The microFET2™ System is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury or for sports medicine applications, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle group being tested.

Device Description

The microFET2™ is an ergonomically designed hand-held, battery operated, digital muscle tester. Which is an accurate, portable Force Evaluation Testing (FET) dynamometer, designed specifically for taking objective, reliable, and quantifiable muscle testing measurements, and is used to record a person's ability to resist force for a specific muscle or muscle group being tested.

The device's ergonomic design allows for its use ambidextrously, depending on stabilization requirements, by being held in either hand using an elastic strap for convenience and comfort. The size and weight of the device allows the examiner/tester to use the same procedures and methods of muscle testing techniques without causing injury to the clinician or patient.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the Hoggan Scientific MicroFET2™ System. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific clinical acceptance criteria in the way an AI/ML medical device submission would.

Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details, are not applicable to this type of submission for a physical medical device like a dynamometer.

The document discusses functional testing of the device (such as electrical safety and software functionality, and biocompatibility), but this is different from the clinical performance evaluation of an AI algorithm.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document broadly states that "All necessary verification steps met pre-determined acceptance criteria to confirm safety and effectiveness" and "All data met pre-determined acceptance criteria." It also lists functional tests performed. However, it does not provide a quantitative table of acceptance criteria vs. specific measured performance for the device's primary function (muscle strength measurement). It focuses on comparative equivalence to a predicate device and safety/EMC standards.

Acceptance Criteria Category	Reported Device Performance (as stated or implied)
Biocompatibility	Materials are the same as Hoggan reference device (K860226). New warning for use over clothing added.
Electrical Safety	Tested to IEC 60601-1 Medical Device Electrical Safety (2012) and IEC 60601-1-2 (2014).
Electromagnetic Compatibility (EMC)	Tested to CISPR 11 Emissions Class B (2009), A1(2010), FCC Part 15B Radiated Emissions, Conducted Emissions.
Software/Firmware Functionality	Controls battery usage, load cell force conversion to LCD, and Bluetooth wireless capabilities. Deemed "minor" level of concern.
Overall Safety and Effectiveness	"Met all acceptance criteria to confirm safety and effectiveness." (General statement)

2. Sample sizes used for the test set and the data provenance:

Not applicable / Not provided. This device is a physical dynamometer, not an AI/ML algorithm that processes a "test set" of data in the sense of patient images or readings. The "testing" refers to hardware and firmware verification. No clinical trial data of specific patient cohorts for performance metrics is discussed.

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

Not applicable. Ground truth in the context of an AI/ML device would refer to disease labels or measurements on patient data. This document describes a physical measurement device where the "ground truth" would be the actual force applied, which is measured by a calibrated load cell. Expert labeling is not relevant here.

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

Not applicable. No expert adjudication process is described as it's not a performance evaluation involving subjective human interpretation of outputs.

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 is not an AI-assisted device. It's a direct measurement tool.

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

Not applicable. This device is a physical tool for direct measurement of force; there is no "algorithm only" performance separate from the device's operation.

7. The type of ground truth used:

The "ground truth" for a dynamometer's accuracy would typically be established by using calibrated weights or force meters to verify the load cell's readings against known forces within its measurement range. The document states "Resistance based strain gauge (Load Cell) with microprocessor to convert analog signal to digital, calibrated data," implying that calibration is an inherent part of its operation. It does not elaborate on the specific calibration process or "ground truth" for accuracy testing.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/ML algorithm.

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

Not applicable. There is no "training set" for this device.

Summary

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

March 9, 2017

Hoggan Scientific, LLC Spencer Walker Director Regulatory Affairs 3653 West 1987 South Bld. # 7 Salt Lake City, Utah 84104

Re: K162412

Trade/Device Name: MicroFET2™ System Regulation Number: 21 CFR 888.1240 Regulation Name: AC-Powered Dynamometer Regulatory Class: Class II Product Code: LBB Dated: February 17, 2017 Received: February 27, 2017

Dear Mr. Walker:

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

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) K162412

Device Name Hoggan Scientific® microFET2TM

Indications for Use (Describe)

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)

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510(k) Summary

Submitter:	Hoggan Scientific, LLC
Contact Person:	Spencer Walker, MSc - Director Regulatory Affairs3653 West 1987 South Bld. # 7Salt Lake City, UT 84104(801) 581-5080
Date Prepared:	August 23, 2016
Trade Name:	microFET2™
Classification Name:	Dynamometer21 CFR §888.1240, Product Code LBB, Class II
Predicate Device(s):	• K042889- Ametek, Inc., Dynamometer, Model ChatillonFCE and MSC series;

Device Description:

Indications for Use:

The microFET2TM system is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury, or for sports medicine applications, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle group being tested.

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Comparative Analysis:

The microFET2™ is comparable to the predicate device in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The microFET2™ system has been fully assessed within the Hoggan Scientific Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to confirm safety and effectiveness.

Technology Comparison of microFET2™ with Predicate Device:
DeviceComponent	Subject Device – K162412	Predicate - K042889 - Ametek(Chatillon FCE & MSC)
Device Name	microFET2™	MSC Series Digital Muscle StrengthComparator, Chatillon/Ametek
Intended Use	The microFET2™ is a dynamometerdiagnostic device used forquantitatively evaluating musclestrength	The Chatillon FCE and MSC seriesdynamometers are diagnostic devicesused for quantitatively evaluatingmuscle strength
Indicationsfor use	The microFET2™ system is adynamometer device for performingmuscle tests to quantitatively measuremuscle weakness caused by injury orfor sports medicine applications, as wellas measure general muscle strength.The device is used to record andconvey an individual's ability to resistforce for a specific muscle or musclegroup being tested.	The intended use of the Chatillon FCEand MSC series dynamometers is forperforming manual muscle testing tomeasure muscle strength. The targetpopulation for this product is individualsrecovering from physical injury or forsports medicine applications
Classification	AC-Powered Dynamometer21CFR 888.1240Product Code: LBBClass II	AC-Powered Dynamometer21CFR 888.1240Product Code: LBBClass II
Prescription(Rx Only)	Yes	Yes
Anatomicalsite	Head, Neck, Shoulders, Arms, Elbows,Wrists, Hands, Fingers, Hips, Legs,Knees, Ankles, Feet, Toes	Head, Neck, Shoulders, Arms, Elbows,Wrists, Hands, Fingers, Hips, Legs,Knees, Ankles, Feet, Toes
Measurement	0.8 Ibf Minimum - 300 Ibf MaximumWith 0.1 lbf resolution	100 lbf Maximum with 0.01 Ibfresolution200 Ibf Maximum with 0.02 Ibfresolution500 Ibf Maximum with 0.05 Ibfresolution
Unit ofMeasurement	Displays force as Ibf, Kgf, N	Displays force as Ibf, Kgf, N, gf, ozf
Power Supply	Battery Powered - May not to beoperated while attached to charger.	Battery Powered - May be operatedwhile attached to a charger
Battery	3.7 V Lithium-Ion Battery90 hours continuous use (non-wireless mode)6 hours continuous use (wireless mode)	4.8V Nickel Metal Hydride Battery30 hours continuous use
Humanfactors	Handheld• <1 lb.• Two small LCD displays• Two switches for user interaction• Wireless RF• Bluetooth data transfer	Handheld• 1.5 lb.• Single large LCD display• Navigation Keys for user interaction with menu
FundamentalScientificTechnology	Resistance based strain gauge (Load Cell) with microprocessor to convert analog signal to digital, calibrated data	Resistance based strain gauge (Load Cell) with microprocessor to convert analog signal to digital, calibrated data
Sterilization	None	None
Radiationsafety:	IEC 60417-5140 (Non-ionizing Radiation)IEC 61000-4-8 Power Frequency (50/60Hz) Magnetic FieldIEC 61000-4-3 RF Radiated Fields ImmunityIEC 61000-4-2 Electrostatic DischargeCISPR 11 Group1 Class B	BS EN 61010-1:2001 SafetyRequirement for Electrical EquipmentBS EN 50081-1:1992 EMC Generic Emissions StandardBS EN 50082-1:1992 EMC Generic Immunity Standard
Applied PartClass (perIEC 60601-2-18; (2009))	Class II METype B	Class II METype B

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Functional/Safety Testing:

The following functional tests were performed. All data met pre-determined acceptance criteria.

. Biocompatibility – The microFET2™ materials are the same as those from the Hoggan reference device per K860226. A new warning was added to the Instructions for Use manual advising the user to use the foam portion of the device over clothing.
Electrical Safety and Electromagnetic Compatibility (EMC) The electrical . safety and EMC series of test demonstrates the safety and compatibility of the electrical and EMC characteristics of the microFET2™. The microFET2™ was tested to the requirements of the following industry standards:
- IEC 60601-1 Medical Device Electrical Safety (2012) o
  - IEC 60601-1-2 Medical Device (2014) o
  - CISPR 11 Emissions Class B (2009), A1(2010) o
  - FCC Part 15B Radiated Emissions Conducted Emissions o

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Software The microFET2™ system uses firmware to control the handheld . device:
- Battery usage, load cell force conversion to LCD display screens . and Bluetooth wireless capabilities

The optional Clinical Software may be used to wirelessly record patient testing results and record keeping.

The optional FET Data Collection Software may be used to plot the data on a computer monitor in real time.

The microFET2™ firmware/software level of concern have been determined to be minor, and are deemed to not result in harm to the patient or misdiagnosis of the patient condition when the device is used by a medical professional.

Conclusion:

The microFET2™ is substantially equivalent to the cited predicate device. Additionally, the microFET2™ met all acceptance criteria to confirm safety and effectiveness.

Regulation Number and Section

§ 888.1240 AC-powered dynamometer.

(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.