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Neurodyn V2.0 Stimulators are intended for:

As a FES device:

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.

As a TENS device:

• Symptomatic relief of chronic (long term) intractable pain

• Symptomatic relief of post-traumatic acute pain and post-surgical pain
  As an Interferential and Premodulated device:

• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

As a Russian device:

• Temporary relaxation of muscle spasms - Prevention of disuse atrophy in post-injury type conditions -Increase local blood circulation - Muscle re-education

• Maintaining or increasing range of motion
  As a Burst Modulated Alternating Current (Aussie) device:

• Temporary relaxation of muscle spasms

• Prevention or retardation of disuse atrophy in post-injury type conditions

• Increase local blood circulation

• Muscle re-education

• Maintaining or increasing range of motion

• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

As a Microcurrent device:

• Symptomatic relief of chronic intractable pain - Symptomatic relief of post-traumatic acute pain

As a DC/Polarized device: -Relaxation of Muscle Spasm

As a High Voltage Pulsed current device:

• Muscle re-education
• Relaxation of Muscle Spasms
• Maintaining or increasing range of motion
• Increasing local blood circulation
• Prevention or retardation of disuse atrophy

Neurodyn Aussie V2.0 Stimulators are intended for:

As a Burst Modulated Alternating Current (Aussie) device:

• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

NEURODYN v2.0 is a transcutaneous neuromuscular stimulator of four channels with independent controls for treatments with: AUSSIE CURRENT (with Medium Frequency Current modulated in Burst), RUSSIAN CURRENT (Medium Frequency Current modulated in Burst), FES CURRENT (Functional Electrical Stimulation),TENS CURRENT(Transcutaneous Electrical Nerve Stimulation), INTERFERENTIAL CURRENT (IFC-T), PREMODULATED INTERFERENTIAL CURRENT (IFC-B) BIPOLAR (Medium Frequency Current modulated in Amplitude), and with two independent control channels for the treatments with: MICROCURRENT (Microcurrent Electrical Neuromuscular Stimulation), DIRECT CURRENT /POLARIZED CURRENT and HIGH VOLTAGE PULSED CURRENT (High Volt Pulsed Current).

NEURODYN AUSSIE V2.0 transcutaneous neuromuscular stimulator is a four-channel stimulator with independent controls for current therapy used in AUSSIE CURRENT (Burst Modulated Medium Frequency).

This FDA 510(k) summary for the Neurodyn V2.0 and Neurodyn Aussie V2.0 powered muscle stimulators focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not directly available or applicable in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance in the context of an effectiveness study. Instead, it provides a comparative table of technological characteristics between the new devices and their predicate devices. The "Performance" line in this table states "Identical" for both the new devices and the primary predicate (Neurodyn Multiwave; Neurodyn Aussie Sport), implying that the performance is considered equivalent due to identical technological characteristics for many modalities.

Key parameters from the "Technological Characteristics Comparison" considered for substantial equivalence, which implicitly act as performance criteria for the new device as compared to the predicates:

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

No clinical test sets or human subject data were used or described in this 510(k) summary for performance evaluation. The substantial equivalence is based on engineering and performance characteristics comparison with predicate devices and compliance with international standards.

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

Not applicable. No ground truth based on expert consensus was established as no clinical test set was utilized for demonstrating effectiveness.

4. Adjudication method for the test set:

Not applicable. No test set requiring adjudication was described.

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. This is not an AI-assisted diagnostic device, and no MRMC study was performed or referenced.

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

Not applicable. This is not an algorithm-only device. Its performance is compared based on physical and electrical characteristics to predicate devices.

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

Not applicable in the context of clinical performance data. The "ground truth" for substantial equivalence is primarily the established performance and safety profiles of the predicate devices and compliance with recognized industry standards.

8. The sample size for the training set:

Not applicable. No machine learning algorithm requiring a training set was mentioned.

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

Not applicable. No machine learning algorithm requiring a training set was mentioned.

Summary of Device Acceptance Approach:

The Neurodyn V2.0 and Neurodyn Aussie V2.0 gained FDA clearance (K210572) through the 510(k) premarket notification pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving independent safety and effectiveness through de novo clinical trials.

The study that "proves" the device meets acceptance criteria, in this context, is primarily a non-clinical engineering and performance characteristic comparison study against legally marketed predicate devices, coupled with compliance to recognized international safety and performance standards:

• Predicate Devices: K131629 (Neurodyn Multiwave; Neurodyn Aussie Sport) and K031077 (Vectra Genesis).
• Methodology: A detailed comparison of the new devices' indications for use and technological characteristics (e.g., number of channels, current types, output ranges, safety features, input voltage, and construction materials) against the predicate devices.
• Performance "Proof": The document explicitly states "Performance: Identical" when comparing key aspects to the predicate devices. Differences in current ranges (e.g., TENS 0 to 120mA (Ipp) vs. Tens 0 to 80 mA for a predicate) are deemed not to interfere with performance because "the intensity does not have fixed parameter, it is according to the sensorial of each patient." This indicates that these parameters are within acceptable safe and effective ranges as evidenced by the predicates.
• Standards Compliance: The devices comply with IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-10 (particular requirements for nerve and muscle stimulators). Non-clinical testing was performed to demonstrate compliance with these standards.

Conclusion from the document: "The Neurodyn V2.0 device and the predicate devices are substantially equivalent when comparing the indications for use, and technological properties. The differences shown in the comparison do not affect the substantial equivalence."

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