Search Results

The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.

The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.

The provided text describes a 510(k) submission for the H-Wave® Sport, a powered muscle stimulator. The regulatory pathway for this device is based on substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria and performance metrics typically associated with AI/ML-based devices or therapies requiring more rigorous clinical evidence.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable to this specific 510(k) summary. The "study" referenced is largely laboratory bench testing to ensure the device functions as intended and supports the use of low-frequency stimulation for endurance and active recovery, rather than a clinical trial proving specific performance metrics against a defined ground truth.

Here's a breakdown of the applicable information based on the provided text:

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

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

• Test Set Sample Size: Not explicitly stated. The text refers to "laboratory bench testing" without specifying the number of devices tested or the specific test parameters.
• Data Provenance: The testing was "laboratory bench testing," implying an engineered environment rather than a human subject study. The country of origin for the data is not specified, but the applicant (Electronic Waveform Lab, Inc.) is based in Huntington Beach, CA, USA.
• Retrospective or Prospective: Not applicable as it was bench testing, not a human study.

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)

• Number of Experts: Not applicable. Ground truth in this context refers to engineering specifications and functional performance metrics, not clinical interpretation by experts.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. Adjudication is typically used for resolving discrepancies in expert interpretations in clinical studies.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable. This device is not AI-driven and does not involve human readers interpreting cases.

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

• Standalone Performance: Not applicable. This is a physical medical device (muscle stimulator), not an algorithm or AI. The "performance" refers to the device's electrical and mechanical functioning.

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

• Type of Ground Truth: The "ground truth" for the bench testing would be the device's design specifications and established engineering principles for powered muscle stimulators. Functional performance was assessed against these expected outcomes.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no training set in the AI/ML sense.

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

• Ground Truth Establishment for Training Set: Not applicable.

Ask a specific question about this device