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510(k) Data Aggregation
(225 days)
NeuroMetrix, Inc.
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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(90 days)
NEUROMETRIX, INC.
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.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Similar Indications for Use | Identical indications for use as ASCEND (K140333) for temporary relief of pain associated with sore and aching muscles in lower extremities and symptomatic relief/management of chronic intractable pain. |
| Similar Technological Characteristics (Basic Unit) | One stimulation channel, single output mode, user-controlled intensity, fixed therapy session timer, LED indicators, battery powered. Specific parameters like power source, leakage current, and output modes are within acceptable limits or identical to the predicate. |
| Similar Technological Characteristics (Output Specifications) | Biphasic, rectangular waveform. Maximum output voltage and current are identical to the predicate. Frequency is random with an 80 Hz mean (range 60-100 Hz), identical to the predicate. Net charge is nominally 0 µC. Differences in phase duration, maximum phase charge, maximum current density, maximum average current, and maximum average power density are acknowledged but deemed acceptable as they are within the range of other 510(k) cleared TENS devices and do not raise new safety/effectiveness questions. |
| New Features Do Not Raise New Safety/Effectiveness Questions | Features like On-skin Timer, Auto-restart Timer, Stimulation Lock, Sleep Settings, Sleep Tracking, Virtual Button, and Mobile App are justified as either convenience features or low-risk functions, with validation testing confirming safety and effectiveness where applicable (e.g., Virtual Button, Mobile App). Sleep tracking is explicitly stated as not for diagnosis or treatment of sleep disorders. |
| Compliance with Voluntary Standards | Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304, IEC 60601-1-11, and 21 CFR 898 (for Electromagnetic Compatibility). |
| Sufficient Performance & Safety Data | Verification, validation, and performance data from non-clinical testing demonstrate substantial equivalence. |
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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(255 days)
NEUROMETRIX, INC.
The ASCEND Electrode is intended for use as disposable, conductive, adhesive interface between the user's skin and a transcutaneous electrical nerve stimulator.
The ASCEND Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a user's skin. It is intended to be disposable and for single person use. It is provided non-sterile.
This document is a 510(k) Pre-Market Notification for a Class II medical device, the ASCEND Electrode. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study that establishes acceptance criteria and proves the device meets them in the way a clinical trial or performance study would for a more complex device.
Based on the provided text, the following information can be extracted, but with significant limitations due to the nature of the document being a substantial equivalence submission for an electrode:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria for the ASCEND Electrode's performance. Instead, it states:
"Verification and performance testing demonstrated that the electrode met user needs as reflected in the functional specification." and "The ASCEND Electrode has the same technological characteristics as the predicate SENSUS Electrode that was validated with electrical and mechanical tests to show that the electrode met its target specifications over a range of operating and storage conditions."
However, no specific performance metrics or their acceptable ranges are listed. The focus is on demonstrating that it performs similarly to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "electrical and mechanical tests" and "verification and performance testing" but does not specify the sample size used for these tests. It also does not explicitly state the data provenance (country of origin, retrospective or prospective). Given that it's a 510(k) for an electrode, these tests would typically be laboratory-based rather than involving human subjects for performance evaluation in the way a clinical study would.
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 is not applicable to the information provided. For an electrode, "ground truth" would typically relate to objective physical or electrical measurements, not expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in studies where multiple human readers interpret data, which is not the case for the described testing of an electrode's physical properties.
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. The device is an electrode, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
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 electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing mentioned, the "ground truth" would be established through objective electrical and mechanical standards and specifications (e.g., conductivity measurements, adhesive strength tests, impedance measurements, biocompatibility standards). The document references "functional specification" directly.
8. The sample size for the training set
This is not applicable as the device is an electrode and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
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(143 days)
NEUROMETRIX, INC.
ASCEND 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.
ASCEND 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.
ASCEND is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is available over the counter. 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 disposable electrodes placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g. SENSUS Electrode, K121816), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. Compatible NeuroMetrix electrodes are comprised of four individual hydrogel pads arranged in a linear array. The hydrogel pads are electrically connected in pairs such that the two outer hydrogel pads constitute one electrode and the two inner hydrogel pads constitute a second electrode. The user interface consists of a push button and a two-color LED. The push button initiates and controls stimulation intensity. The LED indicates stimulation status, battery charging, and error conditions.
Here's a breakdown of the acceptance criteria and study as described in the provided 510(k) summary for ASCEND™:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| At least 80% of participants successfully completed all five basic device tasks (checking battery, placing device and configuring, starting a therapy session, modifying stimulation intensity, and stopping a therapy session) based on reading and following the directions for use. | 86.2% of participants successfully completed all five tasks (25 out of 29 participants). The lower bound of the 95% confidence interval (68.3%) was not explicitly stated to meet the 80% threshold but the upper bound of 96.1% exceeded 80% and the null hypothesis that the true pass rate was ≥ 80% could not be rejected. |
Details of the Usability Study
2. Sample size used for the test set and the data provenance:
- Sample Size: 29 participants.
- Data Provenance: The study was a prospective usability study, likely conducted in the US where NeuroMetrix, Inc. is located. The document does not explicitly state the country of origin, but given the sponsor's address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The study was a usability study focused on whether untrained users could operate the device based on its labeling. Therefore, the "ground truth" was the objective successful completion of predefined tasks by these users, not an expert assessment of a medical condition. No experts were used to establish ground truth in the traditional sense of medical diagnosis.
4. Adjudication method for the test set:
- Not applicable in the context of a usability study where success is objectively measured by task completion by the participants themselves.
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 MRMC comparative effectiveness study was done. This study was a usability study for an over-the-counter transcutaneous electrical nerve stimulator (TENS) device, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a TENS unit, and the study was a human usability study.
7. The type of ground truth used:
- The "ground truth" for this usability study was the objective successful completion of specific device-operation tasks by study participants, as outlined in the device's labeling (instructional video and quick start instructions). It was not based on expert consensus, pathology, or outcomes data related to disease diagnosis or treatment efficacy, but rather on the ability of lay users to correctly operate the device.
8. The sample size for the training set:
- Not applicable. This was a usability study, not a machine learning model development study, so there was no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As noted above, there was no training set for a machine learning model.
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(90 days)
NEUROMETRIX, INC.
The NeuroMetrix SENSUS is intended for use as a transcutaneous electric 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 the NeuroMetrix SENSUS Electrode.
The SENSUS device, is a transcutaneous electrical nerve stimulator with a single output mode. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including pulse shape, amplitude (current), duration, pattern, and frequency. The device is powered by a permanent rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.
The device delivers electrical stimulation to the patient through disposable, single-patient use electrodes placed on the patient's body. The device is labeled for use only with the SENSUS Electrode (K121816), to which it connects through insulated female medical snap connectors embedded within its housing.
The device has a push-button that initiates stimulation, and controls the intensity. The device has a single two color LED for indication of stimulation status, battery charging, and error conditions.
Here's an analysis of the acceptance criteria and study for the NeuroMetrix SENSUS device, based on the provided text:
Acceptance Criteria and Device Performance
The primary focus of the study described is the validation of the device's electrode peeling detection feature, which allows the device to be safely used during sleep.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Outcome |
|---|---|---|---|
| Electrode Peeling Detection | Failure rate of 0%, with the upper bound of the one-sided 95% confidence interval for failure rate being below 5% (i.e., 0 out of 60 tests). | 0 failures out of 66 tests in two separate protocol runs (total 132 tests). | Met |
| Device must halt stimulation when remaining skin contact area is less than 3.5 cm². | Average remaining contact area was 10.2 ± 2.1 cm² (range 6.9 - 19.5 cm²) for the 10-minute run and 10.1 ± 1.7 cm² (range 7.5 - 18.0 cm²) for the 40-minute run. All reported minimum remaining contact areas (6.9 cm² and 7.5 cm²) are greater than 3.5 cm². | Met |
Study Details for Electrode Peeling Detection Validation
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Sample Size Used and Data Provenance:
- Test Set Sample Size: 66 subjects and 132 SENSUS electrodes were used. There were two protocol runs, each with 66 tests, totaling 132 tests. The prospective validation sample size was set to 60 tests to meet the 0% failure rate statistical criterion.
- Data Provenance: The study was described as "prospective validation," indicating it was specifically designed and conducted for this purpose. The country of origin is not explicitly stated, but NeuroMetrix is based in Waltham, MA, USA, suggesting the study was likely conducted in the USA.
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Number of Experts and Qualifications for Ground Truth:
- The document does not explicitly mention the use of external experts to establish ground truth for the electrode peeling detection test. The "ground truth" for this test was the physical measurement of the electrode area remaining on the skin at the instant stimulation halted, as determined by the study methodology.
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Adjudication Method:
- Not applicable/Not mentioned. The study involved objective measurements of physical parameters (electrode contact area).
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This was a technical validation study for a safety feature, not a comparative effectiveness study involving human readers.
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Standalone (Algorithm Only) Performance:
- Yes. The study focused on the automatic performance of the device's embedded algorithm in detecting electrode peeling and halting stimulation. There was no human-in-the-loop component for this safety feature.
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Type of Ground Truth Used:
- Objective Measurement/Engineered Truth: The ground truth was established by direct measurement of the electrode-to-skin contact area at the point where the device halted stimulation. The "failure" condition was defined objectively as the remaining contact area being less than 3.5 cm².
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Sample Size for Training Set:
- Not applicable/Not mentioned. The document describes a validation study for a specific safety mechanism (electrode peeling detection). It does not provide details of any machine learning model training or a "training set" in the context of AI. The device uses "embedded software to control a high-voltage circuit," implying rule-based or control system logic rather than a conventional machine learning model with a distinct training phase.
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How Ground Truth for Training Set was Established:
- Not applicable, as no training set for a machine learning model is described. The device's operational parameters and safety thresholds (like the 3.5 cm² peeling threshold) would have been established through engineering design, risk analysis, and relevant standards, rather than a data-driven training process with a ground truth similar to clinical AI models.
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(159 days)
NEUROMETRIX, INC.
The NeuroMetrix SENSUS Electrode is intended for use as disposable, conductive, adhesive interface between the patient's skin and a transcutaneous electrical nerve stimulator.
The SENSUS Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a patient's skin. It is provided non-sterile, is designed and intended for single patient use only, and to be disposable.
The SENSUS Electrode is comprised of four individual electrodes, each of size 36 by 46 mm. The overall dimensions are 50 by 280 mm. The individual electrodes are electrically connected in pairs such that the two outer electrodes constitute one pair and the two inner electrodes constitute a second pair. The SENSUS Electrode contains two conventional male snap connectors for electrical connection to a transcutaneous electrical nerve stimulator.
The SENSUS Electrode has a multi-layer design. The first and outermost layer is a sheet of Mylar. The second layer contains conductive silver traces and silver electrode pads. Where the silver traces are not covered by hydrogel, they are covered by a dielectric mask. The third layer is the four individual electrodes which consist of a medical grade, self adhering, biocompatible hydrogel (KM-10G, Katecho, Inc., Des Moines, IA). When not in use, the hydrogel is covered by a Mylar release liner. Two male type snap connectors interface the SENSUS Electrode to the transcutaneous electrical nerve stimulator. The patient facing surface of the snap connectors are either under hydrogel or covered by a laminated dielectric polypropylene layer. Therefore in both cases the snap connectors do not directly contact the patient's skin.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Type of Test | Reported Device Performance/Result |
|---|---|---|
| Biocompatibility | Biocompatibility Testing (via related hydrogels) | KM-10G hydrogel's biocompatibility established by combining test results for KM-10B and KM-10P hydrogels (cleared in K000870) |
| Electrical Performance (AC Impedance) | Electrical Testing | Meets target specifications over a range of operating and storage conditions, including after 1 hour of conventional use |
| Electrical Performance (Current Dispersion) | Electrical Testing | Evaluated across the surface of the electrodes |
| Adhesive Performance (Skin Adhesion) | Adhesive Testing | Evaluated by performing a skin adhesion test |
| Electrode Stability (Electrical Performance under Normal Use) | Electrical Stability Testing | Met electrical impedance specifications after 1 hour of conventional use |
| Shelf-life Performance | Accelerated Aging Shelf-life Testing | Performs as intended over the course of its labeled shelf-life (expected 24 months) |
| Mechanical Properties (Snap Connector Resistance) | Mechanical Testing (Snap Connectors) | Measured the resistance of the connection |
| Mechanical Properties (Snap Connector Retention Force) | Mechanical Testing (Snap Connectors) | Measured the connection retention force |
| Compliance with ISO 10993-5:2009 (Cytotoxicity) | Standard Compliance Test | Conforms to the standard |
| Compliance with ISO 10993-10:2010 (Irritation & Skin Sensitization) | Standard Compliance Test | Conforms to the standard |
| Substantial Equivalence to Predicate Device | Overall Comparison and Testing | Verified through comparison of intended use, materials, technological characteristics, and non-clinical testing data |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide explicit sample sizes for the non-clinical tests (electrical, mechanical, biocompatibility). It states that NeuroMetrix determined that non-clinical (i.e., bench) testing was sufficient.
Regarding data provenance:
- Biocompatibility: The biocompatibility data is derived from related hydrogel formulations (KM-10B and KM-10P) from Katecho, Inc., which were previously cleared (K000870). This suggests a retrospective use of existing data from the hydrogel manufacturer.
- Electrical and Mechanical Testing: These appear to be prospective bench tests conducted on the SENSUS Electrode itself. The country of origin for this data is not specified, but the sponsor is NeuroMetrix, Inc. in Waltham, MA, USA, suggesting the testing was likely conducted in the USA or by a contract lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the SENSUS Electrode is a device and its performance is evaluated through objective physical and electrical measurements, not by expert interpretation of images or signals. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective measurements and comparison to standards, not human interpretation that would require adjudication.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI systems where human readers interpret medical data. The SENSUS Electrode is a physical medical device (an electrode), not a diagnostic AI system, so this type of study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the SENSUS Electrode is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Objective physical and electrical measurements: Such as impedance, current dispersion, adhesive strength, connection resistance, and retention force, compared against predefined target specifications.
- Compliance with recognized standards: ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization).
- Existing biocompatibility data: For the hydrogel, established by the manufacturer (Katecho, Inc.) through testing of related formulations.
- Substantial equivalence: To the predicate device, based on comparable intended use, materials, and technological characteristics.
8. The Sample Size for the Training Set
This information is not applicable as the SENSUS Electrode is a physical medical device and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as #8.
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(106 days)
NEUROMETRIX, INC.
The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.
SENSUS is a one-channel transcutaneous electrical nerve stimulator with a single output mode. The stimulator utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including waveform shape, current intensity, waveform duration and frequency. The stimulator is powered by a permanent rechargeable Lithium-Ion battery that is recharged through a USB cable connected to an AC adapter. The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector. The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.
The NeuroMetrix SENSUS is a transcutaneous electrical nerve stimulator (TENS) intended for the symptomatic relief and management of chronic intractable pain.
Here's an analysis of its acceptance criteria and the study that proves its adherence, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the NeuroMetrix SENSUS are primarily based on demonstrating substantial equivalence to a predicate device, the EMPI Active Transcutaneous Nerve Stimulator (K090922). This involves showing similar intended use, technological characteristics, and safety and effectiveness profiles. There are no explicit quantitative acceptance criteria for performance metrics in the provided document beyond being "within the range of output parameters of legally-marketed transcutaneous electrical nerve stimulators."
The device performance is reported by comparing its specifications to the predicate device.
| Parameter | Acceptance Criteria (Substantial Equivalence to Predicate) | Reported Device Performance (NeuroMetrix SENSUS) | Predicate Device Performance (Empi Active Transcutaneous Nerve Stimulator, K090922) |
|---|---|---|---|
| Intended Use | Same intended use: symptomatic relief and management of chronic intractable pain. | Intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain. | Intended for symptomatic relief and management of chronic intractable pain (and additionally for arthritis and post-surgical/post-trauma acute pain). |
| Basic Technological Characteristics | Similar characteristics (one stimulation channel, single output mode, patient controlled intensity, LED indicators, rechargeable battery). Differences should not raise new questions of safety or effectiveness. | One stimulation channel | |
| Single output mode | |||
| Patient controlled intensity | |||
| LED indicators (no intensity display) | |||
| Powered by 1 rechargeable 3.7V Lithium-Ion battery | |||
| Method of Line Current Isolation: Physically isolated; device cannot connect to electrodes and battery recharger concurrently | |||
| Normal Condition Patient Leakage Current: |
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(135 days)
NEUROMETRIX, INC.
NeuroMetrix ASCEND is a peripheral nerve stimulator used for localization and verification of needle placement for perineural application of pharmacological agents.
ASCEND is a battery powered peripheral nerve stimulator. This device is intended for localization and verification of needle placement for perineural application of pharmacological agents. ASCEND consists of the following components: Stimulator, Battery, Bluetooth, Charging Station.
This is a 510(k) premarket notification for the NeuroMetrix ASCEND, a peripheral nerve stimulator. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with specific acceptance criteria and performance metrics described in your request for new devices.
Based on the provided text, the following information can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a table of explicit acceptance criteria with quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the device's function. The submission focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technological characteristics.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a "test set" with a specific sample size or data provenance (country of origin, retrospective/prospective) is provided. This type of data is usually part of clinical studies, which are not typically required for a 510(k) submission seeking substantial equivalence for this class of device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
No information regarding experts establishing ground truth is provided. This is generally associated with performance evaluations that are not part of this 510(k) submission.
4. Adjudication Method:
No adjudication method is mentioned as there is no described test set or performance evaluation requiring such a method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a peripheral nerve stimulator that is not an AI-driven image analysis tool.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study is mentioned. The device is a stimulator, not an algorithm that performs analysis independently. Its function is to provide electrical stimulation for nerve localization.
7. Type of Ground Truth Used:
No specific "ground truth" (e.g., pathology, outcomes data) is mentioned in the context of a performance study. The substantial equivalence relies on the established efficacy and safety of the predicate device and the similar design and intended use of the new device.
8. Sample Size for the Training Set:
No training set or sample size for a training set is mentioned. This is applicable to machine learning or AI-based devices, which this stimulator is not.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned.
Summary of Device Acceptance and Study as Per 510(k) Submission:
The NeuroMetrix ASCEND device gained market clearance through a 510(k) Premarket Notification (K091155) by demonstrating substantial equivalence to a legally marketed predicate device, the Stockert GmbH Stimuplex HNS 12 (K052313).
The basis for acceptance was primarily the comparison of intended use, technological characteristics, and verification and validation testing.
- Intended Use: Both devices are used for "localization and verification of needle placement for perineural application of pharmacological agents."
- Technological Characteristics: The submission states that the "technological characteristics of the stimulator in ASCEND and the Stockert GmbH Stimuplex HNS 12 are the same or similar in specification."
- Verification and Validation Testing: The document mentions that "Based on the verification and validation testing presented, the comparison of ASCEND to the predicate supports a finding of substantial equivalence." (However, the details of this testing, specific metrics, or acceptance criteria within that testing are not elaborated in the provided text).
In essence, the "study" proving the device meets acceptance criteria is the comparison to the predicate device and the underlying engineering verification and validation testing to confirm that the new device functions as intended and safely, similar to the predicate. The FDA's decision to clear the device indicates that they found sufficient evidence of substantial equivalence to the predicate.
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(196 days)
NEUROMETRIX, INC.
The NeuroMetrix Bioamplifier is intended for amplification and transmission of the electrical activity of peripheral nerves and muscles recorded through surface electrodes.
The NeuroMetrix Bioamplifier ("Bioamplifier") is a one channel wireless electromyography amplifier. This device is intended to differentially measure, amplify, digitize, and wirelessly transmit bioelectrical signals from peripheral nerves and muscles transduced by surface electrodes, which are provided separately. The Bioamplifier consists of the following components: Amplifier/Digitization Unit, Battery, RF Trigger, and Bluetooth. The Bioamplifier is typically used with a host device that controls the operation of the Bioamplifier and may provide other functionality such as a user interface, electrical or other stimuli, data analysis, data storage, and document generation.
This 510(k) summary for the NeuroMetrix Bioamplifier primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics. Therefore, much of the requested information regarding specific acceptance criteria, performance data, sample sizes, expert involvement, and ground truth derivation is not explicitly provided in this document.
However, I can extract and infer some information based on the premise of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Formal, quantifiable acceptance criteria with corresponding reported device performance metrics are not explicitly stated in this 510(k) summary. The document focuses on demonstrating comparable functionality and validation of components to a predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Amplification & Digitization: Equivalent ability to measure, amplify, and digitize bioelectrical signals from peripheral nerves and muscles. | "performance of all Bioamplifier system components has been validated." (General statement, no specific metrics provided) |
| Wireless Transmission: Equivalent ability to transmit digitized data to a host device. | Bluetooth wireless link successfully provides communication to a host device. |
| Power Source: Comparable reliable power source. | Powered by a high-capacity rechargeable Li-polymer battery. |
| RF Trigger functionality: Equivalent ability to precisely trigger data acquisition. | Includes an RF receiver that allows a host device to precisely trigger data acquisition. |
| Safety & Effectiveness: No new safety or effectiveness issues raised compared to the predicate. | "Therefore any differences in system component technologies do not raise new safety or effectiveness issues." |
2. Sample Sizes Used for the Test Set and Data Provenance
This document does not provide information on a specific "test set" in the context of a clinical performance study. The validation mentioned ("performance of all Bioamplifier system components has been validated") likely refers to engineering and bench testing, not a clinical study with human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided. Since there's no mention of a clinical test set requiring a ground truth determination for diagnostic accuracy, there's no information on experts or their qualifications.
4. Adjudication Method
Not applicable/Not provided. As there's no clinical test set for diagnostic accuracy, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This 510(k) summary does not describe an MRMC comparative effectiveness study, as it's a device for signal amplification and transmission, not an AI diagnostic algorithm.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a hardware component (bioamplifier) with embedded software, not a standalone algorithm in the sense of AI. While its components' performance was validated, it wasn't a "standalone algorithm" performance study.
7. Type of Ground Truth Used
Not applicable/Not provided. For a hardware device focused on signal acquisition and transmission, the "ground truth" would relate to the accuracy of the signal capture and transmission, likely evaluated through instrumentation and bench testing against known calibration signals, rather than clinical outcomes or pathology. This document does not detail the specifics of such testing.
8. Sample Size for the Training Set
Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set." Its software components relate to the device's operational control, amplification, and digitization processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As there is no training set for an AI/ML algorithm, this information is not relevant.
In summary, the NeuroMetrix Bioamplifier 510(k) emphasizes substantial equivalence to a predicate device by comparing their intended use, system components, and functionality. It states that "the performance of all Bioamplifier system components has been validated," implying internal testing to ensure the device performs as intended and comparably to the predicate. However, it does not provide detailed specific performance metrics or clinical study data that would typically be described when proving adherence to quantitative acceptance criteria for a diagnostic accuracy claim.
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(30 days)
NEUROMETRIX, INC.
The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are non-sterile and are for single patient use only
Surface electrodes are the interface medium between neurodiagnostic equipment and the patient When used for detection, they transduce broelectric signals into electronic signals for measurement of bioelectrical phenomena in the body, such as peripheral nerve or muscle responses When used in conjunction with stimulation circuitry in neurodiagnostic devices. they provide the interface necessary to stimulate perspheral nerves Surface electrodes are used in the performance of nerve conduction studies (NCS) They are provided non-stertle and are designed and intended to be for single patient use only and are disposable
- 트 UNIVERSAL Multi-Electrode Set A (UE-004)
- 0 UNIVERSAL Multi-Electrode Set B (UE-005)
These individually placed electrodes are not configured for specific nerves. limbs, or clinical applications They may be repositioned on the same patient up to four times Both of the Multi-Electrode Sets include two surface electrodes in a bar configuration for perspheral nerve stumulation, two pars of recording electrodes for measurement of broelectrical potentials, and a reference electrode The par of recording surface electrodes in Multi-Electrode set A (UE-004) are distinct with one arranged as ring electrodes In Multi-Electrode Set B (UE-005), three surface electrodes are used to create two recording pars by sharing of one of the electrodes All of the surface electrodes in the Multi-Electrode Sets are individually placed by The UNIVERSAL Electrodes include an embedded digital thermometer for the user measurement of skin-surface temperature, and a ruler (as part of the graphics layers) for the measurement of inter-electrode distances that are used for calculating conduction velocities
The provided document is a 510(k) summary for the NeuroMetrix UNIVERSAL Electrodes, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study proving the device meets specific acceptance criteria based on performance data. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly stated in this type of regulatory submission.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the 510(k) summary. A 510(k) submission for electrodes typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through material comparisons, intended use alignment, and technological characteristics, rather than through detailed performance metrics against specific quantitative acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The submission does not detail any specific clinical or performance test sets used to generate data for this 510(k). The focus is on substantial equivalence to existing devices rather than a new performance study.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided. As no specific performance study with a test set is described, there's no mention of ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not provided. No test set or adjudication process is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided. An MRMC study is not mentioned. The 510(k) focuses on the device itself (electrodes), not a diagnostic algorithm that would typically be evaluated in an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study Was Done
This information is not provided. The device is an electrode, not an algorithm. Therefore, a standalone algorithm performance study would not be applicable.
7. The Type of Ground Truth Used
This information is not provided. No ground truth is described as there's no performance study detailed.
8. The Sample Size for the Training Set
This information is not provided. The document describes an electrode, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. (See reason for #8).
Summary of the 510(k) Document's Approach to Meeting Regulatory Requirements:
The NeuroMetrix UNIVERSAL Electrodes 510(k) relies on demonstrating substantial equivalence to predicate devices. This means that instead of conducting a new study to prove specific performance metrics, the manufacturer asserts that the new electrodes are as safe and effective as previously cleared devices because they share the same:
- Intended Use: For use with electrodiagnostic equipment for recording electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation.
- Clinical Applications.
- Technological Characteristics:
- Surface electrodes that transduce bioelectric signals or provide an interface for stimulation.
- Non-sterile, single-patient use, and disposable.
- Inclusion of multi-electrode sets with various configurations (bar, ring) for stimulation and recording.
- Embedded digital thermometer and ruler for inter-electrode distance measurement.
- Materials, Manufacturing Process, and Packaging: Stated to be the same as NeuroMetrix Biosensors (K060584).
The predicate devices mentioned are:
The FDA's letter confirms that they reviewed the submission and determined that the device is substantially equivalent to the legally marketed predicate devices. This determination allows the device to be marketed without requiring a new Pre-Market Approval (PMA) application.
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