The Motive™ Electrode is intended for use as a disposable, conductive, and adhesive interface between the user's skin and an electrical muscle stimulator. Motive Electrode is intended for adults of 22 years of age and older.

Device Description

The Motive Electrode provides an electrically conductive interface between a neuromuscular electrical stimulator (muscle stimulator) and a user's skin. The Motive Electrode is provided nonsterile, is designed and intended for single patient use only, multiple application use, and is disposable. The electrode sheet is to be worn on the thigh covering the quadriceps muscles to apply electrical stimulation therapy when connected to a muscle stimulator. The electrodes are conductive pads that contact the skin. The electrical stimulation impulses are delivered through the electrodes on the skin in direct proximity to the muscles to be stimulated. The Motive Electrode consists of multiple layers. The skin-contacting layer of the electrode sheet is comprised of three separate medical grade, self-adhering, biocompatible, and conductive hydrogel (gel) pads. These gel pads are placed on a single polyester or polyethylene terephthalate (PET) sheet. These gel pads include two rectangular 2 inch x 4 inch (5.1 x 10.2 cm) and one circular. 2.165 inch diameter (5.5 cm) pads. The outermost layer of the electrode contains a magnetic connector housing for electrical connection to the muscle stimulator. Silver ink printed conductive electrical traces on the PET film are utilized to provide electrical conductivity from the muscle stimulator to the gel pads. When not in use, the electrode sheet is covered by a paper-backed release liner.

AI/ML Overview

The provided text describes a 510(k) summary for the Motive™ Electrode and outlines non-clinical/bench studies conducted to demonstrate its substantial equivalence to a predicate device, the ASCEND Electrode. However, it does not include information about acceptance criteria and a study proving a device meets those acceptance criteria in the context of an AI/algorithm-driven device with human-in-the-loop performance, expert ground truth, or an MRMC study.

The information given pertains to a physical medical device (an electrode), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the requested categories (like effect size of human improvement with AI, number of experts for ground truth, training set details) are not applicable to the content provided.

Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study (Motive™ Electrode)

Based on the provided 510(k) summary, the "acceptance criteria" are implied by a series of non-clinical/bench studies designed to demonstrate the device's safety, effectiveness, and functional equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present "acceptance criteria" in a tabular format with corresponding "reported device performance" against specific quantitative metrics relevant to AI/ML device validation. Instead, it describes compliance with standards and successful completion of various tests for the physical electrode.

Acceptance Criteria (Implied from Study Goals)	Reported Device Performance (Summary of Findings)
Biocompatibility: Meet ISO 10993-5 (In vitro cytotoxicity) and ISO 10993-10 (Irritation and skin sensitization) standards for patient-contacting materials.	Biocompatibility: The test results were acceptable, and the materials (conductive hydrogel, PET backing) were considered biocompatible per ISO 10993-5:2009 and ISO 10993-10:2021.
Shelf-Life: Maintain intended performance over labeled shelf-life via accelerated aging.	Shelf-Life: Accelerated aging shelf-life testing was performed, ensuring the Motive Electrode performs as intended over the course of its labeled 6-month shelf-life.
Electrical Performance: Acceptable impedance measurements, effective and safe delivery of electrical stimulation, comparable Max Current Density and Max Average Power Density to predicate.	Electrical Performance: Electrical tests demonstrated that the electrodes' impedance measurements were acceptable, and they performed effectively and safely in delivering transmitting electrical stimulation. Max Current Density and Max Average Power Density were acceptable and similar to the predicate device, ASCEND Electrode.
Mechanical Integrity: Maintain mechanical integrity of layers and components.	Mechanical Integrity: Mechanical testing demonstrated that the electrodes maintained mechanical integrity for different layers and components.
Visual Evaluation: Intact electrodes and proper interface with muscle stimulator.	Visual Evaluation: Visual evaluation demonstrated that the Motive Electrodes were intact and interfaced with the muscle stimulator.
User Needs/Specifications: Meet user needs as reflected in functional specifications.	User Needs/Specifications: Verification and performance testing further demonstrated that the Motive Electrodes meet user's needs as reflected in the product specification.
Substantial Equivalence: Demonstrate safety and effectiveness comparable to the predicate device.	Substantial Equivalence: Based on the nonclinical tests, the Motive Electrode is concluded to be as safe, as effective, and performs as well as the predicate device (ASCEND Electrode, K140586). Similarities noted in intended use, disposable nature, single-patient multiple application use, adhesive conductive hydrogel interface, multi-layer design, and fundamental composition (flex silver pads/traces on plastic film). Differences (number of electrodes, specific dimensions, connector type) were deemed not to raise issues in equivalency.

2. Sample size used for the test set and the data provenance

This is not applicable to the provided document, as it concerns a physical medical device (electrode) and not an AI/ML algorithm requiring a dataset for testing. The studies mentioned are primarily bench/non-clinical tests involving materials and device prototypes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes tests for a physical electrode, not an AI/ML diagnostic or assistive device that requires expert-established ground truth for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication by multiple experts is typically relevant for establishing ground truth in clinical datasets for AI/ML performance evaluation. This document describes bench testing of a physical device.

5. 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. The device is a cutaneous electrode, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI/ML algorithm. The studies focused on the performance of the physical electrode itself to deliver electrical stimulation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical / bench studies, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 10993 for biocompatibility) and pre-defined engineering specifications for electrical and mechanical performance. Comparability to the established performance of the predicate device also serves as a benchmark for equivalence.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or training set discussed in this document.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML algorithm or training set discussed in this document.

Summary

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March 22, 2023

CyMedica Orthopedics, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K230533

Trade/Device Name: Motive™ Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: February 27, 2023 Received: February 27, 2023

Dear Prithul Bom:

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

Tushar Bansal -S

for Heather Dean, Ph.D Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine 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) K230533

Device Name Motive(TM) Electrode

Indications for Use (Describe)

The Motive™ Electrode is intended for use as a disposable, conductive, and adhesive interface between the user's skin and an electrical muscle stimulator.

Motive Electrode is intended for adults of 22 years of age and older.

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary Motive™ Electrode CyMedica Orthopedics, Inc.

1 Regulatory Information

1.1 Trade/Proprietary Name:	Motive™ Electrode
1.2 Common Name:	Electrode, Cutaneous
1.3 Regulation Names & Numbers:	Cutaneous Electrode, 21 CFR 882.1320
	Product Codes:Code- GXY; Electrode, Cutaneous
1.4 Classification:	Class II
1.5 Manufacturer Name:	CyMedica Orthopedics, Inc.
	2120 East 6t Street, Suite 8Tempe, AZ 85288Telephone (480) 664-1282FAX (866) 296-2772

1.6 Predicate Device Information:

Trade name - ASCEND Electrode, NeuroMetrix, Inc. Common name - Electrode, Cutaneous Code - GXY; Electrode, Cutaneous Classification name - Cutaneous Electrode, 21 CFR 882.1320 510(k) Number – K140586

These devices are reviewed by the Neuromodulation and Physical Medicine Devices (DHT5B).

Submission Information 2

Submission Number:

Date:

Contact:

February 15, 2023

Kereshmeh Shahriari 2120 East 6th Street, Suite 8 Tempe, AZ 85288 kereshmeh@cymedicaortho.com

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Telephone (480) 664-1282 FAX (866) 296-2772

3 Intended Use/Indications for Use

4 Device Description

The Motive Electrode consists of multiple layers. The skin-contacting layer of the electrode sheet is comprised of three separate medical grade, self-adhering, biocompatible, and conductive hydrogel (gel) pads. These gel pads are placed on a single polyester or polyethylene terephthalate (PET) sheet. These gel pads include two rectangular 2 inch x 4 inch (5.1 x 10.2 cm) and one circular. 2.165 inch diameter (5.5 cm) pads.

The outermost layer of the electrode contains a magnetic connector housing for electrical connection to the muscle stimulator. Silver ink printed conductive electrical traces on the PET film are utilized to provide electrical conductivity from the muscle stimulator to the gel pads. When not in use, the electrode sheet is covered by a paper-backed release liner.

Summary of Non-Clinical/ Bench Studies 5

Verification of the Motive Electrode include electrical and mechanical tests to show that it meets its target specifications over a range of operating and storage conditions. Verification and performance testing further demonstrate that it meets user needs as reflected in the functional specification.

To demonstrate the safety, the Motive device was tested per the following standards:

ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro . cytotoxicity
ISO 10993-10: 2010, Biological evaluation of medical devices- Part 10: Tests for ● irritation and skin sensitization

6 Biocompatibility Testing

The patient contacting materials in the Motive™ Electrode include a conductive hydrogel used in the form of gel pads. The hydrogel is placed on a Polyethylene Terephthalate (PET) backing liner. PET is a known biocompatible material. The hydrogel is medical grade, self-adhering, and biocompatible. The gel pads (hydrogel) are skin contacting. A biocompatibility test was conducted on the patient contacting materials per the following standards. The test results were acceptable, and the materials were considered biocompatible.

ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro .

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cytotoxicity

ISO 10993-10: 2021, Biological evaluation of medical devices- Part 10: Tests for skin irritation and sensitization

7 Shelf-Life

The Motive Electrode has a 6-month shelf life. Accelerated aging shelf-life testing was performed to ensure that the Motive Electrode performs as intended over the course of its labeled shelf-life.

8 Summary of Non-Clinical/ Bench Studies

Verification of the Motive Electrode included electrical and mechanical tests. The electrical tests demonstrated the electrodes impedance measurements were acceptable and electrodes performed effectively and safely in delivering transmitting electrical stimulation to the user's tissue. The electrical tests also demonstrated that the Motive Electrode's Maximum Current Density and Maximum Average Power Density were acceptable and similar to the predicate device, ASCEND Electrode.

Mechanical testing demonstrated that the electrodes maintained the mechanical integrity for different lavers and components of the electrode sheet.

Visual evaluation demonstrated that the Motive Electrodes were intact and interfaced with the muscle stimulator.

Verification and performance testing further demonstrate that the Motive Electrodes meet user's needs as reflected in the product specification.

9 Comparison of Technological Characteristics with the Predicate Device

The predicate device for Motive Electrode is ASCEND Electrode manufactured by NeuroMetrix, Inc., 510(k) NUMBER K140586. The Motive Electrode and ASCEND Electrode have the same intended use. Both are intended as disposable. single-patient for multiple application use electrodes with an adhesive conductive hydrogel interface to deliver treatment from an electrical stimulator to the User's skin. Both are multi-layer electrode sheet designs housing multiple individual electrodes in a pre-defined geometry. Both are substantially equivalent in composition and material, consisting of flex silver pads or traces printed onto a plastic film base sheet.

The primary difference between the two devices is that the Motive Electrode consists of three electrodes compared to the ASCEND Electrode's four electrodes. The shape and surface area of the Motive Electrodes are within range of the predicate ASCEND Electrodes. The individual predicate ASCEND Electrodes contain a smaller surface area (36 by 46 mm, surface area of 1656 mm²). In contrast, the smallest Motive Electrode contains a larger surface area (50.8 mm diameter circle, surface area of 2026 mm²).

Table 1 compares design details of the Motive Electrode to the predicate ASCEND Electrode:

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Table 1: Motive Electrode and predicate ASCEND Electrode comparison

	Subject DeviceMotive ElectrodeCyMedica Orthopedics,Inc.510(k), K230533	Predicate DeviceASCEND Electrode,NeuroMetrix, Inc.510(k), K140586	Comparison
General Characteristics
Intended Use	The Motive™ Electrode isintended for use as adisposable, conductive, andadhesive interface between theuser's skin and an electricalmuscle stimulator.	The ASCEND Electrode isintended for use as disposable,conductive, adhesive interfacebetween the user's skin and atranscutaneous electrical nervestimulator.	N/A
Number ofElectrodes	3, two rectangular and onecircular	Not publicly available	Any differences do not raiseany issue in equivalency ofboth as it relates to safety orefficacy.
Sterile	Non-sterile	Non-sterile	N/A
Single-PatientUse	Yes	Yes	N/A
Number ofapplications	Multiple	Not publicly available	N/A
Shelf life	6 months	Not publicly available	N/A
Technical Characteristics
Substrate	Polyethylene terephthalate(PET) film	Not publicly available	N/A
Conductor	Conductive silver ink traces	Not publicly available	N/A
Conductiveinterface	Medical grade conductivehydrogel	Not publicly available	N/A
Connector	Pogo pin connector array	Not publicly available	Any differences do not raiseany issue in equivalency ofboth as it relates to safety orefficacy.
OverallDimensions	15.6 x 21.8 cm, total area 211cm², includes three electrodes	Not publicly available	Any differences do not raiseany issue in equivalency ofboth as it relates to safety orefficacy.
ConductiveSurfaceDimensions	Two rectangular pads 5.1 x10.2 cm and one circular pad5.1 cm diameter, total area124.5 cm²	Not publicly available	Any differences do not raiseany issue in equivalency ofboth as it relates to safety orefficacy.

10 Conclusion

The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the Motive Electrode is as safe, as effective, and performs as well as the predicate device.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).