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The WL-2206B and WL-2106E are the device which generates the small true-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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the IF series True sine interferential stimulator:

First, it is important to note that the provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study demonstrating new efficacy or specific performance metrics with acceptance criteria, as one might find for a novel or higher-risk device.

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

1. A table of acceptance criteria and the reported device performance:

The document does not provide a specific table of acceptance criteria with detailed performance metrics for the device's clinical efficacy (e.g., pain reduction scores, percentage of patients achieving a certain relief level). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to an existing predicate device and compliance with relevant standards.

Therefore, the table would look like this, highlighting the lack of specific quantitative clinical performance criteria in this type of submission:

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Intended Use	The device's intended use must be the same as the predicate device.	"The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain," which is explicitly stated as the intended use, implying it matches the predicate.
Technological Characteristics	The device's fundamental technological characteristics must be substantially equivalent to the predicate device.	"The WL-2206B and WL-2106E have output characteristics and controls that are identical to those of the predicate device." (WL-2206B is functionally identical; WL-2106E has different control interface but same output characteristics). "Verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
Safety and Effectiveness	The device must demonstrate the same safety and effectiveness as the predicate device.	"Verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device." "In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device."
Compliance with Standards	Compliance with applicable voluntary standards.	"Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement."
Software Verification	Software verification according to FDA software guidance.	"In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance."

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

Sample Size for Test Set: The document does not describe a clinical test set with human subjects as part of its substantial equivalence argument. The "verification and validation tests" mentioned are likely engineering and performance bench tests rather than clinical trials.
Data Provenance: Not applicable, as there's no mention of a clinical test set with human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There's no mention of a test set requiring expert ground truth establishment for clinical outcomes. The "ground truth" for the engineering tests would be derived from physical measurements and specifications compared against the standards.

4. Adjudication method for the test set:

Not applicable, as there's no mention of a human-reviewed test set requiring adjudication.

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 device is an interferential stimulator, which is a physical therapy device. It does not involve "readers" or "AI assistance" in the context of diagnostic imaging analysis. Therefore, an MRMC study is not relevant to this device.

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

Not applicable. This is not an AI-driven or algorithmic diagnostic device. The device's "performance" is its ability to generate electrical current as specified and safely, not an interpretation of data by an algorithm.

7. The type of ground truth used:

The de facto "ground truth" for this submission is the predicate device (WL-2206A2 K060975). The new devices are considered substantially equivalent if they meet the same specifications and perform safely and effectively as the predicate device, and comply with relevant voluntary standards (ANSI/AAMI, EN 60601-1, EN 60601-1-2) for electrical safety and performance.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this device.

In summary:

This 510(k) submission relies on demonstrating substantial equivalence to a predicate device and compliance with established performance and safety standards, rather than presenting a novel clinical study with quantitative performance metrics and acceptance criteria for a new clinical claim. The "study" mentioned refers to "verification and validation tests" which are typically engineering and bench tests to confirm the new device's technical specifications and safety are comparable to the predicate and comply with recognized standards.

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