(24 days)
The EEA™ circular stapler with Tri-Staple™ technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The EEA™ circular stapler with Tri-Staple™ technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an end-to-end, end-to-side or side-to-side anastomosis in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go. The diameter of the is determined by the selection of the 33 mm, 31 mm, 25 mm stapler. The EEA™ circular stapler with Tri-Staple™ technology is available in 2 shaft lengths; a standard 22 cm shaft and an XL 35 cm shaft. The staplers are offered in 2 staple sizes, medium/thick and extra thick. Staplers with medium/thick staple size (purple) deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. Staplers with extra thick staple size (black) deploy three heightprogressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. The low profile Tilt-Top™ anvil is available on all staplers. A blunt and a sharp (only applicable to 25mm stapler) tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
The design modification is to add one contraindication per special control 21 CFR 878.4740(b)(2)(ix)(A), and revises IFUs and labels per new regulation requirements.
The provided text is a 510(k) summary for a medical device, the EEA™ Circular Stapler with Tri-Staple™ Technology. It details the regulatory submission and confirms the device's substantial equivalence to a predicate device.
However, the information required to answer your specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria," particularly regarding advanced AI/ML device studies (like those involving multi-reader multi-case studies, ground truth establishment by experts, and sample sizes for training/test sets), is not present in this document. This document describes a traditional medical device submission, not an AI/ML software as a medical device (SaMD) or an AI-enabled device.
The study summarized in this document focuses on non-clinical performance data (specifically, a usability assessment for labeling changes) to demonstrate substantial equivalence, and it explicitly states:
- "Non-clinical performance data - Usability assessment was performed for the proposed labeling changes to demonstrate substantial equivalence to the predicate device."
- "Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies."
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance (in the context of AI/ML metrics).
- Sample sizes for test sets or data provenance for AI/ML validation.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for AI/ML.
- MRMC comparative effectiveness studies or effect sizes for human readers with AI assistance.
- Standalone performance for an algorithm.
- Types of ground truth, training set sample size, or how ground truth was established for a training set (as these are unique to AI/ML development and validation).
This submission is about a physical surgical stapler and a minor change (adding a contraindication) rather than an AI/ML diagnostic or therapeutic device.
§ 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.