The Disposable Circular Staplers, can anastomose organs by firing into the tissues of alimentary canal two staggered (interior and exterior) rings of titanium staples and cutting off inside tissue with the circular blades simultaneously. The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. The instrument is activated by squeezing the handles firmly as far as they will go. Immediately after staple formation, the knife blade resects the excess tissue, creating a circular anastomosis.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Disposable Circular Stapler), which focuses on establishing substantial equivalence to a predicate device based on technical characteristics and performance testing. This document does not describe a study involving an AI/human reader in the loop, or the use of expert consensus/pathology for establishing ground truth as would be relevant for an AI/ML device. Therefore, much of the requested information cannot be extracted from this document.

However, based on the provided text, here's what can be extracted regarding acceptance criteria and the study:

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

The document mentions several performance tests were conducted. While specific acceptance criteria values are not explicitly stated, the implication is that the device met the criteria for each test to claim substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Visual appearance (Acceptable)	Passed (implied, as stated no change in basic design)
Dimensions (Within specifications)	Passed (implied)
Sharpness (Adequate)	Passed (implied)
Operational Performance (Functional)	Passed (implied)
Cutting Performance (Effective)	Passed (implied)
Staple formation and closed staple height (Correct)	Passed (implied)
Pressure resistance (Adequate)	Passed (implied)
Corrosion resistance (Acceptable)	Passed (implied)
Packaging performance (Adequate)	Passed (implied)
Hardness (Within specifications)	Passed (implied)
Firing Force (Within specifications)	Passed (implied)
Energy Testing (Within specifications)	"Testing of the staples during insertion and extraction showed that there are no appreciable differences in the energy needed to insert or extract the staples."
Sterility (Sterile)	Passed (implied, "sterility verfication was completed per USP standards")
Biocompatibility (Biocompatible)	"Biocompatibility testing was performed to ensure the stapler was constructed of material which passes the Biological Evaluation of Medical Devices, parts 1,3,5,6, 10 and 11."

2. Sample sized used for the test set and the data provenance

Sample size: Not specified in the document. The document only states that "the same testing submitted for the predicate was repeated."
Data provenance: The testing was conducted by Changzhou Kangdi Medical Stapler Co., Ltd. The document does not specify the country of origin of the data beyond the company's location in China. The testing appears to be for the device itself rather than patient data, and thus is an in vitro/benchtop study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical stapler, and the "ground truth" for its performance is established through engineering and sterility testing, not expert interpretation of medical images or data.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements (e.g., dimensions, hardness, force, pressure resistance) or pass/fail criteria (e.g., visual inspection, sterility). There is no "adjudication" in the sense of resolving differences between expert opinions.

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. This document describes a medical stapler, not an AI-powered diagnostic device.

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

Not applicable. This document describes a medical stapler, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through:

Engineering specifications and standards: For dimensions, sharpness, operational/cutting performance, staple formation, hardness, firing force, energy testing.
Material standards: For implantable staple material (Standard for Unalloyed Titanium for Surgical Implant Applications).
Biological evaluation standards: For biocompatibility (Biological Evaluation of Medical Devices, parts 1,3,5,6, 10 and 11).
Packaging and sterility standards: USP standards for sterility and packaging verification.
Corrosion resistance tests.

8. The sample size for the training set

Not applicable. This document describes a medical stapler, not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 5, 2017

Changzhou Kangdi Medical Stapler Co., Ltd. % Mr. Charlie Mack Principal Engineer IRC 2091 Oak Drive Lake Havasu City, Arizona 86406

Re: K172561

Trade/Device Name: Disposable Circular Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: October 29, 2017 Received: November 7, 2017

Dear Mr. Mack:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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1000-1050.

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

David Krause -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172561

Device Name Disposable Circular Stapler

Indications for Use (Describe)

The Disposable Circular Stapler has application throughout the alimentary tract for end-to-side and side-toside anastomoses.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: November 2, 2017

Company making the submission:

Name - Changzhou Kangdi Medical Stapler Co., Ltd Address - No.16 Kunlun Road, XinBei Zone, Changzhou City, Jiangsu Province, China 213022 Telephone - 86-519-85162780 Fax - 86-519-85139853 Contact - Ms. Eve Zhou Email - charliemack@irc-us.com

Correspondent:

Name: Charles Mack Address: 2091 Oak Drive, Lake Havasu City, Arizona 86406 Telephone: 931-625-4938 Email: charliemack@irc-us.com

Device:

Trade/proprietary names:

Disposable Circular Stapler	Model KYGWA- 23.5 / 25.5 / 28.5 / 31.5 /33.5; Model KYGWB- 23.5 / 25.5 / 28.5 /31.5 / 33.5; Model KYWC- 17.5 / 21.5 /23.5 / 25.5 / 28.5 / 31.5 / 33.5
-----------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------

Common Name: Implantable Staple Classification Name: Staple, implantable

Predicate Device:

This submission is a modification to the previously cleared Changzhou Kangdi Medical Stapler Co., Ltd Disposable Circular Stapler under 510(k) number K100723 with a decision date on

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04/30/2010.

Classifications Names & Citations:

Classification of the device: Class II Panel: General and Plastic Surgery Product code: GDW, 21CFR878.4750

Description:

General

Indications For Use

Disposable Circular Stapler:

The Disposable Circular Stapler has application throughout the alimentary tract for endto-end, end-to-side and side-to-side anastomoses.

Technical Characteristics:

The Disposable Circular stapler has not changed in basic design. The only difference in the current submitted device is there are new models, using different staple sizes. The KYGWG stapler has a new adjusting nut shape, which does not affect performance. Testing of the staples during insertion and extraction showed that there are no appreciable differences in the energy needed to insert or extract the staples.

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Performance Test Summary:

The implanted staple is the same material as the predicate device and meets the Standard for Unalloyed Titanium for Surgical Implant Applications.

There is no FDA recognized performance standard for implanted staple and stabler. Therefore, the same testing submitted for the predicate was repeated. The testing was as follows:

1. Visual appearance
1. Dimensions
1. Sharpness
1. Operational Performance
1. Cutting Performance
1. Staple formation and closed staple height
1. Pressure resistance
1. Corrosion resistance
1. Packaging performance
1. Hardness
11.Firing Force
1. Energy Testing
1. Sterility

Biocompatibility testing was performed to ensure the stapler was

constructed of material which passes the Biological Evaluation of Medical Devices, parts 1,3,5,6, 10 and 11.

The modifications to the devices have not affected the sterility process, materials or packaging. For verifications, packaging and sterility verfication was completed per USP standards.

Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Changzhou Kangdi Medical Stapler Co.,Ltd. concludes that Disposable Circular Stapler, Models KYGWA/KYGWB/KYGWC are substantially equivalent to predicate devices as described herein.

END

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.