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The model 4400 series of TENS and Microcurrent devices are indicated 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.

The Promax® family of non-invasive nerve stimulation therapy devices are userinteractive microprocessor controlled stimulators, designed for end-user comfort, ease of use, and to assist with therapy compliance. The Promax device has combined two modalities of electrical stimulation: (TENS and Microcurrent) used in a number of legally marketed predicate devices into one device. The Promax family of devices provide low frequency, non-invasive electrical stimulating therapy used for the symptomatic relief of chronic, intractable pain and the management of pain associated with post-traumatic or post-operative conditions. Although only one modality can be operated at a time the Promax with its six available preprogrammed TENS modes and three Microcurrent modes provide a plethora of options, so the patients unique therapeutic requirements can easily be selected. The following ten preprogrammed modes are available within the Promax family: Normal, Strength Duration (SD), SMP, Burst, Rate Modulated, Width Modulated, Multi-modulated, Positive-DC Microcurrent, Biphasic Microcurrent, and Negative-DC Microcurrent.

Each mode is made of a different pattern of electrical impulses and intensity settings. The SD mode delivers the unique pattern of electrical impulses with maximum intensity of 11microColumbs. The SMP mode delivers its pattern of electrical impulses at the highest intensity level (24 microColumbs) the Promax delivers. The intensity variety is another therapeutic option directed to meet the prescribed patients therapy requirements.

Additional to the therapeutic option menu, the Promax devices provide a variety of features such as; last therapy recall, low battery notification, patient usage timers, open channel notification, as well as a self-diagnostic feature. The self-diagnostic feature is credited with notifying the user if the device requires maintenance prior to use. The many functions and features available with the Promax device-family are attributed to the size of the microprocessor. Many of these features available with the Promax are not available on other devices where the microprocessors size limitation or electrical mechanical controls are a factor. The microprocessor performance and unique operating software in the Promax provides for the pull-tables and algorithms that generate the waveforms, pulses, and duration/ time curves that are not available on other devices. One such feature is the last therapy recall protocol. This software driven feature allows the patient to resume therapy with little effort, following shut down or an open lead occurrence, (a result of poor continuity) with the same therapeutic settings. Another software driven feature is the Strength Duration Compensation protocol. This protocol starts out at zero amplitude or no stimulation to prevent patient-startling, and in a short time span based upon the Power Curve algorithm works the patient to the therapy settings without the patients experiencing uncomfortable sensations. This protocol is not available when the Promax is in the SMP mode.

Different models of the Promax family provide different therapeutic modes to support more specifically the therapist with the modes and modalities needed to implement the prescribed clinical-protocol. Only the Promax XP-4400 model will have all 10 modes serving both the TENS and Microcurrent therapy menu. The Promax TN-4410 will have the TENS modes, while the Promax MC-4440 presents the Microcurrent modes. The Promax-Libra model LBR-4420 is the basic TENS model with a Constant and Burst mode.

Here's an analysis of the provided text regarding the Promax Family of TENS devices, focusing on acceptance criteria and study information:

Based on the provided document, there is no specific study described that establishes explicit acceptance criteria for the Promax Family of TENS devices in terms of clinical performance metrics (e.g., pain reduction percentages, patient satisfaction scores, or objective physiological changes).

Instead, the submission for the Promax Family of TENS primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. This is a common pathway for 510(k) submissions where a new device is shown to be as safe and effective as devices already on the market without requiring new clinical trials that establish novel performance criteria.

Therefore, the "acceptance criteria" for this device, as presented in the document, are implicitly met by demonstrating that its technological characteristics and indications for use are comparable to those of the predicate devices, and that it meets relevant electrical safety and performance standards.

Here's a breakdown of the requested information based on the provided text, recognizing the absence of a dedicated performance study with explicit acceptance criteria:

Acceptance Criteria and Study Information for Promax Family of TENS

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable. The document does not describe a specific clinical "test set" or performance study with a defined sample size for the Promax devices. The substantial equivalence argument relies on the established safety and effectiveness of the predicate devices.
• Data Provenance: Not applicable. No new clinical data from a test set is presented.

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

• Number of Experts: Not applicable. There is no described test set requiring expert-established ground truth.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no described test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. The document does not describe an MRMC comparative effectiveness study where human readers (or users in this context) would be evaluated with or without AI assistance. This device is a TENS/Microcurrent stimulator, not an AI-assisted diagnostic tool.
• Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was performed.

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

• Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. The "standalone" performance here refers to the device's electrical output and adherence to safety standards, which is addressed by compliance with EN-60601 and CFR 898 (as noted in the table above). The device's modes and features are described, indicating its functional capabilities without human intervention beyond initial setup.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (clinical efficacy and safety data for those devices, and regulatory compliance of those devices). The Promax devices are being cleared based on their similarity to these established devices. The "ground truth" for the device's own characteristics is its adherence to technical specifications and relevant electrical standards.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a hardware/firmware medical device, not a machine learning or AI model that requires a "training set" in the conventional sense.

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

• Ground Truth Establishment: Not applicable, as there is no training set for an AI/ML model.

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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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The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.

The Ortho De is a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation that will operate in both modes simultaneously or independently. This system is a prescription device intended for use on patients who are undergoing rehabilitation for medical diseases and conditions on the order of a licensed practitioner.

The Ortho Dx Neuromuscular Stimulator, Model 6700S, received a 510(k) clearance based on substantial equivalence to existing predicate devices rather than a study against a pre-defined acceptance criteria.

The submission focuses on verifying that the technical performance of the device matches or is identical to the operating parameters of the predicate devices. It does not present a clinical study with acceptance criteria for device performance in treating medical conditions.

Here's a breakdown of the information based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes engineering verification testing focusing on the device's technical specifications, not a test set for clinical performance. Therefore, there is no "sample size" in the context of patient data. The testing involved measurements of the device's output parameters. The data provenance is internal engineering testing conducted at room temperature (72°C) and 50% relative humidity using a calibrated 5V power supply and calibrated measurement equipment. This is a form of prospective testing, as it's performed on the manufactured device.

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

Not applicable. The ground truth for the engineering tests was established by comparison to the technical specifications of the predicate devices and the operator's manual. There were no human experts involved in establishing a "ground truth" for clinical performance, as this was not a clinical study.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication. The verification of technical parameters was based on direct measurement and comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission is for a medical device (neuromuscular stimulator), not an AI-assisted diagnostic or imaging device where such studies are common. The clearance is based on technological equivalence, not clinical superiority or human reader improvement.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone performance study in the context of an algorithm or AI was not performed. This device is a physical medical stimulator, not software with an algorithm. The "standalone" performance verification relates to its electrical output parameters.

7. Type of Ground Truth Used

The "ground truth" for the engineering verification was essentially:

• Predicate Device Specifications: The technical parameters (waveform, amplitude, pulse width, etc.) of the previously cleared predicate devices (Mentor Neuromuscular II, GV II, and TRI-STIM).
• Operator's Manual Technical Requirements: The device's own specified operating parameters.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable, as there is no training set.

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