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PROTENS reusable, self-adhering, over-the-counter Cutaneous electrodes are indicated for use with electrical stimulation device. Some common types of electrical stimulation device include, but are not limited to, transcutaneous nerve stimulation (TENS), electrical muscle stimulation (EMS) device, Neuromuscular Electrical Stimulation (NMES/FES) device and Microcurrent electrical nerve stimulation (MENS), Interferential stimulation (IF). Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.

Cutaneous electrodes are passive devices serving as an interface between a user's skin and an electrical stimulation device.

This document is a 510(k) clearance letter from the FDA for Bio Protech Inc.'s PROTENS Reusable Stimulating Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the letter does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot provide a response to your request as the document does not contain the necessary information.

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The SCENAR Cutaneous Electrode Family with SCENAR TENS devices is indicated for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.

The SCENAR Cutaneous Electrode Family is intended to be used with electrostimulation devices produced by RITM OKB ZAO as external add-on electrode accessories. The SCENAR Cutaneous Electrode Family does not contain any electrical components. Electrodes are made of stainless steel, brass with silver plated, ABS plastic and fluoroplastic placed in ABS plastic case. The electrodes are connected to electrostimulator by wiring through a connector cable.

Here's the breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) submission for a medical device accessory and the "study" described is a substantial equivalence comparison rather than a clinical trial in the traditional sense.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a predicate device. This means the new device (SCENAR Cutaneous Electrode Family) should have similar technological characteristics and indications for use, and perform at least as safely and effectively as the predicate. The performance evaluation focuses on direct comparison of physical and technical specifications rather than clinical outcomes.

Key Finding: The report asserts that differences in dimensions are "minor" and do not affect the Indications for Use or Fundamental scientific technology. The devices meet relevant electrical safety and EMC standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not describe a clinical "test set" with human subjects or a specified number of devices tested for performance comparison. Instead, the comparison is based on the published specifications of an existing predicate device (InterX5000 optional external electrode accessories) and the specifications of the new SCENAR Cutaneous Electrode Family.
• Data Provenance: This is not a study involving patient data. The data provenance is from the manufacturer's internal specifications and publicly available information (published data) for the predicate device. The information originates from Russia (RITM OKB ZAO) for the new device.

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

Not applicable. This is not a study that establishes ground truth through expert consensus on clinical cases. The "ground truth" for this submission are the technical specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is a technical comparison, not a clinical study involving case assessment.

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 transcutaneous electrical nerve stimulator electrode family, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant to this submission.

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

Not applicable. This device is a passive accessory (an electrode) and does not involve an algorithm or standalone performance in the sense of AI or automated diagnostic systems. The electrodes have no power or software on their own.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the technical specifications and safety standards for transcutaneous electrical nerve stimulator electrodes. The comparison is made against the established characteristics of the legally marketed predicate device (InterX5000 optional external electrode accessories) and relevant international safety and EMC standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and FDA regulations (21 CFR 898.12).

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, no training set is relevant.

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

Not applicable. As there is no training set for an AI model, no ground truth needed to be established for one.

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AMPCARE 50709 Series of cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulation current applications of these electrodes are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief, b) Electrical muscle stimulation (EMS) for neck muscle stimulation, c) Functional electrical stimulation (FES), d) Galvanic stimulation, e) Microcurrent electrical nerve stimulation (MENS), f) Interferential (IF) stimulation, and g) Neuromuscular electrical stimulation (NMES), including for muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

The new AMPCARE 50709 Series Electrodes device is a family of cutaneous electrodes with various shapes and sizes, which are similar in design and construction to several predicate cutaneous electrodes. AMPCARE electrodes are non-sterile, self-adhering, and are for multiple use by a single patient, available with either pin/socket or snap connections. The new AMPCARE device is designed in accordance with the general design approach of the predicate devices referenced above. Specifically, each electrode in the AMPCARE 50709 Series is constructed with a non-conductive top layer, conductive center layer and adhesive bottom layer. The plastic liner at the bottom of the electrode is peeled away just prior to placement on the patient, consistent with the four predicate devices. The pin/socket connector version of the new device will be provided with a lead wire that is 21 CFR 898 compatible, containing a female recessed socket for electrical connection.

The provided document is a 510(k) summary for the AMPCARE 50709 Series Electrodes, which are cutaneous electrodes. This device is a Class II medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new clinical claim or performance. Therefore, the details requested in the prompt, which are typically associated with performance studies for algorithms or diagnostic devices, are not fully applicable to this type of submission.

However, I can extract the information relevant to the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown based on the provided text, addressing the prompt's points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied to be the performance demonstrated by the predicate devices. The "reported device performance" refers to the AMPCARE electrodes' performance in comparison to these predicates during non-clinical testing to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for the test set (number of AMPCARE electrodes tested) or the data provenance (country of origin, retrospective/prospective). It only mentions "AMPCARE electrodes" generally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of non-clinical, substantial equivalence testing for a cutaneous electrode. There's no "ground truth" established by experts in the context of diagnostic or algorithmic performance. The testing involved physical and electrical properties of the electrodes.

4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3.

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:
This information is not applicable. MRMC studies are relevant for diagnostic devices or AI algorithms where human interpretation is involved. This submission is for a physical electrode.

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

7. The type of ground truth used:
For non-clinical testing of electrodes, the "ground truth" is typically defined by objective physical and electrical measurements (e.g., current distribution, impedance values) that meet established engineering standards or comparisons to legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set:
This information is not applicable. There is no "training set" as this is not an algorithmic or AI device requiring machine learning.

9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.

Summary of Non-Clinical Testing Performed (from the document):

• Dispersion testing: Demonstrated "uniform current distribution with no evidence of 'hot spots'." This testing included predicate devices (Columbia K080386 and Uni-Patch K915333) for comparison.
• Electrical impedance testing: Performed on AMPCARE electrodes and predicate devices to demonstrate substantial equivalence and suitability for various electrical stimulation applications.
• Electrical impedance uniformity testing: Performed on AMPCARE electrodes and predicate devices to demonstrate substantial equivalence.

The conclusion of the submission is that AMPCARE considers its electrodes to be "substantially equivalent" to the predicate devices based on similarities in primary intended use, principles of operation, functional design, nonclinical test results, and established medical use. The FDA's letter concurs with this substantial equivalence determination.

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The Rhythmlink International Cutaneous Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of stimulating /recording of biopotential signals. Electrodes are applied in the study of biopotentials such as Electroencephalograph (EEG), surface Electromyography (EMG), nerve conduction Evoked potential signals (EP). Electrodes are non-invasive as they are applied to the patient's skin using a selfadhesive solid-gel surface. The electrodes are non-sterile and for single patient use only. These devices are restricted to sale by or on the order of a practitioner licensed by the Law of the State in which he/she practices.

Rhythmlink International Cutaneous Disposable Electrodes are single patient use, disposable devices. Electrodes are non-invasive as they are applied to the patient's skin using a self-adhesive solid-gel surface. The electrodes consist of a cotton non-woven pad with a Silver/Silver Chloride carbon layer and a solid Hydro-qel adhesive laver. The electrodes are attached to a lead wire and terminate at the opposite end using a DIN 42-802 type safety connectors.

The provided text is a 510(k) summary for Rhythmlink International Cutaneous Pad Electrodes. It describes the device, its intended use, and its technological characteristics. However, it does not contain any information about acceptance criteria, specific performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies.

The document makes a declaration of "substantial equivalence" to a predicate device (Bio-logic Systems Corp, 510(k)#: K941799) and states: "The performance is expected to be the same as the predicate device. No new questions of performance, safety or effectiveness are raised." This statement implies that no specific new studies were conducted or deemed necessary to prove performance against specific acceptance criteria for this 510(k) submission.

Therefore, I cannot fulfill your request for the detailed table and study information because it is not present in the provided document. The 510(k) process for this device appears to rely on the established performance of the predicate device.

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The Electrode Store™ Surface Cutaneous Electrode for EMG is indicated for non-invasive use as recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings.

Not Found

This looks like a 510(k) clearance letter for a medical device and not a study. The document confirms that "The Electrode Store™ Surface (Cutaneous) Electrode for EMG" is substantially equivalent to legally marketed predicate devices.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document. This letter is a regulatory compliance document, not a clinical study report. It does not contain data or design information regarding a clinical investigation to assess performance against specific acceptance criteria.

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