The Moon Maestro System is a 2-arm system which 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. This 510(k) is being submitted to implement design changes to the previously cleared Maestro System. The following modifications have been implemented to the Maestro System:

· System Positioning Guidance
· System Hold Status Indication
Instrument Coupling
· System Setup
Bedside Setup Joint Control

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Maestro System (REF100)". This document is an FDA clearance letter and a 510(k) summary, which outlines the device, its intended use, and a comparison to a predicate device. It also briefly mentions the types of testing performed (design verification and validation testing).

However, the document does not provide a detailed breakdown of acceptance criteria and the results of a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system that would typically have specific performance metrics like sensitivity, specificity, or accuracy.

The Maestro System is described as a two-arm system that utilizes software and hardware to support surgeons by manipulating and maintaining instrument position in laparoscopic surgical procedures. The modifications made to the device relate to user interface, setup guidance, and instrument coupling, rather than an AI component that would perform diagnostic or interpretive tasks.

Therefore, many of the requested elements for an AI-powered device's acceptance criteria and study results (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth type, training set details) are not applicable or not present in this document, as the device is characterized as an operating table accessory with electromechanical functions, not an AI/ML diagnostic or assistive imaging system.

The document indicates that the device has undergone design verification and validation testing, which are standard for medical devices to ensure they meet their specified requirements and are safe and effective for their intended use. These tests typically focus on engineering and functional performance rather than AI-specific metrics.

Here's a breakdown based on the available information and an explanation of why other requested items are not provided:

Acceptance Criteria and Study for Maestro System (REF100)

Based on the provided 510(k) summary, the Maestro System is an electromechanical device designed to assist in laparoscopic surgery by holding and positioning instruments, effectively an accessory to an operating table. It does not appear to be an AI/ML-driven diagnostic or image analysis system. Therefore, the types of "acceptance criteria" and "study" details requested for AI systems (e.g., sensitivity, specificity, expert consensus for ground truth, MRMC studies) are not pertinent to this device's classification and described functionality.

The testing performed is primarily focused on the device's mechanical and software functions to ensure safety and effectiveness in its intended use.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various "Testing Performed" which serve as the verification and validation activities against unstated, but implied, acceptance criteria related to engineering specifications and functional safety. It does not provide explicit numerical acceptance criteria or performance results in a table format typical for AI system performance.

Test Category	Specific Tests Performed	Implied Acceptance Criteria (General)	Reported Performance (Generally Stated)
Functional Safety	Payload capacity, Single fault condition, Emergency stop, Back-up fault response, Drape integrity, System cleaning	Device maintains intended function and safety under various conditions, including faults.	Device found to be safe and effective, substantial equivalence established. (Specific results not detailed in this summary).
Accuracy & Precision	Force accuracy, Hold position accuracy, Positioning guidance and collision detection, System positioning accuracy	Device holds and positions instruments accurately and precisely as intended.	Specific quantitative results not provided, but implicitly met for substantial equivalence.
Software & Control	System end-to-end workflow, Bedside joint control, System setup, System latency, LED status, Software verification, Electrical safety, EMC	Software and controls function correctly, respond as expected, and meet electrical/EMC standards.	All clinical input requirements were validated. Software verified. Electrical and EMC compliance implied. (Specific results not detailed).
Usability	Human factors testing, IFU inspection	Device is user-friendly and instructions for use are clear.	Human factors testing performed. Implies usability and safety in user interaction.
Physical Integrity	Design inspection, Coupler performance	Device components are robust and the instrument coupling works reliably.	Designed inspection performed. Coupler performance tested.
Clinical Relevance	Cadaver testing	Device functions as intended in a simulated surgical environment.	Cadaver testing performed.

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

Not specified for discrete quantitative test sets in the provided summary. The testing appears to be functional and engineering-based rather than data-driven in the sense of AI model validation.
Data Provenance: Not applicable in the context of clinical data for AI model training/testing. The "data" here refers to engineering test results.

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

Not applicable/Not specified. This device does not generate diagnostic outputs that require expert ground truth labeling in the way an AI diagnostic tool would. Testing likely involves engineers, usability experts, and potentially surgeons during cadaver or human factors testing, but not for "ground truth labeling" of imaging data.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication method for ground truth labeling is mentioned or expected for this type of device.

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

No, not indicated. MRMC studies are typically performed for AI-assisted diagnostic tools (e.g., radiology AI) to assess the impact of AI on human reader performance. This is not pertinent to the Maestro System's described function.

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

Partially applicable. For an electromechanical device with software, "standalone performance" refers to the device's functional operation independent of human interaction within its specified parameters (e.g., holding force, positioning accuracy). The various engineering and software verification tests (e.g., "Payload capacity," "Hold position accuracy," "Software verification") would assess various aspects of its standalone performance. The document states "Testing described in this 510(k) consisted of verification of all system input requirements and product specifications."

7. The Type of Ground Truth Used:

Engineering specifications and functional requirements. For this type of device, "ground truth" equates to the pre-defined target values for forces, positions, response times, and the successful completion of intended actions (e.g., maintaining position, allowing easy manipulation). This is established through design validation against known physical principles and user requirements, not from clinical outcomes or expert consensus on clinical data.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model trained on a dataset in the conventional sense. Its "training" is in the form of engineering design, calibration, and software programming.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, there is no "training set" for an AI model. The "ground truth" for the device's design and programming comes from engineering principles, user requirements, and clinical needs defined during the device development process.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 3, 2024

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

Re: K240598

Trade/Device Name: Maestro System (REF100) Regulation Number: 21 CFR 878.4960 Regulation Name: Operating tables and accessories and operating chairs and accessories Regulatory Class: Class I Product Code: QZB Dated: March 2, 2024 Received: March 4, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 H. Chen =S Digitally signed by Long H. Chen-S
Digitally signed Date: 2024.06.03 14:50:58 -04'00'

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K240589

Device Name

Maestro System (REF100)

Indications for Use (Describe)

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

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

(Prescription Use (Part 21 CFR 801 Subpart D)

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

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5. Premarket Notification 510(k) Summary

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: K240589

Applicant Information:

Date Prepared:	July 6, 2023
Name:	Moon Surgical
Address:	9 rue d'Enghien75010 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:	QZB 21 CFR 870.4960
Classification:	Class I

Predicate Device:

Maestro System (K221410)

Subject Device Description

· System Positioning Guidance
· System Hold Status Indication
Instrument Coupling
· System Setup
Bedside Setup Joint Control

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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.

ASPECT	MOON SURGICAL(Predicate Device)	MOON SURGICAL(Subject Device)	COMPARISON
Device Name	Maestro	Maestro	N/A
510(k) Number	K221410	Not yet assigned	N/A
Product Code /Regulation	FQO / 878.4960Table Operating-room, AC-Powered.	FQO / 878.4960Table Operating-room, AC-Powered.	Identical
BriefDescription	The Moon Surgical Maestrodevice is an electricallyactuated device withmovable componentsintended for laparoscopicsurgical procedures tosupport and positionlaparoscopic instruments.Its major components consistof the Surgical Base,Surgical Arms, Control Unit,Instrument Coupling, andControl Station.	The Moon Surgical Maestrodevice is an electricallyactuated device withmovable componentsintended for laparoscopicsurgical procedures tosupport and positionlaparoscopic instruments.Its major componentsconsist of the SurgicalBase, Surgical Arms,Control Unit, InstrumentCoupling, and ControlStation.	Identical
Intended Use /Indications forUse	The Maestro System isintended to hold and positionlaparoscopic Instrumentsduring laparoscopic surgicalprocedures.	Same	Identical
Mechanism ofAction (SystemActuation /Positioning)	The Moon Maestro Systemutilizes DC motors tocompensate for gravitationalforces applied tolaparoscopic instruments.	Same	Identical
ASPECT	MOON SURGICAL(Predicate Device)	MOON SURGICAL(Subject Device)	COMPARISON
	Software and hardware aredesigned to maintaininstrument position.Surgeon control is achievedby grasping the handle ofconventional laparoscopictools and moving the tool tothe desired position. Oncesurgeon hand force isremoved, the Maestrosystem reverts tomaintenance of the specifiedlocation includingorientation.
EndoscopeMovement	Control algorithm applyingmotor current for instrumentmotion triggered byphysician direct movement.	Same	Identical
Platform /Mechanism ofstableattachment ofarms	Jointed arms are attached tostages located on a portablebase that can be locked inposition. The bases arelocked in position duringsystem use.	Same	Identical
Cart Setup priorto procedureinitiation	No positioning guidance	Sensors have been added toimprove system positioningand setup prior to procedureinitiation. These sensorsmonitor OR table positionand distance as the useradvances the system towardthe OR table. The useralways has the freedom toposition the system wherethey want, but the guidanceprovides the recommendedwindow of placement	Substantiallyequivalent with nonew or differentquestions of safety oreffectiveness.
System Setup	User-controlled powered x &z translation of the arms, andmanual translation of the	User-selectable presetposition for each specificclinical procedure to be	Substantiallyequivalent with nonew or different
ASPECT	MOON SURGICAL(Predicate Device)	MOON SURGICAL(Subject Device)	COMPARISON
	shoulder roll via a toggle onthe system console.	performed, chosen off amenu on the systemconsole.	questions of safety oreffectiveness.
		Discrete manual control ofthese degrees of freedomalways remains available tothe user on the systemconsole for fine adjustmentsvia user-controlled poweredx & z translation of thearms, and user-controlledpowered translation of theshoulder roll
Bedside SetupControl	Lack of complete controlover the setup joints from thesurgeon's bedside position.Adjusting x & z setup jointsrequired interfacing with thenon-sterile console on thesystem.	A control collar was addedto each Maestro arm'sforearm. Adjusting x, z andshoulder roll setup joints nolonger requires interfacingwith the non-sterileconsole.In all cases, if an instrumentis attached duringpositioning adjustments, thesystem maintains theinstrument's tip positionduring any setup jointmotion.	Substantiallyequivalent with nonew or differentquestions of safety oreffectiveness.
Arm ProximityIndicator	No Arm Proximity Indicator	Sensors have been added toimprove arm positioning bymonitoring for objectswithin an established range.When an object enters thatrange, the system emits anaudible chime, and providesa notification on theConsole.
Method ofinstrumentattachment	Mechanical clamp aroundlaparoscopic instrument andmagnetic attachment to arm	Mechanical clamp aroundlaparoscopic instrument and	Substantiallyequivalent with nonew or different
ASPECT	MOON SURGICAL(Predicate Device)	MOON SURGICAL(Subject Device)	COMPARISON
		mechanical attachment toarm	questions of safety oreffectiveness
InstrumentCoupling	Self-orienting sterilecouplers attached to theinstrument's shaft. Twocoupler sizes were used, 10mm and 5 mm, toaccommodate the mosttypical surgical instrumentshaft calibers	A modified Coupler designmaintains the samefunctionality and sizes (5and 10 mm).Alignment and constraintsare achieved through newmechanical methods on themodified coupler.	Substantiallyequivalent with nonew or differentquestions of safety oreffectiveness
Mechanismsinvolved inphysicalpositioning	Electro-mechanical jointedarms driven by internalmotors that follow thephysician movements.	Same	Identical
Method ofcontrol	Direct manipulation ofconventional laparoscopicinstrument handles.Endoscope and Instrumentpositions are unlocked viasurgeon applied force tolaparoscope or instrumenthandles. This unlockingforce is on the order ofmagnitude of what would beexpected in holding orrepositioning the endoscopeor instruments themselves.The endoscope orinstruments are repositionedas desired by the surgeon.Once the surgeon releasesthe instruments or scope thesystem maintains the newposition with motor drivenforces sufficient tocompensate for gravity.	Same	Identical
System HoldStatus Indicator	Two LED indicators on thesystem forearms are used toindicate transitions between	The three LED locationshave been expanded andpushed further proximal on	Substantiallyequivalent with nonew or different
ASPECT	MOON SURGICAL(Predicate Device)	MOON SURGICAL(Subject Device)	COMPARISON
	co-manipulation and holdstates as they changebetween purple and blue,respectively	the device. LED indicatorsare present at the elbow andshoulder of the support arm.In addition to the visualindicators, the system nowhas light tactile feedbackupon transition from co-manipulation to hold forinformation purposes to theuser. The system providesshort vibrations along theaxis of the instrument,which the surgeon feelswhile holding theinstrument.	questions of safety oreffectiveness.
Alarm andWarningConditionIndicators	The Maestro has twoprimary LEDs forcommunication to thesurgeon. These LEDs changecolors and pulse tocommunicate system status.In the case of a criticalsystem fault, the LEDs willchange to red.	Same	Identical
	The Maestro is alsoequipped with a touch screengraphical interface. Thisscreen provides messages tothe operating room staffregarding system state.
Single FaultTolerance	Automatic SystemPerformance Monitoring inreal-time with multiple faulttiers + visual supervision bysurgeon via LED indicatingsystem status.	Same	Identical
	Examples include:- Redundant encoders onmotorized axes
ASPECT	MOON SURGICAL(Predicate Device)	MOON SURGICAL(Subject Device)	COMPARISON
	- Velocity, acceleration,current and torque limits- Brakes engage if power isremoved
Back-up faultresponse	Brakes engage on motorizedaxis in the event of a faultstate to prohibit any armmotion	Same	Identical
MaximumApplied Load	4.4 lbs tested.	Same	Identical
SterilizationMethod	Steam - for coupling devicesused to attach laparoscopicinstruments	Ethylene Oxide (EtO) – forsingle use coupling devicesused to attach laparoscopicinstruments	Substantiallyequivalent with nonew or differentquestions of safety oreffectiveness
Sterility barrier	Drape	Same	Identical

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Testing Performed

Design verification testing included the following:

. Payload capacity
Single fault condition ●
Force accuracy ●
Drape integrity ●
Hold position accuracy.
Positioning guidance and collision detection ●
System positioning accuracy ●
Bedside joint control ●
System end-to-end workflow ●
Design inspection ●
System setup ●
System latency ●
System cleaning ●
LED status ●
Emergency stop ●
Coupler performance
IFU inspection ●
Software verification .

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Electrical safety
EMC

Design validation testing included the following:

Cadaver testing ●
Human factors testing ●

Testing described in this 510(k) consisted of verification of all system input requirements and product specifications. All clinical input requirements were validated.

Summary

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.