The A.M.I. EasyInstruments device is a modular instrument system for use in laparoscopic highfrequency (HF) surgery and is designed for monopolar application. The Easylnstruments system comprises three-part detachable instruments, which include 1) different functional handles (EasyHandle), 2) instrument shafts of various diameters and lengths (EasyShaft), and 3) a wide range of different, application-specific attachments (EasyTips). It is intended during laparoscopic procedures to mobilize, manipulate, grasp, hold, fix, retract, dissect, cut, and coagulate tissue.

AI/ML Overview

This FDA 510(k) summary describes a medical device, the EasyInstruments, which are electrosurgical cutting and coagulation devices and accessories. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance against those criteria in a clinical study for a new AI/software component. Therefore, much of the requested information (like number of experts, adjudication methods, MRMC studies, ground truth for test/training sets, effect size of AI improvement) is not applicable or cannot be extracted from this document because it pertains to the evaluation of AI/software in a clinical context, which is not the subject of this 510(k) for electrosurgical instruments.

However, I can extract information related to the performance testing that was conducted to demonstrate safety and efficacy compared to predicate devices for these hardware instruments.

Here's an attempt to answer the questions based on the provided text, noting where the requested information is not present or applicable:

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

The document does not explicitly state acceptance criteria in precise numerical terms or detailed performance metrics in a table. It lists numerous tests performed to demonstrate safety and performance relative to predicate devices. The "reported device performance" is summarized as "The results of these tests indicate that the EasyInstruments are substantially equivalent to the predicate devices" and "it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices."

Below is a summary of the types of tests performed and the general outcome:

Category	Test Performed	Reported Performance (General)
Cleaning & Sterilization	Cleaning validation per AAMI TIR12 and AAMI TIR30. Sterilization validation per ISO 17665-1, ISO 11135, and ISO 11137.	Demonstrated effective cleaning and sterilization.
Longevity & Integrity	Shelf life and packaging validation per ISO 11607.	Device maintains integrity and sterility over its shelf life.
Biocompatibility	Biocompatibility Risk Assessment per ISO 10993-1. Cytotoxicity testing per ISO 10993-5. Irritation and sensitization testing per ISO 10993-10.	Biocompatible; no undue patient risk from materials.
Electrical Safety	Electrical safety per IEC 60601-1 and IEC 60601-2-2. EMC per IEC 60601-1-2.	Meets electrical safety and electromagnetic compatibility standards.
Bench Performance	Performance of disposable tips, reusable tips after reprocessing, EasyHandle reprocessing, and EasyShaft after reprocessing. Performance tests for tips included visual inspection for damage, opening angle, ease of movement in opening/closing, cutting, dissecting, grasping strength, continuity check. Performance tests for EasyShaft and EasyHandle included visual inspection (e.g., cracks, damage, warpage), continuity check, dielectric strength, and compatibility check.	Maintains mechanical and electrical integrity and function.
Thermal Effects	Side-by-side testing on ex vivo animal tissues (liver, kidney, muscle). Thermal damage assessed by measuring depth of damage at minimum, default, and maximum power settings using histology.	Thermal effects are comparable and safe.
Usability	Usability testing per IEC 62366-1, including device assembly, disassembly, reprocessing, and application in a simulated environment.	Usable and safe in simulated use scenarios.
Overall Conclusion	"The results of these tests indicate that the EasyInstruments are substantially equivalent to the predicate devices." "The equivalent indications for use, technological characteristics, and performance characteristics for the proposed EasyInstruments are assessed to be substantially equivalent to the predicate devices." "The subject device does not raise new issues of safety or efficacy compared to the predicate devices."	Substantially equivalent to predicate devices in safety and efficacy.

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

Sample size for test set: Not explicitly specified for each test. For "Thermal effects on tissue," it mentions "ex vivo animal tissues (liver, kidney, and muscle)," implying a sample of tissue, but the quantity is not detailed. For bench performance, it refers to "disposable tips," "reusable tips," "EasyHandle," and "EasyShaft," suggesting multiple units were tested, but precise numbers are not provided.
Data provenance: Not specified. The manufacturer is based in Austria, but the location where the tests were specifically conducted or the origin of the animal tissues is not stated. The tests are non-clinical (bench, ex vivo).

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)

Not applicable. This document pertains to the 510(k) clearance of electrosurgical instruments (hardware), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" here related to performance testing (e.g., measurements of thermal damage, visual inspection criteria, electrical readings), not clinical diagnoses.

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

Not applicable, for the same reasons as #3. Adjudication methods are typically used in clinical studies involving interpretation of medical data, where there might be disagreement among experts.

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 is not an AI/software device, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an AI/software device.

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

For the non-clinical performance and thermal effects testing, the "ground truth" would be established by:

Engineering specifications and standards (e.g., for electrical safety, dimensions, opening angles, grasping strength, continuity checks).
Histological assessment for thermal damage (directly observing tissue changes).
Standardized methods for cleaning/sterilization efficacy.
Biocompatibility test results against established safety limits.

8. The sample size for the training set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable, for the same reasons as #8.

Summary

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March 11, 2019

Agency for Medical Innovations GmbH % Dr. Pierre Bounaud Acknowledge Regulatory Strategies, LLC 2251 San Diego Ave., Suite B-257 San Diego, California 92110

Re: K182013

Trade/Device Name: EasyInstruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories. Regulatory Class: Class II Product Code: GEI Dated: January 25, 2019 Received: January 29, 2019

Dear Dr. Bounaud:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-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,

Digitally signed by Long H. Chen Long H. Chen -S -s -3 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) K182013

Device Name EasyInstruments

Indications for Use (Describe)

The Easylnstruments are indicated for cutting, grasping, dissecting and coagulation of tissue in laparoscopic surgical procedures.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

DATE PREPARED

February 26, 2019

MANUFACTURER AND 510(k) OWNER

Agency for Medical Innovations GmbH Im Letten 1, 6800 Feldkirch, Vorarlberg, Austria Telephone: Fax: +43 5522 90505-4006 Official Contact: Martin Hohlrieder, Ph.D., CTO

REPRESENTATIVE/CONSULTANT

Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave., Suite B-257, San Diego, CA 92110, USA Telephone: Email: pbounaud@acknowledge-rs.com akomiyama@acknowledge-rs.com

PROPRIETARY NAME OF SUBJECT DEVICE

EasyInstruments

COMMON NAME

Electrosurgical, Cutting & Coagulation & Accessories

DEVICE CLASSIFICATION

Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400, Product Code GEI, Class II)

PREMARKET REVIEW

ODE/DSD/GSDB2 General & Plastic Surgery Panel

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PREDICATE DEVICE IDENTIFICATION

EasyInstruments device is substantially equivalent to the following predicates:

510(k)Number	Predicate Device Name / Manufacturer	PrimaryPredicate	ReferencePredicate
K962119	ReNew Laparoscopic Instruments / Microline	✓
K160706	ReNew V Handpiece Laparoscopic Instruments /Microline
K163615	Snowden-Pencer Microlap 3mm LaparoscopicInstruments / CareFusion 2200 Inc.
K933002	Erbotom ICC 350 / Erbe USA, Inc.		✓
K023886	Erbe VIO ESU with Accessories, Model VIO 300 D /Erbe USA, Inc.		✓

DEVICE DESCRIPTION

INDICATIONS FOR USE

The Easylnstruments are indicated for cutting, grasping, dissecting and coagulation of tissue in laparoscopic surgical procedures.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The subject device has a similar design and dimensions and uses similar materials as the devices cleared in K962119, K160706, and K163615. The subject device has equivalent general intended use and similar technological characteristics as the device cleared in K962119, K160706 and K163615. Unlike the predicate devices, the tips, shafts and handles of EasyInstruments are detachable, which allows for easier cleaning and reprocessing of the instruments. A smaller shaft (3 mm) and the associated smaller length of the shaft/handle combination (17 and 26.5 cm) provide the surgeon with more options during laparoscopic procedures. An ergonomic fingertrip trigger is available on the EasyAct device to facilitate coagulation of tissue.

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SUMMARY OF NON-CLINICAL TESTING

Testing was performed per FDA's guidance document Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (Issued August 15, 2016). A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards:

Cleaning validation per AAMI TIR12 and AAMI TIR30 ●
. Sterilization validation per ISO 17665-1, ISO 11135, and ISO 11137
Shelf life and packaging validation per ISO 11607
Biocompatibility Risk Assessment per ISO 10993-1 ●
Cytotoxicity testing per ISO 10993-5
Irritation and sensitization testing per ISO 10993-10
Electrical safety per IEC 60601-1 and IEC 60601-2-2
EMC per IEC 60601-1-2
. Bench performance testing, including performance of disposable tips, performance of reusable tips after reprocessing, performance of EasyHandle reprocessing, and performance of EasyShaft after reprocessing. Performance tests for the tips included visual inspection for damage, opening angle, ease of movement in opening/closing, cutting, dissecting, grasping strength, continuity check between shaft and tip, and compatibility check of the shaft with tips. Performance tests for EasyShaft and EasyHandle included visual inspection (i.e. cracks, damage, warpage), continuity check between shaft and tip, dielectric strength of the shaft, and compatibility check of the shaft with tips.
Thermal effects on tissue. Side by side testing was performed on ex vivo animal tissues (liver, kidney, and muscle) and thermal damage was assessed by measuring the depth of damage at minimum, default, and maximum power settings using histology.
Usability testing per IEC 62366-1, including device assembly, device disassembly, device ● reprocessing, and device application in a simulated environment

The results of these tests indicate that the EasyInstruments are substantially equivalent to the predicate devices.

CONCLUSION

Based on the testing performed, including biocompatibility, cleaning validation, sterilization validation, shelf life validation, packaging validation, electrical safety, EMC testing, non-clinical performance testing (bench), thermal effects on tissue, and usability testing, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The equivalent indications for use, technological characteristics, and performance characteristics for the proposed EasyInstruments are assessed to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.