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actiTENS is intended to be used as:

• Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
• Relief of pain associated with arthritis
  Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode.
• Electrical Muscle Stimulation (EMS), used for the following indications:
• Temporary relaxation of muscle spasms
• Prevent or retard disuse atrophy
• Increase of local blood flow in the treatment area
• Re-educate muscles
• Maintain or increase the range of motion
• Prevention of venous thrombosis of the calf muscles immediately after surgery
  Program P9 corresponds to EMS mode.

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people ages 22 and older.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its nonremovable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app for iPhone which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.

The provided text describes the acceptance criteria and performance data for the actiTENS device, primarily focusing on its substantial equivalence to a predicate device (JKH Stimulator Plus - K182203).

Here's the breakdown of the information requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria" in the format of a requirement with a corresponding "reported device performance" that unequivocally meets that criterion for clinical efficacy or specific diagnostic accuracy. Instead, it demonstrates substantial equivalence to a predicate device by comparing technological characteristics and performance metrics. The underlying acceptance criterion for this 510(k) submission is that the device is "as safe and effective as the predicate device."

The comparison table (Table 1: Comparison of actiTENS with JKH Stimulator Plus (K182203) and Table 2: Comparison of actiTENS with JKH Stimulator Plus (K182203) with regards to TENS and EMS performance) serves as the primary evidence. Here's a summary derived from those tables and surrounding text:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Human Clinical Performance Testing: Clinical testing was not required to demonstrate the safety and effectiveness of the device." Therefore, there is no test set of clinical data from human subjects in the traditional sense for evaluating device performance. The performance data presented are primarily from benchtop testing and comparisons to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical human performance testing was conducted that would require expert-established ground truth.

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

Not applicable, as no clinical human performance testing was conducted that would require adjudication.

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. The device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS), not an AI-assisted diagnostic or imaging device that would involve human readers or MRMC studies.

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

This concept is not directly applicable to a TENS/EMS device. The "standalone" performance is assessed through the electrical safety, EMC, software, and benchtop performance testing, which evaluate the device's technical specifications.

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

For the safety and performance evaluation, the "ground truth" is established through:

• Engineering specifications and standards: IEC 60601-1 series, IEC 62304, ASTM D4169-16, UL 1642, IEC 62366-1, IEC 62133-2.
• Comparison to a legally marketed predicate device: The characteristics and demonstrated safety/effectiveness of the JKH Stimulator Plus (K182203) serve as a benchmark.
• Manufacturer's data: For components like battery shelf-life.

8. The sample size for the training set

Not applicable, as this device does not utilize a "training set" for an algorithm in the way AI/Machine Learning models do.

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

Not applicable.

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