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The EZ-STIK Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The EZ-STIK Electrodes are designed and intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), IF (Inferential), or PGF (Pulsed Galvanic Stimulation). The electrode is for OTC (Over-the-Counter) or Prescription Use.

EZ-STIK Electrodes have a basic 3-layer construction of non-woven polyester material or soft PVC foam, carbon film coated with silver and conductive hydrogel. EZ-STIK Electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.

First layer: Insulating backing material- non-woven polyester material or soft PVC foam coated with biocompatible medical adhesive tape

Second layer: Conductive carbon-carbon film or Carbon film/Carbon film coated with silver film

Third layer: Biocompatible self-adhesive conductive hydrogel

The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, as it would be relevant to an AI/ML medical device.

The document is an FDA 510(k) clearance letter for a medical device called "EZ-STIK Electrodes," which are cutaneous electrodes. The content primarily discusses:

• The FDA's determination of substantial equivalence for the EZ-STIK Electrodes to legally marketed predicate devices.
• Regulatory information regarding the device (classification, product code, general controls).
• Indications for Use for the EZ-STIK Electrodes.
• A 510(k) Summary, including applicant/correspondent details, device names, predicate devices, and a description of the device's construction and intended use.
• A comparison of the subject device's indications for use and technology to predicate devices.
• Summary of non-clinical tests (biocompatibility, electrical performance, pull/peel test, shelf-life test) performed to support substantial equivalence. It explicitly states, "No clinical data were necessary for this submission."

The information you are asking for (acceptance criteria for an AI/ML device, details about ground truth, expert consensus, MRMC studies, training/test set sample sizes, etc.) is not present in this document because the EZ-STIK Electrodes are a physical medical device (electrodes), not an AI/ML-based diagnostic or imaging device.

Therefore, I cannot generate the table or answer the specific questions about AI/ML device performance and validation studies based on the provided text.

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The NAImco, inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAlmco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Electrodes, Cutaneous

The provided document is a 510(k) summary for the Naimco EZ-stik Electrodes. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it asserts substantial equivalence based on component usage and physical testing.

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. No separate "test set" in the context of AI/machine learning or clinical performance evaluation is mentioned. The submission relies on "non-clinical testing" which refers to comparing the components of the proposed device to those of predicate 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. There is no mention of experts establishing ground truth for a test set.

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

Not applicable. No adjudication method is mentioned as there is no test set or expert review process described.

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/machine learning device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. "Ground truth" in the context of device performance is not explicitly discussed. The comparison is based on the characteristics of the device's components and physical testing, with the implicit "ground truth" being the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set is mentioned.

Summary of available information from the K050469 510(k) submission:

• Acceptance Criteria/Performance: The device (EZ-stik Electrodes) is deemed to meet acceptance criteria by demonstrating substantial equivalence to legally marketed predicate devices (K945676, K970426, K012463).
• Study Proving Acceptance: The study provided is a non-clinical testing comparison.
  • Method: The submission states that the "critical components used in NAImco, Inc. EZ-stik electrodes (Amgel 703 or Amgel 702 and Conductive Plastic Film) are the same as used in the predicate device." Physical testing was also conducted, but no details are provided about the specifics of this testing or its results beyond the general statement of "technological characteristics that are substantially equivalent."
  • Conclusion: "Therefore there is no reason to believe that the NAlmco, Inc. EZ-stik electrodes will perform any different than the predicate device."
• Clinical Testing: The document explicitly states "Clinical Testing: Not Applicable."

In essence, this 510(k) submission relies on the established safety and effectiveness of predicate devices and demonstrates that the new device is fundamentally the same in its critical components, thus inferring equivalent performance without requiring a new clinical study.

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