The Moon Maestro System utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location.

AI/ML Overview

The Moon Surgical Maestro System is a device designed to hold and position laparoscopic instruments during surgical procedures. The provided FDA 510(k) summary outlines its design, intended use, and comparison to a predicate device (ENDEX Endoscopic Positioning System K936308) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" with specific quantitative thresholds that are then directly matched with reported device performance in a single table. Instead, it describes various performance tests conducted. The "Performance Testing" section states that "All testing had passed in accordance with the pre-specified success criteria, international standards or FDA guidances." This implies that the acceptance criteria were internal to the company, based on these standards and guidances.

However, we can infer some performance aspects based on the comparison table and the performance testing section.

Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Functional & Mechanical
Positional reach & trocar accommodation	Passed
Payload capacity	4.4 lbs tested (vs. predicate's 5 lbs maximum force generated)
System cart stability	Passed
Emergency stop	Passed
Gravity compensation accuracy	Passed
Coupler performance	Passed
Brake hold	Passed
Safety & Electrical
Electrical insulation	Passed
Electrical safety	Passed
EMC (Electromagnetic Compatibility)	Passed
Single fault condition	Passed (Automatic System Performance Monitoring, redundant encoders, velocity/acceleration/current/torque limits, brakes engage if power removed)
LED status	Passed (LEDs change colors, pulse for status; red for critical fault)
Back-up fault response	Brakes engage on motorized axis in the event of a fault state to prohibit any arm motion
Biocompatibility & Sterilization
Sterilization validation (for couplers)	Passed (steam sterilization)
Sterility barrier (drape integrity)	Passed
Software
Software validation	Passed
Usability
Human factors testing	Passed
Cadaver testing	Passed

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

The document does not specify the sample size used for the various performance tests (e.g., how many units were tested for payload capacity, how many cadaver procedures were performed).

The data provenance is internal to Moon Surgical, described as "Design validation testing." No specific country of origin for the data is mentioned, nor is it explicitly stated whether the tests were retrospective or prospective, though "design validation testing" typically implies prospective testing of the device.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It mentions "Cadaver testing" and "Human factors testing" which would implicitly involve experts (surgeons, medical professionals), but details are absent.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1). The testing appears to be based on pre-specified success criteria and compliance with standards, implying that results were evaluated against these benchmarks.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to a predicate device through technical comparison and performance testing, rather than a clinical effectiveness study involving human readers or operators and their performance with and without AI assistance. The device is a mechanical robotic assist system, not an AI diagnostic tool.

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

The device is a system that supports surgeons, meaning it inherently has a "human-in-the-loop." Therefore, a "standalone algorithm only" performance evaluation is not applicable in the context of this device. The software's role is to maintain instrument position based on surgeon input (movements and release). Software validation was performed, but this is a component of the system's overall function, not a standalone diagnostic AI.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" would be defined by:

Pre-specified success criteria: Internal benchmarks for how the device should perform.
International standards or FDA guidances: Established metrics for device safety and performance.
Engineering specifications: Design parameters for mechanical and electrical functions.
Clinical feasibility (Cadaver testing): Demonstrating the device's ability to be used effectively in a simulated surgical environment.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI algorithm development. The "software validation" mentioned would refer to the validation of its control logic and functions, not typically a machine learning model trained on a dataset. The device's function as described (compensating for gravitational force, maintaining instrument position upon release) relies on electromechanical control and sensor feedback, not a learned model from a training set.

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

Since a training set for machine learning is not applicable as per point 8, the method for establishing its ground truth is also not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

December 2, 2022

Moon Surgical % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460

Re: K221410

Trade/Device Name: Maestro Platform Regulation Number: 21 CFR 878.4960 Regulation Name: Operating Tables And Accessories And Operating Chairs And Accessories Regulatory Class: Class I Product Code: FQO Dated: November 2, 2022 Received: November 3, 2022

Dear Michael Daniel:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Jessica Carr -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K221410

Device Name Maestro System

Indications for Use (Describe)

The Maestro System is intended to hold and position laparoscopic instruments during laparoscopic surgical procedures.

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 (K221410)

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K221410

Applicant Information:

Date Prepared:	November 28th, 2022
Name:	Moon Surgical
Address:	7/11 Blvd Haussmann75009 Paris France
Contact Person:	Michael A Daniel, Consultantmadaniel@clinregconsult.com
Mobile Number:	(415) 407-0223

Device Information:

Device Trade Name:	Maestro System
Common Name:	Maestro System
Classification Name(s):	Table, Operating-Room, AC-Powered
Product Code/ Regulation:	FQO 21 CFR 878.4960
Classification:	Class I

Predicate Device:

ENDEX Endoscopic Positioning System (K936308)

Subject Device Description

Subject Device Intended Use / Indications for Use

The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.

Predicate Device and Subject Device Comparison

The table below compares the Maestro System to the predicate device.

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ASPECT	ANDRONIC DEVICES LTD.(Predicate)	MOON SURGICAL (SubjectDevice)	COMPARISON
Device Name	ENDEX	Maestro	N/A
510(k) Number	K936308	K221410	N/A
Product Code /Regulation	FQO / 878.4960Table Operating-room, AC-Powered	FQO / 878.4960Table Operating-room, AC-Powered.	Previous "Operatingtable" related codes arenow all Class I 510(k)exempt.
Brief Description	The ENDEXEndoscopicPositioning System is anelectrically actuated, air ornitrogen-powered devicewithmovablecomponents intendedforlaparoscopicsurgicalprocedures tosupport andposition laparoscopicinstruments. Its majorcomponents consist of theEndoscopic Positioner(consisting of the PositioningArm and Table Module),Control Unit,Scope Driver(formerly called theInstrument PositioningEffector), Grasper Holder(formerly called theInstrument Holding Effector),Arm Release Button, ScopeDriver ControlFootswitch,ScopeDriverControl Handswitch, and High-PressureHose.	The Moon Surgical Maestro deviceis an electrically actuated devicewith movable components intendedfor laparoscopic surgical proceduresto support and position laparoscopicinstruments.Its major components consist of theSurgical Base, Surgical Arms,Control Unit, Instrument Coupling,and Control Station	Predicate is electricallyactuated pneumatic andsoftware drivenmechanical system.The subject device isstrictly electricallyactuated and utilizessoftware to maintaininstrument position bycompensating forgravity.
Intended Use /Indications for Use	Intended to hold and positionlaparoscopes and laparoscopicinstruments in laparoscopiccholecystectomies andadvanced laparoscopicsurgical procedures.	The Maestro System is intended tohold and position laparoscopes andlaparoscopic instruments duringlaparoscopic surgical procedures.	SubstantiallyEquivalent (SE)
Mechanism of Action(System Actuation /Positioning)	The ENDEX EndoscopicPositioner "remains lockedwhen the gas source is appliedand has a positioner unlockcontrol button that permits thesurgeon to easily unlock andreposition the device withoutcompromising the sterility ofthe surgical field."	The Moon Maestro System utilizesDC motors to compensate forgravitational forces applied tolaparoscopic instruments. Softwareand hardware are designed tomaintain instrument position.Surgeon control is achieved bygrasping the handle of conventionallaparoscopic tools and moving the	The predicate has two(2) operating modes.One locks theinstrument arm/holderin the location desiredby surgeon and thesecond mode allowsmotor driven endoscope

Table 1 - Comparison between subject and predicate device
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ASPECT	ANDRONIC DEVICES LTD.(Predicate)	MOON SURGICAL (SubjectDevice)	COMPARISON
	The ENDEX Scope Driver isan electrically powered devicefor translating the position oflaparoscopic surgicalinstruments. Both instrumentsand endoscope positions canbe adjustedelectromechanically via motordriven polymer "rollers"making contact with theendoscope or instrumentshafts.	tool to the desired position. Oncesurgeon hand force is removed, theMaestro system reverts tomaintenance of the specifiedlocation including orientation.Unlike the predicate, there is nomotorized movement ofinstruments. Only maintenance ofposition.	or instrumentpositioning.
Platform / Mechanismof stable attachment ofarms	Aluminum jointed arms areclamped to operating table railor base via mechanical screwclamps.	Jointed arms are attached to stageslocated on a portable base that canbe locked in position. The bases arelocked in position during systemuse.	SE
Method of instrumentattachment	Mechanical clamp	Mechanical clamp aroundlaparoscopic instrument andmagnetic attachment to arm	SE
Mechanisms involvedin physical positioning	Jointed arms locked in placevia nitrogen or air. Thepneumatic lock and unlockstates are controlled viaelectrical switches in eitherhand or foot switch locations.Endoscope and Instrumentsare held in place againstgravity force by metallicjointed arms.The ENDEX Scope Driver isan electrically powered devicefor translating the position oflaparoscopic surgicalinstruments. Both instrumentsand endoscope positions canbe adjustedelectromechanically via motordriven polymer "rollers"making contact with theendoscope or instrumentshafts. Forward and backwardmotion is controlled byfootswitch.	Electro-mechanical jointed armsdriven by internal motors thatfollow the physician movements.Unlike the predicate, there is nomotorized movement ofinstruments. Only maintenance ofposition.	SE - subject device ismore sophisticated indesign. However,fundamental functionremains substantiallyequivalent in terms ofintended use andfunctions related topositioning and holdingan endoscope andinstruments
Method of control	On/off switch for applicationof pneumatic lockingmechanism. Joystick or footswitch control of laparoscope	Direct manipulation of conventionallaparoscopic instrument handles.Endoscope and Instrument positionsare unlocked via surgeon applied	SE - subject device ismore sophisticated indesign. However,fundamental function
ASPECT	ANDRONIC DEVICES LTD.(Predicate)	MOON SURGICAL (SubjectDevice)	COMPARISON
	or laparoscopic instrumentmovement.Fundamental control isachieved through electricalswitch unlock or release ofpneumatic pressure followedby surgeon movement ofendoscope or instruments intodesired location followed byelectrical switch re-actuationof pneumatic lock.	force to laparoscope or instrumenthandles. This unlocking force is onthe order of magnitude of whatwould be expected in holding orrepositioning the endoscope orinstruments themselves. Theendoscope or instruments arerepositioned as desired by thesurgeon. Once the surgeon releasesthe instruments or scope the systemmaintains the new position withmotor driven forces sufficient tocompensate for gravity.	remains substantiallyequivalent in terms ofintended use andfunctions related topositioning and holdingan endoscope andinstruments.
Alarm and WarningCondition Indicators	The Endex system has twouser indicators: the low-pressure light and the scopemovement tone. The low-pressure light illuminateswhen supply gas pressure fallsbelow 100 psi. Recommendedsupply pressure necessary foroptimal arm strength is 200psi.The scope or instrumentmovement tone is activatedwhenever the driver is movingthe scope or instrument. Thismovement is controlled viathe footswitch. The volume isadjustable and may be turnedoff.	The Maestro has two primary LEDsfor communication to the surgeon.These LEDs change colors andpulse to communicate system status.In the case of a critical system fault,the LEDs will change to red.The Maestro is also equipped with atouch screen graphical interface.This screen provides messages tothe operating room staff regardingsystem state.	SE – subject device ismore sophisticated indesign. However,fundamental functionremains substantiallyequivalent in terms ofintended use andfunctions related topositioning and holdingan endoscope andinstruments.
Single Fault Tolerance	Visual supervision by surgeon	Automatic System PerformanceMonitoring in real-time withmultiple fault tiers + visualsupervision by surgeon via LEDindicating system status.Examples include:- Redundant encoders on motorizedaxes- Velocity, acceleration, current andtorque limits	SE
		- Brakes engage if power isremoved
Back-up fault response	None	Brakes engage on motorized axis inthe event of a fault state to prohibitany arm motion	SE
ASPECT	ANDRONIC DEVICES LTD.(Predicate)	MOON SURGICAL (SubjectDevice)	COMPARISON
Maximum AppliedLoad	5 lbs "maximum forcegenerated by Scope Driver"	4.4 lbs tested.	No exertion of force bysubject device
Sterilization Method	Steam	Steam (for coupling devices used toattach laparoscopic instruments)	SE
Sterility barrier	Drape	Drape	SE

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Performance Testing

Design validation testing included the following:

Positional reach and trocar accommodation ●
Payload capacity
System cart stability
Single fault condition
Force measurement accuracy ●
Brake hold ●
Electrical insulation
LED status
Drape integrity
Emergency stop ●
Software validation
Electrical safety
EMC
Sterilization validation
Gravity compensation accuracy
Coupler performance ●
. Cadaver testing
Human factors testing ●

All testing had passed in accordance with the pre-specified success criteria, international standards or FDA guidances.

Conclusion

Based upon the Intended Use, Indications for Use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the Maestro System has been shown to be substantially equivalent to the cited predicate device.

Regulation Number and Section

§ 878.4960 Operating tables and accessories and operating chairs and accessories.

(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.