Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System.

Device Description

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm based on collaborative robotics technology, providing guidance for the positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil - connected to its stimulator - under the supervision of an optical tracking system. Axilum Robotics TMS-Cobot TS MV comprises the electromechanical collaborative arm on its cart, its optical tracking system, with its software, 3D camera and a coil adaption kits with its mechanical adaptor, to fix the coil on the robotic arm, as well as a contact sensor. The device is intended to be used in combination with the TMS stimulator, treatment coil and treatment chair from the previously-cleared MagVenture MagVita system.

AI/ML Overview

The provided text describes the acceptance criteria and the study performed for the Axilum Robotics TMS-Cobot TS MV device. However, it does not include details regarding a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide specific quantitative results for accuracy, repeatability, or a breakdown of the ground truth establishment process for the test set in the way a typical AI/ML medical device submission might.

The document indicates that the device is a computer-controlled electromechanical arm that assists in positioning a TMS coil, suggesting its role is primarily mechanical assistance rather than an AI/ML algorithm performing independent diagnostic or treatment decisions. Therefore, the "study that proves the device meets the acceptance criteria" focuses on functional performance, safety, and compatibility with a predicate device, rather than the kind of AI/ML performance metrics (e.g., sensitivity, specificity, AUC) typically evaluated for diagnostic AI systems.

Based on the provided text, here's an attempt to extract the information you requested, noting where information is not explicitly available in the document:

Acceptance Criteria and Device Performance for Axilum Robotics TMS-Cobot TS MV

The Axilum Robotics TMS-Cobot TS MV is an electromechanical arm designed to assist in the spatial positioning and orientation of a Transcranial Magnetic Stimulation (TMS) coil. The performance evaluation focuses on safety, functional operation, and compatibility as an accessory to an existing TMS system (MagVita TMS Therapy System).

1. Table of Acceptance Criteria and Reported Device Performance

Category / Acceptance Criteria Type	Specific Criteria (Implied from testing)	Reported Device Performance (Summary from text)
Safety Efficacy	Compliance with electrical safety standards	AAMI ANSI ES 60601-1:2005/(R)2012 And A1:2012 (Electromedical devices Part 1: general requirements for basic safety and essential performances) IEC 60601-1-2: 2014, Edition 4.0 (Electromedical devices - Part 1.2: general requirements for basic safety and essential performances. Collateral Standard: Electromagnetic Disturbances - Requirements and Testing)
	Software/Firmware Validation	Software verification and validation for firmware and software components tested against specifications and according to IEC 62304:2015. Robot controller firmware features validated in accordance with EN 62304:2006 and FDA's Guidance for General Principles of Software Validation.
	Prevention of new unique risks compared to predicate	"The company believes that the TMS-Cobot TS MV does not present any new unique risks compared to the MagVita system..." "The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the TMS-Cobot TS MV and its predicate device raise no new issues of safety or effectiveness."
	Collision Management	Collaborative robotics technology allows for collision detection at each joint level in addition to coil contact sensor level. (Compared to "None (user-managed)" for predicate)
Functional Performance	Accurate coil positioning (equivalent to predicate)	"accurate coil positioning is key for both systems." (The document states this is a general risk common to both manual and robotically controlled arms, implying the new device aims to achieve at least equivalent accuracy, but specific quantitative accuracy results are not provided in this document.)
	Performance of robotic arm's free-drive mode	Functional tests included integrated product testing to "verify key aspects of performance of the system such as accuracy, repeatability, operation of the robotic arm's freedrive mode and ability to provide sufficient head motion compensation." (Specific quantitative results for accuracy and repeatability are not provided in this document summary.)
	Sufficient head motion compensation	"Robot-automated, from real-time camera measurements." (Compared to "User-managed from visual observation" for predicate). Functional tests included verification of "ability to provide sufficient head motion compensation." (Specific quantitative results are not provided in this document summary.)
Usability	Usability standards compliance	Usability testing conducted according to IEC 62366:2015 and FDA Guidance document Applying Human Factors and Usability Engineering to Medical Devices.
Compatibility	Safe operation with MagVita TMS Therapy System components (treatment coil, patient seat)	Compatibility tests verified "that the TMS-Cobot TS MV can operate safely with both the treatment coil and the patient seat of the MagVita TMS Therapy System." "Particularly, accessibility of the patient's head inside the robotic arm's workspace has been checked to be compatible with the range of patient positions permitted by the patient seat included in MagVita TMS Therapy System."
Substantial Equivalence	Demonstrated equivalence to predicate system (MagVita TMS Therapy System) in safety and effectiveness	"The TMS-Cobot TS MV used in combination with the MagVita TMS Therapy System is as safe and effective as the MagVita TMS Therapy System (K150641) alone. The TMS-Cobot TS MV has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device... Performance data demonstrate that the TMS-Cobot TS MV is as safe and effective as the MagVita TMS Therapy System. Thus, the TMS-Cobot TS MV is substantially equivalent."

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

The document does not explicitly state the sample size (e.g., number of subjects, cases, or specific test runs) used for the functional and compatibility tests. It reports that "nonclinical testing" was completed, which typically refers to lab-based testing rather than clinical trials with human subjects for this type of accessory device.

Test Set Sample Size: Not explicitly stated in the provided text.
Data Provenance: The testing appears to be nonclinical (lab-based) as opposed to a clinical study with patient data. Therefore, details like country of origin or retrospective/prospective nature are not applicable in the context of patient data, but rather pertain to the testing environment.

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

This type of information (experts establishing ground truth) is typically relevant for AI/ML diagnostic devices where human expert annotations or diagnoses serve as reference standards. For this device, which is an electromechanical arm for positioning, "ground truth" would relate to precise mechanical measurements and functional performance rather than clinical diagnoses.

Experts: Not explicitly stated or applicable in the traditional sense of clinical ground truth establishment for a diagnostic device. The performance validation relies on engineering measurements and functional verification against specifications and safety standards.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

As the "test set" pertains to nonclinical functional and safety testing of an electromechanical device, an "adjudication method" in the clinical imaging sense (e.g., 2+1, 3+1 consensus) is not applicable. Performance is likely adjudicated by meeting predefined engineering specifications and safety thresholds.

Adjudication Method: Not applicable in the context of clinical ground truth. Performance is presumably evaluated against documented engineering specifications and regulatory standards.

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

No. The provided text does not describe an MRMC comparative effectiveness study involving human readers or AI assistance. This type of study is more common for AI systems that aid in image interpretation or diagnosis. The TMS-Cobot TS MV is a robotic positioning device.

MRMC Study: No, not mentioned.
Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.

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

The device is an electromechanical arm that is "computer controlled" and provides "guidance for the positioning and orientation" of a TMS coil "under the supervision of an optical tracking system." It also mentions "Robot-automated" head motion compensation and a "Human pilot through the free-drive mode." This indicates it's an accessory that operates in conjunction with a human operator and other system components (MagVita TMS Therapy System). It is not a standalone AI algorithm providing a diagnostic output without human intervention.

Standalone Performance: The device is presented as an accessory with human supervision and interaction; therefore, a pure "algorithm only" standalone performance evaluation in the context of diagnostics is not applicable. Its performance is integrated with the larger MagVita TMS Therapy System and human oversight.

7. The Type of Ground Truth Used

The "ground truth" is based on established engineering principles, safety standards, and functional specifications for robotic and medical devices. This includes:

Engineering Specifications: For accuracy, repeatability, range of motion, collision detection, and performance of free-drive mode.
Safety Standards: Compliance with AAMI, IEC, and EN standards for electrical safety, electromagnetic compatibility, and software validation.
Usability Standards: Compliance with IEC 62366 and FDA guidance for human factors.
Compatibility Verification: Ensuring safe and effective operation with the MagVita TMS Therapy System components.

It is not based on expert clinical consensus (e.g., for diagnosis), pathology, or direct patient outcomes data in the way a diagnostic AI would be evaluated.

8. The Sample Size for the Training Set

This device is an electromechanical robot. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model. While the device utilizes "computer controlled" and "collaborative robotics technology," it's not explicitly described as an adaptive AI/ML system that undergoes a data-driven training phase in the traditional sense for medical imaging AI. Its "training" would be more akin to software development, calibration, and engineering design.

Training Set Sample Size: Not applicable or not specified in the context of a machine learning training dataset.

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

As the concept of a training set for an AI/ML model is not explicitly defined for this device, the establishment of "ground truth" for it is not applicable in the way it would be for a data-driven AI. Instead, the design and validation are based on engineering specifications, physical models, and control algorithms.

Ground Truth for Training Set: Not applicable in the context of a typical AI/ML training dataset.

Summary

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February 17, 2019

Axilum Robotics % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K182768

Trade/Device Name: TMS-Cobot TS MV Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: QFF Dated: January 18, 2019 Received: January 18, 2019

Dear Janice Hogan:

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 Actinclude 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/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.

Pamela D. Scott -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182768

Device Name TMS-Cobot TS MV

Indications for Use (Describe)

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System

Type of Use (Select one or both, as applicable)
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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 K182768 Axilum Robotics' TMS-Cobot TS MV

Submitte r

Axilum Robotics, SAS. 8, Rue Schertz, Building B1 67100 Strasbourg France Phone: +33 3 88 55 62 07 Contact Person: Michel BERG, CEO E-mail: michel.berg@axilumrobotics.com Date Prepared: September 28, 2018

Submission Correspondent

Janice Hogan Hogan Lovells US LLP 1735 Market St., 23rd Floor Philadelphia, PA 19103 Phone: (267) 675-4600 Fax: (267) 675-4601 E-mail: janice.hogan@hoganlovells.com

Name of Device: TMS-Cobot TS MV

Common or Usual Name: Electromechanical arm for transcranial magnetic stimulation system

Classification Name: 21 CFR 882.5805, Repetitive Transcranial Magnetic Stimulation System

Regulatory Class: Class II

Product Code: QFF

Predicate Devices MagVita TMS Therapy System (K150641)

Reference Devices Medtech SA ROSA Spine (K151511)

De vice De scription

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Axilum Robotics TMS-Cobot TS MV comprises the electromechanical collaborative arm on its cart, its optical tracking system, with its software, 3D camera and a coil adaption kits with its mechanical adaptor, to fix the coil on the robotic arm, as well as a contact sensor.

The device is intended to be used in combination with the TMS stimulator, treatment coil and treatment chair from the previously-cleared MagVenture MagVita system.

Intended Use / Indications for Use

Axilum Robotics TMS-Cobot TS MV is a computer controlled electromechanical arm indicated for spatial positioning and orientation of the treatment coil of the MagVita TMS Therapy System.

Summary of Technological Characteristics

The TMS-Cobot TS MV is an accessory to the predicate MagVita TMS Therapy System (K150641). The MagVita TMS Therapy System contains a component intended to position the treatment coil called the Super Flexible Arm. The TMS-Cobot TS MV can be utilized in place of the Super Flexible Arm along with the other components of the MagVita TMS Therapy System.

The company believes that the TMS-Cobot TS MV does not present any new unique risks compared to the MagVita system, and that accurate coil positioning is key for both systems. The general risks of contacting the patient's head or mispositioning the coil are risks that are common to both manual and robotically controlled arms:

The use of robotic arms to position tools such as surgical instruments is not novel, see for example, the Medtech SA ROSA Spine device (K151511). Both the TMS-Cobot TS MV and the ROSA Spine are electromechanical arms intended to assist physicians in the spatial positioning and orientation of instrument holders. The TMS-Cobot TS MV and the ROSA Spine both contain a hardware structure that supports the electromechanical arm, along with a holder for the coil or instruments. Recording for both the TMS-Cobot TS MV and the ROSA Spine utilize fiducial markers and an optical registration device.

Feature	MagVita TMS TherapySystem with Super FlexibleArm (alone)K150641 (Predicate)	MagVita TMS Therapy System usingAxilum Robotics TMS-Cobot TS MVin lieu of Super Flexible ArmK182768 (Subject)
Indications forUse	The MagVita TMS TherapySystem is indicated for thetreatment of MajorDepressive Disorder in adultpatients who have failed toreceive satisfactoryimprovement from priorantidepressant medication inthe current episode	Axilum Robotics TMS-Cobot TS MV isa computer controlled electromechanicalarm indicated for spatial positioning andorientation of the treatment coil of theMagVita TMS Therapy System *
Intended use ofElectromechanicalarm	N/A	Axilum Robotics TMS-Cobot TS MVis a computer controlledelectromechanical arm indicated forspatial positioning and orientation ofthe treatment coil of the MagVitaTMS Therapy System.
Coil holderJoints	Passive mechanical arm	Active electromechanical arm
Degrees offreedom	3	6
Coil holder	Coil handle is directlytightened in the tip of thearticulated arm	Coil is attached to the robotic arm via acoil adapter fixed to the coil
Coil holdermaterial	Aluminum	Aluminum
Position of coilholder	Mobile, attached tostimulator wheel cart or(optionally) either to the backof the treatment chair or to atable.	Mobile, mounted on a wheel cart
Piloting system	Human pilot manually actingon the articulated arm	Human pilot through the free-drivemode, and: 3D tracking system
Coil fordepressiontreatment	Cool-B65 coil	Cool-B65-RO coil which is the roboticadaptation of Cool-B65 coil.
Patient chair	Included, FDA-cleared	Can use the chair included in MagVitasystem
Coil positioningstrategy	Guided by user viaanatomical landmarks on thehead (no MRI imaging priorto treatment)	With 3D tracking system: guided byuser via anatomical landmarks onthe head (no MRI imaging prior totreatment), and fine-tuning from thecontrol panel.
Coil to headcontactmanagement	None, user-managed contactfrom visual observation of coiland head	From measurements of a contact sensoradded to the treatment side of the coil
Head motioncompensation	User-managed fromvisual observation of thepatient and acting on thearticulated stand	Robot-automated, from real-timecamera measurements.In addition, user can activate the free-drive mode and manually re-adjustthe position; Or, user can use thedevice's control panel to fine tune theposition and orientation of the coil
Collision management	None (user-managed while acting on the knob of the articulated stand)	Collaborative robotics technology allows for collision detection at each joint level in addition to coil contact sensor level

Substantial Equivalence comparison

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*Although the IFU of the subject device is different than the IFU of the predicate device the subject device is an accessory to the system and its intended use is identical to the intended use of the passive mechanical arm of the predicate device.

Performance Data

TMS-Cobot TS MV was tested to the following standards:

AAMI ANSI ES 60601-1:2005/(R)2012 And A1:2012Electromedical devices Part 1: ● general requirements for basic safety and essential performances
IEC 60601-1-2: 2014, Edition 4.0, Electromedical devices - Part 1.2: general requirements for basic safety and essential performances. Collateral Standard: Electromagnetic Disturbances - Requirements and Testing

The nonclinical testing completed for the TMS-Cobot TS MV included three major categories of testing:

Technical tests, which include: internal hardware, firmware component tests, tests of the software communication protocol used between the various firmware and software components, packaging tests. Software verification and validation for firmware and software components of the device have been tested against their specifications and according to IEC 62304:2015.
Functional tests, which include integrated product testing using the tracking system and TMS coil that have been designed to verify key aspects of performance of the system such as accuracy, repeatability, operation of the robotic arm's freedrive mode and ability to provide sufficient head motion compensation. Moreover, usability testing was conducted on the device according to IEC 62366:2015 and FDA Guidance document Applying Human Factors and Usability Engineering to Medical Devices.
Compatibility tests, which verify that the TMS-Cobot TS MV can operate safely with both the treatment coil and the patient seat of the MagVita TMS Therapy System. Particularly, accessbility of the patient's head inside the robotic arm's workspace has been checked to be compatible with the range of patient positions permitted by the patient seat included in MagVita TMS Therapy System.

Robot controller firmware features have been validated in accordance with EN 62304:2006 and FDA's Guidance for General Principles of Software Validation.

Conclusions

The TMS-Cobot TS MV used in combination with the MagVita TMS Therapy System is as safe and effective as the MagVita TMS Therapy System (K150641) alone. The TMS-Cobot TS MV has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the TMS-Cobot TS MV and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the TMS-Cobot TS MV

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is as safe and effective as the MagVita TMS Therapy System. Thus, the TMS-Cobot TS MV is substantially equivalent.

Regulation Number and Section

§ 882.5805 Repetitive transcranial magnetic stimulation system.

(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.