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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.

Device Description

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.

AI/ML Overview

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."

Performance Test Category	Implicit Acceptance Criteria (based on "substantial equivalence" to predicate devices, and compliance with standards)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, 10993-5, 10993-10; USP 38-NF 33 ; USP 39-NF34:2016	Met the standards
Device Performance	Equivalent to predicate devices (K111825 and K061156) in:	Achieved substantial equivalence to predicate devices
- Firing Force Test	- Satisfactory firing force	Not quantitatively reported
- Staple Formation Test	- Proper staple formation (Image: staple, as shown for predicate devices)	Not quantitatively reported
- Staple Line Pressure Test	- Acceptable staple line pressure	Not quantitatively reported
- Staple Line Tensile Test	- Acceptable staple line tensile strength	Not quantitatively reported
- Hemostasis Evaluation Test	- Satisfactory hemostasis	Not quantitatively reported
- Close Staple Height Test	- Achieved specified closed staple heights (2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.8mm)	Not quantitatively reported
Sterilization	Compliance with ISO 11137-2:2013	Met the standard
Package Integrity	Compliance with ASTM F 88/F88M-09	Met the standard
Shelf Life	Maintained package integrity and performance over time	Achieved satisfactory shelf life
Endotoxin Limit	≤ 20 EU (same as predicate devices)	Met the limit (≤ 20 EU)

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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