The HARMONIC ACE + Shears with Advanced Hemostasis 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), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

Device Description

The Ethicon Endo-Surgery HARMONIC ACE+Shears with Advanced Hemostasis 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.

AI/ML Overview

This document describes a 510(k) submission for the HARMONIC ACE+ Shears with Advanced Hemostasis. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a clinical trial with statistical performance metrics against a defined ground truth.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing and laboratory evaluations in an animal model.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

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

Acceptance Criteria	Reported Device Performance
Not explicitly defined in terms of quantitative metrics or thresholds for specific performance attributes (e.g., success rate for vessel sealing, thermal spread limits).	Bench testing and laboratory evaluations in an animal model demonstrated that the HARMONIC ACE+ Shears with Advanced Hemostasis perform as intended and are as safe and effective as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 7 mm in diameter, as measured in situ.

Note: The document states that the device "perform[s] as intended" and is "as safe and effective and perform[s] as well as the identified legally marketed predicate devices". This implies the acceptance criteria were to demonstrate non-inferiority or equivalence to the predicate, likely based on established performance characteristics of those predicates (e.g., effective sealing of 7mm vessels, minimal thermal injury). However, no specific numerical thresholds or performance targets are provided.

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

Test Set Sample Size: Not specified. The document mentions "laboratory evaluations in an animal model including acute and 30-day chronic survival studies," but does not provide details on the number of animals or procedures performed.
Data Provenance: The studies were "laboratory evaluations in an animal model." The country of origin is not specified, but the submission is to the U.S. FDA, so it's likely conducted under U.S. regulatory guidelines or by a U.S.-based entity, even if the animals themselves could be from various sources. The studies were prospective in nature, as they were specifically conducted to evaluate the new device.

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)

Number of Experts: Not specified.
Qualifications of Experts: Not specified. Standard practice for animal studies evaluating surgical devices would involve veterinary surgeons, pathologists, and potentially histopathologists, but their number and specific qualifications are not detailed in this summary.

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

Adjudication Method: Not specified.

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

MRMC Comparative Effectiveness Study: No, this type of study was not done. This device is a surgical instrument, not an AI-assisted diagnostic tool or an imaging reader system. Therefore, MRMC studies are not applicable.

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

Standalone Performance: Not applicable in the conventional sense. The device does have an "Adaptive Tissue Technology" algorithm that modulates power delivery. The "Performance Data" describes "bench testing and laboratory evaluations in an animal model" which would assess the device's function, including this algorithm's performance in achieving hemostasis and cutting/coagulating tissue. While this is not an "algorithm-only" standalone performance in the context of AI, it represents the device operating as intended to achieve its intended function.

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

Type of Ground Truth: For the animal studies, the ground truth would likely be established through a combination of:
- Direct observation by trained personnel during the procedures.
- Histopathological analysis of excised tissue specimens to assess seal integrity, thermal spread, and tissue effects.
- Outcomes data from the "acute and 30-day chronic survival studies" (e.g., absence of hemorrhage, wound healing, presence/absence of complications).

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is not an AI/machine learning model in the sense that it requires a "training set." The "Adaptive Tissue Technology" algorithm is likely pre-programmed and tuned through engineering and empirical testing, rather than trained on a large dataset of patient cases.

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

Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the context of an AI model being trained. The "ground truth" for the development of the Adaptive Tissue Technology algorithm would have been based on engineering principles, material science, and empirical testing to optimize energy delivery for desired tissue effects.

Summary

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510(k) Summary

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

Contact Brian Godwin, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3623 Fax: (513) 337-4366 Email: bgodwin@its.jnj.com

OCT 17 2013

Date Prepared 20 August 2013

Device Name

Trade Name: HARMONIC ACE+ Shears with Advanced Hemostasis Common Name: Instrument, Ultrasonic Surgical

Classification Name

Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)

Predicate Device

HARMONIC ACE® Shears + Adaptive Tissue Technology, cleared under K120729 on . 17 May 2012
ENSEAL® G2 Tissue Sealers, cleared under K112033 on 08 Nov 2011 .

Device Description

Indications for Use

The HARMONIC ACE+ with Advanced Hemostasis 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), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

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Technological Characteristics

The Ethicon Endo-Surgery HARMONIC ACE+ Shears with Advanced Hemostasis incorporate the same technological characteristics as that of the ultrasonic predicate device. HARMONIC ACE Shears + Adaptive Tissue Technology. The subject devices use 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 with Advanced Hemostasis. The devices have an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level, MAX for maximum power level, and Advanced Hemostasis for large vessel [up to 7 mm] sealing).

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 as Adaptive Tissue Technology regulates the delivery of energy. To do this the generator monitors the thermal condition of the blade during device activation. The Advanced Hemostasis mode utilizes a unique algorithm within Adaptive Tissue Technology that modulates the power delivery from the Generator G11 to the blade of the device maximizing hemostasis.

Performance Data

Bench testing and laboratory evaluations in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the HARMONIC ACE+ Shears with Advanced Hemostasis perform as intended.

Conclusion

The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC ACE+ Shears with Advanced Hemostasis are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 7 mm in diameter, as measured in situ.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA," arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with a single staff entwined by a serpent.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Ethicon Endo-Surgery, LI.C Ethicon Endo-Surgery, Inc. Brian Godwin, RAC Senior Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242

October 17, 2013

Re: K132612

Trade/Device Name: HARMONIC ACE* + Shears with Advanced Hemostasis Regulatory Class: Unclassified Product Code: LFL Dated: August 29, 2013 Received: August 30, 2013

Dear Mr. Godwin:

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 - Brian Godwin

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.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm I 15809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Neil R Ogden Neil K Ogden
2013.10.17 09:22:43 -04'00'

For Mark N. Melkerson Acting 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): K132612

Device Name:

HARMONIC ACE + Shears with Advanced Hemostasis

Indications for Use:

The HARMONIC ACE + Shears with Advanced Hemostasis 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 ioint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

Prescription Use __ × (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)

Long H. Chen	Digitally signed by Long H. Chen -A
A	Dir: c=US, o=U.S. Government, ou=HHS,
	ou=FDA, ou=People, cn=Long H. Chen -A,
	0.9.2342.19200300.100.1.1=1300369056
	Date: 2013.10.16 15:22:24 -04'00

For MXM

(Division Sign-off) Division of Surgical Devices 510(k) Number K132612

Regulation Number and Section

N/A