The HARMONIC ACE® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Device Description

The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology incorporate an ergonomic handle and tapered blade geometry. The instruments have a coated ultrasonic blade and an EEPROM memory chip that stores device identification, usage tracking, and operating parameters for use by the Generator G11 that provides power for the HARMONIC ACE® Shears + Adaptive Tissue Technology.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HARMONIC ACE® Shears + Adaptive Tissue Technology:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implied by the "substantially equivalent" determination to the predicate device. The performance data presented focuses on demonstrating that the device performs as intended and is as safe and as effective as the predicate device.

Acceptance Criteria Category	Reported Device Performance (Implicit from substantial equivalence)
Safety	Demonstrated to be "as safe" as the predicate device through bench testing and animal model studies (acute and 30-day chronic survival studies).
Effectiveness	Demonstrated to be "as effective" as the predicate device in cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ, in thoracic surgical procedures.
Intended Use	Performed as intended for soft tissue incisions where bleeding control and minimal thermal injury are desired, and in specific surgical procedures (general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures).

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated regarding specific numbers of animals or tests. The phrasing is "Bench testing and laboratory evaluations of thoracic procedures in an animal model including acute and 30-day chronic survival studies."
- Data Provenance: Animal model (unspecified species) and bench testing. No country of origin is specified. The studies were likely prospective in nature as they were conducted to demonstrate performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. The studies were "bench testing and laboratory evaluations," implying technical assessments rather than expert clinical review of test data for ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as the "test set" described is material/animal performance, not human clinical data requiring adjudication of interpretations.
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:
- No, an MRMC study was not done. This device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve human "readers" or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device includes "Adaptive Tissue Technology" which is described as a "power output algorithm." The performance data for this algorithm appears to be integrated into the overall bench and animal testing of the device for its intended function (cutting, coagulating, sealing). Therefore, the "algorithm only" performance is implicitly part of the overall device performance demonstrated without a separate standalone study detailed for the algorithm in isolation. Human interaction is inherent in using a surgical instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal model: Outcomes data (acute and 30-day chronic survival) and direct in situ measurements (e.g., vessel seal diameter, effectiveness of cutting and coagulation).
- For bench testing: Likely objective physical measurements related to cutting efficiency, coagulation effectiveness, thermal injury, and seal strength.
The sample size for the training set:
- This information is not applicable in the traditional sense for this device. The "Adaptive Tissue Technology" involves an algorithm, but the text describes it as using "parameters stored on the device EEPROM" and "monitors the frequency of the instrument blade and determines when there is a change in the thermal condition of the blade." This suggests a pre-programmed or rules-based algorithm rather than a machine learning model that would require a "training set" in the common understanding. The parameters would have been developed and refined through engineering and testing, not by training on a large dataset in the way an AI diagnostic tool would.
How the ground truth for the training set was established:
- As noted above, a "training set" in the conventional machine learning sense is not applicable. The "ground truth" for the development of the Adaptive Tissue Technology's parameters would have been based on engineering principles, material science, and experimental data on tissue interaction with ultrasonic energy, likely derived from extensive R&D bench testing and possibly earlier animal studies.

Summary

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K121550

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AUG 222 2012

510(k) Summary of Safety and Effectiveness

Company

Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969

Contact Marcia Arentz Regulatory Affairs Portfolio Leader Ethicon Endo-Surgery. Inc. Telephone: (513) 337-1066 Fax: (513) 337-2016 Email: marentz5@its.jnj.com

Date Prepared: May 24, 2012

Device Name:

Trade Name: HARMONIC ACE® Shears + Adaptive Tissue Technology Common Name: Instrument, Ultrasonic Surgical

Classification Name:

Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)

Predicate Devices:

K120729: HARMONIC ACE® Shears + Adaptive Tissue Technology
K050885: SonoSurg Short Curved Scissors 5 mm O.D., HF Series, Pistol
and Inline Grip submitted as part of the Olympus Ultrasonic
Surgical System SonoSurg
K060245: HARMONIC Scalpel 5 mm Instruments by Ethicon Endo-

Surgery

Device Description:

Indications for Use Statement:

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Technological Characteristics: Both the Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology and the predicate devices operate using ultrasonic technology to cut and coagulate soft tissues. The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology incorporate an ergonomic handle and tapered blade geometry. The instruments have a coated ultrasonic blade and an EEPROM memory chip that stores device identification, usage tracking, and operating parameters for use by the Generator G11 that provides power for the HARMONIC ACE® Shears + Adaptive Tissue Technology.

Adaptive Tissue Technology refers to the power output algorithm that is utilized by the devices. During use the Adaptive Tissue Technology algorithm parameters stored on the device EEPROM are read by the generator and used to reduce the power (current) to the instrument and provide a secondary, higher pitched generator activation tone when there is little or no tissue between the instrument blade and tissue pads. To do this the generator monitors the frequency of the instrument blade and determines when there is a change in the thermal condition of the blade during device activation. This thermal condition of the blade is compared to the values stored on the EEPROM to determine when this minimal tissue condition is present and the Adaptive Tissue Technology features are activated.

DeviceCharacteristic	HARMONIC ACEShears + AdaptiveTissue Technology(subject devices)	SonoSurg Short CurvedScissors 5 mm O.D.,(predicate K050885)	Ethicon Endo-surgeryHARMONIC Scalpel5 mm Instruments(predicate K060245)
Technology	Ultrasonic	Ultrasonic	Ultrasonic
Procedures	Open and laparoscopic	Open and laparoscopic	Open and laparoscopic
Patient Use	Single Use	Reusable	Single Use
SterilizationMethod	Ethylene Oxidesterilized(provided sterile tocustomer)	Steam(autoclave by end user)	Ethylene Oxidesterilized(provided sterile tocustomer)
SAL	$10^{-6}$	n/a	$10^{-6}$
Shaft Diameter	5.5 mm	5.5 mm	5.5 mm
Shaft Length	23 & 36 cm	19 cm	32 cm
Blade Frequency	55.5 kHz	47 kHz	55.5 kHz
Maximum BladeAmplitude(MAX PowerLevel)	91.2 microns (HAR36)85.9 microns (HAR23)	81 microns	100 microns
Blade Shape	Curved	Curved	Curved
EnergyActivationMethod	Foot or Hand Switch	Footswitch	Foot or Hand Switch
Seals vessels upto diameter of	5 mm	5 mm	3 mm

Technological Comparison:

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Performance Data: Bench testing and laboratory evaluations of thoracic procedures in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the HARMONIC ACE® Shears + Adaptive Tissue Technology perform as intended.

Conclusion: The results of the bench top and animal model testing demonstrate that the HARMONIC ACE® Shears + Adaptive Tissue Technology are as safe and as effective as the predicate device in cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ, in thoracic surgical procedures. This testing supports the substantial equivalence of the HARMONIC ACE® Shears + Adaptive Tissue Technology to the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.

Public Health Service

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

Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Incorporated Ms. Marcia Arentz Regulatory Affairs Portfolio Leader 4545 Creek Road Cincinnati, Ohio 45242

AUG 222 2012

Re: K121550

Trade/Device Name: HARMONIC ACE® Shears + Adaptive Technology Regulatory Class: Unclassified Product Code: LFL Dated: July 18, 2012 Received: July 19, 2012

Dear Ms. Arentz:

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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Page 2 - Ms. Marcia Arentz

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

yours,

Melkerson

Mark N. Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ethicon Endo-Surgery, LLC

Premarket Notification (Traditional) HARMONIC ACE Shears + Adaptive Tissue Technology - Thoracic Indication

Indications for Use

510(k) Number (if known): K121550

Device Name: HARMONIC ACE® Shears + Adaptive Tissue Technology

Indications for Use:

The HARMONIC ACE® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Ogden

(Division Sign-Off) (Division Sign Sign Sical, Orthopedic, and Restorative Devices

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510(k) Number K121550

Regulation Number and Section

N/A