The ECHELON CIRCULAR™ Powered Staplers are sterile, single-patient use devices that simultaneously staple and cut tissue with a battery powered firing system to create an anastomosis. The devices deliver 2 rows of staples on the outside of the cut line. The ECHELON CIRCULAR™ Powered Staplers are available in a 24 cm curved shaft length in 4 end-effector sizes: 23mm, 25mm, 29mm and 31mm. Each device has a detachable anvil that allows a surgeon to place the anvil in the desired location. The devices are packaged with a battery pack that must be installed prior to use.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the "ECHELON CIRCULAR™ Powered Stapler." It is a premarket notification for a new device, and it relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, and comparative effectiveness studies with AI is not directly applicable in the context of this 510(k) submission.

This document describes bench and animal testing to demonstrate substantial equivalence, not clinical trials with human subjects.

Here's a breakdown of the available information in relation to your request, with an emphasis on what is not present because it's a 510(k) for a physical medical device, not an AI/software device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a way that would be typical for an AI/software study. Instead, it lists the types of tests performed to demonstrate substantial equivalence:

Performance Test Type	Reported Device Performance (Conclusion)
Staple line integrity equivalency	Substantially equivalent to the predicate device.
Staple form quality equivalency	Substantially equivalent to the predicate device.
Leak onset pressure equivalency	Substantially equivalent to the predicate device.
Force to fire	Substantially equivalent to the predicate device.
Formed staple height	Substantially equivalent to the predicate device.
Battery output	Substantially equivalent to the predicate device.
Fluid ingress	Substantially equivalent to the predicate device.
Acute hemostasis evaluation (animal)	Substantially equivalent to the predicate device.
Device removal acceptability (animal)	Substantially equivalent to the predicate device.
Device insertion tissue effects (animal)	Substantially equivalent to the predicate device.
Healing of stapled anastomosis (animal)	Substantially equivalent to the predicate device.
Staple line perfusion (animal)	Substantially equivalent to the predicate device.

Note: The phrase "substantially equivalent to the predicate device" is the primary performance metric for each category in a 510(k) submission. Specific numerical acceptance criteria or performance values are generally not detailed in the public 510(k) summary, as the goal is to show similarity to an already approved device.

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

Test Set Sample Size: Not explicitly stated numerically for each test. The document mentions "bench and animal tests." It does not involve human data.
Data Provenance: The tests were performed as part of the device development and regulatory submission process by Ethicon, LLC. This is prospective testing related to the new device. There is no mention of country of origin for data as it pertains to clinical data, as this is bench and animal testing.

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

Not applicable. For a physical medical device evaluated through bench and animal testing, the "ground truth" is established by the physical measurements, observations, and histological results of the tests themselves, often interpreted by qualified engineers, scientists, and veterinarians, rather than human experts reviewing images or other decision-making outputs.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for reconciling discrepancies in human expert opinions, typically in an AI/software context when establishing ground truth from human interpretations.

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 device is a surgical stapler, not an AI/software diagnostic tool. There are no "human readers" in the context of interpreting AI outputs.

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

Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used

For the bench tests, the "ground truth" would be objective physical measurements and engineering specifications. For animal testing, it would involve direct observation, histological analysis of tissue, and clinical assessment by veterinary professionals. It is not "expert consensus, pathology, or outcomes data" in the typical AI/software sense, but rather direct physical and biological evidence.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a physical device. This is not an AI/machine learning device.

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

Not applicable (as above).

Summary

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

April 18, 2017

Ethicon Endo-Surgery, LLC Ms. Rubina Dosani Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnati, Ohio 45242

Re: K163523

Trade/Device Name: ECHELON CIRCULAR Powered Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 20, 2017 Received: March 22, 2017

Dear Ms. Dosani:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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/Resourcesfor You/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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K163523

Device Name ECHELON CIRCULAR™ Powered Staplers

Indications for Use (Describe) The ECHELON CIRCULAR™ Powered Staplers have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information:	Ethicon, LLC
	475 Calle Street
	Guaynabo, PR 00969
Application Correspondent
	Rubina Dosani
	Sr. Regulatory Affairs Program Lead
	Ethicon Endo-Surgery, LLC.
Telephone:	(513) 337-3566
Fax:	(513) 337-2314
Email:	rdosani@its.jnj.com

Date Prepared December 14, 2016

Device Trade Name:	ECHELON CIRCULAR™ Powered Staplers
Device Common Name:	Circular Stapler
Classification Regulation:	21 CFR 878.4750
Device Class:	II
Panel:	General & Plastic Surgery
Classification (Product) Code:	GDW

Legally Marketed Predicate Device: Ethicon Endo-Surgery® Curved Intraluminal Staplers (cleared under K983536)

Device Description

Indications for Use

The ECHELON CIRCULAR™ Powered Staplers have applications throughout the alimentary tract for end-to-end, end-to side, and side-to-side anastomoses.

Technological Characteristics

The subject device utilizes battery power to allow powered staple formation and lumen cutting to create the anastomosis. The subject device has a similar design as the predicate with the addition of tighter staple height range and staple pockets extensions to the end-effector of the device as

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well as a slightly different shape of the formed staples. Similar to the predicate, a rotatable adjustment knob enables the compression of tissue and selection of a target staple height based on the tissue compression within the green zone. No energy passes through to the patient in the use of the subject or predicate devices. Neither the subject device or predicate device uses software.

Performance Data

Performance data demonstrate that the subject device is substantially equivalent to the predicate device and the differences between the devices were found not to affect safety or performance. The following bench and animal tests were performed to demonstrate substantial equivalence to the predicate:

staple line integrity and staple form quality equivalency ●
leak onset pressure equivalency
force to fire
o formed staple height
battery output
o fluid ingress

Animal testing performed included acute hemostasis evaluation, device removal acceptability, device insertion tissue effects, healing of stapled anastomosis and staple line perfusion.

The conclusions of the testing demonstrate that the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.

This submission does not include data from Clinical Studies.

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.