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The SuraASSIST™ Right Angle Linear Cutter Digital Loading Unit™, 30 mm, 45 mm and 60 mm, Vascular with Reloads has applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for transection, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.

The devices described here are Right Angle Linear Cutter Digital Loading Units™(DLUs), 30 mm, 45 mm and 60 mm, Vascular, with Reloads for single patient use. All have a maximum diameter of 3.1". Both DLUs and Reloads are supplied pre-sterilized and ready for use upon removal from their packaging.

The 30 mm Vascular DLU can only be used with the 30 mm Vascular Reload.

The 45 mm Vascular DLU can only be used with the 45 mm Vascular Reload.

The 60 mm Vascular DLU can only be used with the 60 mm Vascular Reload.

The DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position layers of tissue in readiness for stapling and cutting. At the same time, the anvil provides support and a means for correctly forming staples while they are closed sequentially along the tissue, followed by the cutting blade. The Right Angle Linear Cutter Vascular DLU is perpendicular to the Flex Shaft, forming an extension to the Flex Shaft, to which they are connected.

A loaded DLU is used to anastomose tubular structures by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together. It also severs the tubular structure.

Right Angle Linear Cutter Vascular Reloads contain staples, a cutting blade. and the means to simultaneously force staples toward the anvil. The cutting blade is advanced in conjunction with the staple pushers so that tissue is simultaneously stapled and cut.

The DLUs are attached to the end of the FlexShaft (FS), which contains a pair of flexible rotary drive shafts within an overall flexible shaft. The other end of the FS is connected to the Power Console (PC), which applies mechanical power to the drive shafts. DLUs have all functions powered by the PC. The FS has a short steerable section at the distal end (near the attached DLU) so that the angle of attack (attitude) of the DLU can be adjusted by the surgeon to optimize patient accessibility.

The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU).

The DLUs have quick attach and release means for coupling to the FS. No tools are required. DLUs are pushed onto the FS end, snapping and locking into place. To remove a DLU from the FS, a sleeve on the DLU at the junction with the FS is rotated by hand.

DLU designs shall allow for attachment of their corresponding Reloads, but shall inhibit attachment of incompatible Reloads. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used.

The provided text describes a 510(k) premarket notification for a medical device called "SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™ 30mm, 45mm, 60mm - Vascular with Reloads." This document is focused on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and device performance as typically found in clinical trials for new technologies like AI.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics, acceptance criteria, or a study designed to prove the device meets such criteria. It focuses on comparing features to a predicate device.
• Sample sizes used for the test set and data provenance: No test set or data provenance is mentioned as this is not a study reporting clinical performance.
• Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth establishment is not relevant in this type of submission.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: This is not a comparative effectiveness study.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Explanation Based on Document Type:

This document is a "Special 510(k) Device Modification Premarket Notification". A 510(k) submission primarily aims to demonstrate substantial equivalence to a legally marketed predicate device, meaning the new device is as safe and effective as the predicate. It does this by comparing device features, intended use, technological characteristics, and safety/performance data (if necessary, though often bench testing or existing data for the predicate is sufficient). It is not a clinical trial report where specific acceptance criteria for performance would be rigorously tested against a defined ground truth.

The "study" in this context is the comparison of the modified device to the predicate device, focusing on demonstrating that the modifications do not raise new questions of safety or effectiveness. The key element presented is a table comparing the features of the subject device to its predicate devices.

Summary of Relevant Information from the Provided Text:

• Device Name: SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™ 30mm, 45mm, 60mm - Vascular with Reloads

• Predicate Devices:

  • SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™, 30 mm. 45 mm and 60 mm with Titanium Implantable Staples and Reloads, Power Medical Interventions, Inc. (K021701)
  • ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin. Ethicon Endo-Surgery, Inc. (K002398)

• Basis for "Acceptance": The FDA's determination of substantial equivalence to the predicate devices. The letter from the FDA (page 6-7) states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the "acceptance" in the context of a 510(k) submission.

• Device Performance (as described in comparison to predicate): The document provides a detailed comparison of physical characteristics between the subject device and the predicate (Ethicon ETS Compact-Flex45). This comparison serves as the "proof" that the device is equivalent for its intended purpose.

  Features & Description	SurgASSIST™ (Subject Device)	Predicate (Ethicon ETS Compact-Flex45)
  Number of Staples	30mm Vascular - 46 staples

45mm Vascular - 69 staples
60mm Vascular - 92 staples | 30mm - 22 staples
45mm - 32 staples
60mm - 46 staples |
| Rows of Staples | 30mm Vascular - 6 rows
45mm Vascular - 6 rows
60mm Vascular - 6 rows | 30mm- 4 rows
45mm- 4 rows
60mm- 4 rows |
| Staple Crown Dimension | 30mm Vascular - 2.4 mm
45mm Vascular - 2.4 mm
60mm Vascular - 2.4 mm | 30mm- 4.0 mm
45mm- 4.0 mm
60mm- 4.0 mm |
| Staple Leg Dimension | 30mm Vascular - 2.3 mm
45mm Vascular - 2.3 mm
60mm Vascular - 2.3 mm | 30mm- 4.4 mm
45mm- 4.4 mm
60mm- 4.4 mm |
| Staple Thickness | 30mm Vascular - 0.20 mm
45mm Vascular - 0.20 mm
60mm Vascular - 0.20 mm | 30mm- 0.23mm
45mm- 0.23mm
60mm- 0.23mm |
| Staple Closed Range | 30mm Vascular - 1.0 mm
45mm Vascular - 1.0 mm
60mm Vascular - 1.0 mm | 30mm- 1.2 / 2.0mm
45mm- 1.2 / 2.0mm
60mm- 1.2 / 2.0mm |
| DLU Internal Power | None | None |
| Digital Information | Memory module containing digital data for identification, etc. | Memory module containing digital data for identification, etc. |
| How Supplied | Sterile - Single Patient Use | Sterile - Single Patient Use |
| Method of Sterilization | Ethylene Oxide Gas (ETO) | Irradiation |
| Packaging | Blister Tray with Tyvek Lid | Blister Tray with Tyvek Lid |

• Intended Use: The subject device has applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for transection, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.
• Regulatory Class: Class II

In essence, the "study" referred to here is the documentation provided in the 510(k) submission itself, demonstrating that the subject device is similar enough to an already approved device to be considered safe and effective without requiring entirely new clinical performance data against explicit acceptance criteria.

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