(49 days)
ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads have application in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads deliver triple staggered rows of staples while simultaneously dividing the tissue between the rows. The instrument's safety lock-out feature is designed to prevent a spent reload from being refired. The instruments deliver a staple line that is approximately 35mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
The provided text describes a 510(k) premarket notification for a medical device, the ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads. This application is for a modification to an existing device, specifically changing a plastic cartridge sled to a metal one.
Key Findings Regarding Acceptance Criteria and Study Details:
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Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it broadly states that "Bench and simulated use testing... confirm that the subject device performs as intended and is substantially equivalent to the predicate devices."Acceptance Criteria (Implicit) Reported Device Performance Device performs as intended Confirmed by Bench and Simulated Use Testing (Force to fire, force to failure, functional, and fragility testing) Substantial equivalence to predicate devices Confirmed by Bench Testing Reduced likelihood of wedge band bypass failure New metal sled increases force to bypass Reduced potential for shearing or bypass during firing Metal sled is stiffer, has higher yield and ultimate strength -
Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" sample size in the context of clinical trials or data for algorithm evaluation. The testing described is "Bench and simulated use testing" which implies in-vitro or laboratory-based testing, not human-patient-derived data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of human data. -
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The testing described is bench and simulated use testing, not based on expert-adjudicated ground truth from medical images or patient outcomes. -
Adjudication Method for the Test Set:
Not applicable. No expert adjudication is mentioned. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done. The document explicitly states: "Clinical testing was not performed in support of this submission." This indicates that no studies involving human readers or cases were conducted. -
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a surgical stapler, not an AI algorithm. Its performance is evaluated through mechanical bench and simulated use testing, not through standalone algorithm performance. -
Type of Ground Truth Used:
The "ground truth" for this device's performance is established through direct physical measurements and observations during "Bench and simulated use testing." This includes evaluating parameters like "force to fire, force to failure, functional testing, and fragility testing." The "ground truth" here is the physical behavior and mechanical properties of the device under test conditions, compared against expected performance and predicate device characteristics. -
Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that would require a training set. -
How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.