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The WL-2206A 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "IF series True sine interferential stimulator / Model: WL-2206A." It describes the device, its intended use, and its substantial equivalence to a predicate device (WL-2206, K024100).

However, the document does not contain details about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically expected for a medical device performance study (e.g., diagnostic accuracy, clinical effectiveness).

Instead, the submission for this device (an interferential stimulator used for pain relief) focuses on demonstrating substantial equivalence to a previously cleared device. This means the primary "study" is a comparison to the predicate device and compliance with relevant standards, rather than a de novo clinical trial with defined performance metrics, patient cohorts, and ground truth establishment.

Therefore, many of the requested details about acceptance criteria and a study proving performance are not available in the provided text.

Here's an breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence (Inferred):

Acceptance Criteria Category	Description (Inferred from 510(k))	Reported Device Performance
Intended Use	Same as predicate device (WL-2206).	"The WL-2206A ... has the same intended use..."
Technological Characteristics	Similar to predicate device (WL-2206).	"...and technological characteristics as the cleared device of WL-2206 (K024100)."
Safety	Maintain same safety as predicate device.	"verification and validation tests... demonstrate that the difference... could maintain the same safety..."
Effectiveness	Maintain same effectiveness as predicate device.	"...could maintain the same... effectiveness as that of cleared device."
Voluntary Standards Compliance	Compliance with ANSI/AAMI, EN 60601-1, EN 60601-1-2.	"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 carried out according to FDA guidance.	"In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance."
Engineering Differences Impact	Differences do not affect intended use or alter fundamental scientific technology.	"...those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device."

Actual performance metrics (e.g., pain reduction scores, specific electrical output specifications) are not detailed as acceptance criteria in this summary for the purpose of a clinical performance study. The acceptance criteria here are about equivalence and compliance.

2. Sample Size for the Test Set and Data Provenance

Not applicable/Not provided. This 510(k) summary does not describe a clinical performance study with a test set of patient data. The evaluation is based on technical specifications comparison and compliance with standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not provided. As there is no clinical performance study involving a patient test set, there is no mention of experts establishing a ground truth for diagnostic or outcome data.

4. Adjudication Method

Not applicable/Not provided. No adjudication method is described as there is no clinical performance study involving multiple reviewers or a ground truth process.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. The document does not describe an MRMC comparative effectiveness study. The device is for pain relief, and the submission focuses on substantial equivalence based on technical characteristics and intended use.

6. Standalone Performance Study

No. While the device itself will operate standalone for a patient, the submission does not detail a standalone performance study in the context of diagnostic accuracy or clinical outcomes that would typically be performed without human intervention for evaluation. The "tests performed" are non-clinical and focus on compliance and technical equivalence.

7. The Type of Ground Truth Used

Not applicable/Not provided in the context of clinical outcomes. The "ground truth" for this submission revolves around the predicate device's established safety and effectiveness and the new device's compliance with technical standards. It's not about a clinical ground truth like pathology or expert consensus on patient data.

8. The Sample Size for the Training Set

Not applicable/Not provided. This type of device (electrical stimulator) does not typically involve a "training set" in the machine learning sense for its primary function. Its design and validation rely on engineering principles, compliance with standards, and comparison to existing technology.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. As there is no training set mentioned, this information is not relevant.

In summary: The provided 510(k) summary focuses entirely on demonstrating substantial equivalence for the IF series True sine interferential stimulator (Model: WL-2206A) to its predicate device (WL-2206). It relies on comparisons of intended use, technological characteristics, and compliance with non-clinical voluntary standards and software verification guidance. It does not detail a clinical performance study with defined acceptance criteria, patient cohorts, ground truth establishment, or human reader performance metrics, as would be common for new diagnostic or AI-powered devices.

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