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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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Symptomatic relief of chronic intractable pain
Adjunctive treatment for the management of post-traumatic or post-surgical pain

The TENS/IF 14 is a combination TENS and Interferential device which delivers nerve stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device may be powered by either 4 AA batteries or by an AC adapter, that when plugged into a wall outlet provides 6 VDC to the unit. A patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours.

Here's an analysis of the provided 510(k) summary for the TENS/IF 14, focusing on acceptance criteria and the supporting study information:

Summary of Acceptance Criteria and Device Performance:

Study Information Pertaining to Acceptance Criteria:

1. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for a test set in the context of clinical or performance data. The testing primarily involved engineering performance and safety testing in accordance with IEC 60601-1-2.
   • Data Provenance: The standard testing (IEC 60601-1-2) would typically be conducted by the manufacturer or a certified testing laboratory. The document doesn't specify a country of origin for any "data" beyond the manufacturing and submission location. This is not a study involving patient data.

2. 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. This device's clearance is based on engineering and safety performance testing against a recognized standard (IEC 60601-1-2) and demonstration of substantial equivalence to predicate devices, not on a clinical test set requiring expert ground truth for diagnostic accuracy or treatment efficacy.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. As stated above, this was not a clinical or comparative performance study that would involve expert adjudication of results. The "adjudication" was effectively by the testing laboratory confirming compliance with the technical standard.

4. 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. This device is a transcutaneous nerve stimulator, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance is not relevant.

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

   • Not applicable. This is a physical medical device (nerve stimulator), not an algorithm or software-as-a-medical-device (SaMD). Its performance is inherent in its electrical output and safety, not in an algorithmic assessment.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the safety and performance testing, the "ground truth" was compliance with the technical specifications and safety limits defined by the IEC 60601-1-2 standard. There was no clinical ground truth (like pathology or outcomes data) being established for this type of submission.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set for this device.

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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The WL-2206 is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.

This 510(k) summary does not contain the information required to populate the requested table and sections regarding acceptance criteria and a study proving the device meets those criteria. The provided document is a 510(k) Summary for a medical device (IF series True sine interferential stimulator) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with specific acceptance criteria.

Specifically:

• No acceptance criteria or reported device performance are mentioned. The document states compliance with voluntary standards (ANSI/AAMI, EN 60601 series) and software verification, but these relate to safety and general electrical performance, not clinical efficacy or specific performance metrics that would typically have acceptance criteria.
• No study details are provided. The submission emphasizes that "verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." However, no details about these specific tests, their methodology, sample sizes, ground truth establishment, or results are given.
• The document explicitly states that the device has the "same intended use and technological characteristics" as the predicate devices, implying that no new clinical performance claims or studies are needed to establish effectiveness beyond demonstrating substantial equivalence to existing cleared devices.

Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. This information is not present in the provided 510(k) summary.

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