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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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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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The Ttech Model 200E + TENS Device is intended for symptomatic relief of chronic intractable pain.

The Ttech 200E + TENS Device is a battery-operated device that includes controllable output channels. This TENS device creates electrical impulses whose intensity, duration, number per second and modulation can be altered with the controls and switches. There are two separate amplitude controls (channels). Every channel can be connected with the lead wire, on which two pieces of electrodes are to be connected to the end of the wire to provide stimulation for the intended part of the body.

There are three operation modes:

• . Convention Mode (c)
• Burst Mode (b)
• Modulated Mode (c) .

The operator may choose any one of them, as applicable.

The device includes the following:

• 1 TENS Unit .
• . 2 Leads
• 1 9v Battery ●
• 1 Operation Manual .
• 1 Carrying Case .

The provided document is a 510(k) summary for the Ttech Model 200E + TENS Device, submitted in 2002. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria derived from clinical trials.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not specify quantitative acceptance criteria for the device's therapeutic effect (e.g., reduction in pain scores by a certain percentage). Instead, the acceptance criteria are entirely based on demonstrating technical and functional equivalence to a legally marketed predicate device and compliance with relevant safety and performance standards.

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

No test set for clinical performance was used or described. The submission relies on a comparison to a predicate device and adherence to engineering standards. There is no information regarding sample size or data provenance related to clinical testing.

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

Not applicable. No ground truth for a clinical test set was established as no clinical testing was performed for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. The submission explicitly states "Discussion of Clinical Tests Performed: Not Applicable."

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

Not applicable. This device is a TENS unit, not an algorithm, and its performance is evaluated through comparison to a predicate device and engineering standards, not through standalone or human-in-the-loop algorithmic performance studies.

7. The Type of Ground Truth Used

The "ground truth" in this submission is the demonstrated "substantial equivalence" to a predicate device for safety and effectiveness, supported by compliance with relevant FDA guidance and international electrical safety standards (IEC 60601-1 and IEC 60601-1-2). There is no "clinical ground truth" in the sense of patient outcomes or pathology reports directly established for this specific device in this submission.

8. The Sample Size for the Training Set

Not applicable. No training set was used as this is not an AI/ML device requiring a training set.

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

Not applicable. No training set was used.

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As an NMES device, the Ttech NMES is indicated for the following conditions:

• Relaxation of muscle spasms .
• . Prevention or retardation of disuse atrophy
• Increasing local blood circulation .
• . Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis; and
• t Maintaining or increasing range of motion

The Ttech NMES is a dual channel NMES device that produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with their lead wires, a battery (9 volt), carrying case, and instructions for use make up the Ttech NMES system.

The provided document is a 510(k) premarket notification for the Ttech NMES device. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain specific acceptance criteria or an analytical study that proves the device meets such criteria in the way typically found for AI/ML-based medical devices with performance metrics like sensitivity, specificity, etc.

Instead, the document focuses on bench testing to demonstrate safety and performance equivalence to existing predicate devices. The conclusion explicitly states: "Bench testing raised no additional patient safety or performance issues so clinical testing was not indicated." This implies equivalence was established through non-clinical means.

Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable or present in this document.

Here's an attempt to answer the questions based on the provided text, while highlighting what is not present:

Acceptance Criteria and Study Details for Ttech NMES

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating that the Ttech NMES device performs "Good" in critical functions like "Current pulse regulation" and that its output parameters are within a range comparable to the predicate devices. The study performed was primarily bench testing to ensure safety and performance equivalence, rather than a clinical trial measuring specific performance metrics against pre-defined acceptance thresholds.

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

Not applicable. The document describes non-clinical "bench testing" and does not refer to a "test set" in the context of patient data for performance evaluation. The data provenance would be laboratory testing in a controlled environment.

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

Not applicable. No expert ground truth on patient data was established, as no clinical testing was performed or deemed necessary.

4. Adjudication method for the test set

Not applicable. No test set involving human interpretation and adjudication was used.

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 device is a powered muscle stimulator (NMES), not an AI/ML-based diagnostic or assistive technology for human readers. No MRMC study was performed.

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

Not applicable. This device is electro-mechanical, not an algorithm.

7. The type of ground truth used

For the safety and performance features, the "ground truth" was established through engineering standards and specifications (e.g., 21 CFR 898 for patient lead safety) and direct comparison of electrical output parameters against established values for predicate devices. There is no biological or clinical "ground truth" like pathology or outcomes data mentioned in this submission.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. See point 8.

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