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The T.E.A.R. Tech3 IF/Muscle Stimulator is intended for the following applications:

The High Volt Pulsed Current Stimulation and Neuromuscular Electrical Stimulation can be used in the following applications:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy .
• Increases local blood circulation .
• Muscle re-education •
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Interferential Stimulation can be used in the following applications:

• Symptomatic relief of post traumatic acute pain
• . Symptomatic relief of chronic pain intractable pain
• . Relaxation of muscle spasms
• Maintaining or increasing range of motion
• Increases local blood circulation

Pulsed Direct Current stimulation can be used in the following applications:

• Reduction of edema (under negative electrode)
• Relaxation of muscle spasm
• . Increasing local blood circulation
• Retardation or prevention of disuse atrophy
• Muscle re-education
• Maintaining or increasing of range of motion

The T.E.A.R. Tech 3 IF/Muscle Stimulator is a device which combines the functionality of Interferential (IF), Neuromuscular (NM), High Voltage (HV) and Pulsed Direct Current (PDC) in one device. The device produces a low electrical current that is transmitted via lead wires to electrodes placed on the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and keypad.

This 510(k) summary does not contain details about acceptance criteria or a study proving device performance against such criteria.

The document is a 510(k) submission for an Interferential/Muscle Stimulator (T.E.A.R. Tech 3). It focuses on establishing substantial equivalence to previously cleared devices based on design, composition, and intended use.

Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and performance studies, as that information is not present in the provided text. The document primarily describes the device, its indications for use, and its substantial equivalence to other predicate devices, which is typical for a 510(k) summary seeking market clearance.

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The High Volt Pulsed Current Stimulator and Neuromuscular Electrical Stimulators share the same indications for use as listed below:

• Relaxation of muscle spasms .
• Prevention or retardation of disuse atrophy ●
• Increases local blood circulation ●
• . Promotes muscle re-education and range of motion
• . Maintaining and increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Interferential Stimulators have one additional indication for use:

• Provides symptomatic relief and management of post surgical, acute, or chronic . pain
  The target population for this device is patients with chronic, acute pain syndrome, and/or recovering from orthopedic related surgery.

The T.E.A.R. Tech3 IF/Muscle Stimulator is a combination device combining the functionality of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators in one device which produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with leads, a battery pack (lithium ion rechargeable and alkaline), carrying case, and instructions for use make up the T.E.A.R. Tech3 stimulation system.

This submission does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

Instead, the submission, K030507 for the T.E.A.R. Tech3, is a 510(k) Premarket Notification, which demonstrates substantial equivalence to legally marketed predicate devices. This type of submission relies on showing that the new device has the same intended use and technological characteristics as existing, approved devices, and does not raise new questions of safety or effectiveness. It does not typically involve extensive clinical trials or the establishment of new performance acceptance criteria as would be seen for novel devices.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission (e.g., a PMA or De Novo classification) that would present new performance data.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts substantial equivalence based on technological characteristics and intended use being similar to predicate devices, rather than presenting a performance study against specific acceptance criteria.

2. Sample size used for the test set and the data provenance: Not applicable. No test set data or provenance is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is mentioned.

4. Adjudication method for the test set: Not applicable. No test set needing adjudication is mentioned.

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 device is an electrical stimulator, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth data is presented.

8. The sample size for the training set: Not applicable. This is not a machine learning device, so there is no training set mentioned.

9. How the ground truth for the training set was established: Not applicable.

Summary of the K030507 Submission:

• Acceptance Criteria and Study: The submission does not define specific acceptance criteria or present a study to demonstrate performance against such criteria. Instead, it argues for substantial equivalence to predicate devices.
• Basis for Substantial Equivalence: The T.E.A.R. Tech3 is deemed substantially equivalent to the predicate devices (Surgi Stim K982388 and Jace Tri-Stim K931781) because it has the "same intended use and technological characteristics" and "no new questions of safety or effectiveness have been raised."
• Technological Characteristics: The device is a combination of Interferential (IF) / Neuromuscular (NMES) and High Volt Pulsed Current (HVPC) stimulators.
• Indications for Use: The shared indications include relaxation of muscle spasms, prevention of disuse atrophy, increased local blood circulation, promotion of muscle re-education and range of motion, maintaining/increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. The Interferential Stimulator has an additional indication for symptomatic relief and management of post-surgical, acute, or chronic pain.
• Target Population: Patients with chronic/acute pain syndrome, and/or recovering from orthopedic-related surgery.

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