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TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.

Transcutaneous Electrical Nerve Stimulation (TENS) has been used successfully for many years in the symptomatic relief and management of chronic, intractable pain. The model 4900 series of Transcutaneous Electrical Nerve Stimulation (TENS) devices are user-interactive, microcontrolled-stimulators designed to provide lowfrequency, non-invasive electrical stimulating therapy to patients for the management of chronic, intractable pain. The model 4900 series design meets the latest electromedical standards and safety requirements, including the Performance Standard for Electrode Lead Wires and Patient Cables. The devices are microprocessor controlled and contain six preprogrammed therapy modes. The TENS devices (model 4900 series) firmware memory functions include: a nonvolatile read-only memory (ROM), last therapy recall, low battery notification and a self-check feature, which notifies the operator when a service condition exists. The ROM is designed to provide the therapy-mode accessibility, while providing the safety features, such as, zero amplitude at "startup" or when an "open channel condition is identified. The 4900 series of TENS devices are "user friendly" with a user interactive, softkey pad and a clearly visible, two-line, sixteen character, liquid crystal display (LCD) to show the operating parameters. The Model 4900S TENS device(s) are portable, personnel and designed to be easily handled with its light weight, trim (0.875" wide by 2.5" by 3.5") rectangular shaped, durable plastic shell. The device is fitted with a belt clip and can easily be worn without inhibiting the mobility of the patient. The device operates efficiently with a 9-volt battery power supply. The device delivers an output of 25 mAmp for 55 hours under a 500K Ohm load. The efficient power allocation (between the operation of the device and the electrical stimulation delivered to the patient) results from the interaction of a microcontroller; microprocessor; a crystal-controlled oscillator; RAM memory; circuit interface drivers; and a custom ROM. The crystal-controlled oscillator insures accurate timing of all pulse waveforms. The microprocessor-controller, in addition to operating the "house keeping functions", such as the LCD readouts, power on, open channel-control and the power off functions, maintains communications to the custom ROM and the variety of modalities available for the different models. The six available nreprogrammed modalities: Constant mode: SMP mode: Burst Mode: Rate Modulated Mode, Width Modulated Mode, and Multi-Modulated Mode. The physician or physical therapist may choose to use, depending on the specific model of TENS device, any one of six available modalities.

The provided document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria, sample sizes, and expert adjudications.

Therefore, the document does not contain the acceptance criteria or a study design that would typically be described for a new, innovative device proving its performance against pre-defined metrics. Instead, it relies on demonstrating that the new device (4900 Series TENS) is substantially equivalent to existing TENS devices already on the market (predicate devices).

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria & Reported Performance: The document describes the technical specifications and features of the 4900 series TENS devices (e.g., output current, battery life, operating modes, safety features) but does not present these as acceptance criteria for a study or report specific performance numbers against such criteria. The "Performance Standard for Electrode Lead Wires and Patient Cables" is mentioned, indicating compliance with general electromedical and safety standards, not a specific performance study.
• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size/Ground Truth: These elements are characteristic of a clinical investigation or a performance study where a device's efficacy or accuracy is being evaluated against a known truth. The 510(k) submission for this TENS device focuses on features, design, and comparison to predicate devices, not a clinical trial to establish new claims of effectiveness. The claim is for "symptomatic relief and management of chronic intractable pain," which is a well-established indication for TENS devices, generally supported by a body of evidence for the TENS modality itself, rather than requiring a de novo clinical study for each new model.

In summary, the provided 510(k) document is a regulatory submission for market clearance based on substantial equivalence, not a report of a study designed to prove device performance against specific acceptance criteria.

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