(9 days)
The Bio Protech, Inc. PROTENS are designed and intended to be used with marketed transcutaneous electrical nerve stimulators (TENS). The PROTENS electrodes provide the conductive interface between the TENS generator and the patient's skin.
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The provided text is a 510(k) premarket notification letter from the FDA for a medical device called the "PROTENS electrode." This type of document establishes substantial equivalence to a predicate device, which means the new device is as safe and effective as a legally marketed device that was on the market prior to May 28, 1976, or has been reclassified.
A 510(k) premarket notification does not typically include detailed information about acceptance criteria, clinical studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as you would find in an approval for a novel device or a PMA. Instead, the substantial equivalence determination for devices like this electrode often relies on comparisons of design, materials, performance specifications, and safety testing to a predicate device, rather than extensive clinical efficacy trials.
Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them because this information is not present in the FDA 510(k) clearance letter. This letter is a notification of substantial equivalence to a predicate device, not a detailed report of clinical trials or performance studies with specific acceptance criteria.
The document indicates:
- Device Name: PROTENS electrode
- Intended Use: Designed and intended to be used with marketed transcutaneous electrical nerve stimulators (TENS) to provide the conductive interface between the TENS generator and the patient's skin.
- Regulatory Class: II
- Product Code: GXY (Cutaneous electrode)
A 510(k) clearance evaluates a device's substantial equivalence to a predicate device, meaning it is as safe and effective as a legally marketed device. This process typically involves demonstrating that the new device has the same intended use and similar technological characteristics to the predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This usually involves bench testing, biocompatibility testing, and electrical safety testing, but generally not extensive clinical efficacy studies with the kind of details requested in your prompt.
Therefore, I cannot fill out the requested table or provide the specific details you asked for regarding:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study and effect size
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 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).