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To be used for temporary relief of pain associated with sore and aching muscles in the back due to strain from exercise or normal household and work activities and relief of pain of the upper and lower back associated with arthritis.

The second-generation WiTouch Pro (a.k.a. WiTouch/Neubac) device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.

The device accessories are the replaceable Gel Pads, the Mobile App, and the optional wireless handheld remote control. The Gel Pads serve to gently adhere the TENS unit to a user's skin on the lower back, and serves to dissipate electrical stimulation across the surface area of the electrode. The Gel Pads are intended for single person use with the number of uses dependent upon skin type, oils, and pH levels.

The TENS unit adheres to the user's lower back across the spine in the area where pain is perceived. Once placed, a user can choose from four 30-minute preprogrammed stimulation output modes, and the level of intensity that is most comfortable. The preprogrammed modes are identified as WiTouch Pro Exclusive, High Frequency, Low Frequency, and High-Low Combo.

Accessories:

• Pairs of replaceable hydrogel pads (Gel Pads) ●
• Mobile Medical Application control using a smartphone via Bluetooth® ● connection (Apple® iOS® or Android® platforms)
• Handheld wireless Remote Control.

Here's an analysis of the provided text regarding the acceptance criteria and study for the WiTouch Pro, WiTouch, Neubac device:

It's important to note that the provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. For such devices, acceptance criteria and studies typically focus on electrical safety, electromagnetic compatibility, biocompatibility, and functional performance, rather than clinical efficacy studies in the same way an AI-powered diagnostic device would require.

The document does not describe an AI/ML-powered device. It's a TENS device, and the "study" mentioned is conformity to recognized standards and non-clinical performance testing against a predicate device. Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable here.

Acceptance Criteria and Device Performance (Not Applicable for AI/ML performance, but for device characteristics and safety standards)

• Number of Output Channels: 1
• Regulated Current or Regulated Voltage?: Voltage
• Waveform: Asymmetrical biphasic (0 net DC charge)
• Amplitude: 0 – 80mA (Measured @ 500 ohm load)
• Pulse Width: 120 - 250μs (Preprogrammed)
• Pulse Rate: 2 - 120 Hz |
  | Safety Features | - Low battery indicator: Yes
• Automatic Shut Off?: Yes
• User Override Control?: Yes (Off button immediately stops treatment) |
  | Physical and Operational Characteristics | - Power Source(s): (2) "AAA" Alkaline Batteries (TENS Unit), (1) "CR 2032" Lithium-ion coin battery (Remote Control)
• Software/Firmware/Microprocessor Control?: Yes
• Indicator Display: On/Off Status (Yes), Low Battery (Yes), Voltage/Current Level (No)
• Timer Range: Nonadjustable (30 minutes)
• Weight: 4.8 oz. w/ batteries included
• Dimensions: 7.5 (w) x 3.5 (h) x 0.7 in (d) |
  | Compliance with Recognized Standards | • FDA Recognition Number 13-79: IEC 62304 Edition 1.1 2015-06
  • FDA Recognition Number 19-4: ANSI/AAMI ES60601-1:2005 Ed. 3 + C1:2009 + A1:2012
  • FDA Recognition Number 19-16/19-7: ANSI/AAMI HA60601-1-11:2015/2011
  • FDA Recognition 19-8. IEC 60601-1-2:2014 Ed. 4
  • FDA Recognition Number 19-14: IEC 60601-1-11 Edition 2.0 2015-01
  • FDA Recognition Number 17-11: IEC 60601-2-10 Edition 2.0 2012-06
  • FDA Recognition Number 5-40: ISO 14971 Second edition 2007-03-01 |

Detailed Analysis for AI-Specific Questions (Not Applicable as per the document):

Given that this is a 510(k) for a TENS device and not an AI/ML-powered device, the following points are largely not applicable based on the provided text. The "study" here refers to non-clinical testing and conformity to engineering and safety standards, demonstrating substantial equivalence to a predicate device.

1. Sample size used for the test set and the data provenance:

   • Not Applicable. The document describes non-clinical testing for substantial equivalence to a predicate TENS device, not a diagnostic AI test. No "test set" in the context of an AI algorithm's performance is mentioned. The device's performance characteristics (e.g., amplitude, pulse width, pulse rate) are tested against engineering specifications and compared to the predicate device.

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

   • Not Applicable. This is not an AI diagnostic device requiring expert-established ground truth.

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

   • Not Applicable. No ground truth adjudication process for AI performance is described.

4. 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 a direct-to-patient TENS unit, not an AI assistance tool for human readers/clinicians, so no MRMC study or AI assistance effect size is relevant or described.

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

   • Not Applicable. The device is a standalone TENS unit, but not a standalone AI algorithm. Its performance is evaluated through non-clinical metrics (e.g., electrical output, adherence to safety standards).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. For this TENS device, "ground truth" would relate to its physical and electrical properties meeting specifications and safety standards, rather than a clinical diagnostic truth. The "truth" is whether it functions as designed and is safe.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set.

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

   • Not Applicable. No training set or ground truth establishment for AI is mentioned.

Summary of the Device Evaluation per the Document:

The evaluation for the WiTouch Pro, WiTouch, Neubac device focused on demonstrating substantial equivalence to its predicate device (the first-generation WiTouch Pro K120398). This was achieved through:

• Non-Clinical Testing: Verification, validation, and performance data of the second-generation device.
• Conformity with Recognized Standards: Various IEC and ANSI/AAMI standards related to electrical safety, medical device software, and biocompatibility (though biocompatibility testing itself is not detailed, it's typically covered by standards compliance).
• Comparison of Characteristics: A detailed table comparing the subject device's features (e.g., indications for use, power source, output parameters, safety features) to those of the predicate device. The document explicitly states, "The differences between the predicate device and the subject device do not raise new questions about safety or effectiveness."

The document concludes that "Clinical testing was not required to support substantial equivalence for the second-generation WiTouch Pro TENS device" because the intended use is well-established, and hardware/software verification demonstrates comparable performance to the predicate.

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