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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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The Innovative Neurotronics WalkAide External Functional 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 patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/ retardation of disuse atrophy, increased local blood flow, muscle re-education, 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.

The provided text describes a 510(k) summary for the Innovative Neurotronics, Inc. WalkAide System, which is an external functional neuromuscular stimulator. The summary focuses on demonstrating substantial equivalence to predicate devices, particularly regarding changes in output specifications (voltage, pulse width, and addition of ramp modulation).

Here's an analysis of the acceptance criteria and the "study" (which in this context refers to the technical comparison and testing described for regulatory approval):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable manner as "acceptance criteria" for a study in the typical sense of clinical trials. Instead, the document frames "acceptance" as meeting applicable safety and performance standards (like IEC 60601-2-10) and being substantially equivalent to predicate devices. The "reported device performance" refers to the technical specifications and measured values of the proposed WalkAide (K123972) and a comparison to its predicate (K052329) and other competitive devices (Bioness L300 Plus, Odstock Pace).

Below is a table summarizing key electrical output criteria and the proposed device's performance, as derived from the "Predicate Comparison Table" and the "Discussion of Table 6.1 equivalent parameters" section.

2. Sample Size Used for the Test Set and the Data Provenance

This document describes a premarket notification (510(k)) based on substantial equivalence, not a clinical trial with a "test set" in the traditional sense of patient data. The "test set" here refers to the extensive technical testing and benchmarking performed to assess the electrical and functional characteristics of the device against established standards and predicate device specifications.

• Sample Size for Test Set: The document does not specify a "sample size" of patients or data points for a clinical test set. The evaluation is based on technical specifications, direct measurements, and comparisons of the device's electrical output to standards and predicate devices. For example, voltage and current measurements are taken on the device itself under specified load conditions.
• Data Provenance: The data primarily comes from bench testing and technical performance evaluations of the WalkAide (K123972) and its predicate (K052329). The comparative data for Bioness L300 Plus and Odstock Pace is extracted from their respective 510(k) summaries or available specifications. This is not patient-derived data (retrospective or prospective) in the context of clinical outcomes. The document repeatedly refers to "V012 'WalkAide Performance Test Protocol'" as the method used to validate the device's adherence to applicable requirements of IEC 60601-2-10.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

In this 510(k) context, "ground truth" for the test set is established by the applicable international and national consensus standards (e.g., IEC 60601 series, ANSI/AAMI NS4-1985) and the specifications of legally marketed predicate devices.

• Number of Experts: Not applicable in the sense of a panel of clinical experts defining ground truth for patient outcomes. The "experts" are the engineers, regulatory specialists, and standards committees who developed and codified the safety and performance standards.
• Qualifications of Experts: The experts who establish these standards typically include biomedical engineers, physicians, regulatory scientists, and other specialists with deep knowledge of medical device safety and efficacy, functional electrical stimulation, and relevant biophysical principles. The document itself does not specify the qualifications of individuals involved in the actual testing or in its submission from Innovative Neurotronics, Inc., beyond identifying a "Director of Quality and Regulatory."

4. Adjudication Method for the Test Set

Not applicable in the sense of clinical adjudication. The "adjudication" is essentially the regulatory approval process by the FDA, which reviews the submitted data and arguments for substantial equivalence against its own internal expertise and guidance. The technical validation is done by demonstrating compliance with established standards and direct comparative analysis against predicate device specifications, without an external adjudication panel for the technical results.

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

• No MRMC study was done, nor is it applicable. This device is an external functional neuromuscular stimulator, not an imaging or diagnostic AI device that involves "human readers" or "AI assistance" in interpretation. The product directly provides therapeutic stimulation.

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

• Not directly applicable as an "algorithm only" study. The device itself is designed to function largely automatically based on configurable parameters set by a clinician and using integrated sensors (tilt or foot sensor). The performance described in the document is the standalone device performance (electrical output, safety parameters) rather than an isolated algorithm. The "human-in-the-loop" aspect exists during the initial setup by a clinician and ongoing patient use, but the core performance data presented is about the device's physical output characteristics.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is primarily:

• Established safety and performance standards: Such as IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2, ANSI/AAMI NS4-1985, and FDA guidance documents (e.g., "Guidance Document for Powered Muscle Stimulator 510(k)s").
• Specifications and demonstrated performance of legally marketed predicate devices: The historical data and approved specifications of the parent WalkAide (K052329), Bioness L300 Plus (K103343), and Odstock Pace (K102115) form the comparative basis for "ground truth" for substantial equivalence.

This is a regulatory "ground truth" for device approval, not a clinical "ground truth" based on pathology or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. This document describes a 510(k) submission for a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data. No training set was used.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as no training set was used.

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The Innovative Neurotronics 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 electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the patient's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle re-education, 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.

The provided 510(k) summary for the Innovative Neurotronics, Inc. WalkAide System does not contain the detailed information requested regarding specific acceptance criteria, a study proving performance against those criteria, or the ground truth establishment process.

The document states that "Applicable performance and safety testing was performed to verify technological and functional characteristics including any design modification," and that "Any design modifications do not raise any safety or effectiveness issues." However, it does not elaborate on what these performance and safety tests entailed, the acceptance criteria used, or the results of such tests.

Therefore, I cannot populate the table or answer most of the specific questions. Based on the provided text, here is what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

Here are the answers to the specific questions, based on the provided text:

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

   • As shown in the table above, the document does not specify quantitative acceptance criteria or detailed reported device performance. It only states that the device is "substantially equivalent" to predicate devices and that "applicable performance and safety testing was performed."

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

   • This information is not provided in the 510(k) summary.

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)

   • This information is not provided in the 510(k) summary.

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

   • This information is not provided in the 510(k) summary.

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

   • This is not applicable as the WalkAide is an FES device, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

   • This is not applicable in the context of an FES device. The device itself is the "algorithm" delivering stimulation, but the performance is measured on the patient's gait, not against a diagnostic benchmark. The document does not describe standalone performance testing beyond the general statement of "technological and functional characteristics."

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

   • The document does not specify the type of ground truth. Given the nature of an FES device, "ground truth" would likely relate to objective measures of gait improvement or physiological effects, but this is not detailed.

8. The sample size for the training set

   • This information is not provided in the 510(k) summary. The WalkAide is a medical device, not a machine learning algorithm that typically requires a "training set" in the computational sense. The "training" for such a device would refer to clinical use and patient adaptation.

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

   • This information is not provided. As noted above, the concept of a "training set" and "ground truth for training" in the machine learning context does not directly apply here without further explanation within the document.

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