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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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Interferential stimulation can be used for the following applications:

• Relieve acute pain .
• . Relieve and manage chronic pain
• Relax muscle spasms .
• Maintain and increase the range of motion .
• Increase local blood circulation .

Neuromuscular stimulation can be used for the following applications:

• Relax muscle spasms .
• Prevent or retard disuse atrophy .
• Increase local blood circulation .
• Re-educate muscles .
• Maintain or increase the range of motion .
• Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles

Pulsed direct current stimulation can be used for the following applications:

• Reduction of edema (under negative electrode) t
• Reduction of muscle spasm .
• Influencing local blood circulation (under negative electrode) .
• Retardation or prevention of disuse atrophy .
• Facilitation of voluntary motor function .
• Maintenance or increase of range of motion .

Interferential and Neuromuscular combination stimulation can be used for the following applications:

• Reduction of edema (under negative electrode) .
• Reduction of muscle spasm .

The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES).

The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly.

Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.

This K510(k) submission describes the IF 3Wave Interferential Muscle Stimulator System, Model 7110S. The submission focuses on establishing substantial equivalence to previously cleared predicate devices rather than reporting on a new clinical study with acceptance criteria.

Therefore, many of the requested sections related to acceptance criteria and study data are not applicable to this 510(k) submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary demonstrating substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined thresholds for clinical or diagnostic performance metrics. Instead, the device's technical characteristics are compared to those of its predicate devices to demonstrate equivalence. The "reported device performance" is essentially the listed technical specifications of the IF 3Wave.

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