(435 days)
P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The P-Stim is a miniaturized, battery-powered, transcutaneous electrical nerve stimulator that has a pre-programmed frequency, pulse, and duration for the stimulation of auricular acupuncture points. The device connects via three stainless steel wires to acupuncture needles that have been applied to the appropriate auricular acupuncture points. The device is powered by three zinc air batteries, each with a voltage of 1.4 V. The device is on for 180 minutes, then off for 180 minutes, for a maximum period of up to 96 hours.
This device submission does not contain a study that demonstrates the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on proving new performance claims through a clinical or technical study with defined acceptance criteria.
Here's a breakdown based on the information provided and the absence of certain details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (Specific Metric & Threshold) | Reported Device Performance |
|---|---|---|
| Performance (Clinical/Technical) | Not defined in the provided document. | Not reported in the provided document. |
| Intended Use | Device is an electro-acupuncture device to stimulate auricular acupuncture points. | P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners to stimulate appropriate auricular acupuncture points. (Meets intention) |
| Operating Principles | Similar operating principles to the Acu-Stim. | Both P-Stim and Acu-Stim are transcutaneous electrical nerve stimulators with a single output channel and mode, and similar pulse widths and frequencies. (Meets intention) |
| Technological Characteristics | Technical differences from predicate do not affect safety or efficacy. | Statement made: "Technical differences do not affect the safety or efficacy of the product." (Meets intention) |
Notes on the Absence of Performance Criteria:
- The 510(k) summary for the P-Stim focuses on demonstrating substantial equivalence to a legally marketed predicate device (Acu-Stim, K014273).
- For substantial equivalence, manufacturers typically show that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. This often does not involve new clinical performance studies unless the technological differences are significant enough to warrant them.
- The document states, "Substantial equivalence is claimed because the P-Stim has the same intended use and similar operating principles to the Acu-Stim." This is the primary "acceptance criterion" for a 510(k) submission of this nature.
2. Sample size used for the test set and the data provenance:
- Not applicable. The provided document does not describe a performance study with a test set. It's a regulatory submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process is described.
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 device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical electro-acupuncture stimulator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No performance study with ground truth is described.
8. The sample size for the training set:
- Not applicable. No training set is described.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth establishment is described.
In summary, the provided 510(k) summary for the P-Stim device is a regulatory document focused on demonstrating substantial equivalence to a predicate device, not on presenting data from a clinical or technical performance study with specific acceptance criteria, test sets, or ground truth.
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