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The Ouell-FM is a transcutaneous electrical nerve stimulation (TENS) device indicated as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The Quell-FM may be used during sleep. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes.

Ouell-FM is a wearable, transcutaneous electrical nerve stimulator designed to stimulate sensory nerves in the upper-calf region. The device utilizes a microprocessor running embedded software and a custom high-voltage Application Specific Integrated Circuit (ASIC) to generate current regulated stimulating pulses with specific characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device utilizes Bluetooth® low energy (BLE) to communicate with a mobile device that allows the user to start and stop therapy, control stimulation intensity, and modify certain operating characteristics. The device is powered by an embedded rechargeable lithium-ion polymer battery that is charged through a USB cable connected to an AC adapter.

The primary components of the device include the Quell-FM device, Band, Electrodes, and Quell-FM mobile app.

• A. Quell-FM Device
  The Quell-FM device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes (previously cleared in K140586), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used.

• B. Band
  A flexible band secures the Quell-FM device and the electrode to the user's leg using a hook and loop material.

• C. Electrodes
  The Quell-FM device is labeled for use only with compatible NeuroMetrix electrodes (i.e., electrodes cleared under K140586). This use specification, in part, ensures the safe use of the device during sleep because NeuroMetrix electrodes have a known surface area that allows the device to quantitively determine relative skin contact area. Stimulation will be automatically stopped if device detects a decrease in skin-contact area which may lead to unsafe current density to be delivered as would occur during unattended use such as sleeping.

• D. Quell-FM Mobile App
  Quell-FM is used with a mobile app, running on an iOS or Android mobile device, to which it communicates via Bluetooth. Using the mobile app, the user can start and stop the therapy, control stimulation intensity, and modify certain operating characteristics.

The provided document describes a clinical study to evaluate the effectiveness and safety of the Quell-FM device, a transcutaneous electrical nerve stimulator for fibromyalgia symptoms. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Quell-FM device are primarily demonstrated through its clinical effectiveness in reducing fibromyalgia symptoms and its safety profile. While explicit "acceptance criteria" in a pass/fail table format aren't directly provided for clinical endpoints (as would be typical for an AI/algorithm-based device), the successful grant of the De Novo request implies that the FDA found the following evidence acceptable for product classification. The "reported device performance" reflects the key findings from the clinical study.

Study Information

This document describes a clinical trial, not directly an AI/algorithm performance study in the typical sense with a "test set" and "ground truth" derived from expert consensus on images. Instead, it's a randomized controlled trial designed to assess clinical efficacy. Therefore, some of the requested points related to AI/algorithm testing (e.g., number of experts for ground truth, MRMC study, standalone performance) are not directly applicable or are interpreted within the context of a clinical trial.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: 119 subjects were randomized: 62 to the active group and 57 to the sham group.
   • Data Provenance: The study was a "double-blind, randomized, sham-controlled trial," implying prospective data collection in a clinical setting. The country of origin of the data is not explicitly stated, but the mention of the American College of Rheumatology 2010 diagnostic criteria and the FDA De Novo request suggest the study was conducted in the United States and used patients primarily from that region.

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

   • Context: This question is not directly applicable in the sense of establishing "ground truth" for an AI algorithm's diagnostic performance from expert reads (e.g., radiologist interpreting an image). Instead, the "ground truth" for clinical efficacy in this trial is derived from objective and subjective patient-reported outcomes (PROs) and clinical assessments.
   • Expert involvement was in:
     • Diagnosis: Inclusion criteria required a "physician diagnosis of fibromyalgia in the medical record" based on American College of Rheumatology 2010 criteria. The specific number and qualifications of these diagnosing physicians are not detailed in the document but would generally be rheumatologists or pain specialists.
     • Clinical Assessments: Study endpoints relied on standardized questionnaires (e.g., PGIC, FIQR, BPI) and quantitative sensory testing (QST).
     • Adverse Event Assessment: The principal investigator assessed the relatedness of adverse events to TENS use. Qualifications of the principal investigator are not specified but are implied to be a medical professional.

3. Adjudication Method for the Test Set:

   • Context: Adjudication is not applicable in the typical sense of resolving discrepancies between multiple expert readings for image interpretation.
   • Clinical Trial Design: The clinical trial used a double-blind, randomized, sham-controlled design. This design inherently controls for bias by blinding both subjects and study coordinators to the treatment allocation. Blinding effectiveness was assessed at the end of the study.
   • Statistical Analysis: Missing data for effectiveness measures were handled by single imputation for the primary endpoint and multiple imputation for secondary endpoints. Significance was assessed by two-sample t-tests within an ANCOVA model.

4. 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:

   • Not applicable. This study is a clinical trial evaluating the effectiveness of a medical device (TENS) on fibromyalgia symptoms, not an AI algorithm. Therefore, there are no "human readers" or "AI assistance" in this context. The study compares the device (active treatment) directly against a sham device.

5. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

   • Not applicable. This device is a transcutaneous electrical nerve stimulator, a physical device that delivers electrical stimulation to a patient. It is not an AI algorithm, nor does it operate in a "standalone" algorithmic sense from a diagnostic or interpretative perspective. Its performance is measured by its physiological impact on patients.

6. The Type of Ground Truth Used:

   • Clinical Ground Truth: The ground truth for effectiveness was established through patient-reported outcomes (PROs) and objective measures of fibromyalgia symptoms and their impact, as defined by validated clinical questionnaires and quantitative sensory testing.
     • Primary Endpoint: Patient's Global Impression of Change (PGIC) - a subjective patient assessment.
     • Secondary Endpoints: Fibromyalgia Impact Questionnaire Revised (FIQR), Brief Pain Inventory Short Form (BPI), painDETECT Questionnaire (PDQ), Pain Disability Index (PDI), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS) - a mix of subjective patient reports and derived scores.
     • Subgroup Analysis: Quantitative Sensory Testing (QST) at baseline was used to subgroup patients by pain sensitivity. This involved objective measurements of responses to mechanical and cold stimuli.
   • Safety Ground Truth: Established through reported adverse events and their assessment by the principal investigator and through compliance with recognized safety standards (biocompatibility, electrical safety, EMC, software V&V).

7. The Sample Size for the Training Set:

   • Not applicable. This was a clinical trial of a medical device, not a machine learning model. Therefore, there was no separate "training set" for an algorithm. The 119 subjects served as the study population for evaluating the device's efficacy and safety.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable. As there was no training set for an AI/algorithm, this question is not relevant to this clinical trial. The "ground truth" for the overall study's clinical endpoints was established as described in point 6.

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The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee. The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.

Here's a summary of the acceptance criteria and study information for the Omron Focus TENS Therapy, Model PM710-M/-L, based on the provided FDA 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" against which a clinical study's performance metrics are directly compared. Instead, it demonstrates substantial equivalence through extensive non-clinical testing and comparison of technological characteristics with predicate and reference devices. The "performance data" provided refers exclusively to these non-clinical tests.

However, based on the comparison tables, we can infer some "performance criteria" that the device implicitly meets by matching or being within acceptable ranges of the predicate and reference devices.

2. Sample Size for Test Set and Data Provenance

The submission explicitly states: "Clinical testing was not performed to support this 510(k) submission." Therefore, there is no "test set" in the context of clinical data, no sample size, and no data provenance for a clinical test set. The evaluation relies entirely on non-clinical (bench) testing and comparison to legally marketed predicate devices.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable, as no clinical test set was used to establish ground truth in this submission.

4. Adjudication Method for Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done, as traditional clinical studies were not performed. The submission does not discuss human reader improvement with or without AI assistance as this is a TENS device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device, not an AI algorithm. Its performance is evaluated through its physical and electrical characteristics as a TENS unit.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on engineering specifications, adherence to international and national standards (e.g., IEC 60601 series), and the demonstrated performance of legally marketed predicate and reference TENS devices. The "truth" is that the device's electrical outputs and functional characteristics are safe and effective by being substantially equivalent to these established devices.

8. Sample Size for the Training Set

Not applicable, as no AI model or learning algorithm is described, and no clinical "training set" was used. The device is a TENS unit, not a machine learning system.

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

Not applicable, as there is no training set mentioned in the submission.

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The BioWaveGO Neuromodulation Pain Therapy Device is indicated for:

• Symptomatic relief of chronic, intractable pain
• Symptomatic relief of acute pain
• As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

The BioWaveGO Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain the technology of parent devices BioWavePRO. The key difference between the BioWaveGO and the parent device, the BioWaveHOME, is a reduced maximum voltage level, making the device available over-the-counter. The BioWaveGO device has a smaller battery system compared to the BioWaveGO device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain.

The provided text describes the BioWaveGO Neuromodulation Pain Therapy Device, its indications for use, and a comparison with predicate devices to establish substantial equivalence for FDA clearance. However, it does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on regulatory clearance through substantial equivalence, which compares a new device to existing legally marketed predicate devices, rather than an independent performance study with defined acceptance criteria and statistical analysis.

Therefore, the requested information cannot be fully extracted from the provided text. I will detail what can be inferred or is explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum pain reduction, specific accuracy metrics). Instead, it focuses on functional and electrical safety compliance.

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

This information is not provided in the document. The "Performance Testing Summary" outlines a list of tests conducted, but it does not specify the sample size of devices tested or any patient data provenance. The clearance is based on comparison to predicates and engineering/safety testing, not clinical performance data in patients.

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

This information is not provided. The document describes technical performance testing and safety evaluations, not a study that would require expert-established ground truth related to clinical outcomes or image interpretation.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical or interpretive "ground truth" establishment by experts is mentioned, an adjudication method is not applicable to the described engineering and safety tests.

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 (MRMC) comparative effectiveness study was not performed or mentioned in this document. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic tool.

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

This concept is not applicable to the BioWaveGO device. It is a physical medical device providing electrical stimulation, not an algorithm, and it is intended for human use, either over-the-counter or with a prescription (for its predicate).

7. The Type of Ground Truth Used

The "ground truth" for the tests described appears to be based on engineering specifications, safety standards, and functional requirements of the device. For example, ensuring the session timer is operational only during active treatment means verifying the device's software behaves according to its design specification under various conditions. There is no mention of pathology, expert consensus on clinical findings, or outcomes data being used as ground truth for the technical tests performed.

8. The Sample Size for the Training Set

This information is not provided. Since this is a hardware device cleared based on substantial equivalence and engineering tests, rather than an AI/ML algorithm or a device requiring a clinical efficacy trial with a training set, this concept is not applicable in the context described.

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

This information is not applicable as there is no mention of a training set for an algorithm or a device requiring such.

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