The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation;
saver protection, interposed between the stimulator and the patient's arm.

The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.

The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Shoulder Pacemaker™," an electrotherapy device for neuromuscular electrical stimulation (NMES). It outlines the device's characteristics, indications for use, comparison to predicate devices, and performance data to support its substantial equivalence.

However, the document does not contain the level of detail typically found in a clinical study report or a formal acceptance criteria document for an AI/ML medical device. Specifically, it lacks information regarding:

Quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on electrical safety, EMC, and compliance with standards rather than clinical performance metrics for a specific diagnostic or therapeutic outcome.
A "study" that proves the device meets acceptance criteria in the context of clinical effectiveness with quantitative results. The performance data section refers to non-clinical testing (electrical safety, EMC, software validation) and compliance with standards, not a clinical trial or performance study involving a test set, ground truth, or expert readers.
Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods as these pertain to clinical performance studies.
MRMC studies or standalone algorithm performance as these are relevant for AI/ML devices analyzing complex data like images, which is not the primary function described for this NMES device.

Given that the device is a Powered Muscle Stimulator (Product Code IPF) intended for NMES, its performance evaluation focuses on electrical parameters, safety, and functional equivalence to predicate stimulators, rather than diagnostic accuracy as one might expect from an AI/ML imaging device.

Therefore, I cannot populate all sections of your requested outline based on the provided text. I will, however, extract the relevant information regarding acceptance criteria (as implied by the testing performed) and the "study" (non-clinical testing) that demonstrates compliance.

Acceptance Criteria and Device Performance for Shoulder Pacemaker™

Based on the provided 510(k) Summary, the acceptance criteria and performance are primarily related to electrical safety, electromagnetic compatibility (EMC), software validation, and general functional equivalence to predicate devices. There are no explicit quantitative performance metrics (e.g., sensitivity, specificity, or accuracy scores) for a clinical outcome mentioned for the Shoulder Pacemaker™, as it is a muscle stimulator focused on electrical stimulation parameters rather than a diagnostic AI/ML device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Acceptance Criteria Category (Implied by Testing)	Specific Criteria (Based on Standards and Comparisons)	Reported Device Performance/Compliance
Electrical Safety	Compliance with IEC 60601-1 (General Requirements for Basic Safety and Essential Performance)	Complies with CEI EN 60601-1.
	Compliance with IEC 60601-2-10 (Particular requirements for nerve and muscle stimulators)	Complies with CEI EN 60601-2-10.
	Compliance with IEC 60601-1-11 (Requirements for ME equipment and systems used in the home healthcare environment)	Complies with CEI EN 60601-1-11.
	Patient Leakage Current within specified limits (comparison to SP)	Normal condition (μA): Not specified, assumed within limits; Single fault condition (μA): Not specified, assumed within limits. (Stated as "Same to SP Note 1", indicating compliance with similar safe levels as the Secondary Predicate which has 4.88 μA normal, 8.00 μA single fault).
	Average DC current through electrodes (when no pulses applied) - negligible	<0.01 μA. (Stated as "negligible value for the subject device, hence it does not impact on its safety").
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (General requirements for basic safety and essential performance - Collateral Standard: EMC)	Complies with CEI EN 60601-1-2.
	Compliance with FCC 47 CFR PT 15 SPT B (Unintentional Radiators)	BLE module testing conducted in accordance. (Implies compliance).
	Compliance with FCC 47 CFR PT 15 SPT C (Intentional Radiators)	BLE module testing conducted in accordance. (Implies compliance).
Software Validation	Compliance with FDA Guidance for the Content of Premarket Submissions for Software (May 11, 2005)	Software validated in accordance with the requirements.
	Compliance with IEC 62304 (Medical device software - Software life cycle processes)	Software validated according to CEI IEC 62304.
	Software meets design requirements.	Software validation tests demonstrated that the software version meets its design requirements.
Usability	Compliance with IEC 60601-1-6 (General requirements for basic safety and essential performance - Collateral standard: Usability)	Tested according to IEC 60601-1-6. (Implies compliance).
	Compliance with IEC 62366-1 (Application of usability engineering to medical devices)	Tested according to CEI EN 62366-1. (Implies compliance).
Risk Management	Compliance with ISO 14971 (Application of risk management to medical devices)	Tested according to ISO 14971. (Implies compliance). The document states differences "do not raise any new questions of safety or effectiveness".
Battery Safety	Compliance with IEC 62133-1 (Nickel systems) & IEC 62133-2 (Lithium systems)	Battery testing conducted in accordance. (Implies compliance). The device uses a rechargeable Li-ion battery, 3.7V / 550 mAh.
Functional Equivalence	Similar indications for use and primary function to predicate devices.	Indications for Use are a subset of predicates. "Same intended use to PP and SP." "Shoulder Pacemaker is an electrotherapy device intended for neuromuscular electrical stimulation (NMES)."
	Output specifications (waveform, voltage, current, pulse width, frequency, charge, density) are safe and effective.	Biphasic waveform, complex shape. "Net charge is zero uC and the excitation pulse results fully compensated." Max current density (0.48 mA/cm2) "is lower than the critical value (2mA/cm2)." Max power density (0.003 W/cm2) "is lower than the predicates ones." Pulse width (1-200 μs) "satisfies the desired stimulation conditions." Overall, differences "do not raise any new questions of safety or effectiveness."

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

The document describes non-clinical testing (e.g., electrical safety, EMC, software validation) performed on the device itself. It does not refer to a "test set" in the context of a clinical performance study with human data. Therefore, details like data provenance (country of origin, retrospective/prospective) are not applicable or provided for a clinical test set. The testing was conducted on samples of the Shoulder Pacemaker™ device itself.

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

Not applicable. The "ground truth" for this device's evaluation is primarily established by regulatory standards (e.g., IEC 60601 series, ISO 14971) and engineering specifications, tested by qualified laboratory personnel. There is no mention of experts establishing ground truth for a clinical test set.

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

Not applicable, as there is no mention of a human-reviewed clinical test set requiring adjudication.

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. This device is an NMES stimulator, not an AI/ML-driven diagnostic imaging device that assists human readers.

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

Not applicable in the context of an AI/ML algorithm's standalone performance. The device itself operates independently to deliver electrical stimulation. Its "standalone" performance relates to its ability to meet electrical output specifications, which were assessed through non-clinical bench testing.

7. The type of ground truth used

The "ground truth" for the device's safety and effectiveness determination is based on:

International Consensus Standards: e.g., IEC 60601 series for electrical safety, EMC, usability; ISO 14971 for risk management.
Regulatory Guidance: e.g., FDA guidance for software, FDA Final Guidance Document for Powered Muscle Stimulators.
Engineering Specifications: Internal design parameters and output characteristics (e.g., voltage, current, waveform) that are tested against pre-defined safe and effective ranges.

This is not a clinical "ground truth" like pathology, expert consensus on images, or outcomes data.

8. The sample size for the training set

Not applicable. The device is a hardware and software system, not a machine learning model developed with a "training set" of data in the AI/ML sense.

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

Not applicable, as there is no "training set" for an AI/ML model for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health and Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in bold blue letters. Below that, the word "ADMINISTRATION" is written in a smaller font size, also in blue.

August 24, 2021

NCS Lab Srl Matteo Mantovani Technical Director- CEO Via Pola Esterna 4/12 Carpi, Modena, Italy 41012

Re: K210674

Trade/Device Name: Shoulder Pacemaker™ Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. KOX Dated: May 18, 2021 Received: May 24, 2021

Dear Matteo Mantovani:

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

{1}------------------------------------------------

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,

Patrick Antkowiak, PhD Assistant Director (Acting) DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210674

Device Name Shoulder PacemakerTM

Indications for Use (Describe)

Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for Shoulder PacemakerTM are:
Prevention or retardation of disuse atrophy;
Muscle re-education;
Maintaining or increasing range of motion.

The device is intended for adults only.

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)
----------------------------------------------	---------------------------------------------

|| | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo for "COMBINED SOLUTIONS FOR INDUSTRY". The logo consists of three stylized letters, "N", "C", and "S", each formed by a combination of black and white blocks with rounded corners. The letters are arranged horizontally, with the text "COMBINED SOLUTIONS FOR INDUSTRY" appearing in a smaller font size below the letters.

510(k) Summary (21 CFR 807.92)

1 GENERAL INFORMATION

Submitter

NCS Lab Srl Via Pola Esterna 4/12 Carpi (MO), Italy 41012 Telephone: +39 059 669813 Fax: +39 059 669813

Contact Person

Matteo Mantovani Technical Director – CEO E-mail: quality@ncs-company.com

Date Prepared: 30,07,2021

2 DEVICE

Trade Name	Shoulder Pacemaker™
Common/Usual Name	Muscle Stimulator
Regulation Description (RegulationNumber)	Powered Muscle Stimulator (21 CFR890.5850)Goniometer, AC-powered (21 CFR888.1500)
Device Class, Submission Type	Powered Muscle Stimulator Class II, 510(k)Goniometer AC-powered Class I, 510(k)exempt
Product Code	IPF, KQX
Review Panel	Physical Medicine, Orthopedic

3 PREDICATE DEVICE

	Brand Name	510(k) number	Manufacturer	Product code
Primary Predicate	CyMedica e-viveSystem; CY-1000	K163067	CyMedicaOrthopedics, Inc	IPF, GZJ, KQX
Secondary Predicate	ChattanoogaRevolutionWireless	K153696	DJO, LLC	IPF, GZJ

4 DEVICE DESCRIPTION

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo with three distinct symbols, each resembling a stylized letter. The first symbol looks like a modified 'n' or 'H', the second resembles a 'C', and the third is similar to a 'Z' or 'S'. Below the symbols, the text "COMBINED SOLUTIONS FOR INDUSTRY" is displayed in all caps. The logo appears to be for a company that provides combined solutions for the industry.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

conductive electrodes, that are applied directly to the patient's skin to ensure muscle । electrostimulation;
saver protection, interposed between the stimulator and the patient's arm. -

The electrodes, identified to meet the requirements to be compatible accessories of the Subject device, are FDA cleared:

"ValuTrode® Neurostimulation Electrodes" (K130987), made by Axelgaard manufacturing co., Ltd. Therefore, the biocompatibility aspects of these electrodes were already reviewed and cleared.

5 INDICATIONS FOR USE

Shoulder Pacemaker™ is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for Shoulder Pacemaker™ are:

Prevention or retardation of disuse atrophy;
Muscle re-education;
Maintaining or increasing range of motion.

The device is intended for adults only.

6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The present 510(k) submission would demonstrate that the Shoulder Pacemaker results substantially equivalent to the following predicate devices:

Primary Predicate: CyMedica e-vive System; CY-1000, which has been cleared through
510(k) application K163067
Secondary Predicate: Chattanooga Revolution Wireless, which has been cleared through 510(k) application K153696

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo with three distinct symbols, each resembling a stylized letter. The first symbol looks like a modified "n", the second resembles a "c", and the third appears to be a "j". Below the symbols, the text "COMBINED SOLUTIONS FOR INDUSTRY" is printed in a smaller font, indicating the name or slogan associated with the logo.

Multiple predicate devices, as listed above, have been identified, to support the substantial equivalence determination for the Shoulder Pacemaker; the Applicant would combine features from the two predicates with the same intended use into the subject device, to provide a complete muscle stimulator system, according to the user's needs.

Both the subject and the predicate devices are intended for the neuromuscular electrical stimulation (NMES). Although there are few minor differences, the indications for use of the Shoulder Pacemaker device can be considered as a subset of those of the predicates.

The predicate devices have additional features, and applications that are not included in the Shoulder Pacemaker.

Concerning the technological characteristics, the following tables summarizes similarities and differences among the subject and the predicate devices. A discussion on the comparison about the technological characteristics, underlying that the differences do not raise any new questions of safety or effectiveness in the Shoulder Pacemaker, compared to the chosen predicates, is reported below the following tables.

DeviceCharacteristic	Subject device(This 510(k)Application)	PrimaryPredicate (PP)	SecondaryPredicate (SP)	Comparison
Manufacturer	NCS Lab Srl	CyMedicaOrthopedics, Inc.	DJO, LLC	-
510(k) Number	Under present review	K163067	K153696	-
Device Name, Model	Shoulder Pacemaker	e-vive System;CY-1000	ChattanoogaRevolutionWireless	-
ClassificationRegulation	890.5850888.1500	890.5850888.1500882.5890	890.5850882.5890	Subset to PPand SP
Product Code	IPF: Powered MuscleStimulatorKQX: Goniometer AC-powered	IPF: PoweredMuscle StimulatorKQX:Goniometer AC-poweredGZJ:Stimulator, Nerve,Transcutaneous,For Pain Relief	IPF: PoweredMuscle StimulatorGZJ:Stimulator, Nerve,Transcutaneous,For Pain Relief	Same mainproduct codeto PP and SPSubset to PPand SP
Class	II	II	II	Same
Primary Function	Shoulder Pacemaker isan electrotherapydevice intended forneuromuscularelectrical stimulation(NMES).	The CyMedica e-vive System is amultifunctionalelectrotherapydevice that allowforneuromuscularelectricalstimulation(NMES) andtranscutaneouselectrical nervestimulation(TENS).	TheChattanooga®RevolutionWireless is aneuromuscularelectricalstimulation(NMES)device, whichstimulates nervefibers by means ofelectricalimpulsestransmitted byelectrodes andtranscutaneous	Same
DeviceCharacteristic	Subject device(This 510(k)Application)	PrimaryPredicate (PP)	SecondaryPredicate (SP)	Comparison
Indication for Use	Shoulder PacemakerTMis an electrotherapydevice intended forneuromuscularelectrical stimulation(NMES).The Indications for Usefor ShoulderPacemakerTM are:- Prevention orretardation of disuseatrophy;- Muscle re-education- Maintaining orincreasing range ofmotion.The device is intendedfor adults only.	The CyMedica e-vive System is amultifunctionalelectrotherapydevice with twotreatment modesthat allow forneuromuscularelectricalstimulation(NMES) andtranscutaneouselectrical nervestimulation(TENS).Indications forUse:As an NMESdevice,indications are forthe followingconditions:- Relaxation ofmuscle spasms- Retardation orprevention ofdisuse atrophy- Increasing localblood circulation- Re-educatingmuscles- Immediate post-surgicalstimulation of calfmuscles toprevent venousthrombosis- Maintaining orincreasing rangeof motionAs a TENSdevice,indications are forthe followingconditions:- Symptomaticrelief andmanagement ofchronicintractable pain- Adjunctivetreatment forpost-surgical andpost-trauma acutepain.	The ChattanoogaRevolutionWireless is aclinicalelectrotherapydevice intendedfor use under thesupervision of aHealthcareProfessional.Indications forUse:As an NMESdevice,indications are forthe followingconditions:- Retarding orpreventing disuseatrophy- Maintaining orincreasing rangeof motion- Re-educatingmuscles- Relaxation ofmuscle spasms- Increasing localblood circulation- Prevention ofvenousthrombosis of thecalf musclesimmediately aftersurgeryAs a TENSdevice,indications are forthe followingconditions:- Symptomaticrelief andmanagement ofchronic,intractable pain- Post-surgicaland post-traumaacute painAs a pulsed modedevice,indications are forthe followingconditions:- Relaxation ofmuscle spasm	Same intendeduse to PP andSPSubsetIndications foruse withrespect to PPand SP
DeviceCharacteristic	Subject device(This 510(k)Application)	PrimaryPredicate (PP)	SecondaryPredicate (SP)	Comparison
Basic Unit Characteristics
Power Source(s)	Rechargeable Li-ionbattery, 3.7V / 550mAh1.01 x 1.67 x 0.25 (in)	SingleVD434053:3.7V; 1000mAh;Lithium-ionpolymerbattery	Remote controlbattery:Rechargeable3.7[V] / ≥1,500[mAh]lithium polymer(LiPo) battery.Module battery:Rechargeable3.7[V] / ≥450[mAh] lithiumpolymer (LiPo)battery.	SimilarNote 1
Method of LineCurrent Isolation	N/ABattery operated device	No lineconnection	N/ABattery operateddevice	SameNote 1
PatientLeakageCurrent	Normalcondition(μΑ)	N/ABattery operated device	4.88	N/ABattery operateddevice	Same to SPNote 1
	Singlefaultcondition(μΑ)	N/ABattery operated device	8.00	N/ABattery operateddevice	Same to SPNote 1
Average DC currentthrough electrodeswhen device is on butno pulses are beingapplied (μΑ)	<0.01μΑ	N/A	N/A	DifferentNote 1
Number of OutputModes	1	3	Musclestimulator:Electrodes	DifferentNote 2
Number of OutputChannels	1	2	4	DifferentNote 2
●	Synchronous orAlternating?	N/A	Alternating	See OutputSpecificationsBelow(Ref. 510(k)summary -K153696)
●	Method ofChannelIsolation	N/A	Transistor	Each channel isthemiddle of a HBridge.Except when it isactivated, eachchannel is alwaysinhigh impedance
COMBINED SOLUTIONS FOR INDUSTRYCERTIFIED QUALITY MANAGEMENT SYSTEM UNI EN ISO 9001:2015 UNI CEI EN ISO 13485:2016 6
Regulated Current orRegulated Voltage?	Regulated power	Regulated power	Regulated currentonall channels	Same to PPNote 3
Software/Firmware/MicroprocessorControl?		Yes	Yes	Yes	Same
Automatic OverloadTrip?		No	No	Yes	Same to PPNote 3
Automatic No-LoadTrip?		No	No	Yes	Same to PPNote 3
Automatic Shut Off?		Yes	Yes	Yes, On/Offswitch	Same
Patient OverrideControl?		Yes	YesStop Buttons	Yes	Same
Indicator	On/OffStatus?	Yes	Yes	Yes	Same
Display:	LowBattery?	Yes	Yes	Yes	Same
	Voltage/CurrentLevel?	Yes	No	Yes, unit [miliAmps]	Same to SPNote 3
Time Range (minutes)		120 minutes	20-open	Yes, unit[minutes]Max 30 [minutes]	DifferentNote 4
Compliance withVoluntary Standards?		Yes:CEI EN 60601-1CEI EN 60601-1-2IEC 60601-1-6CEI EN 60601-2-10CEI EN 62304CEI EN 62366-1CEI EN 60601-1-11IEC 62133	Yes:IEC 60601-2-10IEC 60601-1-11IEC 60601-1-6ISO 10993-1	Yes:AAMI/ANSI ES60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-6IEC 62304ISO 14971IEC 62366	SimilarNote 5
Compliance with 21CFR 898?		Yes	Yes	Yes	Same
Weight		Electrostimulator: 4.62oz. (131g)Tablet: 10.76 oz.(305g)Receiver: 0.49 oz.(14g)	1.76 oz. (50g)	Remote: 0.24 lbswith batteryStimulationModule:0.11 lbs permoduleDocking Station:3lbs	DifferentNote 4
Dimensions (in.) [W xH x D]		Electrostimulator: 3.5 x0.81 x 3.5 (in)Tablet: 4.79x0.32x7.56 (in)Receiver: 2.75 x 0.55 x1.06 (in)Electrodes: 2 x 2 (in) or2 x 4 (in)Saver protection(height): 3 (in)	1.93 x 0.64 x 3.28(in)	Remote: 4.3 x 2.7x 0.8 inStimulationModule:0.8x(2.36 x 0.8)inDocking Stationtablet:5.5x10.6x1.2 [in]	DifferentNote 4
Housing Materialsand Construction		Electrostimulator:ABSTablet: PlasticReceiver: PVCElectrodes: ConductivehydrogelSaver protection:	Molded PC/ABSPlasticBayblend FR3010	N/A	Similar to PPNote 4

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows three distinct, abstract symbols arranged horizontally. Each symbol is composed of black and white geometric shapes with rounded corners, creating a modern and minimalist design. The first symbol resembles a stylized letter 'n', the second symbol looks like a plus sign, and the third symbol is an 'L' shape. The symbols are evenly spaced and presented against a white background.

VAT No. IT02550041202 2

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows three distinct abstract shapes arranged horizontally. The first shape resembles a stylized letter 'n' formed by black squares and white space. The second shape is a cross-like figure, also composed of black squares and white space. The third shape is an 'L' shape with rounded corners, presented in solid black.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows a logo with three distinct symbols. The first symbol resembles a stylized letter 'n', the second symbol resembles a stylized letter 'c', and the third symbol resembles a stylized letter 's'. Below the symbols, the text "COMBINED SOLUTIONS FOR INDUSTRY" is displayed in a smaller font size.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows a logo with three distinct shapes, each resembling a letter or symbol. The first shape looks like the letters 'ni', the second resembles a 'C', and the third appears to be an 'S'. Below the shapes, the text "COMBINED SOLUTIONS FOR INDUSTRY" is printed in a smaller font. The logo is simple and modern, using a dark color against a light background.

Note 1

The subject and the predicate devices are substantially equivalent for "Power Source", "Method of Line Current Isolation", "Patient Leakage Current" and "Average DC current through electrodes when device is on but no pulses are being applied (uA)".

The three devices are all supplied with similar internal rechargeable Li-ion battery with no line connection, with no or negligible.

"Average DC current through electrodes when device is on but no pulses are being applied" value is not specified in the predicate devices available information, while it has a negligible value for the subject device, hence it does not impact on Its safety.

Note 2

The subject device presents differences in the functions' specifications for "Number of Output Modes" and "Number of Output Channels", with a single output mode and a single channel, compared to the multiple outputs of predicate devices. This does not raise any safety or effectiveness issue for subject device. Moreover, both the subject and the predicates can rely on their compliance with IEC 60601-1 and IEC 60601-2-10 requirements.

Note 3

For "Regulated Current or Regulated Voltage", "Automatic Overload Trip", "Automatic No-Load Trip", the subject device is equivalent to the primary predicate, while It implements the "Voltage/Current Level Indicator Display" as the secondary predicate. Hence, on this item there is no impact on safety or effectiveness for Shoulder Pacemaker.

Note 4

The subject and both the predicates have a specific "Time Range" limit, with different values. The differences in specific values do not represent any impact on safety, but they rather characterize a parameter optimized for the specific treatment. Although the "Weight", "Dimensions" and "Housing Materials and Construction" of the subject device show slight difference compared to the predicates, they all comply with IEC 60601-1 and IEC 60601-2-10 standards requirements. Hence, these differences do not raise any safety or effectiveness issue for Shoulder Pacemaker.

Note 5

The subject device has been tested according to IEC 60601-1, 60601-1-6, 60601-1-6, 60601-1-11, 60601-2-10 standards and meets all these standards requirements and FDA guidance requirements too.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows a logo for a company called "Combined Solutions for Industry". The logo consists of three distinct symbols, each formed by a combination of squares and rounded corners. The symbols are arranged horizontally, with the company name printed in a smaller font size below them.

DeviceCharacteristic	ShoulderPacemakerTM(This 510(k)Application)	CyMedica e-vive System; CY-1000PrimaryPredicate (PP)		ChattanoogaRevolutionWirelessSecondaryPredicate (SP)	Comparison
		NMESPOST-OP	NMES POST-STRENGTH
			Output Specifications
Waveform(e.g.,Pulsedmonophasic,biphasic)	Biphasic	PulsedMonophasic	PulsedMonophasic	SymmetricalBiphasicWaveform	Different
Shape (e.g.,rectangular,spike, rectifiedsinusoidal)	Complex	Complex	Complex	Rectangular	Same as PP
MaximumOutputVoltage(specify units)(+/- %)	VRMS 4.7V@500 ΩVRMS 9.4V@2 kΩVRMS 17V@10 kΩ	8.5V@500Ω15.5V@2kΩ20.2V@10kΩ	8.4V@500ΩN/A@2 kΩN/A @ 10 kΩ	60 V @ 500 Ω180V @ 2 kΩ180 V @ 10 kΩ	Similar to PPDifferent fromSP
MaximumOutputCurrent(specify units)(+/- %)	IRMS 9.4mA@ 500 ΩIRMS 4.7mA@2 kΩIRMS 1.7mA@10kΩ	17.1mA@500 Ω7.7 mA@2 kΩ2.0 mA@10kΩ	N/A	120 mA@500 Ω90 mA @ 2 kΩ18 mA @ 10 kΩ	Similar to PPDifferent fromSP
Pulse Width(specify units)	1-200 [μs](microseconds)	5000 μs	5000 μs	300 to 400 [µs](microseconds)	Different
Frequency(Hz)	1 to 100 Hz	50 Hz	50 Hz	1 to 100 Hz	Same to SPSimilar to PP
Forinterferentialmodes only:BeatFrequency(Hz)	N/A	N/A	N/A	N/A	Same
Formultiphasicwaveformsonly:Symmetricalphases?	N/A	N/A	N/A	Yes	Same as PPDifferent fromSP
Formultiphasicwaveformsonly:PhaseDuration(include units)(state range, ifapplicable)(both phases, ifasymmetrical)	Stim phase:1-200[μs]Compensationphase: 9800-999.999 [μs]	N/A	N/A		Different
DeviceCharacteristic	ShoulderPacemakerTM(This 510(k)Application)	CyMedica e-vive System; CY-1000PrimaryPredicate (PP)		ChattanoogaRevolutionWirelessSecondaryPredicate (SP)	Comparison
		NMESPOST-OP	NMES POST-STRENGTH
(μC per pulse)(If zero, statemethod ofachieving zeronet charge)	500ΩExcitationpulse fullycompensated			Excitation pulsefullycompensated
MaximumPhase Charge(μC)	10 [μC] @500 Ω	342 @500Ω	336 @500Ω	48 [μC] @500Ω	Different
MaximumCurrentDensity(mA/cm2)	0.48 mA/cm2	0.66 @500Ω	0.65 @500Ω	2.1mA/cm2	Similar to PPDifferent fromSP
MaximumPower Density(W/cm2) (usingsmallestelectrodeconductivesurface area)	0,003W/cm2@500Ω	0.005 @500Ω	0.006 @500Ω	0,036 W/cm2@500Ω	Similar to PPDifferent fromSP
Burst Mode(i.e., pulsetrains):a. pulses perburstb. bursts persecondc. burstduration(seconds)d. Duty Cycle[Line (b) xLine (c)]	N/A, no burstmode	1500.08730.26	500.2310.23	N/A, no burstmode	Same as SP

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows a logo with three distinct shapes, each resembling a stylized letter. The first shape looks like a modified 'n', the second resembles a 'c', and the third appears to be a 'j'. Below the shapes, the text "COMBINED SOLUTIONS FOR INDUSTRY" is written in a simple sans-serif font. The logo is presented in a dark color, likely black or a dark gray, against a light background, creating a strong contrast.

Considering the output specifications, it can be noticed that:

ı The subject device has a biphasic waveform with a complex shape. Primary predicate has the same shape (complex), but its waveform is limited to a single phase (pulsed monophasic). The presence of the second phase in Shoulder Pacemaker waveform allows to implement the compensation effect. The pulse compensation can eliminate any direct current component to prevent the risk of residual polarization at skin level. This waveform implementation approach is typically adopted in muscle stimulators (as in the secondary predicate, chosen for the present substantial equivalence demonstration). In fact, as for the secondary predicate device case, in the subject device the net charge is zero uC and the excitation pulse results fully compensated, so the risks of polarization are eliminated.

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows a logo with three distinct shapes, each resembling a letter or symbol. The first shape looks like a stylized "n" or "H", the second resembles a "C", and the third is similar to an "S". Below the logo, the text "COMBINED SOLUTIONS FOR INDUSTRY" is printed in a smaller font, suggesting the name or slogan of the organization represented by the logo.

The maximum current density value is different in the subject device compared to the predicates, but its value is lower than the critical value (2mA/cm2), as reported in the IEC 60601-2-10 standard.
The maximum power density value depends on the dimension of electrode conductive . surface area. The values are different between the devices; anyway, the subject device value is lower than the predicates ones; therefore, this is a condition of greater safety in the subject device compared to the predicates.
. The Shoulder Pacemaker has the same range of frequency of the secondary predicate.
The Maximum Output Voltage and Maximum Output Current values are different between the devices. The primary predicate has a complex shape waveform like the subject device, so these two devices show comparable output values.
· The Maximum Phase Charge of the subject device is the lowest of the two predicates, ensuring less impact on the patient, by satisfying the technical requirements for hardware operation as well.
· The Pulse Width range of the subject device is lower than the two predicates; anyway, this range value satisfies the desired stimulation conditions.

In conclusion, the few differences in the Basic Unit Characteristics and Output Specifications between the interested devices, as shown in above reported table, do not raise any new questions of safety or effectiveness in the Shoulder Pacemaker, compared to the chosen predicates.

7 PERFORMANCE DATA

Non-clinical testing data are submitted, referenced, or relied upon, to support the demonstration of substantial equivalence of the Subject with the chosen Predicate devices. To demonstrate the safety, the Shoulder Pacemaker was tested for electrical safety, electromagnetic compatibility, usability, and risk management requirements, according to the following standards:

CEI EN 60601-1 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
CEI EN 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
CEI EN 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
CEI EN 60601-1-11 Medical electrical equipment General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows a logo with three distinct symbols, each composed of geometric shapes. The symbols are arranged horizontally and appear to be stylized letters or abstract representations. Below the symbols, the text "COMBINED SOLUTIONS FOR INDUSTRY" is printed in a simple, sans-serif font. The logo has a modern and industrial feel due to its geometric design and the text below it.

IEC 60601-1-6 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
CEI EN 62366-1 Medical devices -- Part 1: Application of usability engineering to medical devices
CEI EN 62304 Medical device software Software life cycle processes -
ISO 14971 Application of risk management to medical devices

BLE module testing was conducted in accordance with the following standards:

FCC 47 CFR PT 15 SPT B, Issued: 2013/01/28 Title 47 CFR Part 15 Subpart B: - Unintentional Radiators [FCC §15.107 & FCC §15.109]
FCC 47 CFR PT 15 SPT C, Issued:2007/10/01 Title 47 CFR Part 15 Subpart C: - Intentional Radiators [FCC §15.247]

Battery testing was conducted in accordance with:

IEC 62133-1:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems
IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

To demonstrate the Shoulder Pacemaker' effectiveness and performance substantial equivalency with the chosen predicate devices and to draft the present submission, the following FDA guidance document was used:

FDA Final Guidance Document for Powered Muscle Stimulator 510(k), issued on June 9, 1999
Electrical safety and Electromagnetic Compatibility (EMC) testing were conducted on the Shoulder Pacemaker; It complies with CEI EN 60601-1, CEI EN 60601-2-10, and CEI EN 60601-11 standards for safety and with CEI EN 60601-1-2 standard for EMC.

The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and according to CEI IEC 62304 Medical device software – Software life cycle processes. The software validation tests demonstrated that the software version meets its design requirements.

8 CONCLUSIONS

Based on the performance testing and the supporting documentation, it can be concluded that the Shoulder Pacemaker is as safe and effective as, and substantially equivalent to, the chosen predicate devices.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).