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The BioniCare Stimulator, Model BIO-1000™, 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 BIO-1000 is a portable, rechargeable, battery-operated dual-channel device that utilizes a voltage regulated output circuit to generate a spike-shaped monophasic pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. The device consists of electrodes, lead wires and a signal generator.

This submission describes a transcutaneous electrical nerve stimulator for pain relief (BioniCare® Stimulator Model BIO-1000™). It is a modification of an existing predicate device (K030332). The new device's signal generator is identical to the predicate. The only modifications are to the electrical connection to the glove electrode and the addition of a garment.

Given that the device is a transcutaneous electrical nerve stimulator and the modifications are minor, it is highly likely that the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" would refer to electrical safety and electromagnetic compatibility (EMC) testing, as well as performance testing of the electrical output to ensure it matches the predicate device. Clinical effectiveness is not typically re-evaluated for such minor modifications to a legally marketed device if the underlying therapeutic mechanism and electrical output are unchanged.

However, the provided text does not contain information about specific acceptance criteria or a study proving performance against them. It primarily focuses on the 510(k) summary, device description, and substantial equivalence to a predicate device. Therefore, I cannot extract the requested information from the provided text.

Based on the typical requirements for such a device and the nature of the modifications described, here's what "acceptance criteria" and "study" would likely entail, even though the specifics are not in the document:

Hypothetical Acceptance Criteria and Study (Based on device type and typical 510(k) requirements for minor modifications):

1. Table of Acceptance Criteria and Reported Device Performance

Study That Proves the Device Meets Acceptance Criteria (Hypothetical):

For this type of device with minor modifications, the "study" would typically be a benchtop verification and validation (V&V) testing program.

1. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Typically, a small number of production units (e.g., 3-5 units or one production lot) are selected for comprehensive bench testing. Since the "signal generator is identical" and the changes are to the glove connection and garment, the focus would be on verifying those specific changes and ensuring the overall system still performs correctly.
* Data Provenance: Prospective, as the tests would be performed on newly manufactured devices. Country of origin for testing is usually where the manufacturer's R&D or quality assurance facilities are located, likely in the USA (given the submitter's location).

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* Not applicable as this is benchtop engineering testing, not a clinical study or expert review for ground truth in a diagnostic context. The "ground truth" would be the established engineering specifications and international standards (e.g., IEC 60601-1 for medical electrical equipment).

3. Adjudication Method for the Test Set:
* Not applicable. Results are typically pass/fail based on objective measurements against predefined specifications. Any discrepancies would lead to investigation and re-testing until compliance is confirmed or design changes are made.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No, this would not be done. MRMC studies are relevant for diagnostic devices where human readers interpret medical images or data. This device is a therapeutic electrical stimulator, and the modifications are purely mechanical/electrical without altering the core therapeutic mechanism. The predicate device's clinical effectiveness would have already been established.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
* No, this is not applicable. This device does not involve algorithms or AI for standalone performance evaluation in the way a diagnostic AI tool would. Its performance is evaluated by its electrical output characteristics.

6. The Type of Ground Truth Used:
* For the electrical and safety performance testing, the "ground truth" would be the engineering specifications and international consensus standards (e.g., IEC 60601-1 for safety, IEC 60601-1-2 for EMC) that the device must meet. For verifying the "identical" signal generator, the ground truth would be the specifications and performance characteristics of the predicate device (K030332).

7. Sample Size for the Training Set:
* Not applicable. This device does not use machine learning or AI that requires a "training set."

8. How the Ground Truth for the Training Set was Established:
* Not applicable, as there is no training set.

In summary, the provided 510(k) document is a regulatory submission for substantial equivalence based on minor modifications. It does not detail specific acceptance criteria or studies in the format requested, as those would typically be internal V&V reports rather than part of the public 510(k) summary for such a device.

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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.

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."

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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.

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.

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