The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.

Device Description

The Human Xtensions HandX is a handheld powered laparoscopic device. The HandX enables, by its attached instruments Grasper, Needle Holder and Monopolar Hook, the surgeon to perform a variety of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension," enhancing maneuverability and control.

The HandX device is electromechanically controlled and includes both hardware and software. The device is comprised of two main parts: the Handpiece and the Instrument. The Handpiece consists of a reusable Control Interface (CI) handle and Handpiece Body that translates the surgeon's maneuvers and movements of their hands by means of control buttons to the instrument-articulating tip. The tip moves according to the CI's direction. Prior to use, a set of Power Cable, Finger Pads, Arc and Spacer are assembled on the Handpiece and the Handpiece is covered with a standard sterile cover (not provided with the HandX device). After use, the Instrument is disposed of, and the Handpiece is cleaned and disinfected per specifications in the Instructions for Use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for Human Xtensions Ltd.'s HandX device:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. Therefore, the "study" demonstrating the device meets acceptance criteria primarily revolves around usability testing for a new operating mode and showing that this modification does not introduce new safety or effectiveness concerns. There is no large-scale clinical trial data presented to assess diagnostic accuracy or treatment efficacy as might be seen for AI-driven diagnostic tools.

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" here relate to the safety and effectiveness of the new "inverted control mode" and ensuring that the modified device (HandX) remains substantially equivalent to its predicates (HX Device and Monopolar Hook).

Acceptance Criteria (Implicit from 510(k) context)	Reported Device Performance (from "Performance Data" section)
Safety: The addition of the inverted control mode does not introduce new or unacceptable safety risks.	"The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users."
Effectiveness: The device, with the new control mode, remains effective for its intended use.	The document states this difference ("inverted control mode") "does not raise new questions of safety or effectiveness, as it does not alter the fundamental therapeutic purpose of the device or its basic principles of operation (users control the inserted instruments in the same manner, just using one or another set of vectors)." It also notes, "The new mode also does not change the key metrics for evaluating device safety and performance, and is supported by successful usability testing." The implication is that since usability was successful, and the fundamental principle of operation remains, effectiveness is maintained. No specific quantitative effectiveness metrics are provided beyond this qualitative statement based on usability.
Usability: The inverted control mode is usable and understandable by target users.	"The company conducted usability testing of the inverted control mode in line with IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, as well as FDA's 2016 guidance document. The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users."
Substantial Equivalence: The HandX (with new mode) is substantially equivalent to predicate devices.	The overall conclusion of the 510(k) is: "Based on the intended use, technological characteristics, principles of operation, and usability testing, it can be concluded that the HandX is substantially equivalent to its predicate devices." The detailed comparison table in Section 5 shows the similarities and only identifies the addition of the "inverted control mode" as a notable difference, which they argue does not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample size (number of participants) for the usability testing. It mentions "both novel and experienced users," implying a mix of experience levels, but no specific count.
Data Provenance: The document does not explicitly state the country of origin for the usability testing data. However, the submitter is "Human Xtensions Ltd., Netanya, Israel," suggesting the testing could have been conducted in Israel or elsewhere (e.g., US, given the US legal representation). It was prospective usability testing conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

For this type of 510(k) (device modification based on usability), the concept of "ground truth" as it applies to diagnostic image analysis (e.g., presence/absence of disease) is not directly applicable.
Instead, the "ground truth" is established by adherence to usability standards and the ability of users to successfully and safely operate the device. The "experts" involved would implicitly be human factors engineers, clinical experts (surgeons) participating in the usability study, and potentially regulatory experts reviewing the study design and results.
The document does not specify the number or qualifications of these implicit "experts" beyond mentioning "novel and experienced users" in the usability study.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in studies where multiple readers interpret medical images to resolve discrepancies.
This is a usability study for a surgical instrument's control mode. The "adjudication" would involve human factors engineers observing user performance, collecting user feedback, and analyzing quantitative (e.g., task completion time, errors) and qualitative (e.g., subjective ratings, comments) data against pre-defined success criteria for usability and safety.
The document does not describe a specific adjudication method in the sense of reconciling differing expert opinions on a "ground truth" diagnosis. Usability assessment is a different paradigm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done.
- This type of study is common for AI-driven diagnostic tools to show improvement in human reader performance.
- The HandX device is a surgical instrument with a modified control mode, not an AI diagnostic tool.
- The study described is a usability study for the new control mode, not a comparative effectiveness study pitting human readers with vs. without AI assistance.

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

Not applicable.
- The HandX is a physical surgical instrument with electromechanical and software components, designed for human operation. It is not an "algorithm" in the sense of an AI model that operates in a standalone capacity (e.g., analyzing images without human input).
- Its "performance" is inherently human-in-the-loop, as it's a tool controlled by a surgeon.

7. The Type of Ground Truth Used

For the usability study, the "ground truth" is based on usability standards and successful task completion/safe operation.
- This is established by adherence to standards like IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, and the observation that "potential safety-critical consequences are reasonably mitigated" and instructional materials were "clear and easy to understand."
- It is not clinical "outcomes data" or "pathology" in the traditional sense for a diagnostic device.

8. The Sample Size for the Training Set

Not applicable / No training set described.
- This device is not an AI/ML algorithm that requires a "training set" of data in the manner that a deep learning model would.
- The software aspect discussed pertains to the control interface logic ("direct control" vs. "inverted control"), which is programmed, not "trained" on a dataset in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no described training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The device's functionality is based on engineering design and programming, verified through testing (including usability).

Summary

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September 13, 2021

Human Xtensions Ltd. % Randy Prebula Partner Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K212214

Trade/Device Name: HandX Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, NAY, GEI Dated: July 15, 2021 Received: July 15, 2021

Dear Randy Prebula:

We have reviewed vour 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): 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement on last page

510(k) Number (if known) K212214

Device Name

HandX

Indications for Use (Describe)

The HandX is intended to assist in the control of Human Xtensions instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.

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

Z 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (6/20)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6740 ER

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510(k) SUMMARY

Human Xtensions Ltd.'s HandX

Submitter:	Human Xtensions Ltd.4 Meir Ariel StreetNetanya, 4250574, IsraelTelephone: + (972) 77 36 30 300
Contact:	Randy J PrebulaHogan Lovells US LLPColumbia Square555 Thirteenth Street, NWWashington, DC 20004Telephone: +1 202 637 5600Direct: +1 202 637 6548Fax: +1 202 637 5910Email: randy.prebula@hoganlovells.com
Date Prepared:	September 9, 2021
Subject Device:
Device Name:Common Name:Classification Name:Product Codes:Product Class:Regulation Number:	HandXHandXLaparoscope, General & Plastic SurgeryGCJ, NAY, GEIClass II21 CFR 876.1500, 876.4400
Predicate Devices:	HX Device, Human Xtensions (K173919)Monopolar Hook, Human Xtensions (K203603)

Purpose of the Special 510(k) Notice

The HandX is a modification to the prior versions of the device that were cleared under K173919 (HX Device) and K203603 (Monopolar Hook).

Intended Use

Device Description

The Human Xtensions HandX is a handheld powered laparoscopic device. The HandX enables, by its attached instruments Grasper, Needle Holder and Monopolar Hook, the surgeon to perform a variety

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of minimally invasive surgeries. As the device is controlled by the surgeon's hand, it acts as a "surgeon's hand extension," enhancing maneuverability and control.

The HandX has nearly identical technological characteristics and principles of operation as the combined predicate devices. The only notable difference between the subject HandX and the combined predicates is the addition of the inverted control mode; whereas the predicate devices' software included only direct control ("Ro-bo style") for the Cl. the subject HandX provides direct control as well as inverted control ("La-pro style") as an additional, optional CI control mode. This difference does not raise new questions of safety or effectiveness, as it does not alter the fundamental therapeutic purpose of the device or its basic principles of operation (users control the inserted instruments in the same manner, just using one or another set of vectors). The new mode also does not change the key metrics for evaluating device safety and performance, and is supported by successful usability testing (as noted below).

Performance Data

The company conducted usability testing of the inverted control mode in line with IEC 62366-1:2015 and ANSI/AAMI HE75:2009/(R)2018, as well as FDA's 2016 guidance document. The testing demonstrated that potential safety-critical consequences are reasonably mitigated by the design of the inverted control mode and its associated instructional materials, which were clear and easy to understand by both novel and experienced users.

Conclusion

Based on the intended use, technological characteristics, principles of operation, and usability testing, it can be concluded that the HandX is substantially equivalent to its predicate devices.

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Substantial Equivalence (SE) Table

	Human Xtensions HandX (ModifiedDevice)	Human Extensions HX Device(K173919)	Human Xtensions Monopolar Hook(K203603)	Comparison ofSubject to Predicates
Intended Use	Intended for use in various laparoscopicsurgeries to perform a variety of surgicalfunctions, including grasping,approximation, ligation, suturing, cuttingand/or coagulation	Intended for use in variouslaparoscopic surgeries to perform avariety of surgical functions,including grasping, approximation,ligation, and suturing.	Intended for use in various laparoscopicsurgeries to perform a variety of surgicalfunctions, including grasping,approximation, ligation, suturing, cuttingand/or coagulation	Same
Indications for Use	The HandX is intended to assist in thecontrol of Human Xtensions laparoscopicinstruments including needle holder,grasper and monopolar instruments, forendoscopic manipulation of tissue,including grasping, approximation,ligation, suturing, cutting and/orcoagulation, during laparoscopic surgicalprocedures. The HandX monopolarinstruments are connected by a standardcable to a standard electrosurgical powersource. It is intended to be used bytrained physicians in an operating roomenvironment in accordance with itsInstructions for Use.	The HX Device is intended to assistin the accurate control of HXlaparoscopic instruments includingneedle holder and grasper, forendoscopic manipulation of tissue,including grasping, approximation,ligation, suturing, duringlaparoscopic surgical procedures. Itis intended to be used by trainedphysicians in an operating roomenvironment in accordance with itsInstructions for Use.	The HandX is intended to assist in thecontrol of Human Xtensionslaparoscopic instruments includingneedle holder, grasper and monopolarinstruments, for endoscopicmanipulation of tissue, includinggrasping, approximation, ligation,suturing, cutting and/or coagulation,during laparoscopic surgical procedures.The HandX monopolar instruments areconnected by a standard cable to astandard electrosurgical power source.It is intended to be used by trainedphysicians in an operating roomenvironment in accordance with itsInstructions for Use.	Same - Identical toK203603; only addsMonopolar Hook toindications cleared inK173919
Specialty	Laparoscopic			Same
Mode of Operation	Electromechanically operated, software controlled			Same
Components	Handpiece and compatible instruments(Grasper, Needle Holder, MonopolarHook); Arc, Pads, Spacer, Power Cable	Handpiece and compatibleinstruments (Grasper, NeedleHolder); Arc, Pads, Spacer, PowerCable	Instrument compatible with HandXHandpiece (Monopolar Hook)	Same as combinedpredicates
Grasper Type	Fenestrated		N/A*	Same as K173919
Needle Holder Type	Straight - Single Action		N/A*	Same as K173919
ElectrosurgicalInstrument Type	Monopolar hook	N/A	Monopolar hook	Same as K203603
Articulation	Yes	Yes	Yes	Same
Control InterfaceMode	Direct control and inverted control	Direct control	N/A*	Adds inverted controlmode
Single Use /Reusable	Handpiece: reusableInstruments: single use	Handpiece: reusableInstruments: single use	Instrument: single use	Same as combinedpredicates
Sterile Components	Instruments, Arc, Finger Pads, Spacer,and Power Cable	Instruments, Arc, Finger Pads,Spacer and Power Cable	Instrument (does not include othercomponents)	Same as K173919

*The K203603 filing only included the Monopolar Hook and did not re-include the entire system.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.