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The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are sterile. single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reloads are sterilized by irradiation. 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 (192±20mm), regular (252±20mm) and long (352±20mm). 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.

This document is a 510(k) Pre-market Notification for a medical device, specifically a "Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads." This type of document is filed with the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its safety and effectiveness through a comprehensive clinical study per se.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/Software device performance is not applicable to this document. This document describes a physical surgical stapler and its reloads, not a software or AI medical device.

The "Performance Data" section (Section 9) describes non-clinical performance tests conducted to demonstrate substantial equivalence to a predicate device, not to establish performance criteria for an AI or software algorithm.

Here's why each of your requested points cannot be answered from this document:

1. A table of acceptance criteria and the reported device performance: The document lists non-clinical tests (e.g., Visual Appearance, Sterility, Hardness, Anastomosis and Cutting Performance) and states, "During verification testing, all data meets pre-defined criteria." It does not provide specific numerical acceptance criteria or reported performance values for these physical device attributes. It also doesn't relate to AI/software performance.
2. Sample sized used for the test set and the data provenance: Not applicable. The tests are for a physical device, not an algorithm's test set. There's no "data provenance" in the sense of clinical data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/software device is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. There is no training set mentioned as this is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission focuses on demonstrating the substantial equivalence of a physical surgical stapler to an existing one. It does not involve AI or software, and therefore, the questions about acceptance criteria and study design for such devices are not relevant to the information provided in this document.

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