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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.

- **However, in the higher pain sensitivity subgroup:** Mean PGIC score for active treatment (3.54) was significantly greater than sham (3.14), with a mean difference of 1.25 (95% CI [0.25, 2.24], p=0.015). This difference was considered clinically meaningful. 

• Secondary Endpoints (ITT population): Active treatment showed significant improvement over sham in FIQR Total Score (p=0.015), BPI Interference (p=0.031), PDQ (p=0.027), and PDI (p=0.044).
• Secondary Endpoints (Higher Pain Sensitivity Subgroup): Active treatment showed significant improvement over sham in FIQR Total Score (p=0.031), FIQR Pain Item (p=0.003), BPI Severity (p=0.035), and PDQ (p=0.018).
• Responder Analyses: In the higher pain sensitivity subgroup, PGIC responder rate was 28% higher for active (57.8%) vs. sham (30.2%, p=0.025). FIQR responder rate was 30% higher for active (57.5%) vs. sham (28.1%, p=0.019). Pain intensity responder (>30% reduction) was 42% higher for active (59.5%) vs. sham (17.5%, p

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Quell is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities.

Quell is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.

Quell is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is sold without a prescription. - The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates currentregulated stimulating pulses with specific technical characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device is powered by an embedded rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.

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

The user interface consists of a push button and a linear 6 LED array consisting of 5 white LEDs and 1 amber LED. The LED array indicates stimulation status, battery charging, and error conditions.

A Quell user may initiate therapy, increase stimulation intensity and decrease stimulation intensity through a wireless control mechanism that is collectively referred to as the "virtual button." The virtual button is available through the Quell mobile app and is intended for use in the same environments as the Quell device.

The provided text is a 510(k) premarket notification letter and summary for the Quell device, a Transcutaneous Electrical Nerve Stimulator (TENS). It describes the device, its intended use, and compares it to a predicate device (NeuroMetrix ASCEND).

Based on the document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format requested. Instead, it details that Quell was found substantially equivalent to the predicate device, ASCEND (K140333), based on similar indications for use, technological characteristics, and compliance with various standards.

The acceptance criteria implicitly relate to meeting the performance and safety requirements of the predicate device and relevant industry standards.

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

The document states, "NeuroMetrix determined that bench and non-clinical testing were sufficient to demonstrate that Quell is as safe and effective as the predicate ASCEND device."

• Sample Size for Test Set: Not applicable or not specified in terms of human subjects. The testing was primarily non-clinical (bench testing), focusing on electrical, mechanical, and software aspects.
• Data Provenance: The data provenance is from non-clinical verification and validation testing conducted by NeuroMetrix, Inc. The document does not mention any human clinical trials for this 510(k) submission, nor does it refer to country of origin for human data.

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

As the evaluation was based on non-clinical testing and comparison to a predicate device, the concept of "ground truth" established by clinical experts for a test set (e.g., image interpretation) does not directly apply in this context. The "ground truth" here is adherence to engineering specifications, safety standards, and the performance characteristics of the predicate device. The experts involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at NeuroMetrix. Their specific qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study involving subjective interpretation requiring adjudication among experts. The "adjudication" was effectively through the established engineering and regulatory compliance processes of the manufacturer and subsequent FDA review.

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

Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is outside the scope of this device and documentation.

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

The device is a physical TENS unit. While it includes "embedded software" and a "mobile app" with "virtual button" functionality, it is not an algorithm that performs a diagnostic task independently. The "standalone" performance here refers to the device's electrical, mechanical, and software function as a physical unit without a human directly manipulating its physical buttons (though human interaction via the app is an extension of control).

The document notes:

• "Verification testing of Quell included electrical, mechanical and software tests to show that the device meets its target specifications over a range of operating and storage conditions."
• "Validation and performance testing demonstrates that the device meets as reflected in the functional specification."
• The "virtual button functionality was validated in system testing, and in a validation protocol designed to confirm that the virtual button is safe and effective..."
• "Those features of the mobile app that relate to the control and function of the Quell device were validated in system testing."

These statements confirm that the device's functional integrity, including its software and wireless control, was tested comprehensively in what can be considered standalone performance tests in an engineering context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for this submission is primarily based on:

• Engineering Specifications: The device's electrical, mechanical, and software characteristics meeting predefined targets.
• Regulatory Standards: Compliance with relevant IEC standards (IEC 60601-1, 60601-1-2, 60601-1-6, 62304, 60601-1-11), and 21 CFR 898.
• Predicate Device Equivalence: The performance and safety characteristics being substantially equivalent to the legally marketed predicate device (NeuroMetrix ASCEND K140333).
• Risk Assessment: Demonstration that new features do not introduce new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable. This document describes a 510(k) submission for a physical medical device, not a machine learning model that requires a distinct training set in the typical sense. The "training" for the device would be its design and manufacturing processes adhering to specifications.

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

Not applicable, as there isn't a "training set" in the context of machine learning. The "ground truth" for the device's design and manufacturing is established by engineering principles, regulatory requirements, and historical data from similar devices (especially the predicate).

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