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The iRelieve Microcurrent Pain Relief System is intended to be used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain.

The iRelieve Microcurrent Pain Relief System is a microcurrent TENS device that operates by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The iRelieve Microcurrent Pain Relief System is a single channel device that produces microampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 3.0 volts. It is controlled by analogue electrical parts (voltage regulator, frequency oscillator, multiple resistors, etc.) and a digital microprocessor chip that contains embedded programmed software (firmware) that generates a sequence of current flows and frequencies during the course of a single treatment session. The iRelieve Microcurrent Pain Relief System performs this sequence of current flows without user manipulation or device controls other than switching the device on after application of the device to the electrodes.

The provided text is a 510(k) Summary for the iRelieve Microcurrent Pain Relief System. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to clinical performance or efficacy.

Instead, the performance testing for the iRelieve Microcurrent Pain Relief System focuses on:

• Output Performance: Micro Current Stimulator Measurements, Validation of Electrodes, Output sequence with Oscilloscope captures.
• Device Integrity/Safety: Shelf-life testing, Packaging testing (ASTM D4169-16), Battery use life testing, Biocompatibility testing (leveraged from predicate), Electromagnetic compatibility (EMC) and electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 standards).
• Software Validation: Software verification and validation per FDA guidance for Class B level of concern (IEC 62304).

The document explicitly states that the determination of substantial equivalence is based on the device having the "same intended use and similar technical characteristics, performance and applications" as the predicate device (Model 7500 Microcurrent TENS Device, Version MCT-F50, K013167), and that it "does not pose any new question of safety or effectiveness."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets clinical acceptance criteria because this information is not present in the provided document. The document details technical performance and safety testing to demonstrate substantial equivalence to a predicate device, not a new clinical efficacy study with acceptance criteria.

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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:

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The Innovative Neurotronics WalkAide External Neuromuscular Stimulator (WalkAide System) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide System electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the gait in patients with chronic stroke. Medical benefits of Functional Electrical Stimulation (FES) may include prevention of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.

The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit. The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.

Here's an analysis of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document describes the WalkAide System and primarily focuses on extending its "Indications for Use" to specifically include chronic stroke patients for improved gait. Given that the device itself (hardware and software) is stated to be "identical to the predicate K123972" except for this indication, the acceptance criteria here are implicitly tied to demonstrating the device's effectiveness and safety for this expanded indication compared to a standard treatment.

The document doesn't present a specific table of quantitative acceptance criteria from the FDA for a new device, but rather a Comparison Conclusion Table (on pages 16-17) that highlights the identity of the current device to its predicate (K123972) in terms of technical specifications. The key acceptance is based on the clinical study supporting the new indication.

Implicit Acceptance Criteria (for the new indication) and Reported Device Performance:

Study Information:

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

   • Sample Size: The exact sample size is not explicitly stated in the provided document. It only mentions "a randomized trial utilized an unblinded, parallel group design."
   • Data Provenance: The document does not specify the country of origin. The study was a "randomized trial," which suggests it was prospective. Data analysis used "an intention to treat analysis with missing data points calculated using multiple imputations."

2. 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)

   • This information is not provided in the document. The study compared the device (WA) to an Ankle-Foot Orthosis (AFO) and measured "gait velocity, SIS composite score and safety." These seem to be objective and standardized outcome measures, rather than requiring subjective expert ground truth establishment for the test set.

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

   • This information is not provided in the document. Given the outcome measures (gait velocity, SIS score, safety), it's unlikely that an adjudication method for image interpretation or diagnosis was required.

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

   • No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This was a clinical trial comparing a medical device (WalkAide) against a conventional treatment (AFO) in patients. The document does not mention human readers or AI assistance in the context of interpretation.

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

   • No. The WalkAide System is a functional electrical stimulator used by patients with setup and monitoring by a clinician. It is a human-in-the-loop device. The study itself was a clinical trial assessing patient outcomes with the device.

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

   • The "ground truth" for evaluating the device's effectiveness was based on clinical outcomes data, specifically:
     • Gait velocity
     • SIS composite score (Stroke Impact Scale or similar, implying a functional assessment)
     • Safety data

7. The sample size for the training set

   • This information is not applicable and therefore not provided. The WalkAide system is a hardware device (functional electrical stimulator) with accompanying software for configuration and analysis. It is not an AI/ML algorithm that is trained on a dataset in the typical sense. The study was a clinical trial to demonstrate effectiveness for an indication, not to train or validate an algorithm.

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

   • This information is not applicable for the reasons stated above. The device doesn't have a "training set" in the context of artificial intelligence. Its functionality is based on established principles of electrical stimulation and biomechanics. Its performance is validated through clinical trials.

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