(126 days)
The BioniCare® Stimulator, 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 (clinical studies.)
The BioniCare® Stimulator, Model BIO-1000™ consists of the electrodes, the lead wires, and the BioniCare Stimulator. The stimulator is portable, battery operated and rechargeable. The lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
This document is a 510(k) Summary for the BioniCare® Stimulator, Model BIO-1000™, a transcutaneous electrical nerve stimulator for pain relief associated with osteoarthritis of the knee. The document focuses on comparing the new device (Version B) to its predicate device (Version A) regarding technological characteristics and demonstrating substantial equivalence.
Based on the provided text, the complete information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted for the following reasons:
- No explicit "acceptance criteria" table is present. The document describes technological characteristics and claims substantial equivalence to a predicate device. It does not define specific performance metrics with target thresholds that the device must meet independently.
- No specific study designed to "prove the device meets acceptance criteria" is detailed. The document refers to "clinical studies" in the "Indications for Use" but does not provide details about these studies, their methodology, or their results in relation to specific performance criteria for the new device itself. The focus is on comparing the technological characteristics of the new device (Version B) against the predicate device (Version A).
Therefore, a table of acceptance criteria and reported device performance, and the detailed study information requested, cannot be fully generated from the provided text.
However, I can extract and infer some related information:
1. A table of acceptance criteria and the reported device performance
As mentioned, explicit acceptance criteria (e.g., minimum pain reduction % or specific improvement scores) are not provided for the new device. The document focuses purely on the technological equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Version B vs. Version A) |
|---|---|
| Electrical Output (Frequency): Same as predicate device | Same frequency at 100 ± 5Hz, fixed. |
| Waveform: Same as predicate device | Same monophasic spike shaped pulse. |
| Voltage Output Range: Same as predicate device | Same 0-12 volts peak. |
| Voltage Pulse Width: Same as predicate device | Same |
| Current Output Range: Same as predicate device | Same |
| Current Pulse Width: Same as predicate device | Same |
| Maximum Output Change/Channel: Same as predicate device | Same |
| Compliance with ANSI/AAMI NS-4: 1988: Same as predicate device | Both Version A and Version B comply with the standard ANSI/AAMI NS-4: 1988. |
| Ability to reduce pain and symptoms associated with OA of the knee and improve overall knee assessment: Implied to be equivalent due to technological equivalence. | 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 (clinical studies.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "clinical studies" in its Indications for Use, but offers no details about these studies, including sample size, design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document doesn't detail any specific "test set" or how its ground truth was established. The clinical context mentioned refers to "physician's global evaluation," implying expert assessment, but the number or qualifications of these physicians are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable as the device is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is an electrical stimulator, not an algorithm. Its performance is in delivering electrical signals to the body, not interpreting data or making diagnoses.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "Indications for Use" states that the device is indicated for reducing pain and symptoms and for "overall improvement of the knee as assessed by the physician's global evaluation (clinical studies)." This implies that expert assessment (physician's global evaluation) was a key type of outcome/ground truth in the underlying "clinical studies." However, no details on how "ground truth" was established for any specific "test set" for the new device's performance validation are provided.
8. The sample size for the training set
This information is not provided as the device is a hardware stimulator and not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as the device does not use a "training set."
§ 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).