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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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