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Interferential stimulation indications

• Relieve acute pain .
• Relieve and manage chronic pain .

Muscle stimulation indications

• Relax muscle spasms .
• Prevent or retard disuse atrophy
• Maintain or increase range of motion ●
• . Increase local blood circulation
• Re-educate muscle .
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

The RS-4i Plus is 4 channel electrical stimulator that incorporate traditional muscle stimulation and interferential current stimulation modalities into a single unit. It has the capability to program the device's output by the care giver to match the patient's condition through the use of pre-set selections. The RS-4i Plus is hand held with an electronic display, digital single processor, software/firmware controlled functions, user keypad, cable leads and electrode pads, multiple output channels, removable, rechargeable battery, and patient data files and retrieval capability.

The provided text describes a 510(k) summary for the RS-4i Plus Sequential Stimulator. It outlines the device's intended use, technological characteristics, and its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance metrics like accuracy, sensitivity, or specificity.

Instead, the submission focuses on demonstrating substantial equivalence based on technological characteristics and compliance with safety and performance standards. The "study" mentioned is primarily a series of tests to confirm the device's basic unit characteristics and output specifications, ensuring it performs equivalently to the predicate and meets relevant electrical, mechanical, and software safety standards.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not mention a "test set" in the context of clinical or diagnostic performance data. The testing described pertains to engineering and safety standards, likely performed on a limited number of devices during development and verification. There is no mention of human subject data, country of origin, or retrospective/prospective study design for performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" here is compliance with engineering and safety standards, which would be assessed by qualified engineers and testers, not clinical experts establishing a diagnosis.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication in the context of 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 device is a sequential stimulator, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is an electrical stimulator, not an algorithm. Its performance is inherent to its physical and functional output.

7. The type of ground truth used

The "ground truth" implied for this submission is adherence to recognized international and national standards for medical electrical equipment safety, electromagnetic compatibility, software life cycle, and physical/environmental resilience, as well as demonstrating that its output specifications match those of the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and does not have a "training set" in that context.

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

Not applicable.

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The RS Medical Conductive Garments and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower, middle and upper back.

The RS Medical Conductive Garments consist of the RS-LB™ Low Back Conductive Garment and RS-FBG" Full Back Conductive Garment. The RS-LB" Low Back Conductive Garment is a wrap designed for the low back that uses Velcro® closures to affix the garment around the waist and lower back. The garment contains eight conductive metal snaps onto which a snap cable can be connected to the outside of the garment. These snaps extend through the garment and an adhesive backed electrode pad is affixed to the snap surface on the inner surface of the garment. The garment allows for easy electrode placement and stabilization of electrode locations on the back for repeated electrostimulation treatments to facilitate treatment compliance. The RS-FBG" Full Back Conductive Garment is a similar vest type compliance accessory that has sixteen metal snaps spaced from the lower back on either side of the spinal column to the middle and upper back. The RS Medical Conductive Garments utilize the identical UltraStim® Electrode pads used with the predicate device.

The provided document describes a 510(k) submission for RS Medical Conductive Garments (RS-LB™ Low Back Conductive Garment, RS-FBG™ Full Back Conductive Garment). This is a premarket notification for a Class II medical device, indicating that its review focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on extensive clinical trials for effectiveness.

Therefore, the study did not involve human subjects, and many of the requested fields related to clinical study design and human reader performance are not applicable. The assessment primarily relied on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified for the non-clinical tests. Typically, for such tests, a small number of representative units would be tested (e.g., 3-5 units).
• Data Provenance: Not applicable. The tests were non-clinical, likely conducted in a lab setting by the manufacturer, RS Medical, or a contracted testing facility (e.g., Underwriters Laboratories, Inc. is mentioned in the FDA letter).

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

N/A - This was a non-clinical performance study; therefore, no human experts were involved in establishing ground truth for clinical outcomes. The "ground truth" here would be the physical and electrical properties of the materials and design, evaluated against engineering specifications.

4. Adjudication Method for the Test Set

N/A - No human adjudication was involved. The tests were objective measurements against predefined engineering specifications.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

N/A - No MRMC study was conducted. The device is a conductive garment, not an imaging or diagnostic device requiring human interpretation of results. The study was focused on the device's physical and electrical performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

N/A - This device is a conductive garment, not an algorithm or AI system. Its performance is assessed based on its physical and electrical properties.

7. Type of Ground Truth Used

For the non-clinical performance tests, the ground truth was established by engineering specifications for electrical continuity and mechanical forces (attachment/removal). These are objective, measurable parameters relevant to the device's function as a conductive garment.

8. Sample Size for the Training Set

N/A - This refers to a manufactured product; there is no "training set" in the context of machine learning or algorithms.

9. How the Ground Truth for the Training Set Was Established

N/A - Not applicable as there is no training set. The design and manufacturing processes for the garments would be guided by industry standards, material specifications, and internal engineering design documents.

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The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.

The RS-4i Sequential Stimulator consists of a hardware/software svstem that is the same as was described in its previous 510(k) notification (K032652). The RS-4i Sequential Stimulator also includes a TENS output. The RS-4i Sequential Stimulator incorporates traditional muscle stimulation and interferential current stimulation modalities, as well as TENS output into one unit. Only one modality may be operated at a time, but modalities can be automatically sequenced. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.

The provided text is a 510(k) summary for the RS-4i Sequential Stimulator, a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document primarily focuses on describing the device, its indications for use, and its substantial equivalence to predicate devices, which is typical for a 510(k) submission. Therefore, I cannot extract the requested information from this text.

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Muscle Stimulation, Interferential and Non-Interferential Modality

• Relax muscle spasms
• Prevent or retard disuse atrophy
• Maintain or increase range of motion
• Increase local blood circulation
• Re-educate muscle
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
  Pain Relief, Interferential Current Modality
• Relieve acute pain
• Relieve and manage chronic pain

The RS-4i device family consists of a hardware/software system that is identical to its predicate device (the RS-4M+ device family K100114). The RS-4i device family manufacturing process has been changed to a Surface Mount process and components. The RS-4i device family includes a 'Pattern Stimulation' modality that allows sequential 'pattern' output of the standard muscle stimulation pulses.
The RS-4i device family incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4i pulse mode muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec. (+/-10%) and a cycle frequency of 71 Hz (+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4i interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

The provided document is a 510(k) summary for the RS-4i Muscle Stimulator family. It describes the device, its indications for use, and declares substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. This type of premarket notification for a Class II device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with detailed performance metrics against pre-defined acceptance criteria.

The key points from the provided text are:

• Predicate Device: The RS-4i family is substantially equivalent to its legally marketed predecessor, the RS-4M+ (K000114) muscle stimulator.
• Device Changes: The primary changes are a manufacturing process change to Surface Mount technology and components, and the addition of a 'Pattern Stimulation' modality.
• Performance Specifications: The document lists technical specifications (e.g., peak voltage, mA, pulse width, frequency for muscle stimulation; mA peak for interferential modality) but these are device specifications, not acceptance criteria for a clinical outcome study.

Therefore, based on the provided text, I cannot complete the requested tables and information. A 510(k) submission for a device like this typically relies on bench testing and comparisons to the predicate's technical specifications and safety profile, rather than extensive clinical efficacy trials with predefined acceptance criteria and human expert evaluation in the way you've described.

A 510(k) submission is generally intended to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It does not typically require a new clinical study to establish "acceptance criteria" for clinical performance in the way a PMA (Pre-Market Approval) or a de novo classification might.

If this were a PMA or a de novo application, or if the FDA had required specific clinical data beyond substantial equivalence, then the document would contain the type of information you're asking for.

In summary, the provided document does not contain the information required to populate your requested table and study details.

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Muscle Stimulation, Interferential and Non-Interferential Modality

• Relax muscle spasms .
• Prevent or retard disuse atrophy .
• Maintain or increase range of motion ●
• Increase local blood circulation .
• Re-educate muscle .
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Pain Relief, Interferential Current Modality

• Relieve acute pain .
• Relieve and manage chronic pain .

The RS2mi device family consists of a hardware/software system that can be setup as one of four devices: an RS2m which is a pulse mode muscle stimulator only, an RS2i which is an interferential stimulator only, an RS2c which can act as either a pulse mode muscle stimulator or an interferential stimulator, or an RS2s which acts as a sequential stimulator by first providing an interferential treatment segment followed by a pulse mode muscle stimulation segment. The software system is setup to emulate one of these four devices and the device faceplate is setup to indicate to the user the features of that device only. To provide flexibility, the faceplates can be interchanged by RS Medical to create the type of device needed in the marketplace. Throughout this document the name RS2mi is used to indicate this 'family' of four separate devices.

The RS2mi device family, like a number of legally marketed predicate devices, incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS2mi is housed in a plastic enclosure. The front of the enclosure houses LED patient indicators. The accessories provided with the RS2mi include the output cables, the electrode pads, and the AC Charging Adapter.

The RS2mi pulse mode muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec.( +/-10%) and a cycle frequency of 71 Hz(+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.

The RS2mi interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

The provided text is a 510(k) Pre-market Notification for the RS2mi Muscle Stimulator family, dated May 15, 2002. It describes a medical device that provides muscle stimulation and interferential current modalities.

However, the provided document does not contain information about acceptance criteria, the study that proves the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment relevant to the request.

The FDA's review letter confirms that the device was found substantially equivalent to a predicate device (RS-4M Plus, K000114), meaning it has the same intended use and similar technological characteristics. The document primarily focuses on the device description, indications for use, and a comparison to its predicate device to establish substantial equivalence. It does not detail specific performance studies with acceptance criteria as typically understood for AI/ML devices or novel medical technologies requiring extensive clinical validation.

The "device performance" described in the document pertains to the technical specifications of its electrical output (e.g., peak voltage, mA, pulse width, frequency) and how they compare to the predicate device. These are engineering specifications, not clinical performance metrics against specific acceptance criteria in a study.

Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria and a study that proves the device meets those criteria, as the information is not present in the provided text.

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Muscle Stimulator Modality

• Relax muscle spasms
• Prevent or retard disuse atrophy
• Maintain or increase range of motion
• Increase local blood circulation
• Re-educate muscle
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
  Interferential Current Modality
• Relieve acute pain
• Relieve and manage chronic pain
• Relax muscle spasms
• Maintain or increase range of motion
• Increase local blood circulation

The RS-4V, like a number of legally marketed predicate devices, incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4V is housed in a plastic enclosure. The front of the enclosure houses LCD operator display. The accessories provided with the RS-4 V include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4V muscle stimulation modality operates at approximately 100 volts peak (no load) and 60 mA peak (1000 ohm load) with a pulse width of 415 uSec.(maximum) and a cycle frequency of 71 Hz. The pulses are bi-phasic. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4V interferential modality operates at approximately 100 mA peak-to-peak on a 500 ohm load. The carrier and interferential signals are true sine wave symmetric outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).

The provided text is a 510(k) summary for the RS-4V Muscle Stimulator. It describes the device, its indications for use, and declares substantial equivalence to predicate devices (RS-4M and Stellar HS-04). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or clinical study methodologies.

The 510(k) summary is a regulatory filing that demonstrates substantial equivalence to a legally marketed predicate device, rather than providing the detailed results of a performance study. It states that the device is "substantially equivalent" to its predecessors, implying that its performance is implicitly considered acceptable based on the predicate devices.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance
• Sample sizes for test sets or data provenance
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results or effect size
• Standalone performance information
• Type of ground truth used
• Sample size for training set
• How ground truth for the training set was established

The document focuses on the technical specifications and regulatory aspects (device description, indications for use, and comparison to predicate devices for substantial equivalence) rather than a detailed performance study.

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