ViMove2 is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

Device Description

ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device obiectively measures, records and analyzes angular movement and muscle activity.

Under the direction of the healthcare professional, the software quides the patient through a series of dynamic movements and static postures in standing and sitting positions. ViMove2 then measures the range of motion and muscle activity, streams the data live via BTLE to a host device, e.g. PC, tablet or smart phone, and generates a personalized assessment report including comparisons to normative values.

ViMove2 is comprised of the following key components:

· 4 Wireless Sensors (2 movement and 2 muscle activity)
· Disposable Application Pads for attaching sensors to the patient.
· ViMove software package

AI/ML Overview

The provided text describes a 510(k) submission for the ViMove2 device, which is a wireless system for measuring movements and muscle activity of the lower back/lumbar spine. The submission aims to demonstrate substantial equivalence to a predicate device (ViMove, K142494).

However, the provided text does not contain acceptance criteria or detailed results of a study proving the device meets specific performance criteria beyond general compliance with standards. It states that "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but it does not present the specific acceptance criteria for these assessments or the numerical results from such testing.

Therefore, I cannot fulfill all parts of your request with the information provided. I will fill in the available information and indicate where data is missing from the text.

Acceptance Criteria and Device Performance (Based on available information)

The document primarily focuses on establishing substantial equivalence for the ViMove2 device to its predicate ViMove, emphasizing changes in size, components, and wireless technology. It mentions that "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but does not provide specific quantitative acceptance criteria or the reported performance data against such criteria.

Acceptance Criterion	Reported Device Performance
Lumbo-pelvic ROM Measurement (Flexion, Extension, Lateral Flexion)	(Specific quantitative acceptance criteria and performance data for accuracy/precision vs. a gold standard are not provided in the document.)
Normal Standing Lordotic Angle Measurement	(Specific quantitative acceptance criteria and performance data are not provided in the document.)
Pelvic Tilt Measurement (Sitting and Standing)	(Specific quantitative acceptance criteria and performance data are not provided in the document.)
Various Sitting Postures Assessment (Normal, Upright, Slouched)	(Specific quantitative acceptance criteria and performance data are not provided in the document.)
Compliance to ISO 14971 (Risk Management)	Met/Compliant (Implied by submission and FDA clearance)
Compliance to ISO 13485 (Quality Management System)	Met/Compliant (Implied by submission and FDA clearance)
Compliance to IEC 60601-1 (Basic Safety & Essential Performance)	Met/Compliant (Implied by submission and FDA clearance)
Compliance to IEC 60601-1-2 (Electromagnetic Compatibility)	Met/Compliant (Implied by submission and FDA clearance)
Compliance to ISO 15223 (Medical Device Labels & Info)	Met/Compliant (Implied by submission and FDA clearance)
Compliance to ISO 10993-5 (In vitro Cytotoxicity)	Met/Compliant (Implied by submission and FDA clearance)
Compliance to ISO 10993-10 (Irritation & Skin Sensitization)	Met/Compliant (Implied by submission and FDA clearance)
Compliance to IEC 62366 (Usability Engineering)	Met/Compliant (Implied by submission and FDA clearance)
Compliance to IEC 62304 (Software Life Cycle Processes)	Met/Compliant (Implied by submission and FDA clearance)

Study Details (Based on available information):

The document mentions "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but it doesn't provide specific details about this "validation testing" that would allow us to answer all your questions.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document states "testing was performed," but does not specify the number of subjects or the data collection methodology (retrospective/prospective, country of origin).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document does not describe how the ground truth for the "validation testing" was established, nor does it mention the involvement or qualifications of experts for this purpose.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. No details on adjudication methods for establishing ground truth are mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. The ViMove2 device is described as a measurement and reporting tool for movement and muscle activity, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies. The document does not mention any studies evaluating human reader improvement with the device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the device is a standalone measurement system that provides objective data and reports. The "validation testing" would likely represent standalone performance, but the specific metrics and results are not provided. The device quantifies movement and muscle activity; it's not an "algorithm" in the sense of an AI model interpreting complex data for a diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated/Provided. For ROM measurements, ground truth is typically established using highly accurate motion capture systems or goniometers. The document only mentions that testing was done to validate ROM and posture assessment but does not specify the ground truth method.
The sample size for the training set:
- Not applicable/Not provided. The ViMove2 device is a sensor-based measurement system, not a machine learning/AI device that requires a "training set" in the typical sense for algorithm development. If there was any internal calibration or model fitting, the details are not provided in this public summary.
How the ground truth for the training set was established:
- Not applicable/Not provided. (See point 7).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 14, 2017

Dorsavi Ltd % Bosmat Friedman Regulatory Consultant Pushmed LLC 1208-12 Rockford Rd Toronto, LAJ 7Y9 CA

Re: K163150 Trade/Device Name: ViMove2 Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN, HCC, KQX Dated: June 16, 2017 Received: June 16, 2017

Dear Bosmat Friedman:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for 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) K163150

Device Name ViMove2

Indications for Use (Describe)

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 (as required by section 807.92(c))

VIMOVE2

510(K) NUMBER

K163150

I. SUBMITTER

dorsaVi Ltd Level 1, 120 Jolimont Road East Melbourne 3002, Australia Establishment Registration No. 3010872373 Owner Operator Number: 10046462

Contact Person: Dan Ronchi Phone: +61-(0)3-9652-2191 Fax: +61-(0)3-8610-1024 Email: dr@dorsavi.com

Date Prepared: Oct 15, 2016

II. DEVICE

Trade Name:

Name of Device:

ViMove2

BioFeedback System

Common or Usual Name:

Classification:

Diagnostic Electromyograph Product Code: IKN Regulation No: 890.1375 Requlatory Class: II Classification Panel: Physical Medicine

Electromyograph and Goniometer with

Biofeedback Device Product Code: HCC Regulation No: 882.5050 Requlatory Class: II Classification Panel: Neurology

Goniometer Product Code: KQX Regulation No: 888.1500 Regulatory Class: I Classification Panel: Orthopedic

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III. PREDICATE DEVICE

Predicate Device(s):

ViMove manufactured by dorsaVi Ltd (K142494) (This predicate has not been subject to any product recalls).

IV. DEVICE DESCRIPTION

ViMove2 is comprised of the following key components:

· 4 Wireless Sensors (2 movement and 2 muscle activity)
· Disposable Application Pads for attaching sensors to the patient.
· ViMove software package

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The modified ViMove presented in this 510(k) is substantially equivalent to the predicate in terms of intended use, fundamental scientific technology, operating principles and mechanism of action. The main differences between the devices are a reduction in size of the movement (MDM) and muscle activity (MDE) sensors; changes to battery, electronic components, circuitry and DAPs to accommodate the smaller sensors, the addition of Bluetooth compatibility (BTLE), changes to the user interface and format of the assessment report. The RFD Biofeedback device utilized in the predicate device are no longer required for the modified ViMove2 device.

A summary of the differences between the ViMove predicate and ViMove2 is provided in Table 1 below. A more detailed comparison is provided in Attachment G.

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	Predicate ViMove	ViMove2
510(k) Number	K142494	K163150
Manufacturer	dorsaVi Ltd	dorsaVi Ltd
Product codes	IKNHCCKQX	IKNHCCKQX
Indications for Use	ViMove is a wirelessmedical device thatmeasures, records, andreports movements andmuscle activity of the lowerback / lumbar spine. Thesystem also measuresrange of motion in thesagittal and coronalanatomical planes.	ViMove is a wirelessmedical device thatmeasures, records, andreports movements andmuscle activity of the lowerback / lumbar spine. Thesystem also measuresrange of motion in thesagittal and coronalanatomical planes.
Non-invasive medical device	Yes	Yes
System Components	4 Wireless Sensors (2 movement MDMs and 2 muscle activity MDEs) Disposable Application Pads (DAPs) for holding the wireless sensors (DAP-M for movement and DAP-E for muscle sensors) Recording and Feedback Device (RFD) Recharging Cradle with AC Adaptor USB ViMove software	4 Wireless Sensors (2 movement MDMs and 2 muscle activity MDEs) Disposable Application Pads (DAPs) for holding the wireless sensors (DAP-M for movement and DAP-E for muscle sensors) AC Adaptor USB ViMove software Recharging Cradle with AC Adaptor
Performance data submitted tosupport range of motionmeasurements	FlexionExtensionLateral FlexionPelvic TiltSingle Leg StandingSitting (normal, upright andslouched)	FlexionExtensionLateral FlexionPelvic TiltSingle Leg StandingSitting (normal, upright andslouched)
Assessment report includes	Yes	Yes
normative values for ROMProvides real time biofeedback tothe user	Yes (via RFD device)	Yes (directly to hostdevice)
Movement Sensor Type	AccelerometerGyroscopeMagnetometer	AccelerometerGyroscopeMagnetometer
Wireless Type	ANT	BTLE
Muscle Activity sensor	Surface EMG	Surface EMG
Battery Type	Lithium-Polymer	Lithium-Polymer
Includes DAPs for holding thewireless sensors	Yes	Yes
Charging	Recharging Cradle or ACAdaptor (5VDC)	AC Adaptor, USB Port(5VDC) or Recharging Cradle
Includes dedicated software	Yes	Yes
Rechargeable batteries in thesensors	Yes	Yes
Real-time objective measurementof range of motion	Yes	Yes
Report generated for HealthcareProfessional	Yes	Yes
Includes Bluetooth compatibility(BTLE)	No	Yes

Summary Comparison of the Modified ViMove and Predicate Table 1.

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dorsaVi Ltd. ViMove2 Special 510(k)

VII. PERFORMANCE DATA

In support of the modifications presented in this 510(k), testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture, including flexion, extension, lateral flexion, normal standing lordotic angle, pelvic tilt (sitting and standing) and various sitting postures (normal, upright and slouched).

Additional design verification was performed on the ViMove2 in accordance with 21 CFR 820.30, including testing to demonstrate compliance testing to the following standards:

ISO 14971	Medical Devices - Application of Risk Management to MedicalDevices
ISO 13485	Medical devices - Quality management systems - Requirements forregulatory purposes
IEC 60601-1	Medical electrical equipment, Part 1: General requirements for basicsafety and essential performance
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests
ISO 15223	Medical devices - Symbols to be used with medical device labels,labeling, and information to be supplied - Part 1: Generalrequirements.
ISO 10993-5	Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity.
ISO 10993-10	Biological evaluation of medical devices - Part 10: Tests for irritationand skin sensitization
IEC 62366	Medical devices - Application of usability engineering to medicaldevices.
IEC 62304	Medical device software - Software life cycle processes.

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VIII. CONCLUSIONS

Based on the information provided in this submission, the modified ViMove2 is substantially equivalent to the predicate ViMove device and does not raise any questions relating to safety and/or effectiveness.

The modifications proposed in the ViMove2 do not affect the intended use, fundamental scientific technology, principles of operation or clinical application when compared to the predicate device.

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).