures for transccion, resection, and/or creation of anastomoses and can be used with staple line buttressing materials.

Endocutter 60 Endoscopic Linear Cutter: EC60, SC60, LONG60: Sterile, single patient use instruments that deliver staples while simultaneously diving tissue between rows. ECHELON' 60instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 60mm long and a cut line that is approximately 57mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.

ETS45 Endoscopic Linear Cutter: TSB45, TSG45, 6SB45; ETS-Flex45 Endoscopic Articulating Linear Cutter: ATB45, ATG45, 6TB45, LONG45A; ETS Compact Flex45 Articulating Linear Cutters: SCB45, SCG45, 6CB45: Sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. Instruments with blue (standard) reloads deliver two double- or triple-staggered rows of staples; instruments with green (thick) reloads deliver two double-staggered rows of staples only. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during and transportation. An articulation lever on some instruments enables bilateral movement of the instrument jaws.

ETS-Flex45 No-Knife Endoscopic Articulating Linear Stapler: NAB45, NAG45; ETS Compact-Flex45 No-Knife Articulating Linear Stapler: NSB45, NSG45: Sterile, single patient use instruments with blue (standard) reloads deliver two double- or triple-staggered rows of staples; instruments with green (thick) reloads deliver two double-staggered rows of staples only. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. An articulation lever on the instruments enables bilateral movement of the instrument jaws.

EZ45 Endoscopic Linear Cutter: ET45B, ET45G: Sterile, single patient use instrument that delivers two double-staggered rows of staples while simultaneously diving the tissue between rows. The instrument is designed for use in procedures with or without insufflation. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.

EZ45 No-Knife Endoscopic Linear Stapler: NK45B, NK45G: Sterile, single patient use instrument that delivers two double-staggered rows of staples. The instrument is designed for use in procedures with or without insufflation. The instrument's safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.

Thoracic Endoscopic Linear Cutter: EZ45B, EZ45G: Sterile, single patient use instrument that delivers two double-staggered rows of staples while simultaneously diving the tissue between rows. The instrument is designed for use in procedures without insufflation. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instrument has a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.

The provided text is a 510(k) Summary for a medical device (ENDOPATH Linear Cutters and Staplers) and an approval letter from the FDA. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria through a rigorous testing process with defined metrics.

Instead, the document states:

"Technological Characteristics The technological characteristics are identical to the predicate devices. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the Directions for Use and Indications Statements."

And then mentions:

"Performance Data Ethicon Endo-Surgery conducted animal testing (Section 19) and a clinical literature search (Section 20) to establish the use of the stapling devices (No-Knife ETS and EZ products only) in the open Left Atrial Appendage Exclusion procedure."

This means the device is being cleared based on its substantial equivalence to a predicate device, arguing that its technological characteristics are the same. The "performance data" mentioned (animal testing and literature search) is specifically for "establishing the use... in the open Left Atrial Appendage Exclusion procedure," not for demonstrating fulfillment of general performance acceptance criteria.

Therefore, it is not possible to fill out the table and answer most of the questions you've posed, as the required information is not present in the provided document.

Summary of missing information:

• Acceptance Criteria and Reported Device Performance: This document does not define specific performance acceptance criteria (e.g., staple formation success rate, cut line length consistency, etc.) nor does it report quantitative performance results against such criteria. The device is cleared based on equivalence to a predicate.
• Sample size and data provenance for test set: Not applicable, as no such performance study with a 'test set' as typically understood for an AI/diagnostic device is described.
• Number/qualifications of experts for ground truth: Not applicable.
• Adjudication method for test set: Not applicable.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth: Not applicable in the context of device performance metrics.
• Sample size for training set: Not applicable, as this is a surgical stapler, not an AI/algorithmic device requiring training data.
• How ground truth for training set was established: Not applicable.

The document focuses on establishing substantial equivalence to predicate devices and clarifying indications for use. It does not provide the kind of detailed performance study data you've requested.

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The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials.

ENDOPATH Endocutter 60 Endoscopic Linear Cutter models are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. These instruments may be used in either open or endoscopic procedures. The devices will be available in three shaft lengths: standard, compact and long, and will be furnished without a cartridge. Cartridges for the Endocutter 60 devices will be available in sizes that correspond to the thickness of tissue that is to be transected or resected: white (vascular/thin), blue (standard), gold (thick, less dense) and green (thick).

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets those criteria. It describes the device, its intended use, and its technological characteristics. It also states that "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device will perform as intended," but it does not provide any results, specific criteria, or details about these tests.

Therefore, I cannot provide the requested information in the structured table and numbered points.

The document is a 510(k) summary for a medical device (ENDOPATH Endocutter 60 Endoscopic Linear Cutter), which typically provides an overview of the device and its equivalence to a predicate device, rather than detailed study results or performance data. Such detailed information is usually found in the full 510(k) submission, which is not provided here.

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