(86 days)
The devices are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 70mm, 160mm three lengths. Reloads of easyEndoTM Linear Cutting Stapler and Loading Units for Single Use are available in three staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm and 4.8mm. Reloads of easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use are available in four staple sizes to accommodate various tissue thickness: 2.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.
The provided text is a 510(k) summary for the easyEndo™ Linear Cutting Stapler and Loading Units, a medical device. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical performance and design comparisons. It does not present a study with specific acceptance criteria that the device meets numerically, as would be expected for an AI/ML device.
Therefore, I cannot fully answer your request by filling out the table and detailed points as it's designed for an AI/ML device evaluation. The information provided is a premarket notification for a traditional medical device, where "acceptance criteria" are typically met through adherence to recognized standards (e.g., ISO, ASTM, USP) and direct comparison to predicates.
Here's a breakdown of why and what information can be extracted/inferred:
Why the Request Cannot Be Fully Answered as Posed:
- No AI/ML Component: The device is a mechanical stapler, not an AI/ML system. Therefore, concepts like "algorithm only without human-in-the-loop performance," "effect size of human readers improving with AI," "training set," "ground truth for training set," "number of experts for ground truth," and "adjudication method" are not applicable.
- "Acceptance Criteria" Different: For a traditional device like this, "acceptance criteria" are implied by compliance with performance standards and the demonstration of equivalence to legally marketed predicate devices. There isn't a specific quantitative "accuracy" or "performance metric" with a numerical threshold tied to the device's function that is then measured in a study. The "performance test" section describes what was tested, but not the specific thresholds for "acceptance."
- No "Study" as Defined for AI/ML: The document describes "non-clinical tests" (bench testing) and states "No clinical study is included in this submission." This means there wasn't a comparative clinical trial to measure human-in-the-loop performance or standalone performance in a real-world setting against a defined ground truth.
Extracted Information (and why some points are N/A):
Based on the provided text, here's what can be addressed:
- Device Name: easyEndo™ Linear Cutting Stapler and Loading Units for Single Use, easyEndo™ Universal Linear Cutting Stapler and Loading Units for Single Use
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category (Derived from Non-Clinical Tests) | Specific Criterion (Implicitly Met by Design/Testing) | Reported Device Performance (Implied by "complies" and "determined SE") |
|---|---|---|
| Biocompatibility | Biologically safe for patient contact. | Complies with ISO 10993-1, -5, -10; USP 38-NF 33 ; USP 39-NF34 . |
| Sterilization | Sterilizable to an appropriate level. | Complies with ISO 11137-2 (Radiation sterilization). |
| Package Integrity | Maintains sterility and functionality. | Test result: Met. |
| Shelf Life | Maintains specified performance over its claimed life. | Test result: Met after accelerated aging. |
| Performance - Firing Force | Appropriate force for operation. | Test result: Met, comparable to predicate. |
| Performance - Staple Formation | Staples form correctly. | Test result: Met, comparable to predicate. |
| Performance - Staple Line Pressure | Maintains appropriate pressure. | Test result: Met, comparable to predicate. |
| Performance - Staple Line Tensile Test | Withstands appropriate tensile stress. | Test result: Met, comparable to predicate. |
| Performance - Hemostasis Evaluation Test | Effective in preventing bleeding. | Test result: Met, comparable to predicate. |
| Performance - Close Staple Height Test | Staples close to specified height. | Test result: Met, comparable to predicate. |
| Labeling | Complies with regulatory labeling requirements. | Conforms with 21 CFR 801. |
| Endotoxin Limit |
§ 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.