(17 days)
The ECHELON families of endoscopic linear cutters are intended for transection, resection, 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 instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The Echelon Flex Powered 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 three shaft lengths: compact, 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 instruments are shipped without a staple cartridge and must be loaded prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.
The provided text describes a 510(k) Premarket Notification for the "Echelon Flex Powered Articulating Endoscopic Linear Cutters." However, the document does not contain specific acceptance criteria or a detailed study that proves the device meets those criteria in the format typically used for AI/ML device evaluations.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Echelon Flex Powered Articulating Endoscopic Linear Cutters cleared under K110385). Substantial equivalence is the pathway for many medical devices to market in the US, where a new device is shown to be as safe and effective as a legally marketed device.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The text states:
"Ex-vivo tests (bench) were performed to ensure that the devices perform as intended and meet design specifications. Device performance was assessed against the design requirements, and included process verification, design verification and design validation."
This indicates that internal design specifications and requirements served as the acceptance criteria. However, the specific metrics, thresholds, and the actual performance results in relation to these criteria are not detailed in this summary. For example, it doesn't specify tensile strength of staple lines, leak rates, or time to complete a staple line.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The text mentions "Ex-vivo tests (bench)" but does not specify the number of samples or the origin of the tissue/materials used for these tests. It also doesn't clarify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/not provided for this type of device submission. The Echelon Flex is a mechanical surgical stapler, not an AI/ML diagnostic or prognostic device that relies on expert interpretation to establish ground truth for image or data analysis. Its performance is assessed through objective engineering and biological tests (e.g., staple line integrity, cutting ability).
4. Adjudication Method for the Test Set
This information is not applicable/not provided. As explained above, this is a mechanical device, and its performance evaluation involves objective physical and biological testing, not subjective expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where the AI assists human readers (e.g., radiologists interpreting images). The Echelon Flex is a surgical instrument.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a mechanical surgical tool, not an algorithm. Its operation inherently involves a human surgeon. The "standalone performance" of the device would refer to its function in a benchtop testing environment where a machine operates it, which is implied by the "ex-vivo tests" mentioned.
7. The Type of Ground Truth Used
The "ground truth" for this device would be established through objective measures of mechanical and biological function. For example:
- Mechanical Integrity: Measuring staple line strength, staple formation, cutting completeness, articulation range, firing force, etc., against predefined engineering specifications.
- Biological Performance (Ex-vivo): Testing on animal tissue or cadaveric tissue to evaluate staple line hemostasis, tissue compression, and the ability to cut and staple effectively without leakage or tissue damage.
The document implicitly refers to meeting "design requirements" and "design specifications" established through "process verification, design verification and design validation" as the basis for proving performance.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a mechanical instrument, not an AI/ML algorithm that requires a training set. The "training" for such a device would involve engineering design and iterative testing, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
Summary of Information from the Provided Text:
The document explains that the new Echelon Flex Powered Articulating Endoscopic Linear Cutters are substantially equivalent to a previously cleared predicate device (K110385). This substantial equivalence is based on:
- Intended Use: The device shares the same intended use for transection, resection, and anastomoses in various surgical procedures.
- Technological Characteristics: The device utilizes similar technology (insulated tubular shaft, ergonomic handle with an integrated motor, battery power, articulation system) for cutting and stapling. The stated modification "does not affect the intended use of the device or alter the fundamental scientific technology."
- Performance Testing: "Ex-vivo tests (bench) were performed to ensure that the devices perform as intended and meet design specifications. Device performance was assessed against the design requirements, and included process verification, design verification and design validation."
- Biocompatibility: Testing was in accordance with AAMI/ANSI/ISO 10993-1:2009 for biological evaluation of medical devices.
Conclusion:
The provided text describes a medical device submission based on substantial equivalence, which primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate. It does not provide the detailed acceptance criteria and study results typical for an AI/ML device where performance is often quantified by metrics like sensitivity, specificity, or AUC against a ground truth established by experts.
For the Echelon Flex Powered Articulating Endoscopic Linear Cutters, "acceptance criteria" are implied by "design specifications and requirements," and "performance" is demonstrated through "ex-vivo (bench) tests," rather than clinical studies with human subjects or AI-specific validation studies.
§ 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.