The TAMA BEMS Device is a microcurrent stimulator producing electrical currents up to 800 microamps. It is intended for aesthetic purposes. It has built-in pushbuttons to allow the user to adjust the output current from 0 to 800 micro-amps, as well as changing the modality (output frequency). The BEMS device is a battery-operated device that uses a rechargeable battery. When the device is plugged into the AC outlet for charging, it becomes disabled and no treatments can be performed. The BEMS device also has LED indicators to show output intensity, battery level, and output mode. A Flow light shows when probes contact the skin, and current is flowing through the patient. If the measured current through the probes does not match the set point selected by the user, the Flow LED turns off to indicate insufficient current flow.

AI/ML Overview

The provided text describes a 510(k) submission for the TAMA BEMS Device, a microcurrent stimulator for facial tissues for aesthetic purposes. However, it does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance.

The document focuses on demonstrating substantial equivalence to a predicate device (Beautiful Image Model 900 Facial Toning Device - K130065) based on:

Indications for Use
Materials of Construction
Design Features
Energy Source
Benchtop performance testing (Biocompatibility, Electrical safety and EMC, Software V&V, Mechanical and Acoustic Testing, Human Factors).

Crucially, the document explicitly states:

"Clinical testing was not required to demonstrate the safety and effectiveness of the TAMA BEMS Device. Instead, substantial equivalence is based upon benchtop performance testing." (Page 4, Section VII)
"Animal performance testing was not required to demonstrate safety and effectiveness of the device." (Page 4, Section VII)

Therefore, I cannot provide the requested information regarding AI acceptance criteria and study details because the submission is for a physical medical device (Transcutaneous Electrical Nerve Stimulator for Pain Relief, reclassified for aesthetic purposes) and does not involve AI or algorithms that would typically require such performance studies (e.g., diagnostic accuracy, sensitivity, specificity, or reader improvement).

To explicitly address your points based on the provided text's scope:

A table of acceptance criteria and the reported device performance:
The document presents a comparison table (pages 5-6) that shows the technological characteristics of the TAMA BEMS Device against its predicate, rather than performance against pre-defined acceptance criteria for an AI algorithm.

Acceptance Criteria (based on predicate equivalence)	TAMA BEMS Device Performance
Indications for Use: Stimulate facial tissues for aesthetic purposes	The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes
Power Source: Comparable	Internal 4.3V rechargeable Lithium Polymer battery (Predicate: One 6V Battery)
Number of Output Modes: Compared	Four (Predicate: One)
Number of Output Channels: Compared	One (Predicate: One)
Software/Firmware/Microprocessor Control?: Yes	Yes (Predicate: Yes)
Automatic Overload Trip?: Yes	Yes (Predicate: Yes)
Automatic No-Load Trip?: Yes	Yes (Predicate: Yes)
Automatic Shut Off?: Yes	Yes (Predicate: Yes)
User Override Control?: Yes	Yes (Predicate: Yes)
On/Off Display Status?: Yes	Yes (Predicate: Yes)
Low Battery Indicator?: Yes	Yes (Predicate: Yes)
Voltage/Current Level Indicator?: Yes	Yes (Predicate: Yes)
Timer Range: Compared	0-30 minutes (Predicate: None)
Compliance with Voluntary Standards?: IEC60601-1, 21 CFR 989	IEC60601-1, 21 CFR 989 (Predicate: IEC 60601-1, 21 CFR 989)
Weight (lbs., oz.): Compared	9.5 ounces (Predicate: 10 lbs)
Dimensions (in.) [WxHxD]: Compared	3x5x0.7 (Predicate: 5.5x15.3x11.3)
Housing Materials and Construction: Compared	Anodized aluminum 6061 (Predicate: Thermoplastic)
Waveform: Biphasic	Biphasic (Predicate: Biphasic)
Shape: Rectangular	Rectangular (Predicate: Rectangular)
Maximum Output Voltage (volts) (+/-5%): Compared	±0.400 @500Ω, ±1.600 @2kΩ, ±8.00 @10kΩ (Predicate: 0.347 @500Ω, 1.242 @2kΩ, 5.780 @10kΩ)
Maximum Output Current (mA) (+/-5%): Compared	±0.800 @500Ω, ±0.800 @2kΩ, ±0.800 @10kΩ (Predicate: 0.647 @500Ω, 0.625 @2kΩ, 0.584 @10kΩ)
Duration of primary (depolarizing) phase (msec): Compared	26.3 – 1200 (Predicate: 0.648 – 322)
Pulse Duration (msec): Compared	52.6 – 2400 (Predicate: 3.24 – 1610)
Frequency (Hz) [or Rate (pps)]: Compared	0.045 – 2560 (Predicate: 0.621 – 308.6)
Symmetrical phases? Phases Duration (msec): Yes, 26.3 – 1200	Yes, 0.324-161
Net Charge (micro coulombs (µC) per pulse): 0µC @500Ω	0µC @500Ω (Predicate: 0µC @500Ω)
Maximum Phase Charge, (µC): Compared	400 µC positive phase, (50% duty cycle), all loads (Predicate: 190 @500Ω)
Maximum Current Density (mA/cm², r.m.s.): Compared	1.591 @500Ω (1) (Predicate: 1.486 @500Ω)
Maximum Average Current (average absolute value), mA: Compared	0.800 @500Ω (Predicate: 0.493 @500Ω)
Maximum Average Power Density, (W/cm²): Compared	318E-6 @500Ω (2), 0.012 @18.75 KΩ (3) (Predicate: 366E-6 @500Ω)
Burst Mode (e.g., pulse trains): Yes/No, Pulses per burst, Bursts per second, Burst duration (seconds), Duty Cycle	Yes, 5 - 20, 10 - 40, 0.00195 - 0.0078, 0.0195 – 0.1719 (4) (Predicate: N/A for burst mode)
ON Time (seconds): Compared	Constant (Predicate: 10-30)
OFF Time (seconds): Compared	None (Predicate: 1-6)

Sample size used for the test set and the data provenance: Not applicable. No test set for an AI algorithm's performance was used, as clinical testing was "not required." The data provenance is primarily from bench testing, and no "test set" in the context of AI evaluation is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert review for ground truth establishment for an AI algorithm test set was mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI performance. The "ground truth" for the substantial equivalence would be the established safety and effectiveness of the predicate device, demonstrated through bench testing and compliance with standards.
The sample size for the training set: Not applicable. No AI training set is mentioned.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services-USA logo. The second logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

June 5, 2018

TAMA Research Corporation % Robert Packard President Medical Devices Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05728

Re: K173093

Trade/Device Name: TAMA BEMS device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: May 7, 2018 Received: May 7, 2018

Dear Robert Packard:

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

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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); 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.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

VivekJ. Pinto -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) K173093

Device Name TAMA BEMS Device

Indications for Use (Describe)

The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

1. SUBMITTER TAMA Research Corporation 7600 North 16th Street. Suite 205 Phoenix, AZ, 85020 USA Tel: +1 (602) 354-8185

Contact Person:	Ali Shambayati
Date Prepared:	June 4, 2018

Name of Device:	TAMA BEMS Device
Classification Name:	Neurological Therapeutic Device
Regulation:	21 CFR §882.5890
Regulatory Class:	Class II
Product Classification Code:	NFO

PREDICATE DEVICE 111

Predicate Manufacturer:	Biosonic Technologies, LLC
Predicate Trade Name:	Beautiful Image Model 900 Facial Toning Device
Predicate 510(k):	K130065

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

The TAMA BEMS Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

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Indications for Use
Materials of Construction ●
Design Features
. Energy Source

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

A biocompatibility certification statement was provided indicating that the components with patient contact are fabricated from biocompatible metal that is also used for other TENS devices legally marketed in the USA. In addition, cytotoxicity testing was performed to demonstrate that there are no residuals present that negatively impact biocompatibility.

Electrical safety and electromagnetic compatibility (EMC)

The following electrical safety and EMC tests have been performed:

. IEC 60601-1 Electrical Safety Testing
IEC 60601-1-2 EMC Testing ●
. IEC 60601-2-10 Medical Electrical Equipment Safety Standard for Nerve and Muscle Stimulators

Software Verification and Validation Testing

Verification and validation testing of the software was conducted in accordance with IEC 62304.

Mechanical and acoustic Testing

A risk analysis was completed and risk controls were implemented in accordance with ISO 14971. Human factors testing was conducted in accordance with IEC 60601-1-6. ISO 62366 and the FDA guidance on human factors engineering to demonstrate that the ergonomics of patient and user interfaces for the subject device are substantially equivalent to the predicate device.

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the TAMA BEMS Device. Instead, substantial equivalence is based upon benchtop performance testing.

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	TAMA BEMS Device –Subject Device	Beautiful Image Model900 Facial Toning Device – K130065
Indications for Use	The TAMA BEMSDevice uses microcurrentelectrical to stimulatefacial tissues for aestheticpurposes	The Beautiful ImageModel 900 Facial ToningDevice uses microcurrentelectrical energy tostimulate facial tissues foraestheticpurposes.
Design
Power Source	Internal 4.3Vrechargeable LithiumPolymer battery	One 6V Battery
Method of Line Current Isolation	N/A	N/A
Patient Leakage Current	N/A	N/A
Normal Condition (μΑ)	N/A	N/A
Single Fault Condition (µA)	N/A	N/A
Average DC current through electrodes whendevice is on but no pulses are being applied (μΑ)	None	None
Number of Output Modes	Four	One
Number of Output Channels	One	One
Synchronous or Alternating?	N/A	N/A
Method of Channel Isolation	N/A	N/A
Manufacturer	TAMA ResearchCorporation	Biosonic Technologies,LLC
Regulated Current or Regulated Voltage?	Both	Both
Software/Firmware/Microprocessor Control?	Yes	Yes
Automatic Overload Trip?	Yes	Yes
Automatic No-Load Trip?	Yes	Yes
Automatic Shut Off?	Yes	Yes
User Override Control?	Yes	Yes
Indicator Display Status
On/Off Display Status?	Yes	Yes
Low Battery?	Yes	Yes
Voltage/Current Level?	Yes	Yes
Timer Range (minutes)	0-30 minutes	None
Compliance with Voluntary Standards?	IEC60601-1	IEC 60601-1
Compliance with 21 CFR 989?	Yes	Yes
Weight (lbs., oz.)	9.5 ounces	10 lbs
Dimensions (in.) [WxHxD]	3x5x0.7	5.5x15.3x11.3
Housing Materials and Construction	Anodized aluminum 6061	Thermoplastic
Waveform (e.g., pulsed monophasic, biphasic)	Biphasic	Biphasic
Shape (e.g., rectangular, spike, rectified sinusoidal)	Rectangular	Rectangular
Maximum Output Voltage (volts) (+/-5%)	±0.400 @500Ω±1.600 @2 k Ω±8.00 @10k Ω	0.347 @500Ω1.242 @2 k Ω5.780 @10k Ω
Maximum Output Current (mA) (+/-5%)	±0.800 @500 Ω±0.800 @2 k Ω±0.800 @10k Ω	0.647 @500 Ω0.625 @2 k Ω0.584 @10k Ω
Duration of primary (depolarizing) phase (msec)	26.3 – 1200	0.648 – 322
Pulse Duration (msec)	52.6 – 2400	3.24 – 1610
Frequency (Hz) [or Rate (pps)]	0.045 – 2560	0.621 – 308.6
For multiphasic waveforms only:Symmetrical phases?Phases Duration (msec), (state range, if applicable), (both phases, if asymmetrical)	Yes26.3 – 1200	Yes0.324-161
Net Charge (micro coulombs (µC) per pulse) (If zero, state method of achieving zero net charge.)	0µC @500 Ω	0µC @500 Ω
Maximum Phase Charge, (µC)	400 µC positive phase,400 µC positive phase,(50% duty cycle), all loads	190 @500 Ω
Maximum Current Density (mA/cm², r.m.s.)	1.591 @500 Ω (1)	1.486 @500 Ω
Maximum Average Current (average absolute value), mA	0.800 @500 Ω	0.493 @500 Ω
Maximum Average Power Density, (W/cm²), (using smallest electrode conductive surface area)	318E-6 @500Ω (2)0.012 @18.75 KΩ (3)	366E-6 @500 Ω
Burst Mode (i.e., pulse trains)(a) Pulses per burst(b) Bursts per second(c) Burst duration (seconds)(d) Duty Cycle: Line (b) x Line (c)	5 - 2010 - 400.00195 - 0.00780.0195 – 0.1719 (4)	N/AN/AN/AN/A
ON Time (seconds)	Constant	10-30
OFF Time (seconds)	None	1-6
Additional Features (specify if applicable)	None	None

The following table provides a Substantial Equivalence Comparison of TAMA BEMS with Beautiful Image Model 900 Facial Toning Device (K130065):

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VIII. CONCLUSIONS

Based on a comparison of indications for use, technological characteristics and performance data; it can be concluded that the TAMA BEMS Device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).