(181 days)
The Bionicare Stimulator System Model BIO-1000" is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffiess associated with pain, from rheumatoid arthritis of the hand.
The Bionicare Stimulator System, Model BIO-1000" is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. Electrodes are applied to the hand and arm using a standard clectrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08). The signal is applied across the cathodic hand electrode and the anodic arm electrode.
The provided 510(k) summary for the "Bionicare® Stimulator System, Model BIO-1000™" does not contain information about a study proving the device meets specific acceptance criteria in the manner described by your request.
This 510(k) submission primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device (another Bionicare Stimulator System, Model BIO-1000™ for osteoarthritis of the knee). The "performance data" mentioned refers to electrical characteristics and compliance with voluntary standards, rather than clinical efficacy or specific performance metrics against pre-defined acceptance criteria for the new indication (rheumatoid arthritis of the hand).
Therefore, I cannot populate the requested table and answer the study-related questions as the provided document does not describe such a study and acceptance criteria in the context of device performance for its intended clinical use.
Here's a breakdown of why the information isn't available in the provided text:
- No Clinical Study Details: The document makes no mention of a clinical trial (prospective or retrospective), patient cohorts, ground truth established by experts, or statistical analysis of device performance (sensitivity, specificity, accuracy) against a clinical endpoint.
- Focus on Substantial Equivalence: The core of this 510(k) is to show that the new device (for rheumatoid arthritis of the hand) is equivalent to a predicate device (for osteoarthritis of the knee) based on similar technological characteristics and the same underlying mechanism (TENS).
- "Performance Data" Defined Differently: The section titled "Performance Data" explicitly states it provides "greater detail regarding the Bionicare's electrical characteristics, its conformance with voluntary standards." This refers to engineering and safety specifications, not clinical performance metrics.
In summary, the provided text describes a regulatory submission centered on demonstrating substantial equivalence based on technological characteristics and compliance with industry standards, not on presenting a clinical study proving device efficacy against specific 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).