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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.

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The X-Force external, non-invasive, non-narcotic, clectrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

The X-Force is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffess associated with pain, from rheumatoid arthritis of the Hand.

These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product can be used in the home or clinic by all patients in need.

The X-FORCE device is a microcomputer controlled digital device featuring a NT Mode output. The device provides simple programming facility to customize the treatment. The panel and its keys provide easy selection for treatment. It is device that deploys the use of electrotherapy and compression to treat Osteoarthritis (OA) and rheumatoid arthritis of the knee or hand.

The X-Force consists of electrodes, the lead wires, and the signal generator. The device is portable and rechargeable battery operated. The lead wires connect the electrodes to the device. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

The provided text describes a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "X-Force" and compares it to a predicate device, "J-Stim 1000".

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" through a table or specific quantitative thresholds for performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a predicate device, the J-Stim 1000. The key "acceptance criterion" here is that the new device, X-Force, is "as safe, as effective and performs as well as its predicate device."

The "reported device performance" is essentially that the X-Force operates under the same principles and delivers similar electrical parameters as the J-Stim 1000. The comparison focuses on technological characteristics and basic unit characteristics, where "similarity" or "sameness" acts as the performance metric.

• Device Housing: Similar (ABS material, different sizes/weights).
• Channels: Same (Two Channels).
• Modes: Same (One).
• Display: Similar (Customized LCD).
• Waveform: Same (NT (HiVolt) - Pulsed Monophasic).
• Treatment Timer: Same (YES).
• Target Populace: Same. |
  | Basic Unit Characteristics Equivalence | - Power Source: Different (Rechargeable 4x1.2V vs. 9V Li-ion).
• Line Current Isolation: Same (battery operated, isolated from mains).
• Patient Leakage Current: Same (less than 100μA normal, less than 300µA single fault, Referenced IEC 60601-1).
• Output Modes/Channels: Same (Synchronous, 1 mode, 2 channels).
• Regulated Output: Same (Regulated Voltage).
• Max Output Current/Voltage/Phase Charge/Current Density/Power Density: All reported as identical.
• Software/Firmware/Microprocessors: Same (YES).
• Automatic Trips/Shut-off/Patient Override: All same (YES).
• Indicator Display: Same (YES for On/Off, Low Battery, Voltage/Current).
• Timer: Same (YES).
• Compliance with 21 CFR 898: Same (YES).
• Program Lock Feature: X-Force has this, J-Stim 1000 does not. This is deemed not to affect safety or effectiveness.
• Digital Control of Output Power: X-Force uses digital control via microcontroller, J-Stim 1000 uses analog pots. This difference is presented without explicit safety/effectiveness impact beyond it being a technological variation. |
  | Safety and Effectiveness (Overall Equivalence Conclusion) | X-Force is concluded to be as safe, as effective, and performs as well as the predicate device, J-Stim 1000. |

2. Sample Size Used for the Test Set and the Data Provenance

The submission explicitly states:

• "Non-Clinical Testing: Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device"
• "Clinical Testing: Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device"

This means there was no specific test set or clinical study conducted for the X-Force device to prove its performance in an independent test, nor is there data provenance like country of origin or retrospective/prospective status for such a test set. The submission relies entirely on the established safety and effectiveness of the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Since no specific test set or clinical study was conducted for the X-Force device, there were no experts used to establish ground truth for a test set in this submission. The ground truth for the device's equivalence is based on engineering and performance specifications comparison to the predicate device.

4. Adjudication Method for the Test Set

As no test set was used, there was no adjudication method applied.

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 device (TENS stimulator) is not an AI-powered diagnostic device, and the submission does not involve any "human readers" or "AI assistance" in the context of interpreting medical images or data. Therefore, no MRMC comparative effectiveness study was done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not an algorithm-only device. It is a physical medical device. There's no standalone algorithm performance study as it's not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this submission is the established safety and effectiveness of the predicate device (J-Stim 1000), as previously determined by the FDA's approval (K073386). The new device (X-Force) claims equivalence through comparative analysis of its specifications and intended use against this established ground truth.

8. The Sample Size for the Training Set

Since no new clinical or non-clinical testing was performed for the X-Force for this submission, there was no specific training set in the context of device performance studies. The "training" in an abstract sense comes from the design and manufacturing experience informed by devices like the predicate.

9. How the Ground Truth for the Training Set Was Established

Given that no specific training set was used for this submission, the question of how its ground truth was established is not applicable. The submission leverages the pre-existing FDA approval of the predicate device as its basis for demonstrating safety and effectiveness.

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The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand.
The J-Stim 1000 external, non-invasive, non-narcotic, electrotherapy system 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.
The J-Stim 1000 is also 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 J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. 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 to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

The provided text is a 510(k) summary for the J-Stim 1000™, a Transcutaneous Electrical Nerve Stimulator (TENS) device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Based only on the provided text, here's what can be extracted and what information is not available:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., specific pain reduction percentages, range of motion improvements, or statistical significance levels) for the J-Stim 1000™.

Instead, the core of the submission revolves around establishing substantial equivalence to a predicate device, the Bionicare Stimulator, Model Bio 1000 (K030332). The "performance" reported is that the J-Stim 1000™ has identical electrical output compared to the predicate device.

2. Sample size used for the test set and the data provenance:

The provided document does not describe any new clinical study or test set with human subjects that directly tested the J-Stim 1000™. The submission hinges on the established performance of the predicate device (Bionicare Stimulator, Model Bio 1000). Therefore, there is no sample size for a test set, nor is there data provenance mentioned for such a study in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since no new clinical study or test set for the J-Stim 1000™ is described, there is no information on experts used to establish ground truth.

4. Adjudication method for the test set:

As no new clinical study or test set for the J-Stim 1000™ is described, there is no information on an adjudication method.

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 question is not applicable to the J-Stim 1000™ TENS device. AI assistance and human reader improvement are concepts typically associated with diagnostic imaging or decision support systems, not with a TENS device.

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

This question is not applicable to the J-Stim 1000™ TENS device. It is a physical device that delivers electrical stimulation, not an algorithm.

7. The type of ground truth used:

For the purpose of this 510(k) submission, the "ground truth" for demonstrating the J-Stim 1000™'s effectiveness is established by the prior approval of the predicate device (Bionicare Stimulator, Model Bio 1000). The assumption is that because the J-Stim 1000™ is "electrically identical" to the predicate, it will have comparable therapeutic effects for the stated indications.

8. The sample size for the training set:

There is no mention of a training set in this document as it does not describe the development or testing of an algorithm, but rather a medical device seeking substantial equivalence based on its physical and electrical characteristics.

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

As no training set is mentioned, there is no information on how its ground truth was established.

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The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.

The RS-4i Sequential Stimulator consists of a hardware/software svstem that is the same as was described in its previous 510(k) notification (K032652). The RS-4i Sequential Stimulator also includes a TENS output. The RS-4i Sequential Stimulator incorporates traditional muscle stimulation and interferential current stimulation modalities, as well as TENS output into one unit. Only one modality may be operated at a time, but modalities can be automatically sequenced. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.

The provided text is a 510(k) summary for the RS-4i Sequential Stimulator, a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document primarily focuses on describing the device, its indications for use, and its substantial equivalence to predicate devices, which is typical for a 510(k) submission. Therefore, I cannot extract the requested information from this text.

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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 stiffiess associated with pain, from rheumatoid arthritis of the hand.

The Bionicare Stimulator System, 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 hand and arm using a standard clectrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08). The signal is applied across the cathodic hand electrode and the anodic arm electrode.

The provided 510(k) summary for the "Bionicare® Stimulator System, Model BIO-1000™" does not contain information about a study proving the device meets specific acceptance criteria in the manner described by your request.

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device (another Bionicare Stimulator System, Model BIO-1000™ for osteoarthritis of the knee). The "performance data" mentioned refers to electrical characteristics and compliance with voluntary standards, rather than clinical efficacy or specific performance metrics against pre-defined acceptance criteria for the new indication (rheumatoid arthritis of the hand).

Therefore, I cannot populate the requested table and answer the study-related questions as the provided document does not describe such a study and acceptance criteria in the context of device performance for its intended clinical use.

Here's a breakdown of why the information isn't available in the provided text:

• No Clinical Study Details: The document makes no mention of a clinical trial (prospective or retrospective), patient cohorts, ground truth established by experts, or statistical analysis of device performance (sensitivity, specificity, accuracy) against a clinical endpoint.
• Focus on Substantial Equivalence: The core of this 510(k) is to show that the new device (for rheumatoid arthritis of the hand) is equivalent to a predicate device (for osteoarthritis of the knee) based on similar technological characteristics and the same underlying mechanism (TENS).
• "Performance Data" Defined Differently: The section titled "Performance Data" explicitly states it provides "greater detail regarding the Bionicare's electrical characteristics, its conformance with voluntary standards." This refers to engineering and safety specifications, not clinical performance metrics.

In summary, the provided text describes a regulatory submission centered on demonstrating substantial equivalence based on technological characteristics and compliance with industry standards, not on presenting a clinical study proving device efficacy against specific acceptance criteria.

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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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