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The Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses.

The Circular Staplers for Single Use has applications throughout the alimentary for end-to-end, end-to-side and side-to-side anastomoses.

The Linear Cutter Staplers and Loading Units for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 60mm, 80mm and 100mm length with reload in 2.5mm and 4.5mm staple size to accommodate various tissue thicknesses. The device may be reloaded and fired up to 8 times in a single procedure.

The Circular Staplers for Single Use 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 is available in 33mm, 29mm, 25mm and 21mm five specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.

The provided document, K182217, does not describe a study involving AI or human readers for diagnostic purposes. Instead, it details a 510(k) submission for surgical staplers (Linear Cutter Staplers and Loading Units for Single Use, and Circular Staplers for Single Use).

Therefore, I cannot extract the information requested about acceptance criteria and studies related to AI performance, human reader improvement with AI assistance, standalone algorithm performance, or ground truth establishment for such studies, as these concepts are not applicable to this device's regulatory submission.

The document focuses on demonstrating substantial equivalence to existing predicate surgical staplers through:

• Non-clinical performance tests: These tests verify the physical and functional aspects of the staplers, such as firing force, staple formation, staple line pressure, staple line tensile strength, and closed staple height.
• Biocompatibility tests: These ensure the materials used in the staplers are safe for contact with human tissue.
• Package integrity and bacteria endotoxin tests.

The "Acceptance Criteria" in this context refer to the results from these non-clinical and biocompatibility tests meeting predefined specifications and being comparable to those of the predicate devices.

Here's a breakdown of the information that is present in the document, framed in response to your request, but highlighting the irrelevance of AI-specific questions:

Acceptance Criteria and Device Performance (for Surgical Staplers)

The document specifies non-clinical tests performed to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" are implied by the successful completion and comparability of these tests to the predicate devices. The performance data is presented implicitly through the statement that the proposed device "met all design specifications" and "the test results demonstrated that the proposed device complies with the following standards."

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for surgical staplers, the "acceptance criteria" are based on engineering performance specifications and comparison to predicate device performance. The document doesn't provide specific quantitative "reported device performance" in a table format for each criterion, but rather states that the tests were performed and demonstrated compliance and substantial equivalence.

Irrelevant/Not Applicable Information for this Device (as per your original request's intent for AI)

The following points are not applicable to this 510(k) submission for surgical staplers, as no AI-based diagnostic or analysis component is described.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical stapler units and materials subjected to engineering, biocompatibility, and sterilization tests, not a dataset for AI analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment by medical experts for diagnostic interpretation is mentioned. The ground truth for this device is its physical performance and biological safety.
4. Adjudication method: Not applicable.
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. No human reader studies with or without AI assistance were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For these staplers, the "ground truth" is defined by established engineering and biocompatibility standards (e.g., ISO, ASTM, USP) and the performance characteristics of predicate devices, not by expert consensus or pathology on a diagnostic dataset.
8. The sample size for the training set: Not applicable. No training set for an AI model is involved.
9. How the ground truth for the training set was established: Not applicable.

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The device is intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally 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 70mm, 160mm three lengths. Reloads of Endoscopic Linear Cutting Staplers and Loading Units for Single Use are available in in five staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm, 4.1mm and 4.8mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.

This document is a 510(k) Premarket Notification from Ezisurg (Suzhou) Medical Co., Ltd. for their Endoscopic Linear Cutting Staplers and Loading Units for Single Use. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding ground truth, expert opinions, and multi-reader studies is not applicable or available in this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance tests conducted, but it does not explicitly state specific numerical acceptance criteria or quantitatively report the device's performance against them in a tabular format. Instead, it makes a general statement that "The test results demonstrated that the proposed device complies with the following standards" and were performed "to determine substantial equivalence."

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

This information is not provided in the document. The document only mentions that "Non clinical tests were conducted," but does not specify the sample sizes for these tests or the origin of any data used.

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/not provided. The document describes a pre-market notification process for a surgical stapler, which relies on physical and mechanical performance testing, not on interpretation of medical images or expert consensus for diagnosis. Therefore, there is no "ground truth" established by experts in this context.

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

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation), which this submission does not describe. The tests mentioned are non-clinical, mechanical, and biological evaluations.

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/not provided. The device is an endoscopic linear cutting stapler, a physical surgical tool, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable/not provided. As explained above, the device is a mechanical surgical instrument, not an algorithm.

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

For the non-clinical tests described, the "ground truth" would be established by objective measurements and adherence to international standards and internal design specifications. For example, the "Staple Formation Test" would have an objective standard for what constitutes a properly formed staple, likely visually assessed and measured against specifications. "Biocompatibility" is assessed against specific ISO standards. "Endotoxin Limit" is measured quantitatively against a defined limit. There is no expert consensus, pathology, or outcomes data used as ground truth for these types of engineering and biological performance tests.

8. The sample size for the training set

This information is not applicable/not provided. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable/not provided as there is no training set for a physical medical device.

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