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K Number
K020516
Device Name
CARE IFC PLUS
Manufacturer
CARE REHAB, INC.
Date Cleared
2002-05-16

(90 days)

Product Code
LIH
Regulation Number
882.5890
Type
Traditional
Panel
NE
Reference & Predicate Devices
K924961
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain

Device Description

A portable Interferential device for pain control

AI/ML Overview

The provided text describes a 510(k) summary for the "CARE IFC plus™" interferential stimulator. This device is a portable interferential device for pain control, and its 510(k) submission relies on demonstrating substantial equivalence to a predicate device (HMP4000 Interferential Stimulator, K924961) through bench testing. This means that no clinical studies were conducted to establish acceptance criteria or device performance based on human data.

Therefore, the requested information, which pertains to clinical study design and results, cannot be provided directly from the given text.

Here's a breakdown of why each point cannot be addressed:

  1. A table of acceptance criteria and the reported device performance: This document explicitly states "Clinical Testing: Not applicable." The "acceptance criteria" here would be related to electrical output characteristics, and the "reported device performance" would be comparing those electrical characteristics to the predicate device. The document states: "Bench testing demonstrated that the output characteristics or CARE IFC plus™ are substantially equivalent to that of the predicate device."
  2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth was established by experts for clinical performance.
  4. Adjudication method for the test set: Not applicable as no clinical test set was used.
  5. 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 as this is not an AI device, and no MRMC study was conducted.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI device. The "standalone" performance here would refer to the bench testing of the device's electrical output.
  7. The type of ground truth used: For regulatory purposes of substantial equivalence in this context, the "ground truth" was the electrical output characteristics of the predicate device. The CARE IFC plus™ device was tested to ensure its electrical output matched these characteristics within acceptable parameters.
  8. The sample size for the training set: Not applicable as no training set (in the machine learning sense) was used.
  9. How the ground truth for the training set was established: Not applicable as no training set was used.

In summary: The submission for the CARE IFC plus™ relied on demonstrating substantial equivalence in technological characteristics (specifically, electrical output) through bench testing against a legally marketed predicate device, rather than through clinical studies with human participants. Therefore, the detailed information requested about clinical acceptance criteria, study populations, expert ground truth, and AI performance metrics is not contained within this 510(k) summary.

§ 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).