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Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It is intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with osteoarthritis.

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I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for Transcutaneous Electronic Nerve Stimulators. It discusses:

• The FDA's review and determination of substantial equivalence for the listed devices.
• Regulatory aspects such as general controls, special controls, quality system regulations, UDI rules, and adverse event reporting.
• Contact information for FDA resources.
• Crucially, it includes the "Indications for Use" for the devices.

There is no mention of:

• Specific performance metrics or acceptance criteria for the TENS device's functionality (e.g., electrical output, consistency, safety).
• Any studies involving test sets, training sets, ground truth establishment, expert readers, or multi-reader multi-case (MRMC) studies. These types of studies are typically associated with AI/ML-enabled devices, diagnostic imaging devices, or devices requiring clinical performance evaluation beyond basic safety and electrical parameters.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC studies or effect sizes for human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

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TENS:

For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities(leg) due to strain from exercise or normal household work activities.

For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with overthe-counter pain medications.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

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This document is an FDA clearance letter for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about a sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information.

FDA clearance of this type (510(k)) is based on demonstrating substantial equivalence to a predicate device, not necessarily on a de novo study proving new performance against specific acceptance criteria. While the manufacturer would have performed testing to ensure safety and effectiveness for their 510(k) submission, the detailed study information you're asking for is not typically included in the public-facing clearance letter.

To obtain the information you're looking for, you would typically need to review the actual 510(k) submission and its supporting documentation, which is generally not publicly available in this level of detail unless specifically requested through a Freedom of Information Act (FOIA) request.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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1. When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:

• for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
• to temporarily increase local blood circulation in healthy leg muscles
• to stimulate healthy muscles in order to improve and facilitate muscle performance
• to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties
• to relax muscle spasm
• to increase blood flow circulation
• for prevention of retardation of disuse atrophy
• for muscle re-education
• for maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Provide quadricep strengthening
• Improve knee stability secondary to quadricep strengthening

2. When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:

• symptomatic relief and management of chronic, intractable pain
• relief of pain associated with arthritis
• temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. The proposed model KTR-405 provides a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands. Modes 1-8 are for foot and can be switched to another mode for a minute automatically, while mode 9 is for knee and mode 10 for body. Modes for foot, knee and body can be switched manually during a session; 2) wonderful electric pulse combination, 0~150 levels can be adjusted and chosen according to personal preference; 3) rechargeable battery which can work up to 36 hours 4) wireless and rechargeable remote control allows easy control of the device 5) use while seated or reclining with Relax and Recline mode; 6)foot cover helps keep feet warm and cosy; 7) LCD display and power display make the operation simple and easy; 8) carry handle for easy transportation; 9) magnetic power cable for simple and safe connection. Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it can be run either from the mains power supply or via its internal rechargeable battery. To start therapy, you need to connect the device to the mains power supply. This will charge the battery, allowing you to use the device wirelessly in subsequent sessions. Then while seated, place both your bare feet onto the footpads of the device or paste the electrode pads onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.

I am unable to provide information about the acceptance criteria and study proving device efficacy based on the provided text. The document is an FDA 510(k) clearance letter for a Transcutaneous Electrical Nerve Stimulator (TENS), Model: KTR-405.

Here's why:

• 510(k) Clearance vs. Clinical Efficacy: A 510(k) clearance primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily extensive clinical efficacy trials. The manufacturer demonstrates that the new device is as safe and effective as a previously cleared device.
• Lack of Clinical Study Details: The document explicitly states "Clinical information: Not applicable" (page 10). This confirms that no clinical studies were performed or submitted for this particular 510(k) application to prove the device's performance against specific acceptance criteria in patient populations.
• Non-Clinical Studies: The "Non-clinical studies and tests performed" section (page 9-10) focuses on engineering and safety standards (e.g., IEC standards for electrical safety, ISO standards for biocompatibility, software verification). These are crucial for safety but do not provide clinical performance metrics like sensitivity, specificity, or changes in patient outcomes.
• Predicate Device Comparison: The comparison table between the subject device and the predicate device (pages 6-7) mainly highlights similarities in intended use, regulations, and basic technical specifications. It does not include performance data or acceptance criteria that would typically be found in a clinical study report.

Therefore, the provided text does not contain the information needed to answer your questions about acceptance criteria or a study proving device performance as you've requested. The "reported device performance" in the context of this document is adherence to safety and performance standards for TENS devices, rather than clinical effectiveness metrics.

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