Search Results

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.

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.

Ask a specific question about this device

For Prescription Use Model SE-100:

• Relief of chronic intractable pain. .
• Adjunctive treatment of post-surgical or post-traumatic acute pain. .

For Prescription Use Models ST-150, ST-200 and ST-300:

• Relief of chronic intractable pain. .
• Adjunctive treatment of post-surgical or post-traumatic acute pain. .
• Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the ● knee.
• Adjunctive therapy in reducing the level of pain from rheumatoid arthritis of the hand. .

The MedRelief" ST Series™, consisting of models ST-100, ST-150, ST-200 and ST-300, is designed to provide subthreshold electrical stimulation for acute and chronic pain, including pain, including pain from osteoarthritis and rheumatoid arthritis, in a single compact, lightweight and user-friendly package. "Subthreshold" stimulation does not normally cause sensation or muscle contraction, but acts at a cellular level to relieve pain.

Each device in the ST Series is comprised of the following main components.

• A power section consisting of battery, switch, test and conditioning components; .
• A dosing timer, initialized at power-on and providing a choice of treatment times; .
• A control oscillator, providing pulse-burst timing; .
• A pulse oscillator, providing timing for individual pulses; and .
• An output section, providing filtering, DC blocking and intensity control.

While some components are digital, all functions are hard-wired and there is no microprocessor or software used. Output is by means of lead wires and skin-contact electrodes already commercially available and legally sold by others.

The member devices in the ST Series™ differ only in the complexity of their controls and number of physician or user options which each model offers.

The provided document (K060669) is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called the MedRelief ST Series. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on detailed clinical study results and acceptance criteria derived from them.

Therefore, the document does not contain the information required to fully answer the request, particularly regarding specific acceptance criteria for device performance, outcomes of a study proving those criteria were met, sample sizes, expert qualifications, or ground truth establishment.

However, based on the comparative tables, we can infer that the general acceptance criteria for the MedRelief ST Series are substantial equivalence in technological characteristics and intended use to the predicate devices. The study proving this, in the context of a 510(k), is the comparison of the proposed device's characteristics to those of the predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied to be that the proposed device's characteristics fall within acceptable limits or are the "same as" the predicate devices. The "reported device performance" is essentially the detailed description of the proposed device's characteristics.

The "study" proving these "criteria" are met is essentially the technical comparison presented in the 510(k) submission, where the characteristics of the MedRelief ST series are directly compared against those of the predicate devices (Healthonics MedRelief SE-50 and Bionicare Model BIO-1000). The FDA's issuance of the 510(k) clearance signifies their agreement that the device is substantially equivalent based on this comparison.

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 510(k) summary. 510(k) submissions for TENS devices demonstrating substantial equivalence rarely require clinical studies with human test sets, especially if the new device is technologically similar to previously cleared devices. The "test set" here would implicitly be the technical specifications and performance measurements detailed in the tables, which were likely derived from in-house engineering tests and comparisons.

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. As no clinical study is detailed, the concept of establishing ground truth by medical experts in this context is not applicable. The "ground truth" for this submission would be the verifiable specifications and performance of the device and its predicates.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Not applicable in the context of a technical comparison for substantial equivalence.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This is a TENS device, and the submission is a 510(k) for substantial equivalence, not an AI or imaging device requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. The device does not contain a microprocessor or software (except for Version B of one predicate), therefore, it does not rely on algorithms in the way modern AI devices do. Its performance is based on its hardware characteristics.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission consists of technical specifications and performance measurements of both the proposed device and its predicate devices (some measured by Healthonics from predicate devices, some from predicate's 510(k) information). For example, electrical output measurements, timing values, pulse characteristics, current/power densities, and material compositions.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this device and submission type.

9. How the ground truth for the training set was established

This information is not applicable/not provided. There is no "training set" for this device.

Ask a specific question about this device