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Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

TENS Series Electro-Stimulator, which includes models TENS 2800 and TENS 3000, are Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients. These TENS electro-stimulator have the same housing in a molded portable plastic case, an accessible, switch, and accessible battery storage compartment. The case shape is rectangular, The process to set the parameter and attach lead wires to the two models is also the same except the Housing printing artwork, Mode No. TENS 3000 stimulator has three treatment mode: normal mode, burst mode and modulation mode. The treatment mode can by selected by switch. TENS 2800 only one treatment mode: normal mode. The difference on the two device can be identified by panel, Mode No.

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS device) seeking substantial equivalence to a predicate device. This type of submission does not typically involve clinical trials with acceptance criteria, human readers, or ground truth as would be seen in studies for AI/ML-based diagnostic or prognostic devices. Instead, it focuses on non-clinical engineering and safety performance.

Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information and indicate where information is not applicable.

1. Table of acceptance criteria and the reported device performance

Note: Some criteria from the predicate device differ slightly or are not explicitly stated as "acceptance criteria" but serve as a basis for substantial equivalence comparison. For example, timer range, pulse width range, frequency range, weight, and dimensions are compared but aren't presented as strict acceptance criteria in the same way as safety metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission for a TENS device, which relies on non-clinical testing (bench testing, safety reports, risk analysis) rather than clinical studies with test sets in the context of diagnostic performance. The document focuses on performance specifications and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth, in the context of expert review, is not relevant for this type of device submission. The "truth" is established by adherence to engineering specifications and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication method was used, as this was not a clinical evaluation of diagnostic performance.

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 TENS device, not an AI-assisted diagnostic or prognostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.

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

Not applicable. This device is a hardware-based TENS stimulator, not an algorithm or AI model.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on established electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and performance specifications that are expected for TENS devices, as demonstrated through bench testing and risk analysis. The comparison to the predicate device's characteristics also serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. This is an electrical medical device submission, not a machine learning model, so there is no concept of a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply.

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APPLICABLE FOR TENS 7000 AND TWIN STIM:

This device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief and management of chronic (long term) intractable main and (2) adjunctive treatment in the management of post surgical and post traumatic pain problems

APPLICABLE FOR EMS 7500 and TWIN STIM:

This device is an electrically powered muscle stimulator indicated for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing ouscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy

This series, which includes models TENS 7000, EMS 7500, and TWIN STIM, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.

The three models have the same housing. The process to set the parameter and attach lead wires to the unit are also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.

The TENS 7000 is a TENS device with 5 modes and adjustable pulse rate, pulse width and timer. The EMS 7500 is an EMS device with 3 modes and adjustable pulse rate, pulse width, contraction time, relaxation time, ramp time and timer. The TWIN STIM is a combination unit with both TENS and EMS functions. The function can be selected by press buttons. The range of settings are identical to those of TENS 7000 and EMS 7500. The difference on the three units can be identified by the liquid crystal display.

The provided text is a 510(k) summary for TENS and EMS devices (Koalaty Products, Inc., K080661). It describes the devices' intended use and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.

The 510(k) summary primarily focuses on:

• Device Identification: Trade names (TENS 7000, EMS 7500, TWIN STIM), common names, and classification names.
• Description of the Device: General function as Transcutaneous Electrical Nerve Stimulators (TENS) for pain relief and/or Electrical Muscle Stimulators (EMS) for muscle stimulation, noting adjustable parameters and shared housing.
• Intended Use: Detailed indications for TENS (pain relief, chronic/intractable pain, post-surgical/traumatic pain) and EMS (relaxing muscle spasms, increasing local blood circulation, preventing venous thrombosis, muscle re-education, maintaining/increasing range of motion, preventing disuse atrophy).
• Substantial Equivalence Claim: The devices are claimed to be safe and effective as compared to specific predicate devices (Models EV-804, EV-805, EV-806 from Everyway Medical Instruments Co., Ltd. - K020749, K071951).

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) because it is not present in this 510(k) summary document.

To answer your specific questions, one would need access to the full 510(k) submission, which would typically include detailed testing reports and clinical data (if applicable for the specific device type and regulatory pathway). Based on the provided text, the device's "performance" is implicitly deemed equivalent to the predicate devices, but no explicit performance metrics or studies are detailed.

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Electrical Muscle Stimulator Series (Model Numbers EMS 5.0, EMS 5.1) is an electrically powered muscle stimulator intended for use for medical purposes to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for:

• Relaxing muscle spasms
• Increasing local blood circulation.
• -Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• Muscle re-education.
• Maintaining or increasing range of motion
• Preventing or retarding disuse atrophy

EMS is a battery operated pulse generator that sends electrical impulses through electrodes to the body and reaches the underlying or muscle group. Both EMS 5.0 and EMS 5.1 are analogue units with dual channel. EMS 5.0 has a selectable pulse rate of 5, 30 and 100 Hz, while EMS 5.1 has an adjustable pulse rate of 2 to 150 Hz.

The provided text from K072795 is a 510(k) summary for an Electrical Muscle Stimulator (EMS) device. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on the regulatory aspects of demonstrating substantial equivalence, which often relies on comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than requiring new clinical efficacy or performance studies for this type of device.

Therefore, I cannot populate the requested table and details because the information is not present in the provided text. The submission explicitly states: "This series is safe and effective as the predicate devices cited above." This implies that the safety and effectiveness are established by reference to the predicate devices, not through a separate study detailed in this document.

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