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

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.

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:

1. 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)

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. 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.

8. The sample size for the training set: Not applicable. No AI training set is mentioned.

9. How the ground truth for the training set was established: Not applicable.

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