(352 days)
The AWQ-104 is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.
The device consists of a battery powered instrument with four channel outputs. A hand held probe allows treatment at individual sites. Output polarity, frequency, intensity, and voltage are controlled by four independent channels. Each channel drives a pair of self adhesive electrodes. A grounding pole electrically grounds the device when using the hand held probe.
The provided text describes a 510(k) submission for a transcutaneous electrical nerve stimulator (TENS) device, the AWQ-104. However, it does not contain a study proving the device meets specific acceptance criteria in the way medical imaging or AI diagnostic devices typically would.
Instead, the "Performance" section states that the device has been "designed and tested to conform to the following standards." This implies compliance with recognized safety and performance standards rather than a clinical study demonstrating efficacy against specific metrics for pain relief.
Therefore, the requested information elements related to a "study that proves the device meets the acceptance criteria" cannot be fully addressed from the provided text because such a study, with performance metrics like sensitivity, specificity, accuracy, or a multi-reader comparative effectiveness study, is not present.
Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Adherence to Safety Standards (e.g., electrical safety, biocompatibility, risk management) | "The AWQ-104 has been designed and tested to conform to the following standards: ISO 14971:2000, EN ISO 10993.1:1997/EN ISO 10993.5:1999/ EN ISO 10993.10.2002 EN 60601-1:1990+A1:1993+A2:1995+A13:1996/ IEC 60601-1:1988+A1:1991+A2:1995, EN 60601-1-2:2001/IEC 60601-1-2:2001, EN 980:2003." |
| Functional Equivalence to Predicate Device | "Both devices use one 9 volt battery. During stimulation, the electrical output for both devices is square waveform pulses. Details of electrical output are different but new safety concerns are not raised by the differences. Controls on each device modulate pulse outputs and regulate stimulation intensity. Material composition of the electrodes is identical. Electrode 510(k) number: K946230." The FDA letter also states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
| Intended Use | "The AWQ-104 is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain." (This is for a TENS device, which provides symptomatic relief, not a diagnostic or AI-powered device with performance metrics). |
Missing Information (Not applicable or not present in the document):
- 2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI diagnostic device. The "test set" would be the device itself undergoing engineering and safety tests, not a dataset of patient cases.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for pain relief via TENS is subjective and usually assessed clinically, not via expert labeling of data for a device performance study as described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a TENS device, "ground truth" for its effectiveness would typically be patient-reported pain scales or outcomes data from clinical trials. However, the provided document focuses on substantial equivalence to a predicate device and compliance with technical standards, not new clinical efficacy data.
- 8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a TENS device, which relies on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant safety and performance standards. It does not describe a clinical study with performance metrics or ground truth establishment in the way the prompt's questions imply for AI-powered or diagnostic devices.
§ 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).