The devices are 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 easyEndoTM Linear Cutting Stapler and Loading Units for Single Use are available in three staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm and 4.8mm. Reloads of easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use are available in four staple sizes to accommodate various tissue thickness: 2.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.

AI/ML Overview

The provided text is a 510(k) summary for the easyEndo™ Linear Cutting Stapler and Loading Units, a medical device. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical performance and design comparisons. It does not present a study with specific acceptance criteria that the device meets numerically, as would be expected for an AI/ML device.

Therefore, I cannot fully answer your request by filling out the table and detailed points as it's designed for an AI/ML device evaluation. The information provided is a premarket notification for a traditional medical device, where "acceptance criteria" are typically met through adherence to recognized standards (e.g., ISO, ASTM, USP) and direct comparison to predicates.

Here's a breakdown of why and what information can be extracted/inferred:

Why the Request Cannot Be Fully Answered as Posed:

No AI/ML Component: The device is a mechanical stapler, not an AI/ML system. Therefore, concepts like "algorithm only without human-in-the-loop performance," "effect size of human readers improving with AI," "training set," "ground truth for training set," "number of experts for ground truth," and "adjudication method" are not applicable.
"Acceptance Criteria" Different: For a traditional device like this, "acceptance criteria" are implied by compliance with performance standards and the demonstration of equivalence to legally marketed predicate devices. There isn't a specific quantitative "accuracy" or "performance metric" with a numerical threshold tied to the device's function that is then measured in a study. The "performance test" section describes what was tested, but not the specific thresholds for "acceptance."
No "Study" as Defined for AI/ML: The document describes "non-clinical tests" (bench testing) and states "No clinical study is included in this submission." This means there wasn't a comparative clinical trial to measure human-in-the-loop performance or standalone performance in a real-world setting against a defined ground truth.

Extracted Information (and why some points are N/A):

Based on the provided text, here's what can be addressed:

Device Name: easyEndo™ Linear Cutting Stapler and Loading Units for Single Use, easyEndo™ Universal Linear Cutting Stapler and Loading Units for Single Use

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category (Derived from Non-Clinical Tests)	Specific Criterion (Implicitly Met by Design/Testing)	Reported Device Performance (Implied by "complies" and "determined SE")
Biocompatibility	Biologically safe for patient contact.	Complies with ISO 10993-1, -5, -10; USP 38-NF 33 <85>; USP 39-NF34 <151>.
Sterilization	Sterilizable to an appropriate level.	Complies with ISO 11137-2 (Radiation sterilization).
Package Integrity	Maintains sterility and functionality.	Test result: Met.
Shelf Life	Maintains specified performance over its claimed life.	Test result: Met after accelerated aging.
Performance - Firing Force	Appropriate force for operation.	Test result: Met, comparable to predicate.
Performance - Staple Formation	Staples form correctly.	Test result: Met, comparable to predicate.
Performance - Staple Line Pressure	Maintains appropriate pressure.	Test result: Met, comparable to predicate.
Performance - Staple Line Tensile Test	Withstands appropriate tensile stress.	Test result: Met, comparable to predicate.
Performance - Hemostasis Evaluation Test	Effective in preventing bleeding.	Test result: Met, comparable to predicate.
Performance - Close Staple Height Test	Staples close to specified height.	Test result: Met, comparable to predicate.
Labeling	Complies with regulatory labeling requirements.	Conforms with 21 CFR 801.
Endotoxin Limit	<20 EU	Reportedly <20 EU. (Same as predicate)

Note: The document states "test results demonstrated that the proposed device complies with the following standards" and that it was "determined to be Substantially Equivalent (SE) to the predicate devices." For a 510(k), this general statement implies that the specific acceptance criteria for each test (e.g., max firing force, specific staple height range) were met, even if the exact numerical values aren't provided in this summary.

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

Sample Size: Not explicitly stated for each test. The text mentions "performance test performed on both proposed device and predicate device" but not the number of units/tests.
Data Provenance: The tests were conducted internally by Ezisurg Medical Co., Inc. (China). The data would be considered retrospective in the sense that it was collected as part of the development and submission process.

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)

N/A. This applies to AI/ML devices where human expert annotations create a 'ground truth' dataset. For this mechanical stapler, the "ground truth" is defined by engineering specifications and objective test methods (e.g., Firing Force measurements, visual staple formation checks).

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

N/A. Not applicable to objective mechanical bench testing. Adjudication methods are typically used for expert consensus in image interpretation for AI/ML.

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

N/A. This is a mechanical device, not an AI/ML system assisting human readers. The document explicitly states "No clinical study is included in this submission."

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

N/A. No algorithm involved. The "standalone" performance here refers to the device's mechanical function, which was assessed via the non-clinical tests (e.g., Firing Force, Staple Formation).

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

The "ground truth" for this device's performance is based on engineering specifications, established industry standards (ISO, ASTM, USP), and direct comparability to the performance parameters of legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

N/A. There is no "training set" as this is not an AI/ML device.

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

N/A. There is no "training set" or "ground truth for training set."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 21, 2017

Ezisurg Medical Co., Inc. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd. P.O Box 120-119 Shanghai, China 200120

Re: K172960

Trade/Device Name: easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: September 22, 2017 Received: September 26, 2017

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. 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 requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S3

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

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Indications for Use

510(k) Number (if known) K172960

Device Name

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 201.5: Legend Drug) ☐ Over-The-Counter Use (21 CFR 201.6)	☑ Prescription Use (Part 21 CFR 201.5: Legend Drug)	☐ Over-The-Counter Use (21 CFR 201.6)
☑ Prescription Use (Part 21 CFR 201.5: Legend Drug)	☐ Over-The-Counter Use (21 CFR 201.6)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Tab #7 510(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: K172960

1. Date of Preparation: 12/12/2017
1. Sponsor Identification

Ezisurg Medical Co., Ltd.

Rm. 103, Bldg.2, No.1690 Cailun Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, 201203, China.

Establishment Registration Number: Not yet registered.

Contact Person: Sheng Tian Position: VP Quality& Registration Tel: +86-21-50456176 Fax: +86-21-50676156 Email: tinatian@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: easyEndo™ Linear Cutting Stapler and Loading Units for Single Use easyEndo™ Universal Linear Cutting Stapler and Loading Units 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:

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 easyEndo™ Linear Cutting Stapler and Loading Units for Single Use are available in three staple sizes to accommodate various tissue thickness: 2.5mm, 3.5mm and 4.8mm. Reloads of easyEndo™ Universal Linear Cutting Stapler and Loading Units for Single Use are available in four staple sizes to accommodate various tissue thickness: 2.5mm, 3.8mm and 4.1mm. The device may be reloaded and fired up to 25 times for 1 firing in a single procedure.

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ડ. Identification of Predicate Device
Predicate Device 1 510(k) Number: K111825 Product Name: Endo GIA™ Staplers

Predicate Device 2 510(k) Number: K061156 Device Name: ENDOPATH Linear Cutters and 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 results demonstrated that the proposed device complies with the following standards:
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.
A 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
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-NF34:2016 <151> Pyrogen Test

The tests provided in this submission include package integrity test, bacteria endotoxin test, biocompatibility test, shelf life test and performance test 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 Hemostasis Evaluation Test Close Staple Height Test

Biocompatibility test provided in this submission include cytotoxicity test, sensitization test,

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intracutaneous irritation test and pyrogen test.

Shelf life test which include package integrity test and performance test was performed on proposed device after accelerated aging to verify the claimed shelf life of the device.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device 1	Item	Proposed Device	Predicate Device 1	Predicate Device 2
Product Code	GDW	GDW			K111825	K061156
Regulation Number	21 CFR 878.4750	21 CFR 878.4750	Product Code	GDW	GDW	GDW
Intended Use	The devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.	The Endo GIA™ Staplers 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 and for transection and resection of pancreas.	Regulation Number	21 CFR 878.4750	21 CFR 878.4750	21 CFR 878.4750
Cutting Mechanism	Linear	Linear	Intended Use	The devices are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.	The Endo GIA™ Staplers 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 and for transection and resection of pancreas.	The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials.
Operation Principle	Manual	Manual	Cutting Mechanism	Linear	Linear	Linear
Safety Mechanism	Green button is used for preventing from mis-firing.	Green button is used for preventing from mis-firing.	Operation Principle	Manual	Manual	Manual
Suture Length	45mm, 60mm	30mm, 45mm, 60mm	Safety Mechanism	Green button is used for preventing from mis-firing.	Green button is used for preventing from mis-firing.	Green button is used for preventing from mis-firing.
Staple height	2.5mm, 3.5mm, 4.8mm	2.0mm, 2.5mm, 3.5mm, 4.8mm	Suture Length	30mm, 45mm, 60mm	30mm, 45mm, 60mm	60mm
Closed staple form	Image: staple	Image: staple	Staple height	2.5mm, 3.5mm, 3.8mm, 4.1mm	2.0mm, 2.5mm, 3.5mm, 4.8mm	2.5mm, 3.5mm, 3.8mm, 4.1mm
Endotoxin Limit	20 EU	Same	Closed staple form	Image: staple form	Image: staple form	Image: staple form
Labeling	Conforms with 21 CFR 801	Conforms with 21 CFR 801	Endotoxin Limit	20 EU	20EU	20EU
Labeling	Conforms with 21 CFR 801	Conforms with 21 CFR 801	Conforms with 21 CFR 801

Table 1 Comparison for easyEndo™ Linear Cutting Stapler and Loading Units for Single Use

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Table 2 Comparison for easyEndo™ Universal Linear Cutting Stapler and Loading Units for Single Use

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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.

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.