(95 days)
The Bionicare® Stimulator System Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician's global evaluation (see clinical studies).
The Bionicare® Stimulator, 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 knee and thigh using a standard electrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08), The signal is applied across the cathodic knee electrode and the anodic thigh electrode.
Here's an analysis of the Bionicare Stimulator System, Model BIO-1000, based on the provided 510(k) summary, structured to address your specific points:
K971437: Bionicare® Stimulator System, Model BIO-1000 Analysis
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a clinical study to demonstrate the device's effectiveness. However, it does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for statistical significance or clinical relevance that the device needed to meet. Instead, it reports the findings of the study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device must not cause unanticipated adverse effects. | No unanticipated adverse effects reported. Skin rash (39% active, 27% placebo) was observed, similar to literature findings for TENS, transient, resolved with intervention, and attributed to electrode gel. |
| Effectiveness: Must provide "significant improvement" in patients' self-evaluation of pain and physicians' global evaluation of the treated knee in osteoarthritis. | Daily treatment with Bionicare resulted in a clinically relevant and statistically significant reduction in signs and symptoms of osteoarthritis of the knee. Significant improvements in the Bionicare active device group vs. placebo group for: |
| * Physician's global evaluation of the treated knee (statistically significant, both absolute and percentage change). | |
| * Patient's evaluation of pain in the treated knee (statistically significant, both absolute and percentage change). | |
| * Patient's self-evaluation of knee function showed trends favoring the active device group (not statistically significant). | |
| * Secondary efficacy outcomes (morning stiffness, knee tenderness, knee circumference) showed trends favoring the active device group. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the total number of participants in the clinical study. It refers to it as a "multi-center, prospective, parallel, double-blinded, randomized, placebo device controlled clinical study."
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Prospective. The study design is explicitly stated as "multi-center, prospective, parallel, double-blinded, randomized, placebo device controlled clinical study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated. The study involved a "physician's global evaluation," implying multiple physicians across the multi-center study.
- Qualifications of Experts: The document refers to "physician's global evaluation," implying licensed medical doctors. Specific specializations (e.g., orthopedic surgeon, rheumatologist) or years of experience are not provided.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth or resolving discrepancies among experts. Given the subjective nature of "physician's global evaluation" and "patient's self-evaluation of pain," a formal adjudication process may not have been deemed necessary or may not have been reported. The ground truth appears to be based on the individual assessments of the participating physicians and patients themselves.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Done?: No, a traditional MRMC study as understood in medical imaging for comparative effectiveness of human readers with vs. without AI assistance was not done. This device is an electrical stimulator, not an AI-powered diagnostic tool interpreting medical images. The comparative effectiveness study was between the active device and a placebo device.
- Effect Size of AI assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Done?: Yes, in a sense. The clinical study evaluated the Bionicare Stimulator as a standalone intervention (the "active device group") compared to a "placebo device group." The device itself does not involve an AI algorithm that performs a diagnostic or assistive function requiring a "human-in-the-loop" assessment. Its performance is measured by its direct effect on patient symptoms and physician evaluation.
7. Type of Ground Truth Used
The ground truth for effectiveness was established through:
- Expert Consensus/Opinion: The "physician's global evaluation of the active device treated knee." This represents the subjective clinical judgment of the treating physician(s).
- Patient-Reported Outcomes: The "patient's self evaluation of pain in the treated knee" and "patient's self evaluation of knee function."
- Clinical Measurements/Observations: Secondary efficacy outcomes included "morning stiffness, knee tenderness and knee circumference," suggesting objective or semi-objective clinical assessments.
8. Sample Size for the Training Set
- Not Applicable. The Bionicare Stimulator System is an electrical medical device and does not involve an AI algorithm that requires a "training set" in the context of machine learning. The clinical study served as a validation (test) set for its effectiveness, not a training set.
9. How Ground Truth for the Training Set Was Established
- Not Applicable. As explained in point 8, there is no AI algorithm training set for this device.
§ 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).