(429 days)
The Neuro Wave 6 is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
The device consists of a battery powered portable instrument with 6 channel outputs.
Weight- 2.6 kg.
Color- Grey
Pulse Shape- Asymmetrical, Biphasic Triangular Wave
Pulse Rate- 1-100 Hz
Pulse Width-
Impedance Value: 500 ohms, 1000 ohms, 2000 ohms, 5000 ohms, 10000 ohms
Pulse Width: 280 uS, 240 US, 220 US, 220 uS, 220 uS
Output- 80 volts maximum (under 500 ohm test load)
Stimulation time- stimulation time is adjusted by the timer up to 60 minutes.
Device Controls- Clearly indicated are the ON/OFF (Power switch), Frequency Adjuster, Timer, and Output Intensity Knobs.
Power- 6 1.5 volt C batteries
The provided text is a 510(k) summary for the Neuro Wave 6 Transcutaneous Electrical Nerve Stimulator (TENS) device. It focuses on device specifications, intended use, and the FDA's regulatory decision regarding substantial equivalence to a predicate device (ES-160, K051020).
Crucially, this document does not describe any clinical study, acceptance criteria, or performance data for the Neuro Wave 6 device itself.
The 510(k) process for TENS devices often relies on demonstrating substantial equivalence to a predicate device, meaning the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed device. Clinical trials or detailed performance studies with acceptance criteria are not always required for 510(k) clearance, especially for well-established technologies like TENS.
Therefore, I cannot populate the table or answer most of the questions based on the provided text. The document confirms that:
- The intended use of the Neuro Wave 6 is identical to the predicate device, ES-160: symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
- The FDA reviewed the submission and found the device substantially equivalent, allowing it to proceed to market.
Based on the provided text, here's what can be stated and what cannot:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for Neuro Wave 6) | Reported Device Performance (Not Explicitly Stated in a Clinical Context) |
|---|---|
| Not provided in the document. The 510(k) focuses on substantial equivalence to a predicate, not performance against specific acceptance criteria. | The document provides technical specifications for the Neuro Wave 6, such as pulse shape (Asymmetrical, Biphasic Triangular Wave), pulse rate (1-100 Hz), pulse width (220-280 uS), and maximum output (80 volts). However, these are design specifications, not performance outcomes from a study proving clinical effectiveness against acceptance criteria. |
Detailed Study Information (Not available in the provided text)
- Sample size used for the test set and the data provenance: Not mentioned. No clinical test set data is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No test set or ground truth establishment is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 mentioned. This device is a TENS unit, not an AI-assisted diagnostic tool typically assessed with MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not applicable. No training set is involved for this type of device and submission.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided 510(k) summary is a regulatory filing document for a TENS device. It demonstrates substantial equivalence to a predicate device based on its technical specifications and intended use. It does not contain information about clinical studies, acceptance criteria for performance, or detailed data analysis typically found in reports of such studies. Therefore, I am unable to provide the requested information regarding study details and performance against acceptance criteria.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).