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Indications for 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.

Indications for TENS device:

• Symptomatic relief of chronic (long term) intractable pain
• Symptomatic relief of post-traumatic acute pain and post surgical pain

The device NEURODYN PORTABLE TENS/FES is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC converter, with independent controls, Liquid Crystal Display. with 4 ½ digits, mechanical contact keyboard and ABS cabinet.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation)
The equipment must be used only under the prescription and supervision of a licensed health professional.

The device NEURODYN PORTABLE TENS is a two output channel stimulator, operated in power supply 100 to 240 V 50-60 Hz AC/9V DC, with independent controls, Liquid Crystal Display with 4 ½ digits, mechanical contact keyboard and ABS cabinet.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation)
The equipment must be used only under the prescription and supervision of a licensed health professional.

The provided text describes a 510(k) premarket notification for the Neurodyn Portable TENS/FES and Neurodyn Portable TENS devices. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving independent effectiveness through a de novo study with specific performance acceptance criteria.

Therefore, the document does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically seen for novel devices. Instead, it relies on demonstrating that the new devices are as safe and effective as existing legally marketed devices.

However, based on the information provided, we can infer the "acceptance criteria" were related to achieving substantial equivalence to the predicate devices and complying with relevant safety standards. The "study" proving this was a non-clinical assessment and IEC testing.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly that the new devices perform as safely and effectively as the predicate devices, and comply with relevant safety standards. The "reported device performance" section illustrates this equivalence.

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

This document describes a 510(k) submission based on non-clinical testing and comparison to predicate devices, not a clinical trial with a "test set" of patients in the typical sense.

• Sample Size for Test Set: Not applicable in the context of a clinical test set. The validation was based on comprehensive engineering and safety testing.
• Data Provenance: The data provenance for the non-clinical testing would be from the manufacturer's (Ibramed, Brazil) own testing facilities or accredited third-party laboratories. The document indicates the submission country as Brazil. The data is based on the technical specifications and test results of the manufactured devices.

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

Not applicable. The "ground truth" here is compliance with established electrical safety standards (IEC 60601 series) and demonstrating that the device's technical specifications and intended use are substantially equivalent to legally marketed predicate devices. This typically involves engineers and regulatory specialists evaluating test reports and device specifications against standards and predicate device information, not clinical experts establishing a ground truth for a diagnostic or therapeutic outcome.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication by multiple readers or experts in a clinical sense. The evaluation was a technical and regulatory review overseen by the FDA.

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 a medical device for electrical stimulation (TENS/FES), not an AI-powered diagnostic or assistive tool for human readers/clinicians, and no MRMC study was conducted or mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. These are physical hardware devices that apply electrical stimulation directly. There is no "algorithm" in the sense of AI or image processing being evaluated for standalone performance. The device itself operates in a standalone manner as a medical device, but this question typically refers to computational algorithms.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is primarily:

• Compliance with IEC 60601 series standards: Demonstrated through engineering test reports for electrical safety, electromagnetic compatibility, and basic performance.
• Technical Specifications: Verification that the device's electrical output parameters (current, frequency, phase duration), physical dimensions, and safety features align with the stated design and are within acceptable ranges for the intended use and comparable to predicate devices.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for these types of electrical stimulation devices in a 510(k) submission unless it was an adaptive algorithm, which is not the case here.

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

Not applicable. There was no training set established.

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