PALS® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

The Axelgaard PALS® Neurostimulation reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS.

The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, strelchable conductive fabric, conductive hydrogel, and an electrode carrier distribution is delivered via a connector lead wire stripped to an additional length.

The provided document is a 510(k) summary for the Axelgaard PALS® Neurostimulation Electrodes. It is a premarket notification for a medical device seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies.

Therefore, the document explicitly states: "No performance data is required to support the proposed over-the-counter PALS® Neurostimulation Electrode as it has identical technical characteristics (including design) as compared to the predicate device."

Because no performance data or clinical studies are presented in this document to demonstrate the device meets specific acceptance criteria, I cannot provide the requested information. The 510(k) process for this device relies on the established safety and effectiveness of its predicate devices, not on new clinical trials for the subject device itself.

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ValuTrode® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

The ValuTrode® reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS. The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, or snap, conductive carbon film, conductive hydrogel, and an electrode carrier liner. Proper current distribution is delivered via a connector lead wire stripped to an additional length, or use of a printed silver pattern.

The provided document is a 510(k) summary for the ValuTrode® Neurostimulation Electrodes (K130987). It states that "No performance data is required to support this or the proposed over the counter claim, as the Electrode has identical technological characteristics including design and materials to its predicate device."

Therefore, the study that proves the device meets acceptance criteria is a demonstration of substantial equivalence to predicate devices, rather than a separate performance study with specific acceptance criteria. This means the device relies on the established safety and effectiveness of its predicate devices: Lifecare Electrodes (K083302) and ValuTrode® Neurostimulation Electrodes (K970426).

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no new performance data was required, the "acceptance criteria" for the ValuTrode® Neurostimulation Electrodes (K130987) are largely demonstrated by its substantial equivalence to the predicate devices and their established safety and effectiveness.

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

No specific test set or clinical data was generated for the K130987 submission. The claim of substantial equivalence is based on the device having "identical technological characteristics including design and materials" to its predicate devices. Therefore, there is no "sample size" or "data provenance" in the traditional sense of a new study for this submission.

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

Not applicable. No new study requiring experts to establish ground truth was conducted for this 510(k) submission. The safety and effectiveness are established through substantial equivalence to previously cleared devices.

4. Adjudication Method for the Test Set

Not applicable. As no new test set was used, there was no adjudication method.

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

Not applicable. No MRMC study was conducted. The device is a passive electrode, and the submission primarily focuses on physical and material equivalence to existing devices.

6. Standalone Performance Study (algorithm only without human-in-the-loop)

Not applicable. The device is a passive electrode and does not involve an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the current submission is the established safety and effectiveness of the identified predicate devices (K083302 and K970426), as determined by the FDA's previous clearances. This is based on the successful biocompatibility testing, electrical performance, and current distribution tests performed on the predicate devices.

8. Sample Size for the Training Set

Not applicable. No new training set was used. The submission relies on the established performance of predicate devices.

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

Not applicable. There was no training set for this submission. The "ground truth" for the predicate devices, which this submission relies upon, was established through their own respective 510(k) processes, which included biocompatibility testing, electrical performance testing, and current distribution tests as detailed in their summaries. For instance, the K970426 predicate had its power density calculated and reviewed by an FDA Biologist.

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Iontophoresis is indicated by clinicians for the administration of soluble salts or other drugs into the body for medical purposes and can be used as an alternative to hypodermic injection.

Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) consist of an active drug delivery electrode and a passive return electrodes are designed for one use on a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are four sizes and for the roundinen a releaser of roles to accommodate placement on various locations on the body. The size of the return electrode is the same for all drug delivery electrode sizes as the maximum delivery of 80 milliamp-minutes is the same regardless of size. Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) have technological characteristics equivalent to those of the predicate devices, including comparable design, materials, multiple shapes and sizes of active drug delivery electrodes, and equivalent packaging and abeling.

This 510(k) premarket notification for the Comfort Iontophoresis Electrodes (Buffered Iontophoresis Electrode Treatment Kit) does not describe a study to prove the device meets specific acceptance criteria based on its intrinsic performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer argues that their device is as safe and effective as devices already legally marketed.

Therefore, many of the requested sections below related to "acceptance criteria" and "study that proves the device meets acceptance criteria" are not directly applicable in the context of this 510(k) submission, as performance was demonstrated through comparison to known predicates, not independent testing against novel criteria.

Description of Acceptance Criteria and Device Performance

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

As this is a 510(k) submission based on substantial equivalence, there are no specific "acceptance criteria" in the traditional sense of performance metrics against a defined standard that the device itself had to meet in an independent study (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, the acceptance criteria are demonstrated through comparative equivalency to predicate devices. The "performance" is implicitly deemed equivalent if the device shares the same intended use, technological characteristics, and safety profile as the predicates.

The table below summarizes the similarities and equivalencies presented in the 510(k) to demonstrate that the proposed device performs identically to the predicate devices. The "acceptance criteria" here are effectively that the proposed device matches the established characteristics of the predicates.

The key "study" proving the device met the "acceptance criteria" was the detailed comparison of technical and functional characteristics against two predicate devices (North Coast Medical Buffered Iontophoresis Electrodes (K052019) and Dynatron Ion (K060814)). The core argument is stated explicitly: "In comparing the Comfort Iontophoresis Electrodes... it must be noted that there are no product differences since Axelgaard Manufacturing Co., Ltd. manufactures both these electrodes." This implies that the proposed device is literally the same product as the predicates, just marketed under a different name.

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. This 510(k) submission does not include an independent "test set" or clinical study with a sample size for performance evaluation. Approval is based on substantial equivalence to existing devices.

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. No ground truth was established by experts for an independent test set. The "ground truth" for equivalence is rooted in the FDA's prior clearances of the predicate devices.

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

Not applicable. No test set requiring expert adjudication was used.

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 an iontophoresis electrode, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm, and its performance is not evaluated in a standalone or human-in-the-loop context. Its function is to facilitate drug delivery when connected to an iontophoresis machine and used by a medical professional.

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

The "ground truth" in this context is the regulatory clearance and established safety and effectiveness profile of the predicate devices. The argument is that because the proposed device is identical to the predicates (even manufactured by the same company), its historical "performance" (safety and effectiveness) is already established through the predicates' market history and prior FDA clearances.

8. The sample size for the training set

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

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

Not applicable. There is no "training set" for which ground truth would need to be established.

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The UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "UltraStim Kit." It confirms the device's substantial equivalence to predicate devices for its intended use. This type of document does not contain the detailed acceptance criteria or the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results) from this document. This letter is a regulatory approval notice, not a study report.

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Input:

Intended Use / Indications for Use

The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.

Product codes

GXY

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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The Everlast Neurostimulation Electrodes are intended for use with transcutaneous neurostimulation devices.

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The provided text is a 510(k) clearance letter from the FDA for the "Everlast Neurostimulation Electrodes." This document primarily addresses the substantial equivalence of the device to a previously marketed predicate device and grants permission to market the product.

Crucially, the document does not contain information regarding acceptance criteria, a study proving the device meets those criteria, or any details about a clinical study's methodology (sample size, ground truth, expert qualifications, adjudication, MRMC studies, or standalone performance).

Therefore, I cannot provide the requested information. The 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, which may involve non-clinical testing and comparison of device characteristics rather than a full-scale clinical trial with acceptance criteria specific to its performance.

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