(36 days)
The SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures tor resection, transection, creation of anastomoses, for open occlusion of the heart's left atrial appendage.
The devices described here are reloadable Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. The SLS55B4 DLUs are designed to place two, double-staggered rows of titanium staples in various types of tissues. The SLS55B4 DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together.
This 510(k) pertains to a modification of an existing device (SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads) where the only change is an expansion of the "Indications for Use" to include "open occlusion of the heart's left atrial appendage." The document explicitly states that the device itself is "identical to the predicate devices (K030653)" and that "the fundamental scientific technology is identical."
Therefore, the submission does not contain a new study proving the device meets acceptance criteria for its physical performance. Instead, the focus is on demonstrating substantial equivalence for the expanded indication. Since the device's design and mechanism of action for stapling remain unchanged, the original performance data from the predicate device would be referenced or considered implicitly sufficient.
Given this context, I cannot extract information about a new acceptance criteria study, sample sizes, expert involvement, or adjudication methods directly related to this 510(k) for device performance. The only 'acceptance criterion' that can be inferred is that the expanded indication for use does not compromise the established safety and effectiveness of the identical device.
However, I can provide the available information based on the document's content, noting the absence of a new performance study for this specific 510(k submission):
1. Table of Acceptance Criteria and Reported Device Performance
As per the 510(k) submission, the device in question (SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads) is "identical" to its predicate device (K030653). The submission does not detail new performance acceptance criteria or study results for the device's physical function. The acceptance criteria for the expanded indication likely revolve around demonstrating that the device's existing and unchanged stapling capability is suitable for the new anatomical application.
Since no new performance data is presented in this 510(k) submission due to device identicality, a table of new acceptance criteria and new reported device performance cannot be generated from the given text.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for a new performance test set, as the device's physical design and technology are identical to the predicate. The submission focuses on expanding indications, not re-testing the device's core performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for a new performance test set, as the device's physical design and technology are identical to the predicate.
4. Adjudication Method for the Test Set
Not applicable for a new performance test set, as the device's physical design and technology are identical to the predicate.
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 device is a surgical stapler, not an AI-assisted diagnostic or imaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a surgical stapler, not an AI-assisted diagnostic or imaging tool.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable for a new performance test set in this submission. For the initial clearance of the predicate device (K030653), ground truth for performance would typically be established through mechanical testing, simulated use, and potentially in vivo animal studies, with assessment against design specifications and clinical outcomes. This submission relies on the established ground truth of the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
Summary based on the provided document:
The K040398 submission is a Traditional 510(k) for an expanded indication for use of an already cleared device. The device itself is stated to be "identical" to its predicate (K030653). Therefore, this submission does not contain new studies on the device's core performance or new acceptance criteria for its physical function. The substantial equivalence determination for this 510(k) is based on the device's identicality to the predicate and the safety/effectiveness of its existing technology for the newly indicated use.
§ 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.