The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

Device Description

PowerDot PD-01 Muscle Stimulator is a battery-powered neuromuscular stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance and, with that regard, may be considered a technique or method for muscle training. PowerDot PD-01 device is designed to be used together with PowerDot Mobile Application. PowerDot PD-01 device uses Bluetooth™ Low Energy (Bluetooth 4.0, Class II) wireless radio frequency protocol for communication with supported range of mobile devices (such as smartphones and/or tablets) via PowerDot Mobile Application. Accessories include lead cables of 2 different lengths, USB charging cable, 2 types of hydrogel-based self-adhesive electrode pads and carrying case.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you are asking. The document is a 510(k) premarket notification decision letter from the FDA, and it focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance study results.

Here's a breakdown of why I cannot fulfill your request with the given information:

Acceptance Criteria and Reported Device Performance: The document provides a comparison table between the PowerDot PD-01 and a predicate device (Compex Sport Plus) for various technical parameters. However, these are comparative features, not specific acceptance criteria with quantitative performance metrics. For example, for "Patient Leakage Current," it states "< 25 µA" for the PowerDot, but this is presented as a characteristic meeting IEC 60601-1 safety criteria, not as an explicit acceptance criterion for a performance study.
Sample Size and Data Provenance: No information on sample sizes for test or training sets, or data provenance (country of origin, retrospective/prospective) is provided.
Number of Experts and Qualifications: There is no mention of experts used to establish ground truth or their qualifications.
Adjudication Method: No adjudication method is described.
MRMC Comparative Effectiveness Study: The document does not describe an MRMC study or any effect size for human readers. This device is a muscle stimulator, not an AI for image interpretation that would typically involve human readers.
Standalone Performance: The document doesn't explicitly refer to "standalone performance" in the context of an algorithm's output without human intervention. Instead, it describes "Software Verification and Validation" showing that "all software requirement specifications were met."
Type of Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) is not applicable or discussed, as this is a physical medical device (muscle stimulator) rather than a diagnostic or AI-powered imaging device.
Training Set Sample Size and Ground Truth Establishment (for Training Set): There is no mention of a training set or how ground truth for it was established.

What the document does provide regarding testing and compliance is summarized below:

The document focuses on non-clinical tests to establish safety and substantial equivalence:

Biocompatibility Testing:
- Skin-contacting hydrogel (electrode pads) tested to ISO 10993-1:2009.
- TPU, ABS, and PVC Compound materials (housing and lead cables) evaluated for biocompatibility based on Material Safety Data Sheets from vendors.
Software Verification and Validation:
- PowerDot Firmware and PowerDot Mobile Application software documentation provided (consistent with a moderate level of concern).
- System Validation Testing proved that all software requirement specifications were met and all software hazards were mitigated to an accepted risk level.
Electrical Safety and Electromagnetic Compatibility Testing:
- Designed to comply and tested for compatibility with applicable clauses of:
  - IEC/EN 60601-1:2005 (General Safety)
  - IEC 60601-2-10:2012 (Nerve and Muscle Stimulators)
  - IEC/EN 60601-1-2:2014 (EMC)
  - IEC/EN 60601-1-11:2010 (Home Healthcare Environment)
Battery Testing:
- Lithium-Polymer battery tested to FDA-recognized UL 1642 Standard.
Engineering Bench Testing:
- Included testing in accordance with FDA's "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning" (Attachment 11, Section 1 - Output Waveforms).
- Oscilloscope tracings obtained for device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω, 2 kΩ, and 10 kΩ.
- System validation testing scenarios covering mitigation of wireless risks (referencing FDA's "Radio Frequency Wireless Technology in Medical Devices - Guidance").
Clinical Performance Data: "No applicable." The device "does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body." Clinical effectiveness was based on a literature review.

The conclusion states that "Test results demonstrate the PowerDot PD-01 device with PowerDot Mobile Application is safe and effective for its intended use and the results support determination of substantial equivalent." However, this is a general statement about the outcome of the non-clinical tests and literature review, not a specific breakdown of acceptance criteria and performance against those criteria.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name arranged in a circular fashion around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, formed by three intertwined figures in profile.

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

September 30, 2015

Smartmissimo Technologies Pte Ltd Alexey Pisarev Chief Executive Officer #28-01, Sgx Centre II, 4 Shenton Way Singapore, 068807 SG

Re: K150078

Trade/Device Name: PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 18, 2015 Received: August 31, 2015

Dear Alexey Pisarev:

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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 yours,

Michael J. Hoffmann -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) K150078

Device Name

PowerDot® PD-01 Muscle Stimulator (with PowerDot® Mobile Application)

Indications for Use (Describe)

The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

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

☐ Registration Use (Part 21 CFR 201.Subpart D)
☑ Over-The-Counter Use (21 CFR 201.Subpart C)

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

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

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5. 510(k) Summary

This summary is being submitted in accordance with the reguirements of 21 CFR 807.92.

5.1 Submitter

Smartmissimo Technologies Pte Ltd. 4 Shenton Way, #28-01 SGX Centre II, Singapore, 068807

Contact: Alexey Pisarev, Chief Executive Officer Tel. +65 83216256 Email: alexey@getpowerdot.com

5.2 Date Prepared: Sept 29, 2015

5.3 Device Name and Classification Information:

Trade/Proprietary Name: PowerDot® PD-01 Muscle Stimulator (with PowerDot® Mobile Application) Common Name: Smart Wearable Sports Muscle Stimulator Classification Name: Powered Muscle Stimulator for Muscle Conditioning Classification: 21 CFR 890.5850, Class II Product Code: NGX Panel: 89, Physical Medicine

5.4 Predicate Device: Compex® Sport Plus (K083140)

5.5 Device Description:

PowerDot PD-01 device is designed to be used together with PowerDot Mobile Application.

PowerDot PD-01 device uses Bluetooth™ Low Energy (Bluetooth 4.0, Class II) wireless radio frequency protocol for communication with supported range of mobile devices (such as smartphones and/or tablets) via PowerDot Mobile Application.

Accessories include lead cables of 2 different lengths, USB charging cable, 2 types of hydrogel-based self-adhesive electrode pads and carrying case.

5.6 Indications for Use:

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used in conjunction with therapy or treatment diseases of medical conditions of any kind.

5.7 Contraindications

PowerDot PD-01 device and PowerDot Mobile Application should not be used by anyone with a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

Parameter	PowerDot PD-01 (withPowerDot MobileApplication)	Compex Sport Plus(K083140)	SubstantialEquivalence
Intended Use and IndicationsFor Use	The PowerDot PD-01 devicewith PowerDot MobileApplication is intended forthe stimulation of healthymuscles in order to improveor facilitate muscleperformance. The PowerDotPD-01 device and PowerDotMobile Application are notintended to be used inconjunction with therapy ortreatment diseases of medicalor medical conditions of anykind.	Intended for thestimulation of healthymuscles in order toimprove or facilitatemuscle performance.Compex Sport is notintended to be used inconjunction withtherapy or treatment ofmedical diseases ormedical conditions ofany kind. Usage of anyof Compex Sportprograms on injured orailing muscles iscontraindicated.	Same
Use environment	Over-the-counter (non-prescriptive) use in athletictraining facilities or at home	Over-the-counter (non-prescriptive) use inathletic trainingfacilities or at home	Same
Anatomical Sites	Electrodes can be applied tomultiple anatomical sites.	Electrodes can beapplied to multipleanatomical sites.	Same
Stimulation Parameters
Power Source	Battery, Li-Po, rechargeable.Not replaceable by user.	Battery, Ni-MH,rechargeable	Substantiallyequivalent. Bothdevices arepowered withrechargeablebatteries.
Method of Line CurrentIsolation	N/A	N/A
Patient Leakage Current			Unable tocompare.Leakage currentof PowerDotPD-01 isextremely lowand meets IEC60601-1 safetycriteria.
- Normal Condition	< 25 μΑ	Unknown
- Single FaultCondition	< 25 μΑ	Unknown
Average DC current throughelectrodes when device is onbut no pulses are beingapplied	0 μΑ	0 μΑ	Same
Number of output modes	One output mode, but with	One output mode, but	Substantially
	varying stimulationfrequency, pulse width andduty cycle ranges	with varyingstimulation frequencyand duty cycle ranges	equivalent
Number of output channels	2 channels (or 4 channelswhen two PowerDot PD-01devices are used with onePowerDot MobileApplication application)	4 channels	Substantiallyequivalent.
Synchronous or alternating	Synchronous (withasynchronous support)	Synchronous
Method of channel isolation	Galvanic	Galvanic	Substantiallyequivalent
Regulated current orregulated voltage	Regulated voltage	Regulated current	Substantiallyequivalent.Difference isregulationtechnology isnot substantialas bothtechnologies areefficient forpower outputcontrol.
Microprocessor controlled	Yes	Yes	Same
Automatic overload trip	Yes	Yes	Same
Automatic no-load trip	Yes	Yes	Same
Automatic shut-off	Yes	Yes	Same
User over-ride control	Yes	Yes	Same
Indicator display:- On/Off status	Yes	Yes	Same
- Low battery	Yes (available fromPowerDot MobileApplication)	Yes	Substantiallyequivalent.PowerDot andCompexindicators servethe same
- Voltage/currentlevel	Yes (available fromPowerDot MobileApplication)	Yes	purpose.
Timer range in minutes	60 minutes maximum (forthe longest running'Endurance' programpossible)	Maximum program: 60minutes	Substantiallyequivalent.Both devices canbe used forextended periodsof time.
Compliance with voluntarystandards	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10	IEC 60601-1IEC 60601-1-2IEC 60601-2-10	Substantiallyequivalent
Compliance with 21 CFR 898	Yes	Yes	Same
			equivalent.Both devices aresmall andlightweight.
Dimensions	2.4"x1.7"x0.5"	5.6"x1.5"x3.9"	Substantially equivalent
Housing material andconstruction	Plastic injection molding,TPU	Plastic injectionmolding	Substantially equivalentPowerDothousingmaterials areevaluated forbiocompatibility.

5.8 Brief Technical Comparison with the Predicate Device and Discussion of Differences

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5.9 Non-clinical Tests

The following non-clinical testing was provided in this 510(k):

Biocompatibility Testing

Skin contacting hydrogel, which is used in PowerDot electrode pads, has been tested to ISO 10993-1:2009 standard.

TPU. ABS and PVC Compound materials, used in PowerDot PD-01 device housing and lead cables, were evaluated for biocompatibility based on Material Safety Data Sheets provided by the material vendors, and were concluded to be safe and biocompatible.

Software Verification and Validation

PowerDot Firmware and PowerDot Mobile Application software documentation, consistent with a moderate level of concern, is provided with this 510(k).

System Validation Testing proves that all software requirement specifications were met and all software hazards were mitigated to Accepted risk level.

Electrical Safety and Electromagnetic Compatibility Testing

PowerDot PD-01 device together with its controlling PowerDot Mobile Application has been designed to comply and tested for compatibility with the applicable clauses of the following FDA-recognized standards:

. IEC/EN 60601-1:2005 "Medical Electrical Equipment - Part 1: General Requirements for Safety"
IEC 60601-2-10:2012 "Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. Edition 2.0"

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IEC/EN 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and tests. Edition 4.0"
. IEC/EN 60601-1-11:2010 "Medical electrical equipment -- Part 1-11: 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. Edition 1.0"

Battery Testing

Lithium-Polymer battery, used in PowerDot PD-01 was tested by battery manufacturer for compliance with FDA-recognized UL 1642 Standard for Lithium Batteries (Cells).

Engineering Bench Testing

In addition to the full system validation testing, the 510(k) also included testing in accordance with the recommendations of FDA's "Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning", Attachment 11, Section 1 - Output Waveforms. Oscilloscope tracings were obtained of the device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω, 2 kΩ and 10 kΩ.

Also, a number of system validation testing scenarios covering mitigation of wireless risks in accordance with FDA's "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" were added to our full system testing protocol.

5.10 Brief Description of clinical performance data

No applicable. This device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body.

Clinical effectiveness of the device was based on a literature review.

5.11 Conclusion

Test results demonstrate the PowerDot PD-01 device with PowerDot Mobile Application is safe and effective for its intended use and the results support determination of substantial equivalent.

The usage of PowerDot Mobile Application as a wireless user interface for PowerDot PD-01 device as well as any other engineering differences do not: (1) affect the intended use (2) alter the fundamental scientific technology of the device.

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).