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The INF 4160 PLUS 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.

INF 4160 PLUS is an Interferential Current Therapy Device. It generates a set of symmetric sinusoidal electrical signals which are delivered to the user or patient through lead cables to the electrode pads placed on the skin. The electric signals stimulate the nerves underneath. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.

This device, the INF 4160 PLUS, is being cleared through a 510(k) submission, which means it asserts substantial equivalence to a predicate device. This type of submission often focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical studies with specific acceptance criteria as might be seen for novel devices.

Based on the provided document, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "INF4160 PLUS complies with the following standard. EN60601-1 Safety requirement EN60601-1-2 EMC requirements." and "The design control follows the FDA quality system requirement and the software verification has been carried out according to the FDA software guidance."

The primary "study" or demonstration of meeting acceptance criteria for this 510(k) submission is the comparison to the predicate device (IF-4000 [510(k) No.: K952683]) and compliance with relevant safety and EMC standards. There was no clinical testing performed for this device, as explicitly stated in section 8. The conclusion relies on the similarity in operating principle, intended use, and power sourcing to the predicate device, along with adherence to non-clinical standards and quality system requirements.

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Size: Not applicable. No clinical test set was used, as no clinical testing was performed.
• Data Provenance: Not applicable. Since no clinical testing was conducted, there's no data provenance from patient samples to report. The evidence relies on technical comparisons and compliance with engineering standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Not applicable. No clinical test set or ground truth established by experts for clinical performance was used.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical test set was used, there was no adjudication method employed.

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

• No. This is not an AI-powered device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a medical device (Interferential Stimulator) and not an algorithm or AI product. Its performance is inherent in its electrical signal generation and delivery, not in an 'algorithm-only' sense.

7. The type of ground truth used

• The "ground truth" in this context is established by regulatory standards and successful clearance of the predicate device. The fundamental premise is that if the new device is sufficiently similar to a previously cleared device and meets applicable non-clinical safety standards, it is considered safe and effective.
  • Predicate Device Equivalence: The primary ground truth is the established safety and effectiveness of the predicate device, IF-4000 (K952683).
  • Regulatory Standards: Compliance with EN60601-1 (Safety) and EN60601-1-2 (EMC) serves as a ground truth for physical and electrical safety.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model, so there is no training set in that sense.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set, there is no ground truth for a training set to establish.

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