(63 days)
The INF 4160 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
The INF 4160 is a rechargeable battery operated Interferential Current Therapy Device. Its internal circuitry can generate symmetrical sinusoidal waveforms. The associated outputs are delivered through lead cables to electrodes placed on the user/patient skin. The output passes through the skin and activates the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
The provided text describes a 510(k) summary for the device INF 4160, an Interferential Stimulator. However, it explicitly states that no clinical testing was performed for this device as it did not introduce new or innovative aspects.
Therefore, the requested information regarding acceptance criteria derived from a study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for test and training sets cannot be extracted from this document, as such a study was not conducted.
Here's a breakdown of what can be inferred from the document regarding the lack of such a study:
- Acceptance Criteria and Reported Device Performance: This information is not provided as no clinical study was performed.
- Sample Size (test set) and Data Provenance: Not applicable, as no clinical study was performed.
- Number of Experts and Qualifications: Not applicable, as no clinical study was performed requiring expert review.
- Adjudication Method: Not applicable, as no clinical study was performed.
- MRMC Comparative Effectiveness Study: "Not Applicable as there are no new or innovative aspects that have been introduced." This directly indicates that a multi-reader multi-case comparative effectiveness study was not done.
- Standalone Performance: Not applicable, as no clinical study was performed.
- Type of Ground Truth: Not applicable, as no clinical study was performed.
- Sample Size (training set): Not applicable, as no clinical study was performed for the device itself that would involve a training set.
- How ground truth for training set was established: Not applicable, as no clinical study was performed.
The document indicates that the device's substantial equivalence to the predicate device (IF-4000, K952683) was established based on:
- Similar intended use.
- Similar technical characteristics.
- Compliance with applicable voluntary standards (ANSI/AAMI NS4-1986 and EN 60601-1-2).
- Software verification carried out according to FDA software guidance.
- The primary difference, a rechargeable battery pack, was determined not to affect safety and effectiveness.
§ 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).