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The Endo GIA™ Staplers with Endo GIA™ Single Use Duet TRS™ Reloads with Tri-Staple™ Technology have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Endo GIA™ Stapler. The new Duet TRS™ Reload with Tri-Staple™ Technology bears the identical design characteristics as the Endo GIA™ Reloads with Tri-Staple™ Technology described in predicate submissions K083519 and K090419 with the exception that the Reloads have pre-attached staple line reinforcement material which is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each Reload undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture.

The Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology when used with the Endo GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows.

Duet TRS™ Reloads with Tri-Staple™ Technology place two sets of triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one layer on anvil side) and simultaneously divide the tissue and tissue reinforcement material between the two sets of triple-staggered rows. These Reloads have a stepped cartridge configuration whereby for each set of triple-staggered rows, the staples in the outer row are a taller height than the staples in the middle row which in turn are a taller height than the staples in the inner row closest to the cut line. The size of the staples is determined by the selection of the appropriate single use Reload.

The document describes the Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology, which is a new reload cartridge for the existing Endo GIA™ Stapler. This device is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses, including liver substance, hepatic vasculature, and biliary structures.

Here’s an breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the evaluations were conducted "to demonstrate that the ...device... is safe and effective and performs as intended." While specific numerical acceptance criteria are not explicitly listed in this summary, the successful completion of these tests and the FDA's clearance (K103263) imply that the device met the established criteria for safety and effectiveness, likely by demonstrating equivalence to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes for the bench or in vivo test sets. It simply states that "Bench and in vivo performance evaluations were conducted." The data provenance is not explicitly mentioned (e.g., country of origin). The testing would be considered prospective as it was conducted to demonstrate the safety and effectiveness of the new device for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies described are performance tests (bench and in vivo) rather than studies requiring expert interpretation for ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are performance tests (bench and in vivo) and not studies involving expert adjudication of findings.

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 information is not applicable. The device is a surgical stapler reload, not an AI-assisted diagnostic or therapeutic tool that would typically involve a multi-reader multi-case study for human reader performance improvement.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as the device is a medical device (surgical stapler reload), not an algorithm. The "standalone" performance here would refer to the device's functional performance, which was assessed through bench and in vivo tests.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be established by validated engineering and material science standards and measurements (e.g., precise force measurements, visual inspection of staple formation, tensile strength testing).

For the in vivo tests, the "ground truth" would be established by direct observation and measurement in animal models (as is common for such medical device testing), assessing outcomes like proper staple formation, lack of bleeding (hemostasis), and structural integrity (burst strength, absence of air leaks).

8. The Sample Size for the Training Set

This information is not applicable. This device is a mechanical surgical stapler reload, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of medical device.

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The SILS™ Clincher* single use articulating clincher has application in a variety . of endoscopic, gynecological, and general laparoscopic procedures for temporarily clamping or grasping tissues and small tubular structures.

The SILS™ Dissector* single use articulating dissector with monopolar cautery has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

The SILS™ Grasper* single use articulating grasper has application in a variety of endoscopic, gynecological, and general laparoscopic procedures to temporarily grasp or clamp tissues and small vessels or body structures, and for use in blunt dissection.

The SILS™ L-Hook* single use articulating hook with monopolar cautery has application in endoscopic, gynecological, and general abdominal and thoracic laparoscopic procedures. When connected by a standard cable to an electrosurgical power source, the device may be utilized for monopolar cautery.

The SILS™ Shears* single use articulating shears with monopolar cautery has application in a variety of endoscopic, gynecologic, and general laparoscopic procedures for transection and cutting of tissues. When connected to an electrosurgical power source, the device may be used to apply monopolar cautery in accordance with the recommendations of the electrosurgical unit's manufacturer.

Each single use SILSTM Hand Instrument contains a pistol grip, a rigid shaft with an articulating and rotating end effector, and opposing jaws or an electrocautery hook at the distal end.

The clincher, dissector, grasper, and shears contain opposing jaws to manipulate tissue, and the dissector, L-hook, and shears administer electrocautery. The end effector of each instrument articulates when the handle is deflected relative to the shaft and rotates when a rotation wheel is turned.

The provided text describes a 510(k) summary for several endoscopic hand instruments (SILS™ Clincher, Dissector, Grasper, L-Hook, and Shears). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance criteria in a clinical setting. Therefore, many of the requested details, particularly those related to AI algorithm performance studies, will not be present in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy thresholds). The acceptance criteria for a 510(k) submission like this revolve around demonstrating substantial equivalence to legally marketed predicate devices in terms of indications for use, technological characteristics, and safety and effectiveness.

The "performance data" mentioned refers to in-vitro and in-vivo testing to support the intended use and biological evaluation in accordance with ISO 10993-1:2003 for patient contact materials. However, specific quantitative results or how these results meet pre-defined acceptance criteria are not detailed in this summary.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) context):

Study Details (Based on available information in the document)

Since this is a 510(k) summary for conventional surgical instruments, there is no mention of an AI-powered device or associated studies. Therefore, many of the questions related to AI performance, ground truth, and expert evaluation are not applicable.

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

   • Not Applicable / Not provided. The document refers to "in-vitro and in-vivo testing" but does not specify sample sizes, provenance, or whether the data was retrospective or prospective. This kind of detail is typically found in the full test reports, not a 510(k) summary.

2. 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):

   • Not Applicable. As this is not an AI device, there's no concept of establishing "ground truth" by experts in this context for diagnostic performance.

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

   • Not Applicable. This is relevant for diagnostic studies with human readers or AI.

4. 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:

   • No. This document does not mention an MRMC study or AI assistance.

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

   • No. This is not an AI algorithm.

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

   • Not Applicable. For mechanical surgical instruments, "ground truth" would relate to successful mechanical operation, tissue manipulation, and safety, assessed through engineering tests, pre-clinical models (in-vitro/in-vivo), and potentially clinical observations, not derived from expert consensus on images or pathology.

7. The sample size for the training set:

   • Not Applicable. There is no AI model mentioned, thus no training set.

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

   • Not Applicable. There is no AI model mentioned, thus no training set ground truth.

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