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As prescribed by a physician for the following:

TENS- Transcutaneous Nerve Stimulation

• Symptomatic relief of chronic intractable pain .
• . Post traumatic and post surgical pain relief

EMS- Electrical Muscle Stimulation

• . Relaxation of muscle spasm
• . Increasing local blood circulation
• . Muscle re-education
• . Prevention or retardation of disuse atrophy
• Prevention of venous thrombosis of the calf muscles immediately after surgery
• . Maintaining or increase range of motion

The Flex-MT + is a combination TENS and EMS device which delivers nerve or muscle stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device is powered by 700 mAh 4.8V Ni MH rechargeable battery pack. A patient compliance timer can memorize 60 sets of operation records; the total recordable time is 999 hours.

The provided text is a 510(k) summary for the Flex-MT+ device. It outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the "study" (in this case, performance testing) that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for performance, but rather demonstrates substantial equivalence by comparing the Flex-MT+ device's technical characteristics and performance to two predicate devices (K083030 EMSI TENS-EMS-14 (Flex MT) and K021100 EMPI 300 PV). The "Comment" column in the provided tables effectively acts as the "acceptance criteria" by stating whether the subject device's performance is comparable to or within acceptable limits of the predicate devices and relevant standards.

Acceptance Criteria (Derived) and Reported Device Performance (Flex-MT+)

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Indications for FES waveform:

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.

Indications for TENS waveform:

• Symptomatic relief of chronic (long term) intractable pain
• Symptomatic relief of post-traumatic acute pain and post surgical pain

Indications for Russian waveform:

• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion

The device NEURODYN II is a four output channel stimulator, operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F

The device NEURODYN COMPACT is a two output channel stimulator. operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F

The provided submission for the NEURODYN Compact and NEURODYN II devices does not include a detailed study proving the devices meet specific quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices (K121369 Neurodyn/Aussie Powered Muscle Stimulator by Ibramed and K021100 300 PV Complete Electrotherapy System by EMPI) based on similar indications for use, operating principles, hardware configuration, and compliance with recognized electrical safety and performance standards.

The acceptance criteria are implicitly defined by compliance with these standards and the established performance characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The submission does not describe a test set involving patient data or clinical trials. The "testing results" mentioned are non-clinical and relate to engineering and electrical safety compliance. Therefore, there is no sample size for a test set or information on data provenance in the context of clinical performance.

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. The submission focuses on non-clinical engineering and safety standard compliance, not clinical interpretation or ground truth established by medical experts for a diagnostic or treatment outcome.

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

Not applicable, as there is no clinical test set requiring expert adjudication.

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 a powered muscle stimulator, not an AI-assisted diagnostic or imaging device. No MRMC study was performed or mentioned.

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

Not applicable. This device is a physical medical device, not an algorithm, and its performance inherently involves human-in-the-loop (e.g., a therapist or patient operating the device).

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

The "ground truth" in this context is adherence to recognized international electrical safety and performance standards (IEC 60601 series). These standards define acceptable electrical characteristics, safety mechanisms, and electromagnetic compatibility. The device's performance is measured against the specifications of these standards and comparison to predicate devices, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable, as there is no training set.

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Neurodyn Multiwave - Indications for Use:
As a FES device:

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
  As a TENS device:
• Symptomatic relief of chronic (long term) intractable pain
• Symptomatic relief of post-traumatic acute pain and post-surgical pain
  As an Interferential and Premodulated device:
• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
  As a Russian device:
• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
  As a Burst Modulated Alternating Current (Aussie) device:
• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
  As a Microcurrent device:
• Symptomatic relief of chronic intractable pain
• Symptomatic relief of post-traumatic acute pain and post surgical pain
  As a DC/Polarized device:
• Relaxation of Muscle Spasm

Aussie Sport - Indications for Use:
As an Burst Modulated Alternating Current (Aussie) device:

• Temporary relaxation of muscle spasms
• Prevention or retardation of disuse atrophy in post-injury type conditions
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

Neurodyn Multiwave and Aussie Sport Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the following predicate devices: Vectra Genisys K031077, Neurodyn/Neurpdun Aussie K121369 and 400PV Complete K021100.

The Neurodyn Multiwave Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.

The Aussie Sport Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current(MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz.

The provided document is a 510(k) Summary for the Neurodyn Multiwave and Aussie Sport powered muscle stimulators. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, the following information cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the Neurodyn Multiwave or Aussie Sport devices, nor does it report their performance against such criteria. Instead, it relies on demonstrating that the device characteristics are "identical" to predicate devices.
2. Sample size used for the test set and the data provenance: No test set or associated data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment are discussed.
4. Adjudication method for the test set: No adjudication method is mentioned as there is no test set described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance: No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed.
7. The type of ground truth used: No ground truth is specified.
8. The sample size for the training set: No training set is mentioned.
9. How the ground truth for the training set was established: No training set or ground truth establishment is discussed.

Summary of Device Comparison (as provided in the document - not an acceptance criteria table):

The document provides a "Device Comparison Table" to show substantial equivalence, not to present acceptance criteria and performance. The key points from this table are:

Conclusion: The 510(k) summary concludes that the Neurodyn Muscle Stimulators are substantially equivalent to the predicate devices based on similarities in indications for use, technological design, materials, and various performance characteristics. The argument made is that because the new devices are "identical" or sufficiently similar to cleared predicate devices, they do not raise new issues of safety or effectiveness. No specific study demonstrating the new device's performance against defined acceptance criteria is presented.

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The Kneehab XP, Type 412/421, Indications for use are as follows:

In NMES mode (Programs 1-6) the Kneehab XP is intended to:

• Maintain or increase the range of motion.
• Prevention or retardation of disuse atrophy
• Re-educate muscles
• Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
• Relax muscle spasms
• Increase blood circulation

In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to:

• Provide symptomatic relief and management of chronic, intractable pain
• Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain
• Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis
• Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee

The Kneehab XP, Type 412/421 is a portable, battery operated, combination device which can provide both neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The device incorporates multipath®, a patented technology developed by neurotech® which enables the Kneehab XP Conductive Garment to deliver highly focused and accurate NMES muscle contractions. This device also provides a method of pain management and relief through the use of TENS technology.

The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device and the device cannot be used while being charged. The adhesive electrodes have an estimated usage capability of 20 sessions when used under the recommended conditions of use.

All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are nine treatment programs in total (six NMES and three TENS) with a duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.

The provided document is a 510(k) Summary for the Kneehab XP, Type 412/421. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical study data to meet specific performance acceptance criteria. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria.

Instead, it focuses on comparing the technological characteristics and intended uses of the Kneehab XP to existing predicate devices to argue for substantial equivalence. The document primarily highlights technical and functional comparisons rather than performance metrics from a clinical trial.

Based on the provided document, I cannot fulfill all sections of your request as it does not contain the information regarding an acceptance criteria study.

However, I can extract the following relevant information regarding the device and its intended use, which would typically form the basis for performance evaluation in a clinical study:

1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance from a study. It only provides electrical output specifications.

Device Electrical Output Parameters (Technical Characteristics, not performance data):

Intended Use and Indications:

NMES Mode (Programs 1-6):

• Maintain or increase the range of motion.
• Prevention or retardation of disuse atrophy.
• Re-educate muscles.
• Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening.
• Relax muscle spasms.
• Increase blood circulation.
  TENS Mode (Programs 7-9):
• Provide symptomatic relief and management of chronic, intractable pain.
• Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain.
• Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis.
• Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no performance study data is presented in this 510(k) summary.

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, as no performance study data is presented in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no performance study data is presented in this 510(k) summary.

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 medical device application for a physical device (electrical stimulator), not an AI/imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device application for a physical device (electrical stimulator), not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no performance study data is presented in this 510(k) summary.

8. The sample size for the training set
Not applicable, as no performance study data is presented in this 510(k) summary.

9. How the ground truth for the training set was established
Not applicable, as no performance study data is presented in this 510(k) summary.

Summary of Device and 510(k) Submission:

The Kneehab XP is a portable, battery-operated combination device that provides both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). Its primary purpose within this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Kneehab XP Conductive Garment, MediStim XP, MediTens XP, Staodyn Max Preset, 300 PV Complete Electrotherapy System, Bioncicare® Stimulator System). The submission details the technological characteristics, intended use, and indications for use of the Kneehab XP and compares them to these predicate devices, ensuring that there are "no new technological characteristics that could affect safety or effectiveness." The focus is on meeting international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and demonstrating similarity in electrical parameters and functionality to the predicate devices.

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