(7 days)
The MED 4000 Transcutaneous Electrical Nerve Stimulator (TENS) device is intended to by used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain by sending electrical impulses through the skin to the nerves lying directly beneath the skin suarane impulses help to block the body's ability to send a pain message to the brain, thereby reducing the pair. sensation.
The MED 4000 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.
The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for the MED 4000 Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory document does not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or detailed performance metrics as would be found in a later clinical trial or a more recent AI/ML device submission.
The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy and safety through comprehensive studies for novel devices.
Therefore, the specific information requested cannot be extracted directly from these documents. Here's why and what can be inferred:
- A table of acceptance criteria and the reported device performance: Not provided. The 510(k) essentially states the device is "substantially equivalent" to predicate devices for the given indications. No quantitative performance metrics or specific acceptance criteria are listed in this document.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. A 510(k) submission for a TENS device from 1999 would likely rely on existing data and performance of predicate devices, or potentially very limited non-clinical testing if specified. No details about a specific test set, its size, or provenance are in this letter.
- 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 or provided. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation), which is not the primary focus of a TENS device submission for chronic pain relief.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided. Similar to point 3, this is for assessments needing expert consensus.
- 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. The MED 4000 is a TENS device, not an AI/ML diagnostic tool or an AI-assisted device for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The MED 4000 is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated in the provided documents. For TENS devices, "ground truth" for chronic pain relief would typically be patient-reported outcomes or pain scales, observed through clinical studies. However, the 510(k) itself does not detail such studies or their ground truth methodologies.
- The sample size for the training set: Not applicable. This refers to machine learning models, which the MED 4000 is not.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided documents:
The documents confirm the MED 4000 TENS device received 510(k) clearance (K993823) from the FDA on November 19, 1999. This clearance signifies that the device was deemed "substantially equivalent" to a predicate device marketed prior to May 28, 1976, or reclassified devices. The stated "Indications For Use" are for the symptomatic relief of chronic intractable pain by sending electrical impulses to block pain messages to the brain.
The 510(k) process in 1999 primarily required demonstrating that the new device was as safe and effective as a legally marketed predicate device, often by showing it had the same technological characteristics and indications for use, or that any new technological characteristics did not raise new questions of safety or effectiveness. It did not require the detailed performance studies, specific acceptance criteria, or AI/ML-related information requested in the prompt.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).