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510(k) Data Aggregation
(222 days)
BioniCare Hand System
The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand.
The BioniCare Hand System, Model BIO-2000, is indicated for use as an adjunctive therapy in osteoarthritis of the hand to reduce the level of pain and stiffness and to improve the function of the hand.
The BioniCare Hand System, Model BIO-2000 is portable, rechargeable, battery-operated, single Channel device that utilizes a voltage regulated output circuit to generate a spike-shaped Monophasic pulse with adjustable amplitude of 0 - 15 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. The device consists of electrodes, lead wires and a signal generator (BioniCare® Stimulator).
Please note that the provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining strict acceptance criteria for a novel device. The "clinical study results and summary" section describes a study done to support the device's efficacy, but it doesn't establish explicit acceptance criteria in the format typically seen with a novel AI/medical device.
Based on the information provided, here's a breakdown of the closest approximations to your requested points:
A. Table of "Acceptance Criteria" and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense (e.g., minimum sensitivity or specificity targets). Instead, it presents effect sizes from a clinical study to demonstrate the device's efficacy in conditions for which it seeks indications. The "acceptance" is implicitly tied to these observed effect sizes being considered favorable and robust enough to support the intended use, especially when compared to benchmarks like the effect sizes of NSAIDs.
| Performance Metric (Proxy for Acceptance Criteria) | Reported Device Performance (Effect Size) |
|---|---|
| OA pain in the study hand (past 48 hours) | 1.3 (Large effect) |
| OA pain in the study thumb (past 48 hours) | 0.8 (Moderate effect) |
| Patient global assessment | 1.2 (Large effect) |
| Physician global assessment | 1.1 (Large effect) |
| DASH Score (Functional outcome) | 0.5 (Moderate effect) |
| Pinch force (Functional outcome) | 0.4 (Small effect) |
| Grip strength (Functional outcome) | 0.3 (Small effect) |
B. Sample Size and Data Provenance for the Test Set
- Sample Size: 82 patients were enrolled in the study. (66 females, 16 males)
- Data Provenance: The study was a "prospective, multi center, open-label study." The patients were "entered from the investigating physicians practice, without advertising." The document does not specify the country of origin of the data, but given the FDA submission, it's highly likely to be U.S.-based.
C. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their specific qualifications for the "test set" (clinical study data). However, it mentions "physician global assessment" as an efficacy outcome, implying that the assessing physicians served as experts in evaluating the patient's condition. Their qualifications are implicitly that they are "investigating physicians" capable of diagnosing and managing osteoarthritis.
D. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study data. It was an "open-label study."
E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI or imaging device where human reader interpretation would be assisted by AI. The clinical study evaluated the device's direct effect on patients.
F. Standalone Performance
The "standalone performance" of the device is implicitly represented by the clinical study results described in section A and B. The device operates independently on the patient, and the study measures its direct therapeutic effect. There is no "human-in-the-loop" interaction in the typical sense of interpreting AI outputs.
G. Type of Ground Truth Used
The ground truth or primary outcome measures were based on:
- Patient-reported pain (VAS scale)
- Patient global assessment
- Physician global assessment
- Validated functional assessment questionnaire (DASH score)
- Objective physical measurements (pinch force, grip strength using JAMAR Hand Assessment Kit)
These are clinical outcomes and patient self-assessments, commonly used in clinical trials for pain and functional improvement.
H. Sample Size for the Training Set
The document does not mention a training set. This device is a physical therapeutic device (a stimulator), not a machine learning or AI algorithm that requires a training set. The clinical study described served as the primary evidence for its efficacy for regulatory submission.
I. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for this device, this question is not applicable.
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