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The Classic NMS is recommended for use for the following conditions:

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

A portable NMS device for pain control.

The provided text is a 510(k) summary for a neuromotor stimulator (NMS) device. It states that clinical testing was "Not applicable" because the device demonstrated substantial equivalence to a predicate device through bench testing of electrical output characteristics. Therefore, a study demonstrating the device meets specific acceptance criteria as you've requested was not performed, nor was it required for this 510(k) clearance.

This means I cannot provide the detailed information you've asked for regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth, as these elements were not part of the submission or FDA's review for this particular device based on the provided document.

Here's a summary based on the information available:

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

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

• Sample Size: Not applicable, as no clinical test set was used. Bench testing was performed on the device itself.
• Data Provenance: Not applicable.

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

• Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set

• Not applicable, as no clinical test set requiring 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

• No MRMC comparative effectiveness study was done. This device is a neuromotor stimulator, not an AI-assisted diagnostic or imaging device, so "human readers" and "AI assistance" are not relevant in this context.

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

• Not applicable. This is a physical neuromotor stimulator, not an algorithm.

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

• Not applicable, as no clinical ground truth was established or used. The basis for clearance was substantial equivalence in electrical output characteristics to a predicate device.

8. The sample size for the training set

• Not applicable, as no clinical training set was used.

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

• Not applicable, as no clinical training set was used.

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Symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain

A portable Interferential device for pain control

The provided text describes a 510(k) summary for the "CARE IFC plus™" interferential stimulator. This device is a portable interferential device for pain control, and its 510(k) submission relies on demonstrating substantial equivalence to a predicate device (HMP4000 Interferential Stimulator, K924961) through bench testing. This means that no clinical studies were conducted to establish acceptance criteria or device performance based on human data.

Therefore, the requested information, which pertains to clinical study design and results, cannot be provided directly from the given text.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This document explicitly states "Clinical Testing: Not applicable." The "acceptance criteria" here would be related to electrical output characteristics, and the "reported device performance" would be comparing those electrical characteristics to the predicate device. The document states: "Bench testing demonstrated that the output characteristics or CARE IFC plus™ are substantially equivalent to that of the predicate device."
2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth was established by experts for clinical performance.
4. Adjudication method for the test set: Not applicable as no clinical test set 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 as this is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI device. The "standalone" performance here would refer to the bench testing of the device's electrical output.
7. The type of ground truth used: For regulatory purposes of substantial equivalence in this context, the "ground truth" was the electrical output characteristics of the predicate device. The CARE IFC plus™ device was tested to ensure its electrical output matched these characteristics within acceptable parameters.
8. The sample size for the training set: Not applicable as no training set (in the machine learning sense) was used.
9. How the ground truth for the training set was established: Not applicable as no training set was used.

In summary: The submission for the CARE IFC plus™ relied on demonstrating substantial equivalence in technological characteristics (specifically, electrical output) through bench testing against a legally marketed predicate device, rather than through clinical studies with human participants. Therefore, the detailed information requested about clinical acceptance criteria, study populations, expert ground truth, and AI performance metrics is not contained within this 510(k) summary.

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TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

A portable TENS device for pain control.

The CLASSIC TENS™ device, a transcutaneous electrical nerve stimulator (TENS) for pain relief, did not require a study proving its performance against acceptance criteria in the traditional sense, as it was cleared through the 510(k) pathway based on substantial equivalence to a predicate device.

Instead of clinical performance testing, the submission focused on comparing the technological characteristics and labeling of the CLASSIC TENS™ to a legally marketed predicate device (Matrix I, K895473).

Here's a breakdown of the information based on the provided text, addressing your points as much as possible within the context of a 510(k) submission for a TENS device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The device relies on bench testing for technological comparison, not a "test set" of patient data in the typical sense.
• Data Provenance: Not applicable. The "testing" involved bench testing of the device itself against the predicate device's specifications, not clinical data from patients.

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

• Not applicable. Ground truth in this context refers to the characteristics and performance of the predicate device, established by previous FDA clearance and regulatory standards, not by individual experts assessing a test set.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" of cases requiring adjudication by experts.

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

• No Multi-Reader Multi-Case (MRMC) study was done. This type of study is typically used for diagnostic or screening devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This TENS device is a therapeutic device, and its clearance was based on substantial equivalence through bench testing, not clinical performance studies involving human readers.

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

• Yes, in essence, a standalone evaluation was done, but not in the context of an "algorithm." The "Nonclinical Testing" section states "Bench testing demonstrated that the output characteristics or CLASSIC TENS™ are substantially equivalent to that of the predicate device." This means the device's electrical output and technological features were directly evaluated and compared to the predicate without human intervention in operating the device for patient therapy during the evaluation.

7. The Type of Ground Truth Used

• The ground truth used was the established performance and safety profile of the predicate device (Matrix I, K895473), as determined by its prior FDA clearance and existing regulatory standards for TENS devices. The "bench testing" served to confirm that the CLASSIC TENS™ adhered to these established parameters.

8. The Sample Size for the Training Set

• Not applicable. As a TENS device, there is no "training set" in the context of machine learning. The device's design and manufacturing are based on established engineering principles and regulatory standards for TENS units.

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

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

Summary of the Study (Bench Testing and Comparison):

The "study" in this context refers to the bench testing performed to demonstrate the substantial equivalence of the CLASSIC TENS™ to its predicate device, Matrix I (K895473).

• Objective: To show that the CLASSIC TENS™ has comparable technological characteristics, electrical output, and intended use as the predicate device, and that any differences do not raise new questions of safety or effectiveness.
• Methodology:
  • Technological Comparison: The physical design, components (specifically, the jacks and cables), and overall technological characteristics of the CLASSIC TENS™ were compared to the predicate. The only noted difference was the use of FDA-compliant jacks and cables.
  • Nonclinical Testing (Bench Testing): Specific tests were performed on the CLASSIC TENS™ to measure its electrical output characteristics (e.g., waveform, intensity, frequency) and these were compared directly to the known output characteristics of the predicate device.
  • Labeling Comparison: The proposed labeling for the CLASSIC TENS™ was reviewed and compared to the predicate device's labeling to ensure consistency in indications for use, warnings, and instructions.
• Results/Conclusion: The bench testing and comparisons demonstrated that the CLASSIC TENS™ is "substantially equivalent" to the predicate device. This equivalence formed the basis for the FDA's 510(k) clearance, allowing the device to be marketed.

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TENS is used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.

A portable TENS device for pain control.

This K984025 submission describes a TENS (Transcutaneous Electrical Nerve Stimulation) device called CARE TENS. It's important to note that this is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a de novo submission that establishes new performance criteria. Therefore, the "acceptance criteria" here are primarily based on equivalence to the predicate.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission relies on bench testing for technological comparison, not a clinical test set with patient data.
• Data Provenance: Not applicable, as no clinical data was used.

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 with ground truth was established, as the evaluation was based on bench testing for substantial equivalence to a predicate device.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or adjudication method 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 is a TENS device, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

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

• The device itself is a standalone TENS unit. Its "performance" was assessed by comparing its electrical output characteristics to a predicate device through bench testing. There is no "algorithm" in the context of AI being evaluated here.

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

• Not applicable in the traditional sense of clinical ground truth. The "ground truth" for the comparison was the electrical output specifications and performance characteristics of the predicate device (Matrix I, K895473), as determined through bench testing.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or AI models that require a training set.

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

• Not applicable, as there is no training set for this type of device submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the CARE TENS device meets its acceptance criteria (implicitly, substantial equivalence to the predicate) was nonclinical bench testing.

• Methodology: Bench testing was performed to compare the output characteristics of the CARE TENS to its predicate device, Matrix I (K895473). The comparison also included verifying compliance with FDA's Final Rule regarding electrode lead wires and patient cables, which was the only stated technological difference.
• Results: The bench testing demonstrated that the electrical output characteristics of the CARE TENS were "substantially equivalent" to those of the predicate device. The report concluded that any differences between the devices (specifically, the updated jacks and cables) did not raise new questions of safety and effectiveness.
• Conclusion: Based on this nonclinical testing, the FDA determined that the CARE TENS was substantially equivalent to the predicate device, allowing it to be marketed.

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