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The SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™ (DLU) with Reloads has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The devices described here are reloadable Right Angle Linear Cutter DLUs for single patient use. Both the 30mm RALC and the 45mm RALC can be passed through surqical tubing with an inside diameter of 3.1". The 60mm RALC can be passed through surgical tubing with an inside diameter of 4.1". They are all supplied pre-sterilized and ready for use upon removal from their packaging. The 30mm DLU can be used with only the 30mm reloadable cartridge. The 45mm DLU can be used with only the 45mm reloadable cartridge. The 60mm DLU can be used with only the 60mm reloadable cartridge. During the Design Input stage of the Right Angle Linear Cutter, it was determined that the product would evolve into a reloadable device. Features that were incorporated into the non reloadable were designed in such a fashion that the components would yield a reloadable component. These features designed into a non reloadable version that would be useful in a reloadable version include the latch that would allow the cartridge to be removed and the tongs of the cartridge cap that would secure the reload in position but be capable of being removed as well. The design that features the reloadable cartridges maintain much of the features of the non reloadable but with modest modifications. Each DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position lavers 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 30mm, 45mm and 60mm DLUs are perpendicular to the FlexShaft, 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 DLU 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 assembly that contains a pair of flexible rotary drive shafts within an overall flexible shaft called the FlexShaft, hereafter referred to as the FS. The other end of the FS is connected to a Power Console (the 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 cartridges. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used.

This document is a 510(k) PreMarket Notification for a device modification, not a study proving the device meets acceptance criteria. As such, it does not contain the detailed information typically found in a clinical study report.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and reported device performance:

The document does not specify formal acceptance criteria or present a performance study with quantitative results to demonstrate the device meets those criteria. The submission is a 510(k) for a modification (making the device reloadable) and relies on substantial equivalence to predicate devices, rather than new extensive performance testing against defined metrics.

However, we can infer some "performance characteristics" from the comparison table (though not "acceptance criteria" or measured performance against them):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This document does not describe a test set or clinical study with a specified sample size. It's a regulatory submission based on substantial equivalence, design modifications, and likely non-clinical testing (which is not detailed here).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as no clinical test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as no clinical test set requiring adjudication is described.

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:

This is not applicable. The device is a surgical stapler, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. The device is a surgical stapler, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

This is not applicable as no clinical study requiring ground truth is detailed. The "ground truth" for the device's functionality would be its ability to staple and cut tissue effectively and safely, which is assessed through design verification, validation, and historical performance of predicate devices, not typically a "ground truth" as you might see in an AI/diagnostic context.

8. The sample size for the training set:

This is not applicable as the device is not an algorithm or AI system that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable as the device is not an algorithm or AI system that requires a training set and ground truth.

Summary of what the document does provide:

• Device Type: SurgASSIST™ Right Angle Linear Cutter DLU with Reloads (30mm, 45mm, 60mm) - a surgical stapler.
• Modification: The key modification is making the device reloadable.
• Intended Use/Indications For Use: Applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.
• Predicate Devices:
  • SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™ with Titanium Implantable Staple (K012809)
  • EZ45 Endoscopic Linear Cutter/Stapler Reloads (K980815)
• Substantial Equivalence: The submission argues that the modified device is substantially equivalent to these predicates.
• Sterilization Method: Ethylene Oxide Gas (ETO) for both the subject device and the predicate SurgASSIST™ device. The Endopath EZ45 predicate lists Irradiation and ETO.
• Power Source: The device is powered by an external Power Console (PC) via a FlexShaft, and controlled by a Remote Control Unit (RCU).
• Digital Information: Each reload has an integral electronic memory module to identify its type and size.

Essentially, this is a regulatory filing asserting that a modified version of an existing device is safe and effective because its changes are minor and it is substantially equivalent to previously cleared devices. It is not a detailed clinical study report against specific acceptance criteria.

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