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Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Garment Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include elbow, knee or back band.

Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Garment Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.

The provided FDA 510(k) clearance letter and Indications for Use statement for the "Garment Electrodes" (K222863) do not contain information typically found in a study demonstrating device performance against specific acceptance criteria. This document is a regulatory clearance, not a technical report detailing performance testing.

Therefore, I cannot provide the requested information that would usually be found in a performance study, such as:

• A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria (e.g., impedance, current distribution, adhesion) or report performance metrics against them.
• Sample size and data provenance for the test set: Not available.
• Number of experts and their qualifications: Not applicable, as this is not a study requiring expert interpretation of results.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone performance: Not detailed.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable (this is an electrode, not an AI/ML device).
• How ground truth for the training set was established: Not applicable.

What the document does tell us:

The document indicates that the Garment Electrodes are cutaneous electrodes for use with legally marketed TENS or NMES devices. They are described as non-sterile reusable OTC conductive garments intended to deliver stimulation signals.

The FDA's review determined that the device is substantially equivalent to legally marketed predicate devices. This implies that testing was done to ensure the Garment Electrodes meet the same safety and effectiveness standards as previously cleared devices of similar type, but the specific details of that testing are not disclosed in this public clearance letter. Such testing might typically involve electrical performance (e.g., impedance, current density), biocompatibility, durability, and safety aspects relevant to a cutaneous electrode.

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The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

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Based on the provided text, a Conductive Gel (K221724) has received 510(k) clearance from the FDA. However, the document provided is a clearance letter, not a detailed study report. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

This type of clearance (510(k)) generally means that the manufacturer demonstrated that their new device is as safe and effective as a legally marketed predicate device, and does not typically require the submission of a new, extensive clinical study with the kind of detailed performance data and study design requested in your prompt.

Therefore, I cannot provide the information you've requested regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, or specific study methods like MRMC studies, because this type of data is not typically included or required within a 510(k) clearance letter itself, especially for a device like a conductive gel.

The clearance letter focuses on regulatory compliance and substantial equivalence to existing devices.

To answer your prompt directly with information from this document:

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

• Not provided in this document. The document primarily addresses regulatory clearance based on substantial equivalence, not detailed performance metrics against specific acceptance criteria.

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

• Not provided in this document. No "test set" or study details are discussed.

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 provided in this document. No ground truth establishment is mentioned.

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

• Not provided in this document. No adjudication method 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 and not provided in this document. MRMC studies are typically for diagnostic imaging devices involving reader performance, which doesn't apply to a conductive gel.

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

• Not applicable and not provided in this document. This is not an AI/algorithm-based device.

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

• Not provided in this document.

8. The sample size for the training set:

• Not applicable and not provided in this document. This is not an algorithm-based device requiring a training set.

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

• Not applicable and not provided in this document.

In summary: The provided document is a 510(k) clearance letter for a Conductive Gel, indicating that it has been deemed substantially equivalent to a predicate device. This type of regulatory submission and corresponding letter does not typically contain the detailed performance study data you are asking for. For such data, one would usually need to consult the full 510(k) submission summary or a separate publication of a performance study, if one was conducted and published.

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TENS (Transcutaneous Electric Nerve Stimulation): To be used 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. EMS (Electric Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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This document is a 510(k) clearance letter for the TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain acceptance criteria or a study proving the device meets those criteria.

The letter is primarily focused on:

• 510(k) Clearance: Confirming the device's substantial equivalence to predicate devices.
• Regulatory Information: Specifying the regulation number, name, regulatory class, and product code.
• General Controls: Reminding the manufacturer of their obligations under the Act (registration, listing, GMP, labeling, etc.).
• Indications for Use: Detailing the intended uses for both the TENS and EMS functions of the device.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies from this document. This type of detail would typically be found in the 510(k) submission itself, which is not provided here.

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Tone-A-Matic is indicated to be used for

• · Russian and EMS for:
  • o Relaxation of muscle spasms
  • Prevention or retardation of disuse atrophy o
  • Increase local blood circulation o
  • Muscle re-education o
  • Maintaining or increasing range of motion o
  • Immediate postsurgical stimulation of calf muscles to prevent venous 0 thrombosis.
• TENS for: ●
  • Symptomatic relief of chronic, intractable pain. o
  • o Management of pain associated with post-traumatic or post-operative conditions.

The Tone-A-Matic is a Tone-A-Matic Device is Non-TRANSIT-OPERABLE and PORTABLE micro-controller operated device not to be Worn by patient. It generates electrical impulses and effectively transfers your desired choice of these pre-programmed electrical impulses directly through the electrode adhesive pads to the suggested area of the body where the electrodes are placed. Tone-A-Matic was developed based on physics, electro biology and modern micro-electronic technology. You will be more than pleased with this state-of-the-art device.

The Tone-A-Matic is very user friendly with a large liguid crystal display (LCD) screen that displays the treatment mode in use, a countdown timer and battery indicator. The intensity of the treatment can be increased or decreased by Keypads. User can set the time of the treatment from available choice of 1 min. to 60 min.

It is a clinical model with easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model has 3 selectable modes(Russian, TENS, EMS) and treatment parameters. The state of the art Tone-A-Matic is light weight (1.78 Kg), small in size (10.3" X 7.5" X 3.5", LxWxH) and battery powered which allows it to be easily moved to any location for immediate use.

Here's an analysis of the provided text regarding the Acceptance Criteria and Study to prove the device's adherence:

Based on the provided 510(k) Summary for the Tone-A-Matic device, there is a fundamental misunderstanding in your request. A 510(k) submission for this type of device (Powered Muscle Stimulator / TENS) does not typically involve the kind of acceptance criteria, clinical studies with ground truth established by experts, or MRMC comparative effectiveness studies that you are asking about.

This document is a Premarket Notification (510(k)), which demonstrates "substantial equivalence" to a legally marketed predicate device, not necessarily proof of meeting performance acceptance criteria from a clinical study in the way you've outlined for an AI/CAD-type device.

Therefore, I cannot fill out your requested table and information points as they pertain to a different type of medical device evaluation. Instead, I will describe the approach used in this 510(k) submission to demonstrate equivalence, which relies heavily on non-clinical tests and direct comparison of technical specifications and intended use.

Explanation of TONE-A-MATIC 510(k) Submission Approach

The Tone-A-Matic device is a Powered Muscle Stimulator and Transcutaneous Electrical Nerve Stimulator (TENS). For devices like this, the demonstration of safety and effectiveness for a 510(k) clearance typically involves showing that the new device is substantially equivalent to a legally marketed predicate device in terms of:

1. Intended Use: The new device is intended for the same uses as the predicate.
2. Technological Characteristics: The new device has technological characteristics that are similar to the predicate, or if they are different, the differences do not raise new questions of safety or effectiveness.

The provided document does not contain information about clinical studies with human readers, ground truth established by experts, or AI performance metrics because such studies are generally not required for this type of device to demonstrate substantial equivalence.

The "proof" the device meets acceptance criteria is primarily through:

• Comparison of Technical Specifications: Directly comparing the electrical output parameters (voltage, current, waveform, net charge, phase charge, current density, power density) of the new device to the predicate device.
• Compliance with Recognized Standards: Demonstrating adherence to relevant electrical safety and electromagnetic compatibility standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971).
• Software Verification: If applicable, verification activities for embedded software (though the summary states "software verification has been carried out," specific details are not provided beyond adherence to FDA guidance).
• Risk Analysis: A comprehensive risk analysis to address safety and effectiveness concerns.

Re-interpretation for the Context of the Provided Document

Given the nature of the provided document, here's how I can address your request, acknowledging that the criteria and studies described are for substantial equivalence rather than the clinical performance metrics you've requested for an AI/CAD device.

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

The "acceptance criteria" here are points of comparison to the predicate device that demonstrate substantial equivalence. The "reported device performance" is the comparison against the predicate's specifications and the device's compliance with safety standards.

• Waveform: Tone-A-Matic uses Square Wave for all 3 modes; Winstim uses Sinusoidal for Russian and Square Wave for TENS/EMS. (This difference is deemed acceptable, likely due to similar physiological effect or within acceptable electrical safety limits).
• Max Output Voltage: Tone-A-Matic: Russian 50Vpp@500Ω, 60Vpp@2KΩ; TENS/EMS 57Vpp@500Ω, 90Vpp@2KΩ. Winstim: Russian 50Vpp@500Ω; TENS/EMS 57Vpp@500Ω, 225Vpp@2KΩ. (Tone-A-Matic's 2KΩ TENS/EMS voltage is lower, which would be safer, not raising new safety questions).
• Max Output Current: Tone-A-Matic: Russian 100mA@500Ω, 30mA@2KΩ; TENS/EMS 114mA@500Ω, 45mA@2KΩ. Winstim: Russian 100mA@500Ω; TENS/EMS 114mA@500Ω, 112.5mA@2KΩ. (Tone-A-Matic's 2KΩ TENS/EMS current is lower, implying safety).
• Net Charge: Both 0µC for all modes.
• Maximum Phase Charge: Both 20/22.5µC for respective modes.
• Max Current Density: Similar values for both devices.
• Max Power Density: Tone-A-Matic provides specific values for all modes; Winstim shows some differences, but these are likely considered within acceptable limits for equivalence (e.g., Tone-A-Matic TENS/EMS 0.251 W/cm² vs Winstim TENS/EMS 0.064 W/cm² - if the higher value is still safe, it's considered equivalent).
• Treatment Time: Tone-A-Matic (1-60 min) vs Winstim (1-100 min). (The shorter maximum duration would also be considered safe).
• Number of Output: Tone-A-Matic: 8; Winstim: not specified but implies multiple channels. |
  | Electrical Safety and EMC Compliance: Conformity to international standards. | Met: Tone-A-Matic complies with IEC 60601-1 (Ed3.0), IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, and ISO 14971:2007. |
  | Software Verification: Compliance with FDA guidance. | Met: Software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (No specific test results are detailed in this summary). |
  | Risk Analysis: Comprehensive analysis carried out. | Met: A comprehensive risk analysis has been carried out regarding safety and effectiveness. (No specific details provided in this summary). |

Regarding the other information points, these are not applicable to the provided 510(k) submission for a non-AI/CAD device:

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

• Not applicable as this is a comparison to a predicate device based on technical specifications and standards compliance, not a clinical study with a test set of data.

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. There's no "ground truth" establishment by experts in the context of a diagnostic dataset for this submission. The "ground truth" for the device's performance is its adherence to internal specifications and relevant safety standards.

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

• Not applicable.

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 not an AI/CAD diagnostic device.

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

• Not applicable. This is not an AI device.

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

• Not applicable in the AI/CAD sense. The "ground truth" for this device's safety and effectiveness relies on its measured electrical output parameters aligning with specified ranges and its design conforming to established national and international safety standards.

8. The sample size for the training set

• Not applicable. This device does not use machine learning, so there is no training set.

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

• Not applicable.

In summary, the Tone-A-Matic 510(k) submission successfully demonstrated substantial equivalence to its predicate device, Winstim, through a detailed comparison of its intended use, technological characteristics, and technical specifications, alongside compliance with relevant safety and performance standards. It did so without conducting the types of clinical studies involving expert readers, ground truth establishment through consensus/pathology, or AI performance metrics as typically seen for AI/CAD devices.

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