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The easyEndoTM Lite Linear Cutting Stapler and Loading Units for Single Use are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or mimimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.

The proposed device places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The device is available in 260mm, 350mm and 440mm three lengths. The device is available in four five sizes to accommodate various tissue thickness: 2.0mm, 2.5mm, 3.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 13 times in a single procedure.

The provided text does not describe the acceptance criteria or a study proving that a device meets specific acceptance criteria related to an AI/ML medical device.

Instead, the document is an FDA 510(k) summary for a linear cutting stapler and loading unit, which is a physical surgical device, not an AI/ML product. The summary focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests (e.g., biological evaluation, seal strength, ex-vivo tissue tests) and comparisons of technological characteristics (e.g., product code, intended use, staple height, materials).

Therefore, I cannot extract the information required for an AI/ML device study, such as sample size for test sets, data provenance, number of experts, MRMC studies, or ground truth establishment methods for an AI model.

The sections that are present in the document and relate to device performance are:

Acceptance Criteria/Performance Testing (Non-Clinical Tests):

• Ex-vivo tissue test was conducted on porcine stomach and intestine tissue.
  • Test items evaluated: Pressure Resistance Test, Closed Staple Dimension Test, Staple Formation Test, and Force Required to Fire Stapler Test.
• Jugular vein test was conducted on a porcine model for thin tissues (less than 2.5mm staple height).
  • Evaluated: Burst pressure and closed staple formation.
• Biological evaluation: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), ISO 10993-11 (systemic toxicity), USP 43-NF38 (Pyrogen Test), USP 42-NF 37 (Bacterial Endotoxins Tests).
• Material properties: ASTM F88/F88M-15 (seal strength).
• Sterilization validation: ISO 11137-2 (sterilization dose).

Reported Device Performance:

The document states, "The test results demonstrated that the proposed device complies with the following standards" and lists the standards. It implicitly states that the performance met the requirements of these standards. For the ex-vivo and jugular vein tests, it notes what was evaluated but does not provide specific quantitative results or acceptance criteria values for these tests in this summary.

Regarding AI/ML specific information, the document explicitly states:

• "No clinical study is included in this submission." This means no human-in-the-loop or standalone clinical performance trials were conducted or are reported here, which would be typical for AI/ML validation.

In summary, none of the specific AI/ML related questions can be answered from this document because it pertains to a mechanical surgical stapler, not an AI/ML medical device.

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The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.

The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with tissue buttressing materials.

The Single Patient Use Linear Cutter and Reload have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.

The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.

The Single Use Hemorrhodial Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.

The Single Patient Use Transverse Cutter and Reload is intended for transection and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.

The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.

Single Use Circular stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 21mm, 26mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.

Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in five staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm. 3.5mm. 3.8mm and 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.

Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.

Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.8mm, 4.2mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.

Single Use Hemorrhoidal Circular Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.

The provided text is a 510(k) summary for several surgical staplers and does not contain the specific information required to answer the prompt questions regarding acceptance criteria and a study proving device performance against those criteria in the context of an AI-powered diagnostic device.

This document describes surgical staplers, which are physical medical devices, not AI-powered diagnostic devices. The performance tests mentioned (pressure resistance, closed staple height, staple formation, force to fire) are mechanical tests of the staplers themselves, comparing them to predicate devices. There is no mention of "acceptance criteria," "reported device performance" in terms of diagnostic metrics, "sample size for test set," "data provenance," "experts creating ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth" (for diagnosis), "training set size," or "ground truth for training set."

The document concludes that the proposed devices are "Substantially Equivalent (SE) to the predicate devices" based on non-clinical tests (biocompatibility and mechanical performance tests). This is a regulatory finding for a traditional medical device, not a performance evaluation for an AI diagnostic algorithm.

Therefore, I cannot extract the requested information from the provided text.

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The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.

The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediativ surgical procedures. It can be used with tissue buttressing materials.

The Single Patient Use Linear Cutter and Reload are intended for use in multiple open or minimally invasive surgical procedures for the transection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures.

The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.

The Single Use Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.

The Single Patient Use Transverse Cutter and Reload is intended for transection and or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.

The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.

Single Use Circular stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 21mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.

Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in six staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.

Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm, 75mm and 90mm staple for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.

Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 4.2mm and 4.5mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.

Single Use Hemorrhoidal Circular Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.

The provided document is a 510(k) Summary for TGS Medical Co., Ltd.'s range of stapling devices (Circular Stapler, Hemorrhoidal Circular Stapler, Linear Stapler, Linear Cutter, Endo Cutter, and Transverse Cutter). The acceptance criteria and supporting studies are presented in the form of non-clinical tests to establish substantial equivalence to predicate devices, rather than a standalone clinical study on the effectiveness of the proposed devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The acceptance criteria are essentially compliance with specific international and national standards related to medical devices. The reported device performance is that the proposed device complies with these standards, demonstrating substantial equivalence to the predicate devices.

Additionally, the comparison tables (Table 1 through Table 6) implicitly define acceptance criteria by comparing the proposed device's characteristics against those of the predicate devices. The "reported device performance" in these tables is that the proposed device's characteristics (e.g., intended use, cutting mechanism, operation principle, safety mechanism, closed staple height, closed staple form, patient-contact material, sterilization, endotoxin limit, labeling) are "Same" as or comparable to the predicate devices, or compliant with relevant regulations (e.g., 20 EU for Endotoxin Limit, Conforms with 21 CFR 801 for Labeling).

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

The document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications..." However, it does not provide details on the specific sample sizes used for each of the non-clinical tests (e.g., number of devices tested for seal strength, number of samples for cytotoxicity). The data provenance is also not explicitly stated beyond being "non clinical tests." There is no indication of country of origin for the testing itself, nor whether the data is retrospective or prospective.

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

This information is not provided in the document. The document refers to non-clinical tests against established standards and predicate devices, which implies adherence to standardized methodologies rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The evaluation is based on non-clinical tests against defined standards and comparison to predicate devices, not on human adjudication of a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, 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, not an AI-assisted diagnostic or therapeutic device that involves human readers or an MRMC study.

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

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

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is implied by the established international and national standards (e.g., ISO 10993 series, USP, ASTM, ISO 11137-2) and the characteristics of the legally marketed predicate devices. The tests evaluate compliance with these standards and equivalence to the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a 510(k) submission for mechanical surgical devices, not an AI/machine learning device that requires a training set.

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

This information is not applicable for the same reason as above.

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