(129 days)
The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 Row) reloads are sterile, single patient use devices that simultaneously cut and staple tissue. There are four staggered rows of staples, two on either side of the cut line. The Echelon Flex Powered Vascular Stapler with Advanced Placement Tip and reloads have a staple line that is approximately 35 mm long and a cut line that is approximately 30 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 access to the operative site. The instrument is packaged with a primary lithium battery pack that must be installed prior to use. The instrument is 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, transporting, and installing the reload. The instrument's lockout 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 describes the Ethicon Endo-Surgery, LLC's K141952 submission for the Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip, and Endopath Echelon™ Vascular White Reloads for Advanced Placement Tip.
However, the document is a 510(k) summary for a medical device and does not contain the specific acceptance criteria or a study with detailed performance outcomes in a table format as requested. It outlines the types of testing performed to demonstrate substantial equivalence to predicate devices, but it does not provide the quantitative acceptance criteria or detailed results required to complete the requested table.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone (algorithm only) performance details
- Type of ground truth used (beyond general 'bench testing,' 'animal testing')
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to existing predicate devices, which is the primary requirement for a 510(k) submission. It lists the types of testing conducted, such as:
- Bench testing for force-to-close evaluation
- Staple height, staple form, and staple line integrity evaluation
- Animal testing for hemostasis evaluation (in acute and survival models)
- Electrical safety and electromagnetic compatibility testing
- MR compatibility testing
- Aggregate device biocompatibility testing for patient contacting materials
These tests are performed to show that the new device performs as intended and is as safe and effective as the predicate devices, but the specific acceptance criteria (e.g., "force-to-close must be X to Y range") and the quantitative results are not included in this summary document. Similarly, details regarding ground truth establishment, expert involvement, or AI-specific studies (MRMC, standalone algorithm performance) are not present, as this is a mechanical surgical stapler, not an AI/software as a medical device (SaMD).
§ 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.