(43 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, 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 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 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 Ethicon Endo-Surgery Echelon Flex Powered Articulating Endoscopic Linear Cutters (K110385) is a surgical device, not an AI/ML device. Therefore, the typical acceptance criteria and study designs associated with AI/ML device evaluations (e.g., performance metrics like sensitivity/specificity, sample sizes for AI training/testing sets, expert adjudication, MRMC studies) are not applicable.
This device is primarily evaluated through bench testing to demonstrate its mechanical performance and functional equivalence to a predicate device.
Here's an adaptation of the requested information, focusing on what is relevant for a non-AI surgical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from regulatory requirements for such devices) | Reported Device Performance (Inferred from "bench testing was performed to demonstrate that the new devices will perform as intended") |
|---|---|---|
| Mechanical/Functional Performance | Staple Line Formation: Ensure proper staple formation and security across various tissue thicknesses. | Performed as intended, demonstrating satisfactory staple line formation. |
| Tissue Cutting: Demonstrate effective and clean tissue transection. | Performed as intended, demonstrating effective tissue cutting. | |
| Articulation Mechanism: Verify the articulation mechanism operates correctly (e.g., adjusts in 15° increments up to 45°). | Articulation mechanism operates as intended, achieving specified angles. | |
| Firing Mechanism: Ensure reliable and consistent firing of staples and cutting blade. | Firing mechanism performed reliably and consistently. | |
| Safety Lock-Out Feature: Confirm the safety lock-out prevents firing empty/used cartridges. | Safety lock-out feature functioned correctly. | |
| Battery Power System: Demonstrate proper functioning of the battery-powered system. | Battery power system operated as intended, facilitating device function. | |
| Biocompatibility | Materials in contact with tissue meet biocompatibility standards. | Materials are similar to the predicate device and are presumed to meet biocompatibility standards (often addressed by material information, not explicit performance in this summary). |
| Sterility | Device is sterile. | Device is supplied sterile (stated as "sterile, single patient use instruments"). |
| Packaging Integrity | Packaging maintains sterility and device integrity. | Packaging maintained integrity (not explicitly stated in summary but a standard requirement). |
| Durability/Reliability | Device maintains performance throughout its intended single use. | Demonstrated through bench testing to function for its single-use purpose. |
| Substantial Equivalence | Device performs as safely and effectively as the predicate device. | Achieved, as indicated by the FDA's 510(k) clearance based on the submitted data showing "will perform as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. For bench testing of surgical devices, sample sizes vary depending on the specific test (e.g., number of firings, units tested for articulation). These are typically statistical samples sufficient to demonstrate reliability and consistency.
- Data Provenance: The data is from bench testing presumably conducted by the manufacturer, Ethicon Endo-Surgery, LLC. The text does not specify the country of origin of the data beyond the company's location (Guaynabo, PR and Cincinnati, OH). The studies would be prospective in nature, as new devices are manufactured and tested to demonstrate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This concept is not applicable for the type of device and study described. Bench testing of a surgical stapler does not rely on human experts to establish "ground truth" in the way AI/ML algorithms do for image interpretation or diagnosis. The "ground truth" for mechanical performance is defined by engineering specifications and objective measurements (e.g., staple height, pull-apart force, cutting efficiency).
4. Adjudication Method for the Test Set
- Not applicable. Adjudication relates to resolving disagreements among human readers or experts, which is not a component of bench testing for a mechanical surgical device. Performance is verified against objective, measurable criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance (e.g., radiologists interpreting images). This device is a surgical instrument and its evaluation does not involve diagnostic interpretation or human readers in an MRMC context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- This is not applicable as the device is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily objective engineering specifications and physical measurements. This includes:
- Mechanical performance metrics (e.g., staple formation, cutting force, articulation angles).
- Material properties.
- Functional reliability tests.
- Comparison to predicate device performance benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment for it. The design specifications and predicate device performance effectively serve as the "ground truth" for the device's development and testing.
§ 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.