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The Neurotech Plus device is indicated for the following:

In combination Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS) modes, models 431, 432, 433, 434, 436, 439 & 440:

NMES Indications:
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery

TENS Indications:
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain
Adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee (models 431, 432 and 433 only)

In Neuromuscular Electrical Stimulation (NMES) only mode, models 437 & 441:

NMES Indications:
Maintain or increase the range of motion
Prevention or retardation of disuse atrophy
Re-educate muscles
Relax muscle spasms
Increase local blood circulation
Prevention of venous thrombosis of the calf muscles immediately after surgery

In Transcutaneous Electrical Nerve Stimulation (TENS) only mode, model 438:

TENS Indications:
Symptomatic relief and management of chronic, intractable pain
Relief of pain associated with arthritis
Adjunctive treatment in the management of post-surgical and post-trauma pain

The Neurotech Plus is a portable, two-channel; battery operated system which can provide both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). The device is intended be available by prescription only. Included with the Neurotech Plus control unit, are a lead wire assembly, electrodes and instructions for use.

The Neurotech Plus contains ten program sets which have been each allocated an individual type number. Seven of these types offer a combination of NMES and TENS programs. There are two types which offer only NMES programs and one which has only TENS programs.

The lead-wire assembly contains the ID chip (EEPROM) that identifies the required program set. Each of the program set options are pre-programmed during manufacturing and no access to the configuration is available to either the end user or clinician. When each lead wire is connected to the unit and the outputs (A, B, C or D) to the electrodes, the two channels may be operated independently through the unit. Detailed diagrams for correct device usage and placement of the electrodes are available as part of the instructions for use.

This is a 510(k) premarket notification for a medical device (Neurotech Plus, Type 413) and, as such, it does not describe an acceptance criteria study in the way one might for an AI/ML device or software performance. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria and results.

However, I can extract information related to the device's characteristics and the comparison made to establish substantial equivalence, which is a form of meeting "acceptance criteria" in the context of a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" is not explicitly stated as performance metrics like sensitivity/specificity for a diagnostic AI. Instead, substantial equivalence is established by demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially the detailed technical specifications of the Neurotech Plus and how they compare to the predicate devices.

The tables (7.1 through 7.10) in the document provide a detailed comparison of the Neurotech Plus models with their respective predicate devices across various electrical stimulation parameters. These comparisons serve as the basis for demonstrating that the new device performs "as well as or better than" the listed predicate.

Below is an example of an abstracted table, as the original tables (7.1-7.10) are extensive and detailed for each model. I will use the information from Table 7.1 for Model 431 as an example comparison, highlighting how the new device's parameters compare to the predicate devices.

Abstracted Comparison Table (Example for Neurotech Plus Model 431 vs. Predicates)

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

The document explicitly states: "No new clinical tests have been submitted as part of this premarket notification." Therefore, there is no "test set" in the context of patient data, nor is there information on sample size or data provenance from a prospective or retrospective study. The primary "test" for this submission is a comparison of engineering specifications against predicate devices.

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

Since no new clinical tests were conducted and no patient-specific "test set" was used, there were no experts involved in establishing a "ground truth" for such a test set. The "ground truth" for a 510(k) is implicitly the established safety and effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. This is a 510(k) for a TENS/NMES device, not an AI/ML diagnostic or treatment assistance software. No MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a hardware medical device (Neurotech Plus, Type 413), not a standalone algorithm.

7. The Type of Ground Truth Used

In the context of a 510(k), the "ground truth" for demonstrating safety and effectiveness relies on the previously established regulatory clearance of the predicate devices. The technological characteristics and intended use of the Neurotech Plus were compared to these already approved devices. The ground truth is effectively the regulatory precedent set by the predicate devices.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and therefore does not involve a training set.

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

Not applicable, as there is no training set for this type of device submission.

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