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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-2206A1 and WL-2206A2 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. Through the current stimulation the chronic and/or acute pain is to be relieved.

The provided text is a 510(k) summary for an interferential stimulator device, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific metrics (like MRMC studies or standalone performance) is not applicable or available in this document.

The document focuses on demonstrating substantial equivalence to a predicate device (WL-2206A, K050847) by proving that engineering differences do not affect intended use or alter fundamental scientific technology.

Here's a breakdown of what is available based on the provided text, and why the requested information isn't present:

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

• Not Applicable in this context. This device is an interferential stimulator, not an AI/ML diagnostic tool. The "performance" assessment focuses on showing that the new models (WL-2206A1 and WL-2206A2) maintain the same safety and effectiveness as the predicate device (WL-2206A).
• Reported "performance" (as described): "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."
• Acceptance Criteria Mentioned (for substantial equivalence):
  • Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.
  • Software verification according to FDA software guidance.
  • Engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device compared to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. Clinical test sets with patient data are not described for this type of device submission. The verification and validation tests are likely engineering and electrical performance tests, not clinical studies in the AI/ML sense.

3. 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. "Ground truth" in the AI/ML sense (e.g., expert consensus on clinical findings) is not relevant for this physical stimulator device. The "ground truth" for its safety and effectiveness is tied to engineering standards and a comparison to a legally marketed predicate.

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

• Not Applicable. No clinical test set requiring adjudication of findings is described.

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. This is not an AI/ML device, so no MRMC study would be conducted.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. As mentioned, "ground truth" in the AI/ML context is not relevant here. The "truth" for this device revolves around meeting established electrical, safety, and performance standards as set against a predicate device.

8. The sample size for the training set

• Not Applicable. This device does not use a "training set" in the machine learning sense.

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

• Not Applicable. No training set exists for this device.

In summary: The provided 510(k) summary is for an electro-medical stimulator device (IF series True sine interferential stimulator / Model: WL-2206A1 & WL-2206A2), not an AI/ML-driven device. As such, the study design and criteria requested are based on AI/ML device approval processes and are fundamentally different from what is described in this document. The submission focuses on demonstrating substantial equivalence to a predicate device through engineering verification and validation, and compliance with general safety standards.

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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-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.

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):

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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