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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criterion (Test)	Reported Device Performance (Implied)
Non-Clinical Performance Tests:
Firing Force Test	Met design specifications and demonstrated substantial equivalence to predicate devices (no specific quantitative result provided).
Staple Formation Test	Met design specifications and demonstrated substantial equivalence to predicate devices (no specific quantitative result provided). Images of closed staple form were provided for comparison with predicate devices, indicating visual equivalence.
Staple Line Pressure Test	Met design specifications and demonstrated substantial equivalence to predicate devices (no specific quantitative result provided).
Staple Line Tensile Test	Met design specifications and demonstrated substantial equivalence to predicate devices (no specific quantitative result provided).
Closed Staple Height Test	For Linear Cutter Staplers: 1.0mm, 1.5mm, 2.0mm. For Circular Staplers: 1.0~2.5mm. (These are specified as device capabilities/characteristics, and implied to be acceptable and comparable to predicate devices which have similar ranges).
Biocompatibility Tests:
Cytotoxicity Test (ISO 10993-5)	Complied with ISO 10993-5:2009.
Sensitization Test (ISO 10993-10)	Complied with ISO 10993-10:2010 (Part of "Test for irritation and delayed-type hypersensitivity").
Intracutaneous Irritation Test (ISO 10993-10)	Complied with ISO 10993-10:2010 (Part of "Test for irritation and delayed-type hypersensitivity").
Pyrogenicity Test (USP 38-NF 33 <85>, USP 39-NF <151>)	Complied with USP 38-NF 33 <85> Bacterial Endotoxins Tests and USP 39-NF 34 <151> Pyrogen. Endotoxin Limit: 20 EU (for both proposed and predicate devices).
Other Tests:
Package Integrity Test	Complied with ASTM F 88/F88M-09.
Bacteria Endotoxin Test	Complied with USP 38-NF 33 <85> (as above).
Shelf Life Test	Performed on both proposed and predicate devices to determine substantial equivalence (no specific long-term data provided).
Sterilization Dose (ISO 11137-2)	Complied with ISO 11137-2:2013.
Labeling	Conforms with 21 CFR 801.

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.

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.
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.
Adjudication method: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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.
The sample size for the training set: Not applicable. No training set for an AI model is involved.
How the ground truth for the training set was established: Not applicable.

Summary

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S001

Exhibit 2 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K182217

1. Date of Preparation: 2/25/2019
1. Sponsor Identification

Ezisurg (Suzhou) Medical Co., Ltd.

Building 16, No.8 Jinfeng Rd., Suzhou National Hi-Tech District, Suzhou 215163 Jiangsu, China.

Establishment Registration Number: Not yet registered.

Contact Person: Jingtian Ren Position: Regulatory Affairs Engineer Tel: +86-21-50456176-8026 Fax: +86-21-50676156 Email: renjingtian@ezisurg.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 3609253199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Linear Cutter Staplers and Loading Units for Single Use Circular Staplers for Single Use Common Name: Stapler and Reload

Regulatory Information

Classification Name: Staple, Implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery

Classification Name: Stapler, Surgical; Classification: I Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4800 Review Panel: General & Plastic Surgery

Intended Use Statement:

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.

Device Description

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specifications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses.

ર . Identification of Predicate Devices

Predicate Device 1 510(k) Number: K020779 Product Name: ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers

Predicate Device 2 510(k) Number: K983536 Device Name: PROXIMATE Curved and Straight Intraluminal Staplers

Predicate Device 3 510(k) Number: K100723 Device Name: PROXIMATE Curved and Straight Intraluminal Staplers

Non-Clinical Test Conclusion 6.

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 test provided in this submission include package integrity test, bacteria endotoxin test, biocompatibility tests. The shelf life test and performance tests were performed on both proposed device and predicate device to determine substantial equivalence, the performance test include following items.

. Firing Force Test
. Staple Formation Test
. Staple Line Pressure Test
. Staple Line Tensile Test
. Closed Staple Height Test

Biocompatibility tests included cytotoxicity, sensitization, intracutaneous irritation and pyrogenicity.

The test results demonstrated that the proposed device complies with the following standards:

A ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
USP 38-NF 33 <85> Bacterial Endotoxins Tests

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K182217	S001	E2 510(k) Summary
---------	------	-------------------

ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose
USP 39-NF 34 <151> Pyrogen
1. Clinical Test Conclusion

No clinical study is included in this submission.

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K182217
---------

Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device	Predicate Device 1
		K020779
Product Code	GDW	GDW
Regulation Number	21 CFR 878.4750	21 CFR 878.4750
Intended Use	The Linear Cutter Staplers and Loading Units for Single Use have application in gastrointestinal for transection, resection, and/or creation of anastomoses.	The PROXIMATE Linear and Vascular Linear Cutters with Safety Lockout 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
Cutting Mechanism	Linear	Linear
Operation Principle	Manual	Manual
Safety Mechanism	Safety release for prevent from mis-firing	Safety release for prevent from mis-firing
Suture Length	60mm, 80mm, 100mm	55, 75mm
Closed Staple Height	1.0mm, 1.5mm, 2.0mm	1.0mm, 1.5mm, 1.8mm, 2.0mm
Closed staple form	Image: staple form	Image: staple form
Endotoxin Limit	20 EU	Same
Labeling	Conforms with 21 CFR 801	Conforms with 21 CFR 801

Table 1 Comparison for Linear Cutter Staplers and Loading Units for Single Use

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Item	Proposed Device	Predicate Device 2	Predicate Device 3
		K983536	K100723
Product Code	GDW	GDW	GDW
Regulation Number	21 CFR 878.4750	21 CFR 878.4750	21 CFR 878.4750
Intended Use	The Circular Staplers for Single Use hasapplications throughout the alimentaryfor end-to-end, end-to-side andside-to-side anastomoses.	The PROXIMATER Curved andStraight Intraluminal Staplers haveapplication throughout the alimentaryfor end to end, end to side and side toside anastomoses.	The Disposable Circular Stapler hasapplication throughout the alimentarytract for end-to-end, end-to-side andside-to-side anastomoses.
Cutting Mechanism	Circular Knife	Circular Knife	Circular Knife
Operation Principle	Manual	Manual	Manual
Safety Mechanism	Safety Release is used for preventingfrom mis-firing.	Safety Release is used for preventingfrom mis-firing.	Safety Release is used for preventingfrom mis-firing.
Diameter	21mm, 25mm, 29mm, 31mm, 33mm	21mm, 25mm, 29mm, 33mm	25.5mm, 29.5mm
Closed Staple Height	1.0~2.5mm	1.0~2.5mm	1.5~2.0mm
Closed staple form	Image: staple form	Image: staple form	Image: staple form
Endotoxin Limit	20 EU	20EU	20EU
Labeling	Conforms with 21 CFR 801	Conforms with 21 CFR 801	Conforms with 21 CFR 801

Table 2 Comparison for Circular Staplers for Single Use

S001

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K182217

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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Image /page/8/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 16. 2019

Ezisurg (Suzhou) Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. box 120-119 Shanghai, 200120 Cn

Re: K182217

Trade/Device Name: Linear Cutter Staplers and Loading Units for Single Use. Circular Staplers for Single Use

Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: August 6, 2018 Received: August 15, 2018

Dear Ms. Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.