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PowerDot PD-01M2 is NMES/TENS stimulator with the following Over-The-Count indications for use:

NMES

• Stimulation of healthy muscles in order to improve or facilitate muscle performance

TENS

• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

When prescribed by healthcare provider, in addition, PowerDot PD-01M2 Muscle Stimulator can be also used with the following additional Rx only indications for use:

NMES

• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation
• Prevention of venous thrombosis of the calf muscles immediately after surgerv

TENS

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical and post-trauma acute pain

PowerDot PD-01M2 Muscle Stimulator (with PowerDot Mobile Application)

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the PowerDot PD-01M2 Muscle Stimulator. It outlines the regulatory clearance of the device and its intended indications for use.

This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device

The PowerDot PD-01MT2 is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor Mobile Application) or by patient/lay operator in a home environment (when operated from PowerDot Patient Mobile Application).

PowerDot PD-01MT2 has the following indications for use:

NMES

• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation
• Prevention of venous thrombosis of the calf muscles immediately after surgery
• Stimulation of healthy muscles in order to improve or facilitate muscle performance

TENS

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical and post-trauma acute pain
• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

Not Found

This document is a 510(k) clearance letter from the FDA for a muscle stimulator device, the PowerDot PD-01MT2. It does not contain information about acceptance criteria or specific study data proving the device meets those criteria.

The letter grants clearance based on a review, implying that the manufacturer provided sufficient data in their 510(k) submission to demonstrate substantial equivalence to a legally marketed predicate device. However, the details of that submission, including acceptance criteria, performance data, sample sizes, ground truth establishment, or expert qualifications, are not included in this public letter.

Therefore, I cannot provide the requested information based solely on the provided text. The document acts as an approval notice, not a detailed technical report of the studies performed.

Ask a specific question about this device

PowerDot PD-01MT stimulator is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor Mobile Application) or by patient/lay operator in a home environment (when operated from PowerDot Patient Mobile Application).

PowerDot PD-01MT has the following indications for use:

NMES

• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation
• Prevention of venous thrombosis of the calf muscles immediately after surgery
• Stimulation of healthy muscles in order to improve or facilitate muscle performance

TENS

• Symptomatic relief and management of chronic, intractable pain

• Post-surgical and post-trauma acute pain

• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "PowerDot PD-01MT," which is a powered muscle stimulator.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use (NMES and TENS). However, it does not describe any specific performance acceptance criteria for the device, nor does it detail any study conducted to demonstrate the device's performance against such criteria.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device

PowerDot PD-01M device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

PowerDot PD-01M device and PowerDot Mobile Application is not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

PowerDot PD-01M device, used with PowerDot Mobile Application

The provided text is a 510(k) premarket notification letter from the FDA regarding the PowerDot PD-01M device. This document primarily focuses on the regulatory clearance for a powered muscle stimulator and its indications for use. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to an AI/ML algorithm or automated diagnostic task.

Therefore, I cannot extract the requested information points, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Details of MRMC comparative effectiveness or standalone studies.
• Types of ground truth used or how it was established.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been cleared based on a comparison to existing, cleared devices, rather than through a new, comprehensive performance study that would generate the kind of data you are asking for. The clearance is for a "Powered Muscle Stimulator" intended for "stimulation of healthy muscles in order to improve or facilitate muscle performance," not for diagnostic or complex AI-driven tasks.

Ask a specific question about this device