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510(k) Data Aggregation
(225 days)
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.
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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.
| Acceptance Criteria (Implied from De Novo Grant) | Reported Device Performance (Clinical Study Results) |
|---|---|
| Safety: | |
| - Biocompatibility of patient-contacting components. | - Patient-contacting components (device enclosure, band, electrodes) were found to be biocompatible based on evaluations for cytotoxicity, irritation, and sensitization (per ISO 10993-1:2009), referencing prior clearances (K152954 and K140586). |
| - Electrical, thermal, and mechanical safety, and electromagnetic compatibility (EMC). | - Tested according to IEC 60601-1-2:2014, IEC 60601-1:2005+A1;C1:2014, IEC 60601-1-11:2015, and IEC 60601-2-10:2012. Results demonstrated the system meets specifications. |
| - Safe software operation and mitigation of software-related risks. | - Software considered "Moderate" level of concern. All elements of software documentation for this level were provided. Hazard analysis and V&V testing were performed with satisfactory results. |
| - Wireless coexistence testing. | - Wireless coexistence and communication security testing conducted per FDA guidance (August 14, 2013). Results demonstrated the system meets specifications. |
| - Lithium-ion battery safety. | - Tested in accordance with IEC 62133-2:2017. |
| - No serious adverse events; adverse events are minor and resolve with conservative measures. | - No serious adverse events reported. 9 of 12 reported adverse events (rash at site, numbness/tingling, muscle cramping) were definitely or possibly related to TENS use; all were minor and self-limited. Most common was mild rash. |
| Effectiveness: | |
| - Clinically meaningful reduction in fibromyalgia symptoms, particularly in the indicated population (adults with high pain sensitivity). | - Primary Endpoint (PGIC): Not statistically significant in the ITT population (p=0.279). |
- **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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(292 days)
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.
| Feature/Parameter | Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (Omron Focus TENS PM710-M/-L) |
|---|---|---|
| Classification Regulation | 21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief | 21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief |
| Product Code | NUH and NYN (Transcutaneous electrical nerve stimulator for pain relief) | Primary: NUH, Secondary: NYN |
| Indications for Use | Relief of pain associated with sore or aching muscles (lower back, arms, legs, shoulders, or feet) due to strain from exercise or normal household work activities; symptomatic relief and management of chronic, intractable pain, and relief of pain associated with arthritis. The Quell reference device also includes 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, and symptomatic relief and management of chronic intractable pain. | 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. Also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. (Narrower than Avail but similar to Quell for lower extremities and chronic pain/arthritis). |
| Environments of Use | Clinics, hospital, and home environments (for predicate Avail and implied for other TENS devices) | Clinics, hospital, and home environments |
| Patient Population | Adult | Adult |
| Contraindications | Avoid use with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices. | Same as predicate and reference devices regarding cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices. |
| Electrical Parameters | Output parameters within the range of predicate Avail device, and within IEC60601-2-10:2012 (Clause 201.4.2) limit of |
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(129 days)
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.
| Acceptance Criteria (Inferred from Performance Testing Summary) | Reported Device Performance (Summary of Testing) |
|---|---|
| Session timer operational only during active treatment | Confirmed |
| Charging only when device not in use | Confirmed |
| Active treatment sessions cannot start during charging | Confirmed |
| Consistent operation across various intensities and load impedances | Ensured |
| Recognition of cable and electrodes before and during session | Ensured |
| Detection of invalid load impedances before and during session | Ensured |
| Resistance to damage/improper software operation from abuse of charger ports | Determined (no damage/improper operation) |
| Inherent protection from excessive battery drain in over-temperature situations | Determined (device protects against abnormal draw) |
| Functional hardware watchdog timers for device reset | Determined (functional) |
| Evaluation of electrical safety | Concluded as compliant (implied by clearance) |
| Compliance with 21 CFR 898 | Yes |
| Compliance with Voluntary Standards | Yes |
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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