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Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Home Care Jelly," an electroconductive media. It explicitly states that the device is substantially equivalent to legally marketed predicate devices.

This document is a regulatory clearance letter and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot populate the requested table or answer the questions regarding study details, sample sizes, expert qualifications, or ground truth. The letter's purpose is to grant market clearance based on substantial equivalence, not to present a detailed performance study.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

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The provided text is a 510(k) premarket notification letter for a medical device: "J.D. 3-Wheeled Scooter, ES-350 Citybug II/Rabbit". This document is a regulatory approval letter from the FDA and does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval. Substantial equivalence for this type of device typically relies on demonstrating that the new device has the same intended use and technological characteristics as an already approved device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This process usually involves comparison of specifications, performance data (like speed, range, stability, braking), and safety features to the predicate device, rather than a clinical study with detailed acceptance criteria as one might expect for a diagnostic or therapeutic device.

Therefore, I cannot provide the requested information based on the given text.

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• Specific indications: it is used for the symptomatic relief and management . of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
• . Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "Sandidad Health-Up TENS MP-73725," which is a Transcutaneous Electrical Nerve Stimulator (TENS).

Based on the content of this document, none of the requested information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies is available.

This document is a regulatory clearance letter, not a clinical study report or a technical performance evaluation. It confirms that the device has been found substantially equivalent to legally marketed predicate devices, but it does not detail the technical or clinical performance data that would typically be associated with the questions asked.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or any of the other requested study-specific details.

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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a "Biotech Powered Wheelchair C650PW". This document pertains to the regulatory approval of a physical medical device (a powered wheelchair), not a software or AI-based medical device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies is not applicable to this document. The concepts of "device performance" in this context refer to the physical functionality, safety, and effectiveness of the wheelchair, which would be evaluated through different types of testing (e.g., mechanical, electrical, clinical trials for mobility) rather than AI model performance metrics like sensitivity, specificity, or AUC.

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