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The Staodyn® Max Preset Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

The Staodyn® Max Preset is a Transcutaneous Electrical Nerve Stimulator (TENS) that transmits small electrical pulses through the skin to the underlying peripheral nerves. It is battery operated using 3-AAA batteries and includes two controllable output channels. It generates and delivers electrical impulses whose duration, rate and modulation can be altered by selection of 24 preset programs. The amplitude of the impulses can be increased or decreased with the use of two intensity toggle buttons, one for each output channel. The device has an on/off button that enables the device to be turned on off. In addition, the on/off button can be used to pause a treatment program during use. The stimulator is housed in a molded portable plastic case with a viewable LCD display, accessible keypad, and accessible battery storage compartment.

Here's an analysis of the provided text regarding the Staodyn® Max Preset TENS Device, focusing on acceptance criteria and study information:

Key Takeaway: The provided document explicitly states that clinical testing was not required to demonstrate substantial equivalence for the Staodyn® Max Preset TENS Device. Therefore, many of the requested elements related to clinical study design and outcomes are not present.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (510(k) for a TENS device) and the explicit statement that clinical testing was not required, there isn't a table of specific clinical acceptance criteria with corresponding device performance metrics in the document. Instead, the "acceptance criteria" are implied by the non-clinical testing and the comparison to an already marketed predicate device.

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

• Sample Size for Test Set: Not applicable. No clinical test set data is reported. The non-clinical testing would have involved engineering samples and lab tests, not a patient test set in the clinical sense.
• Data Provenance: Not applicable for clinical data. The non-clinical testing was performed by the manufacturer/OEMs.

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

• Not applicable. No clinical ground truth was established, as no clinical study was performed or required. The "ground truth" for the device's performance was its ability to meet engineering specifications and demonstrate equivalence to a predicate device through non-clinical means.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set, thus no adjudication method needed.

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 device is a TENS stimulator, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting data. No MRMC study was conducted or relevant.

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

• Not applicable. This device is a medical device for pain relief, not an algorithm. Its performance is inherent to its physical and electrical characteristics.

7. The Type of Ground Truth Used

• Engineering Specifications and Equivalence to Predicate: The "ground truth" for this submission is that the device's electrical and mechanical characteristics meet its design specifications and are substantially equivalent to a legally marketed predicate TENS device. The intended use, function, and performance were compared to the American Imex Premier Plus - K032003.

8. The Sample Size for the Training Set

• Not applicable. As this is not an AI/ML device, there is no "training set" in the computational sense. The device's design is based on established TENS technology and the predicate device.

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

• Not applicable. No training set was used. The device's functionality is based on its hardware design and the established principles of transcutaneous electrical nerve stimulation, which have been validated through decades of use in this product category.

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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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