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The SigniaTM Loading Units with Tri-StapleTM 2.0 cartridges have applications in abdominal, gynecologic, pediatric and thoracie surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and transection and resection of pancreas.

The SigniaTM Loading Units and Tri-StapleTM 2.0 Cartridges place staggered rows of titanium staples and simultaneously divides the tissue so that three staggered rows of staples are placed on either side of the cut line. The size of the staples is determined by the selection of the following single use Tri-StapleTM 2.0 cartridges:

Tri-Staple TM 2.0 cartridge, vascular/medium:

• Tan- three height progressive rows of 2.0 mm, 2.5 mm, 3.0 mm titanium staples on o either side of the cut line.
  Tri-StapleTM 2.0 cartridge, medium/thick:

• · Purple-three height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the cut line.
  The Tri-StableTM 2.0 Cartridge is available in 45 mm and 60 mm lengths. The SigniaTM Loading Unit is available in articulating 45 mm and 60 mm lengths. Tri-StapleTM 2.0 Cartridges are able to be loaded into the SigniaTM Loading Unit by the User. SigniaTM Loading Units may be used up to twelve times in the same procedure. SigniaTM Loading Units with Tri-Staple TM 2.0 Cartridges, similar to the predicate devices, are compatible with Covidien's Endo GIA TM Ultra Universal manual stapler handles and iDriveTM Ultra powered stapler handle with associated Endo GIATM Adapter.

The provided text describes a medical device, the "Signia Loading Units with Tri-Staple™ 2.0 Cartridges," and its 510(k) submission to the FDA. However, the document does not contain information related to software, algorithms, AI, or diagnostic studies that would typically have the specific acceptance criteria and study design elements you've requested.

This document is a 510(k) summary for a surgical stapler system, which is a physical medical device. The "tests" performed are engineering and biological validations of the stapler's mechanical function and safety, not a study of an AI or algorithm's diagnostic performance.

Therefore, I cannot populate the table or answer most of your detailed questions about acceptance criteria, AI performance, ground truth, or expert involvement as they are not applicable to the information provided in this document.

Here's what can be extracted, focusing on the device performance and the nature of the non-AI testing described:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a mechanical surgical device, the "acceptance criteria" are related to mechanical and biological function rather than diagnostic accuracy. The document states that "design differences were found to not affect safety or performance through applicable design verification activities that showed continued conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing." Specific numerical acceptance targets are not provided in this summary.

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

• Sample Size: Not specified for individual tests. The document mentions "bench tests using simulated tissue medium" and "in vivo and ex vivo tests using porcine and canine animal models."
• Data Provenance: Not specified, but animal models (porcine and canine) were used for some tests. The studies were likely conducted internally or by contract research organizations. The nature suggests they are prospective experiments/tests as part of device development and validation.

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)

• Not Applicable. This is a hardware device validation, not a diagnostic study requiring expert ground truth for interpretation of medical images or data. The "ground truth" here would be the successful mechanical function of the stapler and the physical/physiological outcomes (e.g., successful hemostasis).

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

• Not Applicable. Adjudication methods are typically used in diagnostic studies for resolving discrepancies in expert interpretations. This device undergoes engineering and biological performance testing.

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 a hardware device, not an AI or diagnostic software. Therefore, no MRMC study or AI assistance improvement metrics are relevant or provided.

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

• Not Applicable. No algorithms or AI are described.

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

• For the bench tests: The "ground truth" would be objective engineering measurements and pre-defined acceptance ranges for mechanical parameters (e.g., staple formation geometry, force measurements).
• For the in vivo/ex vivo tests: The "ground truth" would be direct observation of physiological outcomes (e.g., absence of acute air leak, successful hemostasis, measurement of burst pressure, visual assessment of tissue trauma). This is direct observation of device effect on biological tissue.
• For biocompatibility: Conformance to ISO Standard 10993-1.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device. There is no "training set" in the context of the information provided. The development and testing of this device would involve engineering design iterations and subsequent verification/validation tests.

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

• Not Applicable. No training set for an algorithm is described.

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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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