(108 days)
The Cutaneous Electrodes, "Dr-Ho's Foot Pad Electrodes", are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the feet which they are in contact with.
The Dr-Ho's Foot Pad Electrode is a foot-shaped, flexible piece of conductive silicone rubber with a receptacle for a wire that connects the device with electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS).
To stimulate the bottom of the foot the patient simply connects the Foot Pad to a TENS unit, places the Foot Pad onto the floor and then places the foot onto the Foot Pad for stimulation with the TENS device.
The Foot Pad Electrode has a female pin receptacle which accepts the lead wire from the stimulator. The entire Foot Pad Electrode is made up of conductive material to provide uniform current distribution when connected to a stimulator.
The devices can be used dry or wet when in contact with the skin. The entire surface (approx. 35 in') of the Foot Pad Electrode is very conductive, having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.
This document is a 510(k) summary for the Dr-Ho's Foot Pad Electrode. It outlines the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics, or a study proving that the device meets such criteria.
The document focuses on demonstrating that the Dr-Ho's Foot Pad Electrode is substantially equivalent to legally marketed predicate devices, primarily through a comparison of technological characteristics and the results of biocompatibility testing. It explicitly states that no clinical tests were conducted or relied upon to determine substantial equivalence.
Therefore, I cannot fulfill your request for the following information based on the provided document:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating equivalence rather than meeting specific performance criteria.
- Sample size used for the test set and the data provenance: No test set for performance comparison is described. The tests mentioned are biocompatibility tests (irritation and cytotoxicity studies), but these are not performance evaluations in the context of clinical efficacy or accuracy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set with ground truth is described.
- Adjudication method for the test set: Not applicable.
- 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 passive electrode, not an AI-powered diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily states:
- Non-Clinical Tests Performed: Biocompatibility tests (ISO 10993-10 for irritation and skin sensitization in rabbits and guinea pigs, and ISO 10993-5 for in vitro cytotoxitity).
- Conclusion: The device is substantially equivalent to predicate devices based on intended use, technological characteristics, and safety information (biocompatibility and bench testing).
In summary, this document is a regulatory submission focused on substantial equivalence rather than a detailed performance study against specific acceptance criteria.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).