Search Results

The BioWaveGO Rx is indicated for prescription use for:

· Symptomatic relief of chronic, intractable pain

· Symptomatic relief of acute pain

· As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

The BioWaveGO Rx Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain relief based on the technology of parent devices BioWaveHOME. The BioWaveGO Rx device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain. The device is identical in design to the BioWaveGO cleared in K180943. However, this 510(k) seeks clearance of the device for prescription use. The BioWaveGO Rx has the identical battery and software to the original clearance in K180943.

This FDA 510(k) summary for the BioWaveGO Rx device does not contain a typical acceptance criteria table and performance study results. Instead, it focuses on demonstrating substantial equivalence to a predicate device (BioWaveGO, K180943) through a comparison of specifications.

The document explicitly states: "No additional testing was required for this Special 510(k)." This indicates that a new performance study with acceptance criteria was not conducted for the BioWaveGO Rx as part of this submission because it is deemed substantially equivalent in performance to its predicate. The substantial equivalence is based on the device being identical in design and indications to the predicate, with the only change being its availability for prescription use rather than over-the-counter.

Therefore, many of the requested elements for a performance study are not applicable or cannot be extracted from this document, as a specific new performance study wasn't part of this 510(k) submission.

Despite the lack of a dedicated performance study for this specific submission, I can present the information that is available and explain the context:

1. Acceptance Criteria and Reported Device Performance

As no new performance study was conducted, there are no specific acceptance criteria or reported device performance results from a new study presented in this document. The "performance" assessment is by comparison to the predicate device, asserting that its performance is equivalent due to identical design and function. The acceptance criteria, in this context, would be that the BioWaveGO Rx device demonstrates substantial equivalence to its predicate across all specified characteristics.

The table below summarizes the comparison points that implicitly serve as "performance" metrics for substantial equivalence:

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

Not applicable. As stated, "No additional testing was required for this Special 510(k)." The evidence for substantial equivalence relies on the existing clearance of the predicate device (BioWaveGO, K180943) and a reference device (BioWaveHOME, K152437), not a new clinical or performance test set for the BioWaveGO Rx.

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

Not applicable. No new human-read test set was established. This submission is a comparison of technical specifications against previously cleared devices.

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

Not applicable. No test set requiring expert adjudication was part of this submission.

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. The device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic imaging device or a device involving human readers or AI assistance in interpretation.

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

Not applicable. This device is a physical neuromodulation device, not an algorithm, and its performance is inherent to its electrical stimulation characteristics, not a standalone algorithmic output.

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

For the BioWaveGO Rx, the "ground truth" for its substantial equivalence claim is the demonstrated safety and efficacy of its predicate device (BioWaveGO, K180943), which previously underwent its own regulatory clearance process. The current submission's "ground truth" is that the new device largely mirrors the predicate's technical and performance characteristics.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, no training set was used.

Ask a specific question about this device