(136 days)
Meditens XP: The symptomatic relief and management of chronic intractable pain. It is also an adjunctive treatment in the management of post-surgical and post-traumatic pain. The device has no curative value and should only be used in conjunction with medical supervision.
Medistim XP: Neuromuscular Electrical Stimulation (NMES) for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion. Transcutaneous Electrical Nerve Stimulation (TENS) for an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
Meditens XP and Medistim XP are portable two-channel battery operated stimulators. They consist of a Meditens XP or Medistim XP unit, instructions for use, 9-volt battery, two connecting lead-wires for connecting the stimulator unit to the electrodes, adhesive electrodes and a device box. The units for Meditens XP and Medistim XP are identical and can be identified by the use of different bezels. The software for each device is pre-configured during manufacturing and may not be accessed by either the user or clinician. Meditens XP offers a total of five treatment programs and Medistim XP offers nine treatment programs. Safety features are incorporated into the device to reduce the possibility of misuse.
This document is a 510(k) summary for two medical devices, Meditens XP and Medistim XP, which are muscle stimulators. It discusses their characteristics, intended use, and compliance with safety standards. However, it explicitly states that no clinical studies were submitted as part of this premarket notification. Therefore, the document does not contain any information regarding acceptance criteria or a study proving that the devices meet such criteria based on device performance.
Here's a breakdown of why the requested information cannot be provided from this document:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory compliance and substantial equivalence to predicate devices, not specific performance metrics.
- Sample size used for the test set and the data provenance: Not applicable, as no clinical performance data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 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. These are TENS/NMES devices, not AI-powered diagnostic tools.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): 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 explicitly states: "No clinical studies have been submitted as part of this premarket notification." This means the devices' acceptance for market clearance was based on their substantial equivalence to previously cleared predicate devices and compliance with relevant safety standards (EN 60601-1-2, EN 60601-1, IEC 60601-2-10), rather than new clinical performance data from a specific study outlined here. The risk management plan (I.S. EN ISO 14971) also contributes to the safety profile.
§ 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).